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96 results on '"Foglietta J."'

1. Phase II study of eribulin in combination with gemcitabine for the treatment of patients with locally advanced or metastatic triple negative breast cancer (ERIGE trial). Clinical and pharmacogenetic results on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)

Author

Pellegrino, B., Cavanna, L., Boggiani, D., Zamagni, C., Frassoldati, A., Schirone, A., Caldara, A., Rocca, A., Gori, S., Piacentini, F., Berardi, R., Brandes, A.A., Foglietta, J., Villa, F., Todeschini, R., Tognetto, M., Naldi, N., Bortesi, B., Montemurro, F., Ardizzoni, A., Boni, L., and Musolino, A.

Published
2021
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2. Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe, a multicentric, observational study

Author

Di Lisa, F, Krasniqi, E, Pizzuti, L, Barba, M, Cannita, K, De Giorgi, U, Borella, F, Foglietta, J, Cariello, A, Ferro, A, Picardo, E, Mitidieri, M, Sini, V, Stani, S, Tonini, G, Santini, D, La Verde, N, Gambaro, A, Grassadonia, A, Tinari, N, Garrone, O, Sarobba, G, Livi, L, Meattini, I, D'Auria, G, Vergati, M, Gamucci, T, Pistelli, M, Berardi, R, Risi, E, Giotta, F, Lorusso, V, Rinaldi, L, Artale, S, Cazzaniga, M, Zustovich, F, Cappuzzo, F, Landi, L, Torrisi, R, Scagnoli, S, Botticelli, A, Michelotti, A, Fratini, B, Saltarelli, R, Paris, I, Muratore, M, Cassano, A, Gianni, L, Gaspari, V, Veltri, E, Zoratto, F, Fiorio, E, Fabbri, M, Mazzotta, M, Ruggeri, E, Pedersini, R, Valerio, M, Filomeno, L, Minelli, M, Scavina, P, Raffaele, M, Astone, A, De Vita, R, Pozzi, M, Riccardi, F, Greco, F, Moscetti, L, Giordano, M, Maugeri-Sacca, M, Zennaro, A, Botti, C, Pelle, F, Cappelli, S, Cavicchi, F, Vizza, E, Sanguineti, G, Tomao, F, Cortesi, E, Marchetti, P, Tomao, S, Speranza, I, Sperduti, I, Ciliberto, G, Vici, P, Di Lisa F. S., Krasniqi E., Pizzuti L., Barba M., Cannita K., De Giorgi U., Borella F., Foglietta J., Cariello A., Ferro A., Picardo E., Mitidieri M., Sini V., Stani S., Tonini G., Santini D., La Verde N., Gambaro A. R., Grassadonia A., Tinari N., Garrone O., Sarobba G., Livi L., Meattini I., D'Auria G., Vergati M., Gamucci T., Pistelli M., Berardi R., Risi E., Giotta F., Lorusso V., Rinaldi L., Artale S., Cazzaniga M. E., Zustovich F., Cappuzzo F., Landi L., Torrisi R., Scagnoli S., Botticelli A., Michelotti A., Fratini B., Saltarelli R., Paris I., Muratore M., Cassano A., Gianni L., Gaspari V., Veltri E. M., Zoratto F., Fiorio E., Fabbri M. A., Mazzotta M., Ruggeri E. M., Pedersini R., Valerio M. R., Filomeno L., Minelli M., Scavina P., Raffaele M., Astone A., De Vita R., Pozzi M., Riccardi F., Greco F., Moscetti L., Giordano M., Maugeri-Sacca M., Zennaro A., Botti C., Pelle F., Cappelli S., Cavicchi F., Vizza E., Sanguineti G., Tomao F., Cortesi E., Marchetti P., Tomao S., Speranza I., Sperduti I., Ciliberto G., Vici P., Di Lisa, F, Krasniqi, E, Pizzuti, L, Barba, M, Cannita, K, De Giorgi, U, Borella, F, Foglietta, J, Cariello, A, Ferro, A, Picardo, E, Mitidieri, M, Sini, V, Stani, S, Tonini, G, Santini, D, La Verde, N, Gambaro, A, Grassadonia, A, Tinari, N, Garrone, O, Sarobba, G, Livi, L, Meattini, I, D'Auria, G, Vergati, M, Gamucci, T, Pistelli, M, Berardi, R, Risi, E, Giotta, F, Lorusso, V, Rinaldi, L, Artale, S, Cazzaniga, M, Zustovich, F, Cappuzzo, F, Landi, L, Torrisi, R, Scagnoli, S, Botticelli, A, Michelotti, A, Fratini, B, Saltarelli, R, Paris, I, Muratore, M, Cassano, A, Gianni, L, Gaspari, V, Veltri, E, Zoratto, F, Fiorio, E, Fabbri, M, Mazzotta, M, Ruggeri, E, Pedersini, R, Valerio, M, Filomeno, L, Minelli, M, Scavina, P, Raffaele, M, Astone, A, De Vita, R, Pozzi, M, Riccardi, F, Greco, F, Moscetti, L, Giordano, M, Maugeri-Sacca, M, Zennaro, A, Botti, C, Pelle, F, Cappelli, S, Cavicchi, F, Vizza, E, Sanguineti, G, Tomao, F, Cortesi, E, Marchetti, P, Tomao, S, Speranza, I, Sperduti, I, Ciliberto, G, Vici, P, Di Lisa F. S., Krasniqi E., Pizzuti L., Barba M., Cannita K., De Giorgi U., Borella F., Foglietta J., Cariello A., Ferro A., Picardo E., Mitidieri M., Sini V., Stani S., Tonini G., Santini D., La Verde N., Gambaro A. R., Grassadonia A., Tinari N., Garrone O., Sarobba G., Livi L., Meattini I., D'Auria G., Vergati M., Gamucci T., Pistelli M., Berardi R., Risi E., Giotta F., Lorusso V., Rinaldi L., Artale S., Cazzaniga M. E., Zustovich F., Cappuzzo F., Landi L., Torrisi R., Scagnoli S., Botticelli A., Michelotti A., Fratini B., Saltarelli R., Paris I., Muratore M., Cassano A., Gianni L., Gaspari V., Veltri E. M., Zoratto F., Fiorio E., Fabbri M. A., Mazzotta M., Ruggeri E. M., Pedersini R., Valerio M. R., Filomeno L., Minelli M., Scavina P., Raffaele M., Astone A., De Vita R., Pozzi M., Riccardi F., Greco F., Moscetti L., Giordano M., Maugeri-Sacca M., Zennaro A., Botti C., Pelle F., Cappelli S., Cavicchi F., Vizza E., Sanguineti G., Tomao F., Cortesi E., Marchetti P., Tomao S., Speranza I., Sperduti I., Ciliberto G., and Vici P.

Abstract

Background: In triple negative breast cancer patients treated with neoadjuvant chemotherapy, residual disease at surgery is the most relevant unfavorable prognostic factor. Current guidelines consider the use of adjuvant capecitabine, based on the results of the randomized CREATE-X study, carried out in Asian patients and including a small subset of triple negative tumors. Thus far, evidence on Caucasian patients is limited, and no real-world data are available. Methods: We carried out a multicenter, observational study, involving 44 oncologic centres. Triple negative breast cancer patients with residual disease, treated with adjuvant capecitabine from January 2017 through June 2021, were recruited. We primarily focused on treatment tolerability, with toxicity being reported as potential cause of treatment discontinuation. Secondarily, we assessed effectiveness in the overall study population and in a subset having a minimum follow-up of 2 years. Results: Overall, 270 patients were retrospectively identified. The 50.4% of the patients had residual node positive disease, 7.8% and 81.9% had large or G3 residual tumor, respectively, and 80.4% a Ki-67 >20%. Toxicity-related treatment discontinuation was observed only in 10.4% of the patients. In the whole population, at a median follow-up of 15 months, 2-year disease-free survival was 62%, 2 and 3-year overall survival 84.0% and 76.2%, respectively. In 129 patients with a median follow-up of 25 months, 2-year disease-free survival was 43.4%, 2 and 3-year overall survival 78.0% and 70.8%, respectively. Six or more cycles of capecitabine were associated with more favourable outcomes compared with less than six cycles. Conclusion: The CaRe study shows an unexpectedly good tolerance of adjuvant capecitabine in a real-world setting, although effectiveness appears to be lower than that observed in the CREATE-X study. Methodological differences between the two studies impose significant limits to comparability concerning ef

Published
2023

3. Distinct HR expression patterns significantly affect the clinical behavior of metastatic HER2+ breast cancer and degree of benefit from novel anti-HER2 agents in the real world setting

Author

Pizzuti, L, Krasniqi, E, Barchiesi, G, Della Giulia, M, Izzo, F, Sanguineti, G, Marchetti, P, Mazzotta, M, Giusti, R, Botticelli, A, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Iezzi, L, Tomao, S, Tomao, F, Tonini, G, Santini, D, Astone, A, Michelotti, A, De Angelis, C, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Rossi, E, Cazzaniga, M, Moscetti, L, Omarini, C, Piacentini, F, Fabbri, M, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Samaritani, R, Garufi, C, Barni, S, Mirabelli, R, Sarmiento, R, Veltri, E, D'Auria, G, Paris, I, Giotta, F, Lorusso, V, Cardillo, F, Landucci, E, Mauri, M, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Berardi, R, Pistelli, M, Fiorio, E, Cannita, K, Sini, V, D'Ostilio, N, Foglietta, J, Greco, F, Zamagni, C, Garrone, O, Di Cocco, B, Baldini, E, Livi, L, Desideri, I, Meattini, I, Sarobba, G, Del Medico, P, De Tursi, M, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Sperduti, I, Villa, A, Barba, M, Di Leo, A, Vici, P, Pizzuti L., Krasniqi E., Barchiesi G., Della Giulia M., Izzo F., Sanguineti G., Marchetti P., Mazzotta M., Giusti R., Botticelli A., Gamucci T., Natoli C., Grassadonia A., Tinari N., Iezzi L., Tomao S., Tomao F., Tonini G., Santini D., Astone A., Michelotti A., De Angelis C., Mentuccia L., Vaccaro A., Magnolfi E., Gelibter A., Magri V., Cortesi E., D'Onofrio L., Cassano A., Rossi E., Cazzaniga M., Moscetti L., Omarini C., Piacentini F., Fabbri M. A., Scinto A. F., Corsi D., Carbognin L., Bria E., La Verde N., Samaritani R., Garufi C., Barni S., Mirabelli R., Sarmiento R., Veltri E. M., D'Auria G., Paris I., Giotta F., Lorusso V., Cardillo F., Landucci E., Mauri M., Ficorella C., Roselli M., Adamo V., Ricciardi G. R. R., Russo A., Berardi R., Pistelli M., Fiorio E., Cannita K., Sini V., D'Ostilio N., Foglietta J., Greco F., Zamagni C., Garrone O., Di Cocco B., Baldini E., Livi L., Desideri I., Meattini I., Sarobba G., Del Medico P., De Tursi M., Generali D., De Maria R., Risi E., Ciliberto G., Sperduti I., Villa A., Barba M., Di Leo A., Vici P., Pizzuti, L, Krasniqi, E, Barchiesi, G, Della Giulia, M, Izzo, F, Sanguineti, G, Marchetti, P, Mazzotta, M, Giusti, R, Botticelli, A, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Iezzi, L, Tomao, S, Tomao, F, Tonini, G, Santini, D, Astone, A, Michelotti, A, De Angelis, C, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Rossi, E, Cazzaniga, M, Moscetti, L, Omarini, C, Piacentini, F, Fabbri, M, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Samaritani, R, Garufi, C, Barni, S, Mirabelli, R, Sarmiento, R, Veltri, E, D'Auria, G, Paris, I, Giotta, F, Lorusso, V, Cardillo, F, Landucci, E, Mauri, M, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Berardi, R, Pistelli, M, Fiorio, E, Cannita, K, Sini, V, D'Ostilio, N, Foglietta, J, Greco, F, Zamagni, C, Garrone, O, Di Cocco, B, Baldini, E, Livi, L, Desideri, I, Meattini, I, Sarobba, G, Del Medico, P, De Tursi, M, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Sperduti, I, Villa, A, Barba, M, Di Leo, A, Vici, P, Pizzuti L., Krasniqi E., Barchiesi G., Della Giulia M., Izzo F., Sanguineti G., Marchetti P., Mazzotta M., Giusti R., Botticelli A., Gamucci T., Natoli C., Grassadonia A., Tinari N., Iezzi L., Tomao S., Tomao F., Tonini G., Santini D., Astone A., Michelotti A., De Angelis C., Mentuccia L., Vaccaro A., Magnolfi E., Gelibter A., Magri V., Cortesi E., D'Onofrio L., Cassano A., Rossi E., Cazzaniga M., Moscetti L., Omarini C., Piacentini F., Fabbri M. A., Scinto A. F., Corsi D., Carbognin L., Bria E., La Verde N., Samaritani R., Garufi C., Barni S., Mirabelli R., Sarmiento R., Veltri E. M., D'Auria G., Paris I., Giotta F., Lorusso V., Cardillo F., Landucci E., Mauri M., Ficorella C., Roselli M., Adamo V., Ricciardi G. R. R., Russo A., Berardi R., Pistelli M., Fiorio E., Cannita K., Sini V., D'Ostilio N., Foglietta J., Greco F., Zamagni C., Garrone O., Di Cocco B., Baldini E., Livi L., Desideri I., Meattini I., Sarobba G., Del Medico P., De Tursi M., Generali D., De Maria R., Risi E., Ciliberto G., Sperduti I., Villa A., Barba M., Di Leo A., and Vici P.

Abstract

We analyzed data from 738 HER2-positive metastatic breast cancer (mbc) patients treated with pertuzumab-based regimens and/or T-DM1 at 45 Italian centers. Outcomes were explored in relation to tumor subtype assessed by immunohistochemistry (IHC). The median progression-free survival at first-line (mPFS1) was 12 months. Pertuzumab as first-line conferred longer mPFS1 compared to other first-line treatments (16 vs. 9 months, p = 0.0001), regardless of IHC subtype. Median PFS in second-line (mPFS2) was 7 months, with no difference by IHC subtype, but it was more favorable with T-DM1 compared to other agents (7 vs. 6 months, p = 0.03). There was no PFS2 gain in patients with tumors expressing both hormonal receptors (HRs; p = 0.17), while a trend emerged for tumors with one HR (p = 0.05). Conversely, PFS2 gain was significant in HRs-negative tumors (p = 0.04). Median overall survival (mOS) was 74 months, with no significant differences by IHC subtypes. Survival rates at 2 and 3 years in patients treated with T-DM1 in second-line after pertuzumab were significantly lower compared to pertuzumab-naïve patients (p = 0.01). When analyzed by IHC subtype, the outcome was confirmed if both HRs or no HRs were expressed (p = 0.02 and p = 0.006, respectively). Our results confirm that HRs expression impacts the clinical behavior and novel treatment-related outcomes of HER2-positive tumors when treatment sequences are considered. Moreover, multivariate analysis showed that HRs expression had no effect on PFS and OS. Further studies are warranted to confirm our findings and clarify the interplay between HER2 and estrogen receptor pathways in HER2-positive (mbc) patients

Published
2020

11. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Author

De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., Zoboli A., De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., and Zoboli A.

Abstract

Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely removed by surgery, any pathological tumour size, and axillary nodal status. Key exclusion criteria were hormone replacement therapy, recurrent or metastatic disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised minimisation procedure stratified for oestrogen receptor, progesterone receptor, and HER2 status; previous chemotherapy; and pathological nodal status. Neither the patients nor the physicians were masked to treatment allocation. The primary endpoint was disease-free survival. The minimum cutoff to declare superiority of the upfront strategy over the switch strategy was assumed to be a 2% difference in disease-free survival at 5 years. Primary efficacy analyses were done by intention to treat; safety analyses included all patients for whom at least one safety case report form had been completed. Follow-up is ongoing. This trial is regist

Published
2018

12. Distinct HR expression patterns significantly affect the clinical behavior of metastatic HER2+ breast cancer and degree of benefit from novel anti-HER2 agents in the real world setting

Author

Pizzuti, L., Krasniqi, E., Barchiesi, G., Della Giulia, M., Izzo, F., Sanguineti, G., Marchetti, P., Mazzotta, M., Giusti, R., Botticelli, A., Gamucci, T., Natoli, C., Grassadonia, A., Tinari, N., Iezzi, L., Tomao, S., Tomao, F., Tonini, G., Santini, D., Astone, Antonio, Michelotti, A., De Angelis, C., Mentuccia, L., Vaccaro, A., Magnolfi, E., Gelibter, A., Magri, V., Cortesi, E., D'Onofrio, L., Cassano, A., Rossi, E., Cazzaniga, M., Moscetti, L., Omarini, C., Piacentini, F., Fabbri, M. A., Scinto, A. F., Corsi, D., Carbognin, L., Bria, Emilio, La Verde, N., Samaritani, R., Garufi, C., Barni, S., Mirabelli, R., Sarmiento, R., Veltri, E. M., D'Auria, G., Paris, I., Giotta, F., Lorusso, V., Cardillo, F., Landucci, E., Mauri, M., Ficorella, C., Roselli, M., Adamo, V., Ricciardi, G. R. R., Russo, A., Berardi, R., Pistelli, M., Fiorio, E., Cannita, K., Sini, V., D'Ostilio, N., Foglietta, J., Greco, F., Zamagni, C., Garrone, O., Di Cocco, B., Baldini, E., Livi, L., Desideri, I., Meattini, I., Sarobba, G., Del Medico, P., De Tursi, M., Generali, D., De Maria Marchiano, Ruggero, Risi, E., Ciliberto, G., Sperduti, I., Villa, A., Barba, M., Di Leo, A., Vici, P., Astone A. (ORCID:0000-0001-9572-309X), Bria E. (ORCID:0000-0002-2333-704X), De Maria R. (ORCID:0000-0003-2255-0583), Pizzuti, L., Krasniqi, E., Barchiesi, G., Della Giulia, M., Izzo, F., Sanguineti, G., Marchetti, P., Mazzotta, M., Giusti, R., Botticelli, A., Gamucci, T., Natoli, C., Grassadonia, A., Tinari, N., Iezzi, L., Tomao, S., Tomao, F., Tonini, G., Santini, D., Astone, Antonio, Michelotti, A., De Angelis, C., Mentuccia, L., Vaccaro, A., Magnolfi, E., Gelibter, A., Magri, V., Cortesi, E., D'Onofrio, L., Cassano, A., Rossi, E., Cazzaniga, M., Moscetti, L., Omarini, C., Piacentini, F., Fabbri, M. A., Scinto, A. F., Corsi, D., Carbognin, L., Bria, Emilio, La Verde, N., Samaritani, R., Garufi, C., Barni, S., Mirabelli, R., Sarmiento, R., Veltri, E. M., D'Auria, G., Paris, I., Giotta, F., Lorusso, V., Cardillo, F., Landucci, E., Mauri, M., Ficorella, C., Roselli, M., Adamo, V., Ricciardi, G. R. R., Russo, A., Berardi, R., Pistelli, M., Fiorio, E., Cannita, K., Sini, V., D'Ostilio, N., Foglietta, J., Greco, F., Zamagni, C., Garrone, O., Di Cocco, B., Baldini, E., Livi, L., Desideri, I., Meattini, I., Sarobba, G., Del Medico, P., De Tursi, M., Generali, D., De Maria Marchiano, Ruggero, Risi, E., Ciliberto, G., Sperduti, I., Villa, A., Barba, M., Di Leo, A., Vici, P., Astone A. (ORCID:0000-0001-9572-309X), Bria E. (ORCID:0000-0002-2333-704X), and De Maria R. (ORCID:0000-0003-2255-0583)

Abstract

We analyzed data from 738 HER2-positive metastatic breast cancer (mbc) patients treated with pertuzumab-based regimens and/or T-DM1 at 45 Italian centers. Outcomes were explored in relation to tumor subtype assessed by immunohistochemistry (IHC). The median progression-free survival at first-line (mPFS1) was 12 months. Pertuzumab as first-line conferred longer mPFS1 compared to other first-line treatments (16 vs. 9 months, p = 0.0001), regardless of IHC subtype. Median PFS in second-line (mPFS2) was 7 months, with no difference by IHC subtype, but it was more favorable with T-DM1 compared to other agents (7 vs. 6 months, p = 0.03). There was no PFS2 gain in patients with tumors expressing both hormonal receptors (HRs; p = 0.17), while a trend emerged for tumors with one HR (p = 0.05). Conversely, PFS2 gain was significant in HRs-negative tumors (p = 0.04). Median overall survival (mOS) was 74 months, with no significant differences by IHC subtypes. Survival rates at 2 and 3 years in patients treated with T-DM1 in second-line after pertuzumab were significantly lower compared to pertuzumab-naïve patients (p = 0.01). When analyzed by IHC subtype, the outcome was confirmed if both HRs or no HRs were expressed (p = 0.02 and p = 0.006, respectively). Our results confirm that HRs expression impacts the clinical behavior and novel treatment-related outcomes of HER2-positive tumors when treatment sequences are considered. Moreover, multivariate analysis showed that HRs expression had no effect on PFS and OS. Further studies are warranted to confirm our findings and clarify the interplay between HER2 and estrogen receptor pathways in HER2-positive (mbc) patients.

Published
2020

13. Everolimus plus exemestane in advanced breast cancer: Safety results of the BALLET study on patients previously treatedwithout and with chemotherapy in the metastatic setting

Author

Generali, D, Montemurro, F, Bordonaro, R, Mafodda, A, Romito, S, Michelotti, A, Piovano, P, Ionta, M, Bighin, C, Sartori, D, Frassoldati, A, Cazzaniga, M, Riccardi, F, Testore, F, Vici, P, Barone, C, Schirone, A, Piacentini, F, Nolè, F, Molino, A, Latini, L, Simoncini, E, Roila, F, Cognetti, F, Nuzzo, F, Foglietta, J, Minisini, A, Goffredo, F, Portera, G, Ascione, G, Mariani, G, Contributor, Generali D, Montemurro F, Bordonaro R, Mafodda A, Romito S, Michelotti A, Piovano P, Ionta MT, Bighin C, Sartori D, Frassoldati A, Cazzaniga ME, Riccardi F, Testore F, Vici P, Barone CA, Schirone A, Piacentini F, Nolè F, Molino A, Latini L, Simoncini EL, Roila F, Cognetti F, Nuzzo F, Foglietta J, Minisini AM, Goffredo F, Portera G, Ascione G, Mariani G, Cazzaniga M, contributor, Generali, D, Montemurro, F, Bordonaro, R, Mafodda, A, Romito, S, Michelotti, A, Piovano, P, Ionta, M, Bighin, C, Sartori, D, Frassoldati, A, Cazzaniga, M, Riccardi, F, Testore, F, Vici, P, Barone, C, Schirone, A, Piacentini, F, Nolè, F, Molino, A, Latini, L, Simoncini, E, Roila, F, Cognetti, F, Nuzzo, F, Foglietta, J, Minisini, A, Goffredo, F, Portera, G, Ascione, G, Mariani, G, Contributor, Generali D, Montemurro F, Bordonaro R, Mafodda A, Romito S, Michelotti A, Piovano P, Ionta MT, Bighin C, Sartori D, Frassoldati A, Cazzaniga ME, Riccardi F, Testore F, Vici P, Barone CA, Schirone A, Piacentini F, Nolè F, Molino A, Latini L, Simoncini EL, Roila F, Cognetti F, Nuzzo F, Foglietta J, Minisini AM, Goffredo F, Portera G, Ascione G, Mariani G, Cazzaniga M, and contributor

Abstract

Background. The BALLET study was an open-label, multicenter, expanded access study designed to allow treatment with everolimus plus exemestane in postmenopausal women with hormone receptor-positive metastatic breast cancer progressed following prior endocrine therapy. A post hoc analysis to evaluate if previous chemotherapy in the metastatic setting affects the safety profile of the combination regimen of everolimus and exemestane was conducted on the Italian subset, as it represented the major part of the patients enrolled (54%). Patients and Methods. One thousand one hundred and fiftyone Italian patients were included in the present post hoc analysis, which focused on two sets of patients: patients who never received chemotherapy in the metastatic setting (36.1%) and patients who received at least one chemotherapy treatment in the metastatic setting (63.9%). Results. One thousand one hundred and sixteen patients (97.0%) prematurely discontinued the study drug, and the main reasons reported were disease progression (39.1%), local reimbursement of everolimus (31.1%), and adverse events (AEs) (16.1%). The median duration of study treatment exposure was 139.5 days for exemestane and 135.0 days for everolimus. At least one AE was experienced by 92.5% of patients. The incidence of everolimus-related AEs was higher (83.9%) when compared with those that occurred with exemestane (29.1%), and the most commonly reported everolimus-related AE was stomatitis (51.3%). However, no significant difference in terms of safety related to the combination occurred between patients without and with chemotherapy in the metastatic setting. Conclusion. Real-life data of the Italian patients BALLET-related cohort were an adequate setting to state that previous chemotherapy did not affect the safety profile of the combination regimen of everolimus and exemestane.

Published
2017

14. Everolimus Plus Exemestane in Advanced Breast Cancer: Safety Results of the BALLET Study on Patients Previously Treated Without and with Chemotherapy in the Metastatic Setting

Author

Generali D, Montemurro F, Bordonaro R, Mafodda A, Romito S, Michelotti A, Piovano P, Ionta MT, Bighin C, Sartori D, Frassoldati A, Cazzaniga ME, Riccardi F, Testore F, Vici P, Barone CA, Schirone A, Piacentini F, Nolè F, Molino A, Latini L, Simoncini EL, Roila F, Cognetti F, Nuzzo F, Foglietta J, Minisini AM, Goffredo F, Portera G, Ascione G, Mariani G, Cazzaniga M, contributor, Generali, D, Montemurro, F, Bordonaro, R, Mafodda, A, Romito, S, Michelotti, A, Piovano, P, Ionta, M, Bighin, C, Sartori, D, Frassoldati, A, Cazzaniga, M, Riccardi, F, Testore, F, Vici, P, Barone, C, Schirone, A, Piacentini, F, Nolè, F, Molino, A, Latini, L, Simoncini, E, Roila, F, Cognetti, F, Nuzzo, F, Foglietta, J, Minisini, A, Goffredo, F, Portera, G, Ascione, G, Mariani, G, Contributor, Generali, Daniele, Montemurro, F., Bordonaro, R., Mafodda, A., Romito, S., Michelotti, A., Piovano, P., Ionta, M. T., Bighin, C., Sartori, D., Frassoldati, A., Cazzaniga, M. E., Riccardi, F., Testore, F., Vici, P., Barone, C. A. ., Schirone, Alice, Piacentini, F., Nolè, F., Molino, A., Latini, L., Simoncini, E. L., Roila, F., Cognetti, Francesca, Nuzzo, Federica, Foglietta, J., Minisini, A. M., Goffredo, F., Portera, G., Ascione, G., and Mariani, G.

Subjects
0301 basic medicine, Oncology, Cancer Research, Advanced breast cancer, Everolimus, Hormone-receptor positive, Real life, Safety, medicine.medical_treatment, chemistry.chemical_compound, 0302 clinical medicine, Exemestane, Antineoplastic Combined Chemotherapy Protocols, Medicine, Neoplasm Metastasis, Aged, 80 and over, advanced breast cancer, everolimus, hormone-receptor positive, real life, safety, Middle Aged, Metastatic breast cancer, Everolimu, Italy, 030220 oncology & carcinogenesis, Female, medicine.drug, Hormone‐receptor positive, Adult, medicine.medical_specialty, Drug-Related Side Effects and Adverse Reactions, Socio-culturale, Breast Neoplasms, Everolimus Plus Exemestane, Advanced Breast Cancer, BALLET Study, 03 medical and health sciences, Breast cancer, Internal medicine, Post-hoc analysis, Breast Cancer, Humans, Adverse effect, Aged, Chemotherapy, business.industry, medicine.disease, Androstadienes, Regimen, 030104 developmental biology, chemistry, business
Abstract

BACKGROUND: The BALLET study was an open-label, multicenter, expanded access study designed to allow treatment with everolimus plus exemestane in postmenopausal women with hormone receptor-positive metastatic breast cancer progressed following prior endocrine therapy. A post hoc analysis to evaluate if previous chemotherapy in the metastatic setting affects the safety profile of the combination regimen of everolimus and exemestane was conducted on the Italian subset, as it represented the major part of the patients enrolled (54%). PATIENTS AND METHODS: One thousand one hundred and fifty-one Italian patients were included in the present post hoc analysis, which focused on two sets of patients: patients who never received chemotherapy in the metastatic setting (36.1%) and patients who received at least one chemotherapy treatment in the metastatic setting (63.9%). RESULTS: One thousand one hundred and sixteen patients (97.0%) prematurely discontinued the study drug, and the main reasons reported were disease progression (39.1%), local reimbursement of everolimus (31.1%), and adverse events (AEs) (16.1%). The median duration of study treatment exposure was 139.5 days for exemestane and 135.0 days for everolimus. At least one AE was experienced by 92.5% of patients. The incidence of everolimus-related AEs was higher (83.9%) when compared with those that occurred with exemestane (29.1%), and the most commonly reported everolimus-related AE was stomatitis (51.3%). However, no significant difference in terms of safety related to the combination occurred between patients without and with chemotherapy in the metastatic setting. CONCLUSION: Real-life data of the Italian patients BALLET-related cohort were an adequate setting to state that previous chemotherapy did not affect the safety profile of the combination regimen of everolimus and exemestane. The Oncologist 2017;22:1-8Implications for Practice: With the advent of new targeted agents for advanced or metastatic breast cancer, multiple lines of therapy may be possible, and components of the combined regimens can overlap from one line to another. Thus, it is important to assess even the potential of cumulative and additive toxic effects among the drugs. Previous chemotherapy did not affect the safety profile of the combination regimen of everolimus and exemestane. The continuous monitoring of the safety signals of this drug combination from general clinical practice is important, in particular for stomatitis.

Published
2016

15. Phase II study of eribulin in combination with gemcitabine for the treatment of patients with locally advanced or metastatic triple negative breast cancer (ERIGE Trial). Clinical and pharmacogenetic results on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)

Author

Musolino, A, Cavanna, L, Boggiani, D, Zamagni, C, Frassoldati, A, Caldara, A, Rocca, A, Gori, S, Piacentini, F, Berardi, R, Brandes, Aa, Foglietta, J, Villa, F, Pellegrino, B, Todeschini, R, Tognetto, M, Naldi, N, Bortesi, B, Boni, L, Montemurro, F, and Ardizzoni, A

Published
2018

16. Abstract P1-14-05: Phase II study of eribulin in combination with gemcitabine for the treatment of patients with locally advanced or metastatic triple negative breast cancer (ERIGE Trial). Clinical and pharmacogenetic results on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)

Author

Musolino, A, primary, Cavanna, L, additional, Boggiani, D, additional, Zamagni, C, additional, Frassoldati, A, additional, Caldara, A, additional, Rocca, A, additional, Gori, S, additional, Piacentini, F, additional, Berardi, R, additional, Brandes, AA, additional, Foglietta, J, additional, Villa, F, additional, Pellegrino, B, additional, Todeschini, R, additional, Tognetto, M, additional, Naldi, N, additional, Bortesi, B, additional, Boni, L, additional, Montemurro, F, additional, and Ardizzoni, A, additional

Published
2019
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17. The HERBA trial: a retrospective study on patients (pts) with HER2-positive (HER2+ve) breast cancer (BC) and brain metastases (BMs)

Author

Gori, S., primary, Turazza, M., additional, Inno, A., additional, Lunardi, G., additional, Moroso, S., additional, La Verde, N., additional, Frassoldai, A., additional, Tarenzi, E., additional, Garrone, O., additional, Vici, P., additional, Laudadio, L., additional, Cretella, E., additional, Foglietta, J., additional, Leonardi, V., additional, Cavanna, L., additional, Barni, S., additional, Marchetti, F., additional, Valerio, M., additional, Carbognin, G., additional, Alongi, F., additional, and Fabi, A., additional

Published
2017
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18. Breast cancer 'tailored follow-up' in Italian oncology units: a web-based survey

Author

Natoli, C., Brocco, D., Sperduti, I., Nuzzo, A., Tinari, N., De Tursi, M., Grassadonia, A., Mazzilli, L., Iacobelli, S., Gamucci, T., Vici, P., Study, Group, Adamo, V., Airoldi, M., Amoroso, D., Angelini, F., Angiolini, C., Angiolucci, G., Ardizzoia, A., Baldini, E., Ballardini, P., Barni, S., Barone, C., Battelli, N., Bernardi, D., Bianchetti, S., Bianco, N., Biglia, Nicoletta, Bilancia, D., Biti, G., Boni, C., Bordonaro, R., Botta, M., Bretti, S., Brunello, A., Brunetti, C., Bruno, D., Bucci, E., Buzzoni, R., Cagossi, K., Cappelletti, C., Cappuzzo, F., Cardillo, F., Carroccio, R., Cascinu, S., Cavanna, L., Cianchetti, E., Clerico, M., Contu, A., Corsi, D., Cortesi, L., Cretella, E., Crispino, S., Di Lieto, M., Di Lullo, L., Durini, E., Fabi, A., Failla, G., Fattorusso, S., Ferraù, F., Ferro, A., Ficorella, C., Fogazzi, G., Foglietta, J., Francini, G., Fusco, O., Gennari, A., Ghiani, M., Gianni, L., Giordano, M., Giotta, F., Giuliani, R., Gori, S., Graiff, C., Guarneri, V., Guarneri, D., Guglielmi, F., Landriscina, M., Laudadio, L., Lombardo, M., Longo, F., Macellari, G., Madeddu, C., Magnanini, S., Maiorino, L., Mangiameli, A., Marini, G., Massidda, B., Mattioli, R., Michelotti, A., Molino, A., Montesarchio, V., Morale, A., Murgo, R., Naso, G., Natale, D., Orditura, M., Orrù, S., Pace, R., Palazzo, A., Palma, F., Pancotti, A., Pandoli, G., Papaldo, P., Parisi, A. M., Passalacqua, R., Pellegrino, A., Perrucci, B., Proietti, E., Recchia, F., Riccardi, F., Rispoli, A. I., Rocca, A., Romaniello, I., Rossetti, R., Rossi, D., Rosti, G., Ruggeri, E. M., Russo, A., Savarino, A., Savastano, C., Scognamiglio, G., Scognamiglio, M., Seminara, P., Serrachini, S., Sidoti, V., Silva, R. R., Surace, G., Tomao, S., Tonini, G., Trenta, P., Turazza, M., Valenza, R., Veltri, E., Zampa, G., Zaniboni, A., Zanirato, S., C, Natoli, D, Brocco, I, Sperduti, A, Nuzzo, N, Tinari, M, De Tursi, A, Grassadonia, L, Mazzilli, S, Iacobelli, T, Gamucci, P, Vici, Study Group, 'FOLLOW-UP', and Orditura, Michele

Subjects
Oncology, breast cancer, Follow-up, survey, Medical Oncology, law.invention, Randomized controlled trial, law, Aged, Breast Neoplasms, Female, Follow-Up Studies, Health Care Surveys, Humans, Italy, Middle Aged, Secondary Prevention, Guideline Adherence, Breast Tumors, Medicine and Health Sciences, Web based survey, Multidisciplinary, Pharmaceutics, Surgical Oncology, Cancer Therapy, Medicine, medicine.symptom, Disease staging, Research Article, medicine.medical_specialty, Adjuvant Cancer Chemotherapy, Science, MEDLINE, Asymptomatic, Breast cancer, Drug Therapy, Internal medicine, medicine, Cancer Detection and Diagnosis, Chemotherapy, Modalities, business.industry, Cancers and Neoplasms, medicine.disease, Blood chemistry, Women's Health, Clinical Medicine, business
Abstract

PurposeBreast cancer follow-up procedures after primary treatment are still a controversial issue. Aim of this study was to investigate, through a web-based survey, surveillance methodologies selected by Italian oncologists in everyday clinical practice.MethodsReferents of Italian medical oncology units were invited to participate to the study via e-mail through the SurveyMonkey website. Participants were asked how, in their institution, exams of disease staging and follow-up are planned in asymptomatic women and if surveillance continues beyond the 5th year.ResultsBetween February and May 2013, 125 out of 233 (53.6%) invited referents of Italian medical oncology units agreed to participate in the survey. Ninety-seven (77.6%) referents state that modalities of breast cancer follow-up are planned according to the risk of disease progression at diagnosis and only 12 (9.6%) oncology units apply the minimal follow-up procedures according to international guidelines. Minimal follow-up is never applied in high risk asymptomatic women. Ninety-eight (78.4%) oncology units continue follow-up in all patients beyond 5 years.ConclusionsOur survey shows that 90.4% of participating Italian oncology units declare they do not apply the minimal breast cancer follow-up procedures after primary treatment in asymptomatic women, as suggested by national and international guidelines. Interestingly, about 80.0% of interviewed referents performs the so called "tailored follow-up", high intensity for high risk, low intensity for low risk patients. There is an urgent need of randomized clinical trials able to determine the effectiveness of risk-based follow-up modalities, their ideal frequency and persistence in time.

Published
2014

19. Breast cancer 'tailored follow-up' in Italian oncology units: a web-based survey

Author

Natoli, C, Adamo, V, Airoldi, M, Amoroso, D, Angelini, F, Angiolini, C, Angiolucci, G, Ardizzoia, A, Baldini, E, Ballardini, P, Barni, S, Barone, C, Battelli, N, Bernardi, D, Bianchetti, S, Bianco, N, Biglia, N, Bilancia, D, Biti, G, Boni, C, Bordonaro, R, Botta, M, Bretti, S, Brunello, A, Brunetti, C, Bruno, D, Bucci, E, Buzzoni, R, Cagossi, K, Cappelletti, C, Cappuzzo, F, Cardillo, F, Carroccio, R, Cascinu, S, Cavanna, L, Cianchetti, E, Clerico, M, Contu, A, Corsi, D, Cortesi, L, Cretella, E, Crispino, S, Di Lieto, M, Di Lullo, L, Durini, E, Fabi, A, Failla, G, Fattorusso, S, Ferraù, F, Ferro, A, Ficorella, C, Fogazzi, G, Foglietta, J, Francini, G, Fusco, O, Gennari, A, Ghiani, M, Gianni, L, Giordano, M, Giotta, F, Giuliani, R, Gori, S, Graiff, C, Guarneri, V, Guarneri, D, Guglielmi, F, Landriscina, M, Laudadio, L, Lombardo, M, Longo, F, Macellari, G, Madeddu, C, Magnanini, S, Maiorino, L, Mangiameli, A, Marini, G, Massidda, B, Mattioli, R, Michelotti, A, Molino, A, Montesarchio, V, Morale, A, Murgo, R, Naso, Giuseppe, Natale, D, Orditura, M, Orrù, S, Pace, R, Palazzo, Antonella, Palma, F, Pancotti, A, Pandoli, G, Papaldo, P, Parisi, Am, Passalacqua, R, Pellegrino, A, Perrucci, B, Proietti, E, Recchia, F, Riccardi, F, Rispoli, Ai, Rocca, A, Romaniello, I, Rossetti, R, Rossi, D, Rosti, G, Ruggeri, Em, Russo, A, Savarino, A, Savastano, C, Scognamiglio, G, Scognamiglio, M, Seminara, Patrizia, Serrachini, S, Sidoti, V, Silva, Rr, Surace, G, Tomao, Silverio, Tonini, G, Trenta, P, Turazza, M, Valenza, R, Veltri, E, Zampa, G, Zaniboni, A, and Zanirato, S.

Published
2014

21. Clinical and pathological factors predicting long-term disease control with lapatinib and capecitabine for patients with HER2 positive metastastic breast cancer: results from a multicenter retrospective study

Author

Duranti, S., primary, Inno, A., additional, Rossi, V., additional, Turazza, M., additional, Fiorio, E., additional, Fabi, A., additional, Bisagni, G., additional, Foglietta, J., additional, Santini, D., additional, Pavese, I., additional, Zambelli, A., additional, Vici, P., additional, Leonardi, V., additional, Barni, S., additional, Saracchini, S., additional, Bogina, G., additional, Lunardi, G., additional, Marchetti, F., additional, Montemurro, F., additional, and Gori, S., additional

Published
2015
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22. Retreatment with trastuzumab (T)-based therapy in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (MBC) resistant to lapatinib (L)-based therapy.

Author

Gori, S., primary, Montemurro, F., additional, Spazzapan, S., additional, Metro, G., additional, Foglietta, J., additional, Bisagni, G., additional, Ferzi, A., additional, Silva, R. R., additional, Gamucci, T., additional, Clavarezza, M., additional, Stocchi, L., additional, Fabi, A., additional, Cognetti, F., additional, Torrisi, E., additional, and Crivellari, D., additional

Published
2011
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23. A32 - Clinical and pathological factors predicting long-term disease control with lapatinib and capecitabine for patients with HER2 positive metastastic breast cancer: results from a multicenter retrospective study

Author

Duranti, S., Inno, A., Rossi, V., Turazza, M., Fiorio, E., Fabi, A., Bisagni, G., Foglietta, J., Santini, D., Pavese, I., Zambelli, A., Vici, P., Leonardi, V., Barni, S., Saracchini, S., Bogina, G., Lunardi, G., Marchetti, F., Montemurro, F., and Gori, S.

Published
2015
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25. 5089 Shorter Overall Survival (OS) in HER2-positive (HER2+) metastatic breast cancer (MBC) patients (pts) treated with trastuzumab (T)± chemotherapy (CT) and overexpressing HER3 by immunohistochemistry (IHC)

Author

Gori, S., primary, Sidoni, A., additional, Colozza, M., additional, Mameli, M.G., additional, Fenocchio, D., additional, Minenza, E., additional, Foglietta, J., additional, Stocchi, L., additional, De Angelis, V., additional, and Crinò, L., additional

Published
2009
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31. Consider duel independent expander refrigeration for LNG production.

Author

Foglietta, J. H.

Subjects
*LIQUEFIED natural gas, *REFRIGERATION & refrigerating machinery, *HIGH pressure (Technology), *LIQUEFACTION of gases, *GAS expanders, *REFRIGERANTS
Abstract

The article focuses on the growth in business of liquefied natural gas. With such high demand, a new spot trading market is emerging. In LNG production, extensive refrigeration is used to liquefy the natural gas. With turbo expander methods, the refrigeration duty required to liquefy the gas stream is provided by two independent closed compression-expansion circuits. Nowadays expander based process are used. In the expander-based process, a scream of gas at high pressure is expanded isentropically to a lower pressure. Work and refrigeration are extracted from the expansion process. This refrigeration is applied to aid the liquefaction process. The extracted work is used to partially recompress the refrigerant gas.

Published
2004

32. Phase II study of eribulin in combination with gemcitabine for the treatment of patients with locally advanced or metastatic triple negative breast cancer (ERIGE trial). Clinical and pharmacogenetic results on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)

Author

Alba A. Brandes, Claudio Zamagni, Andrea Rocca, Renata Todeschini, Daniela Boggiani, Stefania Gori, Luigi Cavanna, Alessia Caldara, Federica Villa, Filippo Montemurro, Antonino Musolino, Federico Piacentini, A. Ardizzoni, Antonio Frassoldati, Luigi Boni, Jennifer Foglietta, R. Berardi, Beatrice Bortesi, Nadia Naldi, Benedetta Pellegrino, Michele Tognetto, Alessio Schirone, Pellegrino B., Cavanna L., Boggiani D., Zamagni C., Frassoldati A., Schirone A., Caldara A., Rocca A., Gori S., Piacentini F., Berardi R., Brandes A.A., Foglietta J., Villa F., Todeschini R., Tognetto M., Naldi N., Bortesi B., Montemurro F., Ardizzoni A., Boni L., Musolino A., Pellegrino, B, Cavanna, L, Boggiani, D, Zamagni, C, Frassoldati, A, Schirone, A, Caldara, A, Rocca, A, Gori, S, Piacentini, F, Berardi, R, Brandes, A A, Foglietta, J, Villa, F, Todeschini, R, Tognetto, M, Naldi, N, Bortesi, B, Montemurro, F, Ardizzoni, A, Boni, L, and Musolino, A

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Phase II study, Phases of clinical research, Triple Negative Breast Neoplasms, Neutropenia, breast cancer, TNBC, eribulin, gemcitabine, metastatic, pharmacogenetics, Phase II study, locally advanced or metastatic triple negative breast cancer, ERIGE trial, GOIRC, Deoxycytidine, NO, chemistry.chemical_compound, Breast cancer, GOIRC, breast cancer, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Humans, Furan, Prospective Studies, Furans, eribulin, Triple-negative breast cancer, Original Research, pharmacogenetics, Antineoplastic Combined Chemotherapy Protocol, business.industry, locally advanced or metastatic triple negative breast cancer, Pharmacogenetic, Microfilament Proteins, gemcitabine, Ketones, Microfilament Protein, medicine.disease, Ketone, Gemcitabine, metastatic, Regimen, Prospective Studie, chemistry, Female, business, TNBC, Eribulin, medicine.drug, ERIGE trial, Human
Abstract

Background The combination of a microtubule inhibitor (eribulin) with a nucleoside analog (gemcitabine) may synergistically induce tumor cell death, particularly in triple negative breast cancer (TNBC) characterized by high cell proliferation, aggressive behavior, and chemo-resistance. Patients and methods This is an open-label, multicenter phase II study evaluating the combination of eribulin (0.88 mg/m2) plus gemcitabine (1000 mg/m2) on days 1 and 8 of a 21-day cycle as either first- or second-line treatment of locally advanced or metastatic TNBC. The primary endpoint was the objective response for evaluable patients. A prospective, molecular correlative study was carried out to assess the role of germinal BRCA pathogenic variants and single nucleotide polymorphisms (SNPs) in predicting efficacy and toxicity of the combination regimen. Results From July 2013 to September 2016, 83 evaluable patients were enrolled. They received a median number of six cycles of treatment. An overall response rate (ORR) of 37.3% (31 patients) was observed, with a complete response rate of 2.4% and a partial response rate of 34.9%; the clinical benefit rate was 48.8%. With a median follow-up of 28.8 months, the median response duration was 6.6 months, the median progression-free survival (PFS) was 5.1 months, and the median overall survival (OS) was 14.5 months. The most common grade 3-4 adverse events were aminotransferase elevation (in 25% of the patients) and neutropenia (in 23.8%). Women with BRCA1/2 pathogenic variants were associated with worse ORR, PFS, and OS than BRCA1/2 wild-type carriers. CYP3A4 and FGD4 SNPs were associated with increased risk of liver toxicity. Three different SNPs in CDA∗2, RRM1, and CYP2C8 genes were significantly associated with poorer OS. Conclusions The combination of eribulin and gemcitabine showed promising activity and a moderate toxicity profile in metastatic TNBC. BRCA status and pharmacogenetics tests may help identify patients with high probability of response with negligible toxicity. EudraCT number 2012-003505-10., Highlights • Eribulin plus gemcitabine showed a remarkable best ORR of 37.3% and a clinical benefit rate of 48.8%. • The most common grade 3/4 toxicities were liver toxicity and neutropenia without febrile neutropenia. • The study regimen partially lost its efficacy in patients harboring BRCA1/2 pathogenic variants. • SNPs in CYP3A4 and FGD4 genes were associated with increased risk of liver toxicity. • Three different SNPs in CDA∗2, RRM1, and CYP2C8 genes were significantly associated with poorer OS.

Published
2021

33. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Author

Sabino De Placido, Ciro Gallo, Michelino De Laurentiis, Giancarlo Bisagni, Grazia Arpino, Maria Giuseppa Sarobba, Ferdinando Riccardi, Antonio Russo, Lucia Del Mastro, Alessio Aligi Cogoni, Francesco Cognetti, Stefania Gori, Jennifer Foglietta, Antonio Frassoldati, Domenico Amoroso, Lucio Laudadio, Luca Moscetti, Filippo Montemurro, Claudio Verusio, Antonio Bernardo, Vito Lorusso, Adriano Gravina, Gabriella Moretti, Rossella Lauria, Antonella Lai, Carmela Mocerino, Sergio Rizzo, Francesco Nuzzo, Paolo Carlini, Francesco Perrone, Antonello Accurso, Biagio Agostara, Michele Aieta, Oscar Alabiso, Maria Grazia Alicicco, Dino Amadori, Laura Amaducci, Gianna Amiconi, Giustino Antuzzi, Mara Ardine, Antonio Ardizzoia, Caterina Aversa, Giuseppe Badalamenti, Sandro Barni, Carlo Basurto, Rossana Berardi, Cinzia Bergamasco, Paolo Bidoli, Claudia Bighin, Edoardo Biondi, Corrado Boni, Karen Borgonovo, Mario Botta, Stefano Bravi, Paolo Bruzzi, Giuseppe Buono, Alfredo Butera, Alessia Caldara, Giampiero Candeloro, Claudia Cappelletti, Cinzia Cardalesi, Elisabetta Carfora, Anna Cariello, Francesco Carrozza, Giacomo Cartenì, Michele Caruso, Virginia Casadei, Claudia Casanova, Luigi Castori, Luigi Cavanna, Giovanna Cavazzini, Marina Cazzaniga, Mario Chilelli, Paolo Chiodini, Silvia Chiorrini, Fortunato Ciardiello, Mariangela Ciccarese, Saverio Cinieri, Mario Clerico, Mariarosa Coccaro, Mario Comande, Claudia Corbo, Giuseppina Cortino, Stefania Cusenza, Gennaro Daniele, Alfonso Maria D'arco, Giuliana D'auria, Claudio Dazzi, Carmine De Angelis, Filippo de Braud, Gianfranco De Feo, Andrea De Matteis, Michele De Tursi, Anna Di Blasio, Giuseppe di Lucca, Liberato Di Lullo, Francesca Di Rella, Gianfranco Di Renzo, Pia Di Stefano, Aida Di Stefano, Anna Diana, Sara Donati, Agnese Fabbri, Alessandra Fabi, Marina Faedi, Gabriella Farina, Antonio Farris, Antonio Febbraro, Palma Fedele, Piera Federico, Francesco Ferraù, Gianluigi Ferretti, Antonella Ferro, Irene Floriani, Rosachiara Forcignanò, Samantha Forciniti, Valeria Forestieri, Gianni Fornari, Michela Frisinghelli, Vittorio Fusco, Giulia Gallizzi, Antonio Galvano, Antonio Gambardella, Angelo Gambi, Vittorio Gebbia, Erika Gervasi, Mara Ghilardi, Alice Giacobino, Giovanni Giardina, Francesco Giotta, Sara Giraudi, Mario Giuliano, Antonino Grassadonia, Donatella Grasso, Federica Grosso, Lorenzo Guizzaro, Pasquale Incoronato, Lorena Incorvaia, Giovanni Iodice, Nicla La Verde, Vincenzo Labonia, Gabriella Landi, Agnese Latorre, Vita Leonardi, Alessia Levaggi, Gennaro Limite, Linda Lina Bascialla, Lorenzo Livi, Evaristo Maiello, Daniela Mandelli, Ilaria Marcon, Daniela Menon, Michele Montedoro, Lucia Moraca, Anna Moretti, Maria Grazia Morritti, Patrizia Morselli, Antonella Mura, Silvia Mura, Michela Musacchio, Alberto Muzio, Donato Natale, Clara Natoli, Cinzia Nigro, Cecilia Nisticò, Antonio Nuzzo, Michele Orditura, Laura Orlando, Carmen Pacilio, Giuliano Palumbo, Raffaella Palumbo, Felice Pasini, Emanuela Paterno, Antonio Pazzola, Silvia Pelliccioni, Matilde Pensabene, Davide Perroni, Angela Pesenti Gritti, Fausto Petrelli, Maria Carmela Piccirillo, Graziella Pinotti, Claudia Pogliani, Davide Poli, Sonia Prader, Francesco Recchia, Daniele Rizzi, Carmen Romano, Rosalba Rossello, Chiara Rossini, Giuseppina Salvucci, Valeria Sanna, Alessandra Santini, Silvana Saracchini, Clementina Savastano, Giovanni Scambia, Francesco Schettini, Paola Schiavone, Alessio Schirone, Elena Seles, Simona Signoriello, Giuseppe Signoriello, Rosa Rita Silva, Antonia Silvestri, Vittorio Simeon, Ilaria Spagnoletti, Stefano Tamberi, Cristina Teragni, Verena Thalmann, Renato Thomas, Guglielmo Thomas, Amelia Tienghi, Nicola Tinari, Vincenza Tinessa, Federica Tomei, Giuseppe Tonini, Valter Torri, Divina Traficante, Marianna Tudini, Monica Turazza, Roberto Vignoli, Maria Giuseppa Vitale, Alessandra Zacchia, Pasquale Zagarese, Alda Zanni, Laura Zavallone, Maria Zavettieri, Alessandra Zoboli, De Placido, S., Gallo, C., De Laurentiis, M., Bisagni, G., Arpino, G., Sarobba, M. G., Riccardi, F., Russo, A., Del Mastro, L., Cogoni, A. A., Cognetti, F., Gori, S., Foglietta, J., Frassoldati, A., Amoroso, D., Laudadio, L., Moscetti, L., Montemurro, F., Verusio, C., Bernardo, A., Lorusso, V., Gravina, A., Moretti, G., Lauria, R., Lai, A., Mocerino, C., Rizzo, S., Nuzzo, F., Carlini, P., Perrone, F., Accurso, A., Agostara, B., Aieta, M., Alabiso, O., Alicicco, M. G., Amadori, D., Amaducci, L., Amiconi, G., Antuzzi, G., Ardine, M., Ardizzoia, A., Aversa, C., Badalamenti, G., Barni, S., Basurto, C., Berardi, R., Bergamasco, C., Bidoli, P., Bighin, C., Biondi, E., Boni, C., Borgonovo, K., Botta, M., Bravi, S., Bruzzi, P., Buono, G., Butera, A., Caldara, A., Candeloro, G., Cappelletti, C., Cardalesi, C., Carfora, E., Cariello, A., Carrozza, F., Carteni, G., Caruso, M., Casadei, V., Casanova, C., Castori, L., Cavanna, L., Cavazzini, G., Cazzaniga, M., Chilelli, M., Chiodini, P., Chiorrini, S., Ciardiello, F., Ciccarese, M., Cinieri, S., Clerico, M., Coccaro, M., Comande, M., Corbo, C., Cortino, G., Cusenza, S., Daniele, G., D'Arco, A. M., D'Auria, G., Dazzi, C., De Angelis, C., de Braud, F., De Feo, G., De Matteis, Ma., De Tursi, M., Di Blasio, A., di Lucca, G., Di Lullo, L., Di Rella, F., Di Renzo, G., Di Stefano, P., Di Stefano, A., Diana, A., Donati, S., Fabbri, A., Fabi, A., Faedi, M., Farina, G., Farris, A., Febbraro, A., Fedele, P., Federico, P., Ferrau, F., Ferretti, G., Ferro, A., Floriani, I., Forcignano, R., Forciniti, S., Forestieri, V., Fornari, G., Frisinghelli, M., Fusco, V., Gallizzi, G., Galvano, A., Gambardella, A., Gambi, A., Gebbia, V., Gervasi, E., Ghilardi, M., Giacobino, A., Giardina, G., Giotta, F., Giraudi, S., Giuliano, M., Grassadonia, A., Grasso, D., Grosso, F., Guizzaro, L., Incoronato, P., Incorvaia, L., Iodice, G., La Verde, N., Labonia, V., Landi, G., Latorre, A., Leonardi, V., Levaggi, A., Limite, G., Lina Bascialla, L., Livi, L., Maiello, E., Mandelli, D., Marcon, I., Menon, D., Montedoro, M., Moraca, L., Moretti, A., Morritti, M. G., Morselli, P., Mura, A., Mura, S., Musacchio, M., Muzio, A., Natale, D., Natoli, C., Nigro, C., Nistico, C., Nuzzo, A., Orditura, M., Orlando, L., Pacilio, C., Palumbo, G., Palumbo, R., Pasini, F., Paterno, E., Pazzola, A., Pelliccioni, S., Pensabene, M., Perroni, D., Pesenti Gritti, A., Petrelli, F., Piccirillo, M. C., Pinotti, G., Pogliani, C., Poli, D., Prader, S., Recchia, F., Rizzi, D., Romano, C., Rossello, R., Rossini, C., Salvucci, G., Sanna, V., Santini, A., Saracchini, S., Savastano, C., Scambia, G., Schettini, F., Schiavone, P., Schirone, A., Seles, E., Signoriello, S., Signoriello, G., Silva, R. R., Silvestri, A., Simeon, V., Spagnoletti, I., Tamberi, S., Teragni, C., Thalmann, V., Thomas, R., Thomas, G., Tienghi, A., Tinari, N., Tinessa, V., Tomei, F., Tonini, G., Torri, V., Traficante, D., Tudini, M., Turazza, M., Vignoli, R., Vitale, M. G., Zacchia, A., Zagarese, P., Zanni, A., Zavallone, L., Zavettieri, M., Zoboli, A., De Placido, Sabino, Gallo, Ciro, De Laurentiis, Michelino, Bisagni, Giancarlo, Arpino, Grazia, Sarobba, Maria Giuseppa, Riccardi, Ferdinando, Russo, Antonio, Del Mastro, Lucia, Cogoni, Alessio Aligi, Cognetti, Francesco, Gori, Stefania, Foglietta, Jennifer, Frassoldati, Antonio, Amoroso, Domenico, Laudadio, Lucio, Moscetti, Luca, Montemurro, Filippo, Verusio, Claudio, Bernardo, Antonio, Lorusso, Vito, Gravina, Adriano, Moretti, Gabriella, Lauria, Rossella, Lai, Antonella, Mocerino, Carmen, Rizzo, Sergio, Nuzzo, Francesco, Carlini, Paolo, Perrone, Francesco, Accurso, Antonello, Agostara, Biagio, Aieta, Michele, Alabiso, Oscar, Alicicco, Maria Grazia, Amadori, Dino, Amaducci, Laura, Amiconi, Gianna, Antuzzi, Giustino, Ardine, Mara, Ardizzoia, Antonio, Aversa, Caterina, Badalamenti, Giuseppe, Barni, Sandro, Basurto, Carlo, Berardi, Rossana, Bergamasco, Cinzia, Bidoli, Paolo, Bighin, Claudia, Biondi, Edoardo, Boni, Corrado, Borgonovo, Karen, Botta, Mario, Bravi, Stefano, Bruzzi, Paolo, Buono, Giuseppe, Butera, Alfredo, Caldara, Alessia, Candeloro, Giampiero, Cappelletti, Claudia, Cardalesi, Cinzia, Carfora, Elisabetta, Cariello, Anna, Carrozza, Francesco, Cartenì, Giacomo, Caruso, Michele, Casadei, Virginia, Casanova, Claudia, Castori, Luigi, Cavanna, Luigi, Cavazzini, Giovanna, Cazzaniga, Marina, Chilelli, Mario, Chiodini, Paolo, Chiorrini, Silvia, Ciardiello, Fortunato, Ciccarese, Mariangela, Cinieri, Saverio, Clerico, Mario, Coccaro, Mariarosa, Comande, Mario, Corbo, Claudia, Cortino, Giuseppina, Cusenza, Stefania, Daniele, Gennaro, D'arco, Alfonso Maria, D'auria, Giuliana, Dazzi, Claudio, De Angelis, Carmine, de Braud, Filippo, De Feo, Gianfranco, De Matteis, Andrea, De Tursi, Michele, Di Blasio, Anna, di Lucca, Giuseppe, Di Lullo, Liberato, Di Rella, Francesca, Di Renzo, Gianfranco, Di Stefano, Pia, Di Stefano, Aida, Diana, Anna, Donati, Sara, Fabbri, Agnese, Fabi, Alessandra, Faedi, Marina, Farina, Gabriella, Farris, Antonio, Febbraro, Antonio, Fedele, Palma, Federico, Piera, Ferraù, Francesco, Ferretti, Gianluigi, Ferro, Antonella, Floriani, Irene, Forcignanò, Rosachiara, Forciniti, Samantha, Forestieri, Valeria, Fornari, Gianni, Frisinghelli, Michela, Fusco, Vittorio, Gallizzi, Giulia, Galvano, Antonio, Gambardella, Antonio, Gambi, Angelo, Gebbia, Vittorio, Gervasi, Erika, Ghilardi, Mara, Giacobino, Alice, Giardina, Giovanni, Giotta, Francesco, Giraudi, Sara, Giuliano, Mario, Grassadonia, Antonino, Grasso, Donatella, Grosso, Federica, Guizzaro, Lorenzo, Incoronato, Pasquale, Incorvaia, Lorena, Iodice, Giovanni, La Verde, Nicla, Labonia, Vincenzo, Landi, Gabriella, Latorre, Agnese, Leonardi, Vita, Levaggi, Alessia, Limite, Gennaro, Lina Bascialla, Linda, Livi, Lorenzo, Maiello, Evaristo, Mandelli, Daniela, Marcon, Ilaria, Menon, Daniela, Montedoro, Michele, Moraca, Lucia, Moretti, Anna, Morritti, Maria Grazia, Morselli, Patrizia, Mura, Antonella, Mura, Silvia, Musacchio, Michela, Muzio, Alberto, Natale, Donato, Natoli, Clara, Nigro, Cinzia, Nisticò, Cecilia, Nuzzo, Antonio, Orditura, Michele, Orlando, Laura, Pacilio, Carmen, Palumbo, Giuliano, Palumbo, Raffaella, Pasini, Felice, Paterno, Emanuela, Pazzola, Antonio, Pelliccioni, Silvia, Pensabene, Matilde, Perroni, Davide, Pesenti Gritti, Angela, Petrelli, Fausto, Piccirillo, Maria Carmela, Pinotti, Graziella, Pogliani, Claudia, Poli, Davide, Prader, Sonia, Recchia, Francesco, Rizzi, Daniele, Romano, Carmen, Rossello, Rosalba, Rossini, Chiara, Salvucci, Giuseppina, Sanna, Valeria, Santini, Alessandra, Saracchini, Silvana, Savastano, Clementina, Scambia, Giovanni, Schettini, Francesco, Schiavone, Paola, Schirone, Alessio, Seles, Elena, Signoriello, Simona, Signoriello, Giuseppe, Silva, Rosa Rita, Silvestri, Antonia, Simeon, Vittorio, Spagnoletti, Ilaria, Tamberi, Stefano, Teragni, Cristina, Thalmann, Verena, Thomas, Renato, Thomas, Guglielmo, Tienghi, Amelia, Tinari, Nicola, Tinessa, Vincenza, Tomei, Federica, Tonini, Giuseppe, Torri, Valter, Traficante, Divina, Tudini, Marianna, Turazza, Monica, Vignoli, Roberto, Vitale, Maria Giuseppa, Zacchia, Alessandra, Zagarese, Pasquale, Zanni, Alda, Zavallone, Laura, Zavettieri, Maria, Zoboli, Alessandra, Mocerino, Carmela, D'Arco, Alfonso Maria, D'Auria, Giuliana, De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, and Zoboli, A

Subjects
Oncology, Receptor, ErbB-2, Settore MED/06 - Oncologia Medica, letrozole, law.invention, Adjuvant anastrozole, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Exemestane, law, exemestane, tamoxifen, breast cancer, Antineoplastic Combined Chemotherapy Protocols, 030212 general & internal medicine, Aromatase Inhibitors, Letrozole, Hazard ratio, Middle Aged, Receptors, Estrogen, Tolerability, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Receptors, Progesterone, Breast Neoplasm, Human, medicine.drug, medicine.medical_specialty, Socio-culturale, Anastrozole, Breast Neoplasms, Disease-Free Survival, Drug Administration Schedule, 03 medical and health sciences, Breast cancer, Internal medicine, medicine, Aromatase Inhibitor, Humans, Aged, Antineoplastic Combined Chemotherapy Protocol, Androstadiene, business.industry, medicine.disease, Androstadienes, chemistry, business, Tamoxifen
Abstract

Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely removed by surgery, any pathological tumour size, and axillary nodal status. Key exclusion criteria were hormone replacement therapy, recurrent or metastatic disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised minimisation procedure stratified for oestrogen receptor, progesterone receptor, and HER2 status; previous chemotherapy; and pathological nodal status. Neither the patients nor the physicians were masked to treatment allocation. The primary endpoint was disease-free survival. The minimum cutoff to declare superiority of the upfront strategy over the switch strategy was assumed to be a 2% difference in disease-free survival at 5 years. Primary efficacy analyses were done by intention to treat; safety analyses included all patients for whom at least one safety case report form had been completed. Follow-up is ongoing. This trial is registered with the European Clinical Trials Database, number 2006-004018-42, and ClinicalTrials.gov, number NCT00541086. Findings: Between March 9, 2007, and July 31, 2012, 3697 patients were enrolled into the study. After a median follow-up of 60 months (IQR 46–72), 401 disease-free survival events were reported, including 211 (11%) of 1850 patients allocated to the switch strategy and 190 (10%) of 1847 patients allocated to upfront treatment. 5-year disease-free survival was 88·5% (95% CI 86·7–90·0) with the switch strategy and 89·8% (88·2–91·2) with upfront treatment (hazard ratio 0·89, 95% CI 0·73–1·08; p=0·23). 5-year disease-free survival was 90·0% (95% CI 87·9–91·7) with anastrozole (124 events), 88·0% (85·8–89·9) with exemestane (148 events), and 89·4% (87·3 to 91·1) with letrozole (129 events; p=0·24). No unexpected serious adverse reactions or treatment-related deaths occurred. Musculoskeletal side-effects were the most frequent grade 3–4 events, reported in 130 (7%) of 1761 patients who received the switch strategy and 128 (7%) of 1766 patients who received upfront treatment. Grade 1 musculoskeletal events were more frequent with the upfront schedule than with the switch schedule (924 [52%] of 1766 patients vs 745 [42%] of 1761 patients). All other grade 3–4 adverse events occurred in less than 2% of patients in either group. Interpretation: 5 years of treatment with aromatase inhibitors was not superior to 2 years of tamoxifen followed by 3 years of aromatase inhibitors. None of the three aromatase inhibitors was superior to the others in terms of efficacy. Therefore, patient preference, tolerability, and financial constraints should be considered when deciding the optimal treatment approach in this setting. Funding: Italian Drug Agency.

Published
2018

34. Adherence to oral hormonal anticancer agents in breast cancer

Author

Stefania Gori, Alessandra Modena, Jennifer Foglietta, Matteo Verzè, Alessandro Inno, Alessandra Casarin, Antonio Russo, Fabrizio Nicolis, Gori S., Modena A., Foglietta J., Verze M., Inno A., Casarin A., Russo A., and Nicolis F.

Subjects
oral antitumoral agents, Cancer Research, breast cancer, Oncology, Adherence, adjuvant endocrine therapy, General Medicine
Abstract

There is an increasing trend towards using oral antitumoral agents in oncological patients. Compared to parenteral therapy, oral treatment offers convenience for both the patient and the healthcare system, with similar efficacy. However, the benefit deriving from oral drugs will be obtained only if patients adhere strictly to the treatment. Medical oncologists must therefore seek to optimize patient adherence. Breast cancer patients, particularly, are often treated with oral hormonal anticancer agents. In this review, we summarized evidence about adherence of breast cancer patients to oral hormonal anticancer agents and the consequences of poor compliance, the barriers to oral treatment and strategies to overcome them.

Published
2022

35. PANHER study: a 20-year treatment outcome analysis from a multicentre observational study of HER2-positive advanced breast cancer patients from the real-world setting

Author

Angela Maione, Nicola Tinari, Paola Pinnarò, Enzo Maria Ruggeri, Isabella Sperduti, Olivia Bacciu, Emanuela Risi, Icro Meattini, Federica Tomao, Luca Marchetti, Nicola D’Ostilio, Patrizia Vici, Lorenza Landi, Giuseppina Sarobba, Lucia Mentuccia, Elisabetta Landucci, Emilio Bria, A.F. Scinto, Gennaro Ciliberto, Laura Pizzuti, Elena Fiorio, Andrea Michelotti, Ida Paris, Simonetta Stani, Antonio Russo, Clara Natoli, Rosa Saltarelli, Alessandra Cassano, Paolo Marchetti, Maria Agnese Fabbri, Daniele Marinelli, Ferdinando Riccardi, Mauro Minelli, Corrado Ficorella, Anna Ceribelli, Maria Rosaria Valerio, Maddalena Barba, Jennifer Foglietta, Maria Mauri, Teresa Gamucci, Luca Moscetti, Beatrice Taurelli Salimbeni, Fabio Pelle, Daniele Santini, Andrea Botticelli, Vito Lorusso, Mirco Pistelli, Giacomo Barchiesi, Francesco Giotta, Eriseld Krasniqi, Antonino Grassadonia, Simone Scagnoli, Valentina Sini, Katia Cannita, Flavia Cavicchi, Michele De Tursi, Mimma Raffaele, Marco Mazzotta, Sonia Cappelli, Paola Scavina, Francesca Sofia Di Lisa, Giuliana D’Auria, Armando Orlandi, Marcello Maugeri-Saccà, Federico Cappuzzo, Claudio Botti, Nello Salesi, Lorenzo Livi, Beatrice Fratini, Giulia Bon, Silverio Tomao, Giuseppe Sanguineti, Enzo Veltri, Domenico Corsi, Enrico Cortesi, Rossana Berardi, Laura Iezzi, Rosalinda Rossi, Giuseppe Tonini, Elisabetta Maria Capomolla, Pizzuti L., Krasniqi E., Sperduti I., Barba M., Gamucci T., Mauri M., Veltri E.M., Meattini I., Berardi R., Di Lisa F.S., Natoli C., Pistelli M., Iezzi L., Risi E., D'Ostilio N., Tomao S., Ficorella C., Cannita K., Riccardi F., Cassano A., Bria E., Fabbri M.A., Mazzotta M., Barchiesi G., Botticelli A., D'Auria G., Ceribelli A., Michelotti A., Russo A., Salimbeni B.T., Sarobba G., Giotta F., Paris I., Saltarelli R., Marinelli D., Corsi D., Capomolla E.M., Sini V., Moscetti L., Mentuccia L., Tonini G., Raffaele M., Marchetti L., Minelli M., Ruggeri E.M., Scavina P., Bacciu O., Salesi N., Livi L., Tinari N., Grassadonia A., Fedele Scinto A., Rossi R., Valerio M.R., Landucci E., Stani S., Fratini B., Maugeri-Sacca M., De Tursi M., Maione A., Santini D., Orlandi A., Lorusso V., Cortesi E., Sanguineti G., Pinnaro P., Cappuzzo F., Landi L., Botti C., Tomao F., Cappelli S., Bon G., Pelle F., Cavicchi F., Fiorio E., Foglietta J., Scagnoli S., Marchetti P., Ciliberto G., and Vici P.

Subjects
Oncology, medicine.medical_specialty, Advanced breast, T-DM1, Treatment outcome, Lapatinib, Breast cancer, pertuzumab, Internal medicine, Medicine, lapatinib, RC254-282, advanced breast cancer, business.industry, Human epidermal growth factor, HER2-positive, sequence, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Cancer, medicine.disease, Observational study, Pertuzumab, business, medicine.drug
Abstract

Background: The evolution of therapeutic landscape of human epidermal growth factor receptor-2 (HER2)-positive breast cancer (BC) has led to an unprecedented outcome improvement, even if the optimal sequence strategy is still debated. To address this issue and to provide a picture of the advancement of anti-HER2 treatments, we performed a large, multicenter, retrospective study of HER2-positive BC patients. Methods: The observational PANHER study included 1,328 HER2-positive advanced BC patients treated with HER2 blocking agents since June 2000 throughout July 2020. Endpoints of efficacy were progression-free survival (PFS) and overall survival (OS). Results: Patients who received a first-line pertuzumab-based regimen showed better PFS ( p < 0.0001) and OS ( p = 0.004) than those receiving other treatments. Median PFS and mOS from second-line starting were 8 and 28 months, without significant differences among various regimens. Pertuzumab-pretreated patients showed a mPFS and a mOS from second-line starting not significantly affected by type of second line, that is, T-DM1 or lapatinib/capecitabine ( p = 0.80 and p = 0.45, respectively). Conversely, pertuzumab-naïve patients receiving second-line T-DM1 showed a significantly higher mPFS compared with that of patients treated with lapatinib/capecitabine ( p = 0.004). Median OS from metastatic disease diagnosis was higher in patients treated with trastuzumab-based first line followed by second-line T-DM1 in comparison to pertuzumab-based first-line and second-line T-DM1 ( p = 0.003), although these data might be partially influenced by more favorable prognostic characteristics of patients in the pre-pertuzumab era. No significant differences emerged when comparing patients treated with ‘old’ or ‘new’ drugs ( p = 0.43), even though differences in the length of the follow-up between the two cohorts should be taken into account. Conclusion: Our results confirmed a relevant impact of first-line pertuzumab-based treatment and showed lower efficacy of second-line T-DM1 in trastuzumab/pertuzumab pretreated, as compared with pertuzumab-naïve patients. Our findings may help delineate a more appropriate therapeutic strategy in HER2-positive metastatic BC. Prospective randomized trials addressing this topic are awaited.

Published
2021

37. Distinct HR expression patterns significantly affect the clinical behavior of metastatic HER2+ breast cancer and degree of benefit from novel anti-HER2 agents in the real world setting

Author

Isacco Desideri, G. Tonini, Emanuela Magnolfi, L. Pizzuti, Jennifer Foglietta, Marina Elena Cazzaniga, Adamo, Patrizia Vici, Enrico Cortesi, Emanuela Risi, G. D'Auria, Loretta D'Onofrio, Mario Roselli, Isabella Sperduti, N. Tinari, Nicola D’Ostilio, A. Vaccaro, Icro Meattini, Federica Tomao, Giacomo Barchiesi, B Di Cocco, F Cardillo, Enzo Veltri, Claudia Omarini, Mirco Pistelli, Clara Natoli, Carlo Garufi, E. Landucci, M. Mauri, Rosanna Mirabelli, Federico Piacentini, Domenico Corsi, A.F. Scinto, Alice Villa, Alain Gelibter, C. De Angelis, Marco Mazzotta, Gennaro Ciliberto, Claudio Zamagni, Giuseppe Sanguineti, Fiorentino Izzo, Elizabeth H. Baldini, Rossana Berardi, Grr Ricciardi, Maddalena Barba, Ornella Garrone, Ida Paris, Luisa Carbognin, A. Botticelli, Giuseppina Sarobba, Silverio Tomao, Antonio Astone, Lucia Mentuccia, P Del Medico, Lorusso, Daniele Santini, M. Della Giulia, Riccardo Samaritani, Francesco Giotta, Alessandra Cassano, Laura Iezzi, Maria Agnese Fabbri, R De Maria, Eriseld Krasniqi, Raffaele Giusti, Sini, Lorenzo Livi, Ernesto Rossi, Andrea Michelotti, Emilio Bria, A Di Leo, Luca Moscetti, Corrado Ficorella, Antonino Grassadonia, Roberta Sarmiento, Katia Cannita, Filippo Greco, Sandro Barni, Elena Fiorio, Teresa Gamucci, Magri, Antonio Russo, M. De Tursi, N. La Verde, Daniele Generali, Paolo Marchetti, Pizzuti, L, Krasniqi, E, Barchiesi, G, Della Giulia, M, Izzo, F, Sanguineti, G, Marchetti, P, Mazzotta, M, Giusti, R, Botticelli, A, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Iezzi, L, Tomao, S, Tomao, F, Tonini, G, Santini, D, Astone, A, Michelotti, A, De Angelis, C, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Rossi, E, Cazzaniga, M, Moscetti, L, Omarini, C, Piacentini, F, Fabbri, M, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Samaritani, R, Garufi, C, Barni, S, Mirabelli, R, Sarmiento, R, Veltri, E, D'Auria, G, Paris, I, Giotta, F, Lorusso, V, Cardillo, F, Landucci, E, Mauri, M, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Berardi, R, Pistelli, M, Fiorio, E, Cannita, K, Sini, V, D'Ostilio, N, Foglietta, J, Greco, F, Zamagni, C, Garrone, O, Di Cocco, B, Baldini, E, Livi, L, Desideri, I, Meattini, I, Sarobba, G, Del Medico, P, De Tursi, M, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Sperduti, I, Villa, A, Barba, M, Di Leo, A, and Vici, P

Subjects
Oncology, Cancer Research, Multivariate analysis, Settore MED/06 - Oncologia Medica, Receptor, ErbB-2, T-DM1, Estrogen receptor, 0302 clinical medicine, ErbB-2, Trastuzumab, Receptors, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Molecular Targeted Therapy, Neoplasm Metastasis, Cancer Therapy and Prevention, Progesterone, Aged, 80 and over, advanced breast cancer, Tumor, real world, Middle Aged, Prognosis, Metastatic breast cancer, Immunohistochemistry, Gene Expression Regulation, Neoplastic, trastuzumab, Receptors, Estrogen, 030220 oncology & carcinogenesis, Female, HER2 positive, pertuzumab, Adult, Aged, Biomarkers, Tumor, Breast Neoplasms, Humans, Neoplasm Staging, Receptors, Progesterone, Pertuzumab, medicine.drug, Receptor, medicine.medical_specialty, T‐DM1, chemotherapy, 03 medical and health sciences, Breast cancer, Settore MED/04 - PATOLOGIA GENERALE, Internal medicine, medicine, Neoplastic, business.industry, medicine.disease, Estrogen, Settore CHIM/08 - Chimica Farmaceutica, Gene Expression Regulation, MED/06 - ONCOLOGIA MEDICA, business, Biomarkers, Hormone
Abstract

We analyzed data from 738 HER2‐positive metastatic breast cancer (mbc) patients treated with pertuzumab‐based regimens and/or T‐DM1 at 45 Italian centers. Outcomes were explored in relation to tumor subtype assessed by immunohistochemistry (IHC). The median progression‐free survival at first‐line (mPFS1) was 12 months. Pertuzumab as first‐line conferred longer mPFS1 compared to other first‐line treatments (16 vs. 9 months, p = 0.0001), regardless of IHC subtype. Median PFS in second‐line (mPFS2) was 7 months, with no difference by IHC subtype, but it was more favorable with T‐DM1 compared to other agents (7 vs. 6 months, p = 0.03). There was no PFS2 gain in patients with tumors expressing both hormonal receptors (HRs; p = 0.17), while a trend emerged for tumors with one HR (p = 0.05). Conversely, PFS2 gain was significant in HRs‐negative tumors (p = 0.04). Median overall survival (mOS) was 74 months, with no significant differences by IHC subtypes. Survival rates at 2 and 3 years in patients treated with T‐DM1 in second‐line after pertuzumab were significantly lower compared to pertuzumab‐naïve patients (p = 0.01). When analyzed by IHC subtype, the outcome was confirmed if both HRs or no HRs were expressed (p = 0.02 and p = 0.006, respectively). Our results confirm that HRs expression impacts the clinical behavior and novel treatment‐related outcomes of HER2‐positive tumors when treatment sequences are considered. Moreover, multivariate analysis showed that HRs expression had no effect on PFS and OS. Further studies are warranted to confirm our findings and clarify the interplay between HER2 and estrogen receptor pathways in HER2‐positive (mbc) patients., What's new? About half of breast cancers positive for human epidermal growth factor (HER2) also express hormone receptors but the impact of hormone receptor status on the success of HER2‐directed treatments is not fully explored. Here the authors retrospectively assessed tumor behavior and treatment outcomes in 738 women with HER2+ metastatic breast cancer treated with new generation anti‐HER2 agents. Distinct hormone receptor expression patterns significantly affected the progression free and overall survival, justifying further studies to define optimal treatment regimens and the interplay between hormone receptor and HER2 signaling.

Published
2020

38. The HERBA trial: a retrospective study on patients (pts) with HER2-positive (HER2+ve) breast cancer (BC) and brain metastases (BMs)

Author

Gianluigi Lunardi, N. La Verde, A. Fabi, Maria Rosaria Valerio, Stefania Gori, M. Turazza, Alessandro Inno, Luigi Cavanna, Leonardi, Jennifer Foglietta, Filippo Alongi, Lucio Laudadio, G Carbognin, Ornella Garrone, Emiliana Tarenzi, A Frassoldai, S. Moroso, Elisabetta Cretella, Sandro Barni, Patrizia Vici, F. Marchetti, Gori S., Turazza M., Inno A., Lunardi G., Moroso S., La Verde N., Frassoldai A., Tarenzi E., Garrone O., Vici P., Laudadio L., Cretella E., Foglietta J., Leonardi V., Cavanna L., Barni S., Marchetti F., Valerio M., Carbognin G., Alongi F., and Fabi A.

Subjects
Gynecology, Oncology, medicine.medical_specialty, Breast cancer, business.industry, Internal medicine, medicine, Retrospective cohort study, Hematology, medicine.disease, business, ER2-positive (HER2+ve), breast cancer (BC), brain metastases (BMs)
Published
2017

39. Follow-up of early breast cancer in a public health system: A 2024 AIGOM consensus project.

Author

Gori S, De Rose F, Ferro A, Fabi A, Angiolini C, Azzarello G, Cancian M, Cinquini M, Arecco L, Aristei C, Bernardi D, Biganzoli L, Cariello A, Cortesi L, Cretella E, Criscitiello C, De Giorgi U, Carmen De Santis M, Deledda G, Dessena M, Donati S, Dri A, Ferretti G, Foglietta J, Franceschini D, Franco P, Schirone A, Generali D, Gianni L, Giordani S, Grandi G, Cristina Leonardi M, Magno S, Malorni L, Mantoan C, Martorana F, Meattini I, Meduri B, Merlini L, Miglietta F, Modena A, Nicolis F, Palumbo I, Panizza P, Angela Rovera F, Salvini P, Santoro A, Taffurelli M, Toss A, Tralongo P, Turazza M, Valerio M, Verzè M, Vici P, Zamagni C, Curigliano G, Pappagallo G, and Zambelli A

Subjects
Humans, Female, Italy, Consensus, Public Health, Follow-Up Studies, Breast Neoplasms therapy
Abstract

Breast cancer stands as the most frequently diagnosed cancer and the primary cause of cancer-related mortality among women worldwide, including Italy. With the increasing number of survivors, many are enrolled in regular follow-up programs. However, adherence to recommendations from scientific societies (such as ASCO, ESMO, AIOM) for breast cancer follow-up management varies in daily clinical practice across different cancer centers, potentially resulting in unequal management and escalating costs. To address these concerns, the Italian Association of Multidisciplinary Oncology Groups (AIGOM) orchestrated a Consensus on early Breast Cancer follow-up utilizing the Estimate-Talk-Estimate methodology. Following the identification of 18 Items and 38 statements by a select Board, 46 out of 54 (85.1%) experts comprising a multidisciplinary and multiprofessional panel expressed their degree of consensus (Expert Panel). The Expert Panel underscores the potential for the multidisciplinary team to tailor follow-up intensity based on the individual risk of recurrence. In selected cases, the general practitioner may be recommended as the clinical lead for breast cancer follow-up, both after completion of adjuvant treatment and at early initiation of endocrine therapy in low-risk patients. Throughout follow-up, and alongside oncologic surveillance, the expert panel advises osteometabolic, cardiologic, and gynecologic surveillance for the early detection and management of early and late treatment toxicities. Moreover, preserving quality of life is emphasized, with provisions for psycho-oncologic support and encouragement to adopt protective lifestyle behaviors., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: None of the authors has any interests to report directly related to this manuscript. Outside the scope of this manuscript: Stefania Gori, Fiorenza De Rose, no conflict of interests to declare. Antonella Ferro, honoraria from Novartis, MDS, Daiichi Sankyo, Astra Zeneca, Ely Lilly, Gentili. Alessandra Fabi grants from Astra Zeneca (steering committee); consulting fees from Roche, Lilly, Novartis, AstraZeneca, Pfizer, Seagen, Gilead, MSD, Menarini; honoraria from Astra Zeneca, Roche, Lilly, Novartis, Gilead, Pfizer, Daiichi Sankyo Exact Sciences; travel grants from Roche, Lilly, Novartis, AstraZeneca, Pfizer, Seagen, Gilead, MSD, Menarini; advisory board from Roche, Lilly, Novartis, AstraZeneca, Pfizer, Seagen, Gilead, MSD, Menarini. Catia Angiolini, Giuseppe Azzarello, Maurizio Cancian, Michela Cinquini, Luca Arecco no conflict of interests to declare. Cynthia Aristei, grants from PRIN 2023, from the Ministry of University and Research. Project title “The microbiome in breast cancer therapy and its potential for pRobIOtics to improve treatment outcome. Acronym: BARRIO”. Daniela Bernardi, Laura Biganzoli, Anna Cariello no conflict of interests to declare. Laura Cortesi, report grants from Astra Zeneca, MSD, Pfizer; consulting fees and honoraria from Astra Zeneca, Gilead, MSD, Roche, Pfizer, Daijchii Sanchio, Novartis; travel grants from Gilead, Pfizer, Daijchi Sanchio; Advisory Board from Astra Zeneca, MSD, Novartis. Elisabetta Cretella no conflict of interests to declare. Carmen Criscitiello, grants from Seagen, Gilead; consulting fees and honoraria from Pfizer, Novartis, Lilly, MSD; Seagen, Daiichi Sankyo, Gilead, AstraZeneca, Roche. Ugo De Giorgi consulting fees from Amgen, Astellas Pharma, Astrazeneca, Bayer, Bristol-Myers Squibb, Eisai, Ipsen, Janssen, Merck KGaA, MSD, Novartis, Pfizer; travel grants from Pfizer, Ipsen, Astrazeneca. Maria Carmen De Santis, Giuseppe Deledda, Massimo Dessena, Sara Donati, Arianna Dri, Gianluigi Ferretti no conflict of interests to declare. Jennifer Foglietta, honoraria from Novartis; travel grants from Roche, Sophos, Pfizer; Advisory Board from Menarini Stem Line. Davide Franceschini, Pierfrancesco Franco, Alessio Schirone no conflict of interests to declare. Daniele Generali, grants from LILT, University of Trieste, Novartis, Roche; consulting fees from Lilly, Novartis, Pfizer, Roche, Accord, Daiichi Dankyo; honoraria from Lilly, Novartis, Pfizer, Roche, Accord, Daiichi Dankyo, Astrazeneca, Istituto Gentili; travel grants from Roche, Menarini; Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid from Mednote. Lorenzo Gianni, travel grants from Novartis, Lilly, Pfizer; Advisory Board from Astra Zeneca, Novartis, Seagen. Stefano Giordani, Giovanni Grandi, Maria Cristina Leonardi, Stefano Magno, no conflict of interests to declare. Luca Malorni, consulting fees from Menarini, Pfizer, Lilly, Novartis, Roche; travel grants from Roche, Menarini, Celgene, IT Health Fusion; Advisory Board from Novartis. Carlotta Mantoan no conflict of interests to declare. Federica Martorana honoraria from Lilly, Daychii-Sankyo, Pfizer, Astra-Zeneca, Novartis; travel grants from Gilead, Roche, Pfizer, Lilly; advisory board from Amgen. Icro Meattini consulting fees from Pfizer, Astra Zeneca, Daiichi Sankyo, Novartis, Eli Lilly, Seagen, Gilead, Menarini StemLine. Bruno Meduri, Laura Merlini, Federica Miglietta, Alessandra Modena, Fabrizio Nicolis, Isabella Palumbo, no conflict of interests to declare. Pietro Panizza honoraria and travel grants from Bayer AG. Francesca Angela Rovera, Piermario Salvini, Armando Santoro, Mario Taffurelli, no conflict of interests to declare. Angela Toss consulting fees and grants from Lilly, Pfizer, Novartis, MSD, Astrazeneca, Gilead, Seagen, Daiichi Sankyo; travel grants from Gilead, Daiichi Sankyo, Menarini, Astrazeneca. Paolo Tralongo, Monica Turazza, Matteo Valerio, Matteo Verzè no conflict of interests to declare. Patrizia Vici consulting fees from Lilly, Daiichi-Sankyo, Pfizer, MSD, Novartis; honoraria from EISAI, Daiichi-Sankyo, Lilly, Novartis, Pfizer; travel grants from Roche, Pfizer, Daiichi-Sankyo, Novartis, IPSEN; advisory board from Pfizer, Novartis. Claudio Zamagni no conflict of interests to declare. Giuseppe Curigliano advisory board from Roche, Novartis, Lilly, Pfizer, Astra Zeneca, Daichii Sankyo, Ellipsis, Veracyte, Exact Science, Celcuity, Merck, BMS, Gilead, Sanofi, Menarini. Giovanni Pappagallo no conflict of interests to declare. Alberto Zambelli consulting fees Pfizer, Lilly, Novartis, Roche, AstraZeneca, DaiichiSankyo, Seagen, ExactSciences, MSD, Gentili, Gilead; travel grants from Roche, DaiichiSankyo, AstraZeneca, Novartis; advisory board from Roche., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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40. [Hormone therapy, cardio-metabolic profile, and cardiotoxicity. Still a dark side of cardio-oncology - Part 2: Prostate cancer].

Author

Tarantini L, Di Girolamo S, Masini C, Cioffi G, Foglietta J, Bracarda S, Pinto C, and Navazio A

Subjects
Male, Humans, Cardiotoxicity etiology, Cardiotoxicity prevention & control, Medical Oncology, Hormones therapeutic use, Neoplasms complications, Cardiovascular Diseases chemically induced, Cardiovascular Diseases prevention & control, Prostatic Neoplasms drug therapy, Prostatic Neoplasms chemically induced, Antineoplastic Agents adverse effects
Abstract

Hormone therapies (HTs) with anti-androgenic properties are a cornerstone for the treatment of prostate cancer (PC) and have significantly improved the survival of patients, though exposing them to a higher risk of cardiovascular diseases (CVDs), which represent a major cause of morbidity and mortality. This occurs due to the high average age of patients undergoing HT for PC, an age group in which CVDs have a high prevalence and incidence, and due to the type and duration of HTs that are increasingly effective but at the same time more aggressive towards cardiovascular health. Recent evidence from the real world suggests, however, that the cardiometabolic risk is widely underestimated and undertreated with significant impact also on the oncological prognosis. In the light of the results of the PRONOUNCE study, in this review it is emphasized the need for a multidisciplinary management of patients with PC who are candidate for or treated with HT by implementing a personalized treatment program in accordance with the current European guidelines on CVD prevention.

Published
2023
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41. Adherence to oral hormonal anticancer agents in breast cancer.

Author

Gori S, Modena A, Foglietta J, Verzè M, Inno A, Casarin A, Russo A, and Nicolis F

Subjects
Humans, Female, Antineoplastic Agents, Hormonal therapeutic use, Patient Compliance, Chemotherapy, Adjuvant, Medication Adherence, Breast Neoplasms drug therapy, Antineoplastic Agents therapeutic use, Mouth Neoplasms
Abstract

There is an increasing trend towards using oral antitumoral agents in oncological patients. Compared to parenteral therapy, oral treatment offers convenience for both the patient and the healthcare system, with similar efficacy. However, the benefit deriving from oral drugs will be obtained only if patients adhere strictly to the treatment. Medical oncologists must therefore seek to optimize patient adherence. Breast cancer patients, particularly, are often treated with oral hormonal anticancer agents. In this review, we summarized evidence about adherence of breast cancer patients to oral hormonal anticancer agents and the consequences of poor compliance, the barriers to oral treatment and strategies to overcome them.

Published
2023
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42. Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe , a multicentric, observational study.

Author

Di Lisa FS, Krasniqi E, Pizzuti L, Barba M, Cannita K, De Giorgi U, Borella F, Foglietta J, Cariello A, Ferro A, Picardo E, Mitidieri M, Sini V, Stani S, Tonini G, Santini D, La Verde N, Gambaro AR, Grassadonia A, Tinari N, Garrone O, Sarobba G, Livi L, Meattini I, D'Auria G, Vergati M, Gamucci T, Pistelli M, Berardi R, Risi E, Giotta F, Lorusso V, Rinaldi L, Artale S, Cazzaniga ME, Zustovich F, Cappuzzo F, Landi L, Torrisi R, Scagnoli S, Botticelli A, Michelotti A, Fratini B, Saltarelli R, Paris I, Muratore M, Cassano A, Gianni L, Gaspari V, Veltri EM, Zoratto F, Fiorio E, Fabbri MA, Mazzotta M, Ruggeri EM, Pedersini R, Valerio MR, Filomeno L, Minelli M, Scavina P, Raffaele M, Astone A, De Vita R, Pozzi M, Riccardi F, Greco F, Moscetti L, Giordano M, Maugeri-Saccà M, Zennaro A, Botti C, Pelle F, Cappelli S, Cavicchi F, Vizza E, Sanguineti G, Tomao F, Cortesi E, Marchetti P, Tomao S, Speranza I, Sperduti I, Ciliberto G, and Vici P

Abstract

Background: In triple negative breast cancer patients treated with neoadjuvant chemotherapy, residual disease at surgery is the most relevant unfavorable prognostic factor. Current guidelines consider the use of adjuvant capecitabine, based on the results of the randomized CREATE-X study, carried out in Asian patients and including a small subset of triple negative tumors. Thus far, evidence on Caucasian patients is limited, and no real-world data are available., Methods: We carried out a multicenter, observational study, involving 44 oncologic centres. Triple negative breast cancer patients with residual disease, treated with adjuvant capecitabine from January 2017 through June 2021, were recruited. We primarily focused on treatment tolerability, with toxicity being reported as potential cause of treatment discontinuation. Secondarily, we assessed effectiveness in the overall study population and in a subset having a minimum follow-up of 2 years., Results: Overall, 270 patients were retrospectively identified. The 50.4% of the patients had residual node positive disease, 7.8% and 81.9% had large or G3 residual tumor, respectively, and 80.4% a Ki-67 >20%. Toxicity-related treatment discontinuation was observed only in 10.4% of the patients. In the whole population, at a median follow-up of 15 months, 2-year disease-free survival was 62%, 2 and 3-year overall survival 84.0% and 76.2%, respectively. In 129 patients with a median follow-up of 25 months, 2-year disease-free survival was 43.4%, 2 and 3-year overall survival 78.0% and 70.8%, respectively. Six or more cycles of capecitabine were associated with more favourable outcomes compared with less than six cycles., Conclusion: The CaRe study shows an unexpectedly good tolerance of adjuvant capecitabine in a real-world setting, although effectiveness appears to be lower than that observed in the CREATE-X study. Methodological differences between the two studies impose significant limits to comparability concerning effectiveness, and strongly invite further research., Competing Interests: LP received speaker fees from Novartis, outside the submitted work. UDG: Pfizer, BMS, MSD, PharmaMAR, AStellas, Bayer, Ipsen, Novartis; Invited speaker Roche, BMS, SAnofi, AstraZeneca; received research grants from AstraZeneca, SAnofi, Roche, outside the submitted work. AF received honoraria as a speaker from Eli Lilly, Novartis, Pierre-Fabre, outside the submitted work. GT: advisory boards from Novartis, Pfizer, Eisai, Roche, and Eli Lilly, outside the submitted work. DS: advisory boards from Novartis, Pfizer, Eisai, Roche, and Eli Lilly, outside the submitted work. NLV: Roche, MSD, Eisai, Novartis, AstraZeneca, GSK, Pfizer, Gentili, Daiichi Sankyo, Dephaforum, outside the submitted work. OG: Eisai, MSD, Gilead, Seagen, Novartis, Eli Lilly, outside the submitted work. IM: advisory boards from Eli Lilly, Novartis, Gentili, Roche, Pfizer, Ipsen, and Pierre-Fabre, outside the submitted work. GD’A: Novartis, Amgen, Eli Lilly outside the submitted work. TG received travel grants from Eisai, Roche, Pfizer, and Novartis; speaker fees/advisory boards from Roche, Pfizer, Novartis, Gentili, and Eli Lilly, outside the submitted work. MPi Consultant/advisory boards from Gilead, Eli Lilly, Pfizer, Novartis, Gentili, MSD, outside the submitted work. RB received research grant/advisory boards from AstraZeneca, Boehringer Ingelheim, Novartis, MSD, Otsuka, Eli Lilly, Roche, Amgen, GSK, Eisai, outside the submitted work. FGi: advisory boards from Gilead, Daiichi Sankyo, Seagen, outside the submitted work. MEC consultant/advisory role for Pierre-Fabre, Roche, Novartis, Eli Lilly, Celgene, outside the submitted work. RT: AstraZeneca, Eisai, Pfizer, Eli Lilly, MSD, Exact Science, outside the submitted work. AB: MSD, BMS, Pfizer, Novartis, Roche outside the submitted work. AM received travel grants from Eisai, Celgene, and Novartis Ipsen; personal fees/advisory boards from Eisai, Novartis, AstraZeneca, Teva, Pfizer, and Celgene, outside the submitted work. IP received personal fees/advisory boards from Roche, Pfizer, Novartis, Italfarmaco, Gentili, and Pierre-Fabre. LG received congress travel accomodation from Roche, Daiichi Sankyo, AstraZeneca, Pfizer, Novartis; advisory role for Astra Zeneca outside the submitted work. MMin: Novartis, MSD, Eli Lilly, outside the submitted work. LM received personal fees/advisory board from Roche, Novartis, Eisai, and Pfizer, outside the submitted work. EC: Astellas, Roche, BMS, Jansen, MSD, Sirtex, Merck, Bayer, Servier, Novartis, outside the submitted work. PM has/had a consultant/advisory role for BMS, Roche, Genentech, MSD, Novartis, Amgen, Merck Serono, Pierre-Fabre and Incyte, outside the submitted work. PV received speaker fees/advisory boards from Roche, Pfizer, Novartis and Eli Lilly, outside the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Di Lisa, Krasniqi, Pizzuti, Barba, Cannita, De Giorgi, Borella, Foglietta, Cariello, Ferro, Picardo, Mitidieri, Sini, Stani, Tonini, Santini, La Verde, Gambaro, Grassadonia, Tinari, Garrone, Sarobba, Livi, Meattini, D’Auria, Vergati, Gamucci, Pistelli, Berardi, Risi, Giotta, Lorusso, Rinaldi, Artale, Cazzaniga, Zustovich, Cappuzzo, Landi, Torrisi, Scagnoli, Botticelli, Michelotti, Fratini, Saltarelli, Paris, Muratore, Cassano, Gianni, Gaspari, Veltri, Zoratto, Fiorio, Fabbri, Mazzotta, Ruggeri, Pedersini, Valerio, Filomeno, Minelli, Scavina, Raffaele, Astone, De Vita, Pozzi, Riccardi, Greco, Moscetti, Giordano, Maugeri-Saccà, Zennaro, Botti, Pelle, Cappelli, Cavicchi, Vizza, Sanguineti, Tomao, Cortesi, Marchetti, Tomao, Speranza, Sperduti, Ciliberto and Vici.)

Published
2023
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43. [Hormone therapy, cardio-metabolic profile and cardiotoxicity. Still a dark side of cardio-oncology. Part 1: Breast cancer].

Author

Tarantini L, Foglietta J, Gori S, Pinto C, Russo A, and Navazio A

Subjects
Cardiotoxicity etiology, Cardiotoxicity prevention & control, Female, Hormones, Humans, Metabolome, Antineoplastic Agents, Breast Neoplasms drug therapy
Abstract

Hormone therapy with anti-estrogenic purposes is a cornerstone in breast cancer therapy that expresses estrogen receptors, the most frequent immunohistotype among invasive breast cancer. Hormone therapy is administered for a long time and affects the cardio-metabolic profile with possible interactions with the woman's intrinsic cardiovascular risk and the cardiotoxic effects of other treatments (chemotherapy, radiotherapy, target therapy). In this review, we analyze the pathophysiological implications and cardiovascular effects of hormone therapy providing useful elements for the creation of a personalized management program based on the "stepwise approach" as recommended by the 2021 cardiovascular disease prevention guidelines of the European Society of Cardiology and on the possible use of new antidiabetic drugs potentially useful for the management of the metabolic syndrome.

Published
2022
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44. PANHER study: a 20-year treatment outcome analysis from a multicentre observational study of HER2-positive advanced breast cancer patients from the real-world setting.

Author

Pizzuti L, Krasniqi E, Sperduti I, Barba M, Gamucci T, Mauri M, Veltri EM, Meattini I, Berardi R, Di Lisa FS, Natoli C, Pistelli M, Iezzi L, Risi E, D'Ostilio N, Tomao S, Ficorella C, Cannita K, Riccardi F, Cassano A, Bria E, Fabbri MA, Mazzotta M, Barchiesi G, Botticelli A, D'Auria G, Ceribelli A, Michelotti A, Russo A, Salimbeni BT, Sarobba G, Giotta F, Paris I, Saltarelli R, Marinelli D, Corsi D, Capomolla EM, Sini V, Moscetti L, Mentuccia L, Tonini G, Raffaele M, Marchetti L, Minelli M, Ruggeri EM, Scavina P, Bacciu O, Salesi N, Livi L, Tinari N, Grassadonia A, Fedele Scinto A, Rossi R, Valerio MR, Landucci E, Stani S, Fratini B, Maugeri-Saccà M, De Tursi M, Maione A, Santini D, Orlandi A, Lorusso V, Cortesi E, Sanguineti G, Pinnarò P, Cappuzzo F, Landi L, Botti C, Tomao F, Cappelli S, Bon G, Pelle F, Cavicchi F, Fiorio E, Foglietta J, Scagnoli S, Marchetti P, Ciliberto G, and Vici P

Abstract

Background: The evolution of therapeutic landscape of human epidermal growth factor receptor-2 (HER2)-positive breast cancer (BC) has led to an unprecedented outcome improvement, even if the optimal sequence strategy is still debated. To address this issue and to provide a picture of the advancement of anti-HER2 treatments, we performed a large, multicenter, retrospective study of HER2-positive BC patients., Methods: The observational PANHER study included 1,328 HER2-positive advanced BC patients treated with HER2 blocking agents since June 2000 throughout July 2020. Endpoints of efficacy were progression-free survival (PFS) and overall survival (OS)., Results: Patients who received a first-line pertuzumab-based regimen showed better PFS ( p < 0.0001) and OS ( p = 0.004) than those receiving other treatments. Median PFS and mOS from second-line starting were 8 and 28 months, without significant differences among various regimens. Pertuzumab-pretreated patients showed a mPFS and a mOS from second-line starting not significantly affected by type of second line, that is, T-DM1 or lapatinib/capecitabine ( p = 0.80 and p = 0.45, respectively). Conversely, pertuzumab-naïve patients receiving second-line T-DM1 showed a significantly higher mPFS compared with that of patients treated with lapatinib/capecitabine ( p = 0.004). Median OS from metastatic disease diagnosis was higher in patients treated with trastuzumab-based first line followed by second-line T-DM1 in comparison to pertuzumab-based first-line and second-line T-DM1 ( p = 0.003), although these data might be partially influenced by more favorable prognostic characteristics of patients in the pre-pertuzumab era . No significant differences emerged when comparing patients treated with 'old' or 'new' drugs ( p = 0.43), even though differences in the length of the follow-up between the two cohorts should be taken into account., Conclusion: Our results confirmed a relevant impact of first-line pertuzumab-based treatment and showed lower efficacy of second-line T-DM1 in trastuzumab/pertuzumab pretreated, as compared with pertuzumab-naïve patients. Our findings may help delineate a more appropriate therapeutic strategy in HER2-positive metastatic BC. Prospective randomized trials addressing this topic are awaited., Competing Interests: Conflict of interest statement: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: EK, IS, MB, MM, MMaz, EMV, IM, RB, FSDL, MP, LI, ER, NDO, ST, CF, KC, FR, AC, MAF, GB, AB, GDA, AC, AR, BTS, GS, FG, RS, DM, DC, EMC, VS, LMe, GT, MR, LM, MMi, EMR, PS, NS, LL, NT, AG, AFS, RR, MRV, EL, SS, BF, MMS, MDT, AM, AO, VL, EC, GS, PP, FC, LL, CB, FT, SC, GB, FP, FCav, OB, EF, JF, SS, and GC declare no conflicts of interest. LP received travel grants from Eisai, Roche, Pfizer, and Novartis; speaker fees from Roche, Pfizer, Novartis, and Gentili. TG received travel grants from Eisai, Roche, Pfizer, and Novartis; speaker fees/advisory boards from Roche, Pfizer, Novartis, Gentili, and Lilly. CN received travel grants/personal fees from Pfizer, Eisai, Novartis, Merck Sharp & Dohme, and AstraZeneca. EB is supported by the Italian Association for Cancer Research AIRC-IG 20583; he was supported by the International Association for Lung Cancer (IASLC), the LILT (Lega Italiana per la Lotta contro I Tumori), and Fondazione Cariverona; he received speakers’ and travels’ fee from MSD, AstraZeneca, Celgene, Pfizer, Helsinn, Eli Lilly, BMS, Novartis, and Roche; consultant’s fee from Roche, Pfizer; institutional research grants from AstraZeneca and Roche. AM received travel grants from Eisai, Celgene, and Novartis Ipsen; personal fees, advisory boards from Eisai, Novartis, AstraZeneca, Teva, Pfizer, and Celgene. IP received personal fees/advisory boards from Roche, Pfizer, Novartis, Italfarmaco, Gentili, and Pierre Fabre. LM received personal fees/advisory board from Roche, Novartis, Eisai, and Pfizer. GT and DS: advisory board Novartis, Pfizer, Eisai, Roche, and Eli Lilly. PM has/had a consultant/advisory role for BMS, Roche Genentech, MSD, Novartis, Amgen, Merck Serono, Pierre Fabre, and Incyte. PV received travel grants from Eisai, Roche, Pfizer, and Novartis; speaker fees/advisory boards from Roche, Pfizer, Novartis, Gentili, and Eli Lilly., (© The Author(s), 2021.)

Published
2021
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45. Overall Survival in Metastatic Breast Cancer Patients in the Third Millennium: Results of the COSMO Study.

Author

La Verde N, Collovà E, Blasi L, Pinotti G, Palumbo R, Bonotto M, Garrone O, Brunello A, Rimanti A, Bareggi C, Zaniboni A, Frassoldati A, Foglietta J, Berardi R, Moretti A, Farina G, Porcu L, and Barni S

Subjects
Aged, Breast Neoplasms pathology, Disease-Free Survival, Female, Humans, Middle Aged, Neoplasm Metastasis, Neoplasms, Second Primary mortality, Neoplasms, Second Primary pathology, Prognosis, Retrospective Studies, Survival Rate, Breast Neoplasms mortality, Cancer Survivors statistics & numerical data
Abstract

Introduction: Metastatic breast cancer (MBC) is a life-threatening disease, and although some data suggest a trend in survival improvement, it has not yet been unequivocally demonstrated. This study aimed to evaluate the overall survival (OS) of MBC patients, assessing its correlation with prognostic factors., Patients and Methods: COSMO (Checking Overall Survival in a MBC Observational study) is an Italian longitudinal retrospective multicenter study that enrolled patients with MBC diagnosed between 2000 and 2008. The primary objective was to detect a temporal difference in OS; the secondary objective was to identify prognostic factors as causal factors of the temporal variation in OS., Results: A total of 3721 of 3930 patients from 31 centers were distributed in 3 periods: 886 (23.8%), 1302 (35.0%), and 1533 (41.2%) in 2000-2002, 2003-2005, and 2006-2008, respectively. With a median follow-up of 9.3 years, median OS was 2.8 years (95% confidence interval, 2.6-2.9). No difference in OS was found in the 3 cohorts (P for trend = .563). The worst prognosis was observed for patients with triple-negative MBC (OS, 1.5 years) and for those with central nervous system metastases (1.7 years); the best prognosis was observed in those with bone metastases or nonvisceral disease (3.4 and 3.2 years, respectively) and in patients with a disease-free interval, defined as the time between resection of the primary malignancy and diagnosis of MBC, of > 2 years (3 years)., Conclusions: The COSMO study found improvement in OS between 2000 and 2008. Molecular subtype remained the strongest prognostic factor, and the role of other prognostic factors was confirmed, in particular disease-free interval, site of metastasis, and age., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2021
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46. Prevalence and Spectrum of BRCA Germline Variants in Central Italian High Risk or Familial Breast/Ovarian Cancer Patients: A Monocentric Study.

Author

Foglietta J, Ludovini V, Bianconi F, Pistola L, Reda MS, Al-Refaie A, Tofanetti FR, Mosconi A, Minenza E, Anastasi P, Molica C, Stracci F, and Roila F

Subjects
Adult, Aged, Aged, 80 and over, DNA Mutational Analysis, Female, Genetic Predisposition to Disease, Genetic Testing, Hereditary Breast and Ovarian Cancer Syndrome diagnosis, Humans, Immunohistochemistry, Italy epidemiology, Middle Aged, Mutation Rate, Pedigree, Population Surveillance, Prevalence, Risk Assessment, Risk Factors, Young Adult, Genes, BRCA1, Genes, BRCA2, Germ-Line Mutation, Hereditary Breast and Ovarian Cancer Syndrome epidemiology, Hereditary Breast and Ovarian Cancer Syndrome genetics
Abstract

Hereditary breast and ovarian cancers are mainly linked to variants in BRCA1 /2 genes. Recently, data has shown that identification of BRCA variants has an immediate impact not only in cancer prevention but also in targeted therapeutic approaches. This prospective observational study characterized the overall germline BRCA variant and variant of uncertain significance (VUS) frequency and spectrum in individuals affected by breast (BC) or ovarian cancer (OC) and in healthy individuals at risk by sequencing the entire BRCA genes. Of the 363 probands analyzed, 50 (13.8%) were BRCA1/2 mutated, 28 (7.7%) at BRCA1 and 23 (6.3%) at BRCA2 gene. The variant c.5266dupC p.(Gln1756Profs) was the most frequent alteration, representing 21.4% of the BRCA1 variants and 12.0% of all variants identified. The variant c.6313delA p.(Ile2105Tyrfs) of BRCA2 was the most frequent alteration observed in 6 patients. Interestingly, two new variants were identified in BRCA2 . In addition, 25 different VUS were identified; two were reported for the first time in BRCA1 and two in BRCA2 . The number of triple-negative BCs was significantly higher in patients with the pathogenic BRCA1/2 -variant (36.4%) than in BRCA1/2 VUS (16.0%) and BRCA1/2 wild-type patients (10.7%) ( p < 0.001). Our study reveals that the overall frequency of BRCA germline variants in the selected high-risk Italian population is about 13.8%. We believe that our results could have significant implications for preventive strategies for unaffected BRCA -carriers and effective targeted treatments such as PARP inhibitors for patients with BC or OC.

Published
2020
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47. Distinct HR expression patterns significantly affect the clinical behavior of metastatic HER2+ breast cancer and degree of benefit from novel anti-HER2 agents in the real world setting.

Author

Pizzuti L, Krasniqi E, Barchiesi G, Della Giulia M, Izzo F, Sanguineti G, Marchetti P, Mazzotta M, Giusti R, Botticelli A, Gamucci T, Natoli C, Grassadonia A, Tinari N, Iezzi L, Tomao S, Tomao F, Tonini G, Santini D, Astone A, Michelotti A, De Angelis C, Mentuccia L, Vaccaro A, Magnolfi E, Gelibter A, Magri V, Cortesi E, D'Onofrio L, Cassano A, Rossi E, Cazzaniga M, Moscetti L, Omarini C, Piacentini F, Fabbri MA, Scinto AF, Corsi D, Carbognin L, Bria E, La Verde N, Samaritani R, Garufi C, Barni S, Mirabelli R, Sarmiento R, Veltri EM, D'Auria G, Paris I, Giotta F, Lorusso V, Cardillo F, Landucci E, Mauri M, Ficorella C, Roselli M, Adamo V, Ricciardi GRR, Russo A, Berardi R, Pistelli M, Fiorio E, Cannita K, Sini V, D'Ostilio N, Foglietta J, Greco F, Zamagni C, Garrone O, Di Cocco B, Baldini E, Livi L, Desideri I, Meattini I, Sarobba G, Del Medico P, De Tursi M, Generali D, De Maria R, Risi E, Ciliberto G, Sperduti I, Villa A, Barba M, Di Leo A, and Vici P

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Biomarkers, Tumor, Breast Neoplasms drug therapy, Breast Neoplasms mortality, Female, Humans, Immunohistochemistry, Middle Aged, Molecular Targeted Therapy, Neoplasm Metastasis, Neoplasm Staging, Prognosis, Receptor, ErbB-2 metabolism, Receptors, Estrogen metabolism, Receptors, Progesterone metabolism, Breast Neoplasms diagnosis, Breast Neoplasms genetics, Gene Expression Regulation, Neoplastic, Receptor, ErbB-2 genetics, Receptors, Estrogen genetics, Receptors, Progesterone genetics
Abstract

We analyzed data from 738 HER2-positive metastatic breast cancer (mbc) patients treated with pertuzumab-based regimens and/or T-DM1 at 45 Italian centers. Outcomes were explored in relation to tumor subtype assessed by immunohistochemistry (IHC). The median progression-free survival at first-line (mPFS1) was 12 months. Pertuzumab as first-line conferred longer mPFS1 compared to other first-line treatments (16 vs. 9 months, p = 0.0001), regardless of IHC subtype. Median PFS in second-line (mPFS2) was 7 months, with no difference by IHC subtype, but it was more favorable with T-DM1 compared to other agents (7 vs. 6 months, p = 0.03). There was no PFS2 gain in patients with tumors expressing both hormonal receptors (HRs; p = 0.17), while a trend emerged for tumors with one HR (p = 0.05). Conversely, PFS2 gain was significant in HRs-negative tumors (p = 0.04). Median overall survival (mOS) was 74 months, with no significant differences by IHC subtypes. Survival rates at 2 and 3 years in patients treated with T-DM1 in second-line after pertuzumab were significantly lower compared to pertuzumab-naïve patients (p = 0.01). When analyzed by IHC subtype, the outcome was confirmed if both HRs or no HRs were expressed (p = 0.02 and p = 0.006, respectively). Our results confirm that HRs expression impacts the clinical behavior and novel treatment-related outcomes of HER2-positive tumors when treatment sequences are considered. Moreover, multivariate analysis showed that HRs expression had no effect on PFS and OS. Further studies are warranted to confirm our findings and clarify the interplay between HER2 and estrogen receptor pathways in HER2-positive (mbc) patients., (© 2019 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)

Published
2020
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48. The HERBA Study: A Retrospective Multi-Institutional Italian Study on Patients With Brain Metastases From HER2-Positive Breast Cancer.

Author

Gori S, Puglisi F, Moroso S, Fabi A, La Verde N, Frassoldati A, Tarenzi E, Garrone O, Vici P, Laudadio L, Cretella E, Turazza M, Foglietta J, Leonardi V, Cavanna L, Barni S, Galanti D, Russo A, Marchetti F, Valerio M, Lunardi G, Alongi F, and Inno A

Subjects
Adult, Aged, Breast Neoplasms metabolism, Breast Neoplasms pathology, Combined Modality Therapy, Female, Follow-Up Studies, Humans, Middle Aged, Neoplasm Recurrence, Local metabolism, Neoplasm Recurrence, Local pathology, Prognosis, Retrospective Studies, Survival Rate, Biomarkers, Tumor metabolism, Breast Neoplasms therapy, Neoplasm Recurrence, Local therapy, Receptors, Estrogen metabolism
Abstract

Background: There is no sufficient evidence to establish a standard of care for patients with brain metastases (BM) from HER2 + breast cancer (BC). The aim of this study was to assess the impact of local and systemic treatments on the outcome of patients diagnosed with BM from HER2 + BC over a period of 10 years, from 2005 to 2014., Patients and Methods: Data of 154 patients were retrospectively collected at 14 Italian institutions through a specifically designed database., Results: Median overall survival (OS) was 24.5 months. Patients receiving surgery/stereotactic radiosurgery experienced longer OS compared to those receiving whole-brain radiotherapy or no treatment (33.5 vs. 11.4 months; hazard ratio = 0.34; 95% confidence interval, 0.22-0.52; P < .001). Interestingly, whole-brain radiotherapy did not improve OS compared to no treatment (11.4 vs. 9.8 months; hazard ratio = 0.99; 95% confidence interval, 0.62-1.62; P = .99). HER2-targeted therapy was associated with better OS compared to systemic therapy without HER2-targeted therapy or no systemic therapy (27.5 vs. 5.4 months; hazard ratio = 0.26; 95% confidence interval, 0.17-0.41; P < .001). At multivariate analysis stratified by local treatments, systemic therapy, Karnofsky performance status, and neurologic symptoms significantly affected OS. Age, number of BM, steroid therapy, number of previous lines of systemic therapy, status of extracranial disease, and period of diagnosis had no significant impact on OS., Conclusion: Patients with BM from HER2 + BC treated with surgery/stereotactic radiosurgery as local treatment and HER2-targeted therapy as systemic treatment experienced the best outcomes. Patients with low Karnofsky performance status and neurologic symptoms had poor survival., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Published
2019
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49. Enzymes involved in tumor-driven angiogenesis: A valuable target for anticancer therapy.

Author

Ricciuti B, Foglietta J, Bianconi V, Sahebkar A, and Pirro M

Subjects
Animals, Antineoplastic Agents therapeutic use, Biomarkers, Tumor antagonists & inhibitors, Biomarkers, Tumor metabolism, Enzyme Inhibitors therapeutic use, Gene Expression Regulation, Enzymologic drug effects, Gene Expression Regulation, Neoplastic drug effects, Humans, Molecular Targeted Therapy, Neoplasms drug therapy, Neoplasms etiology, Neovascularization, Pathologic drug therapy, Signal Transduction drug effects, Antineoplastic Agents pharmacology, Enzyme Inhibitors pharmacology, Neoplasms enzymology, Neoplasms pathology, Neovascularization, Pathologic enzymology
Abstract

Angiogenesis plays a pivotal role in cancer progression and is required for tissue invasion and metastasis. Starting with Folkman's initial observations in 1971, basic research continued to shed new molecular insight into this multifaceted process, leading to the development of several anti-angiogenic drugs. To date, anti-vascular endothelial growth factor monoclonal antibodies, such as bevacizumab and ramucirumab, and receptor tyrosine kinase inhibitors (e.g., sorafenib, sunitinib, regorafenib and axitinib) have had a profound impact on the way we treat patients with advanced cancer, providing in some cases unprecedented clinical benefit. The molecular mechanisms underlying tumor-driven angiogenesis have been explored extensively and have unveiled a number of potential clinically relevant targets, including several novel enzymes. In this review, we summarized the current strategies to target tumor-driven angiogenesis through the inhibition of relevant and selected classes of enzymes involved in this process., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Published
2019
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50. A multicenter REtrospective observational study of first-line treatment with PERtuzumab, trastuzumab and taxanes for advanced HER2 positive breast cancer patients. RePer Study.

Author

Gamucci T, Pizzuti L, Natoli C, Mentuccia L, Sperduti I, Barba M, Sergi D, Iezzi L, Maugeri-Saccà M, Vaccaro A, Magnolfi E, Gelibter A, Barchiesi G, Magri V, D'Onofrio L, Cassano A, Rossi E, Botticelli A, Moscetti L, Omarini C, Fabbri MA, Scinto AF, Corsi D, Carbognin L, Mazzotta M, Bria E, Foglietta J, Samaritani R, Garufi C, Mariani L, Barni S, Mirabelli R, Sarmiento R, Graziano V, Santini D, Marchetti P, Tonini G, Di Lauro L, Sanguineti G, Paoletti G, Tomao S, De Maria R, Veltri E, Paris I, Giotta F, Latorre A, Giordano A, Ciliberto G, and Vici P

Subjects
Antibodies, Monoclonal, Humanized pharmacology, Antineoplastic Combined Chemotherapy Protocols pharmacology, Breast Neoplasms pathology, Female, Humans, Middle Aged, Retrospective Studies, Taxoids pharmacology, Trastuzumab pharmacology, Antibodies, Monoclonal, Humanized therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy, Taxoids therapeutic use, Trastuzumab therapeutic use
Abstract

We carried out a retrospective observational study of 264 HER2-positive advanced breast cancer (ABC) patients to explore the efficacy of first-line treatment with pertuzumab/trastuzumab/taxane in real-world setting. Survival data were analyzed by Kaplan Meier curves and log rank test. Median follow-up, length of pertuzumab/trastuzumab/taxane treatment and of pertuzumab, trastuzumab maintenance were 21, 4 and 15 months, respectively. The response rate was 77.3%, and the clinical benefit rate 93.6%. Median progression-free survival (mPFS) was 21 months, and median overall survival (mOS) was not reached. When comparing patients by trastuzumab-pretreatment, similar PFS were observed, although a longer OS was reached in trastuzumab-naïve patients (p = 0.02). Brain metastases at baseline and their development in course of therapy were associated with significantly shorter PFS (p = 0.0006) and shorter OS, although at a not fully statistically relevant extent (p = 0.06). The addition of maintenance endocrine therapy (ET) to pertuzumab/trastuzumab maintenance was associated with longer PFS (p = 0.0001), although no significant differences were detected in OS (p = 0.31). Results were confirmed by propensity score analysis (p = 0.003 and p = 0.46, respectively). In multivariate models, longer PFS was related to lower Performance Status (PS) (p = 0.07), metastatic stage at diagnosis (p = 0.006) and single metastatic site (p < 0.0001). An OS advantage was observed with lower PS (p < 0.0001), single metastatic site (p = 0.004), no prior exposure to trastuzumab (p = 0.004) and response to pertuzumab-based treatment (p = 0.003). Our results confirm that trastuzumab/pertuzumab/taxane is the standard of care as first-line treatment of patients with HER2-positive ABC even in the real-world setting. Moreover, the double-maintenance therapy (HER2 block and ET) is strongly recommended when feasible.

Published
2019
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