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233 results on '"Lauria R."'

1. Eribulin in combination with bevacizumab as second-line treatment for HER2-negative metastatic breast cancer progressing after first-line therapy with paclitaxel and bevacizumab: a multicenter, phase II, single arm trial (GIM11-BERGI)

Author

De Angelis, C., Bruzzese, D., Bernardo, A., Baldini, E., Leo, L., Fabi, A., Gamucci, T., De Placido, P., Poggio, F., Russo, S., Forestieri, V., Lauria, R., De Santo, I., Michelotti, A., Del Mastro, L., De Laurentiis, M., Giuliano, M., De Placido, S., and Arpino, G.

Published
2021
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2. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial

Author

Pignata, S, Lorusso, D, Joly, F, Gallo, C, Colombo, N, Sessa, C, Bamias, A, Salutari, V, Selle, F, Frezzini, S, De Giorgi, U, Pautier, P, Bologna, A, Orditura, M, Dubot, C, Gadducci, A, Mammoliti, S, Ray-Coquard, I, Zafarana, E, Breda, E, Favier, L, Ardizzoia, A, Cinieri, S, Largillier, R, Sambataro, D, Guardiola, E, Lauria, R, Pisano, C, Raspagliesi, F, Scambia, G, Daniele, G, Perrone, F, Pignata, Sandro, Lorusso, Domenica, Joly, Florence, Gallo, Ciro, Colombo, Nicoletta, Sessa, Cristiana, Bamias, Aristotelis, Salutari, Vanda, Selle, Frédèric, Frezzini, Simona, De Giorgi, Ugo, Pautier, Patricia, Bologna, Alessandra, Orditura, Michele, Dubot, Coraline, Gadducci, Angiolo, Mammoliti, Serafina, Ray-Coquard, Isabelle, Zafarana, Elena, Breda, Enrico, Favier, Laure, Ardizzoia, Antonio, Cinieri, Saverio, Largillier, Rémy, Sambataro, Daniela, Guardiola, Emmanuel, Lauria, Rossella, Pisano, Carmela, Raspagliesi, Francesco, Scambia, Giovanni, Daniele, Gennaro, and Perrone, Francesco

Published
2021
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3. Weekly docetaxel versus CMF as adjuvant chemotherapy for older women with early breast cancer: final results of the randomized phase III ELDA trial

Author

Perrone, F., Nuzzo, F., Di Rella, F., Gravina, A., Iodice, G., Labonia, V., Landi, G., Pacilio, C., Rossi, E., De Laurentiis, M., D'Aiuto, M., Botti, G., Forestieri, V., Lauria, R., De Placido, S., Tinessa, V., Daniele, B., Gori, S., Colantuoni, G., Barni, S., Riccardi, F., De Maio, E., Montanino, A., Morabito, A., Daniele, G., Di Maio, M., Piccirillo, M.C., Signoriello, S., Gallo, C., and de Matteis, A.

Published
2015
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4. 52P Real-world data of niraparib in platinum sensitive relapsed ovarian cancer: A multicenter experience of the MITO group

Author

Musacchio, L., primary, Palluzzi, E., additional, Lauria, R., additional, Di Napoli, M., additional, Corrado, G., additional, Bergamini, A., additional, Salutari, V., additional, Marchetti, C., additional, Angioli, R., additional, Cassani, C., additional, Gori, S., additional, Palaia, I., additional, Savarese, A., additional, Raspagliesi, F., additional, Mosconi, A.M., additional, Zafarana, E., additional, De Angelis, C., additional, Ferrandina, G., additional, Scambia, G., additional, and Lorusso, D., additional

Published
2023
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5. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial

Author

Pignata, S. Lorusso, D. Joly, F. Gallo, C. Colombo, N. Sessa, C. Bamias, A. Salutari, V. Selle, F. Frezzini, S. De Giorgi, U. Pautier, P. Bologna, A. Orditura, M. Dubot, C. Gadducci, A. Mammoliti, S. Ray-Coquard, I.L. Zafarana, E. Breda, E. Favier, L. Ardizzoia, A. Cinieri, S. Largillier, R. Sambataro, D. Guardiola, E. Lauria, R. Pisano, C. Raspagliesi, F. Scambia, G. Daniele, G. Perrone, F. Joly, F. Gallo, C. Colombo, N. Sessa, C. Bamias, A. Salutari, V. Selle, F. Frezzini, S. Bologna, A. Orditura, M. Dubot, C. Gadducci, A. Mammoliti, S. Zafarana, E. Breda, E. Favier, L. Ardizzoia, A. Cinieri, S. Largillier, R. Sambataro, D. Guardiola, E. Lauria, R. Pisano, C. Raspagliesi, F. Scambia, G. Daniele, G. Perrone, F. MITO16b/MANGO-OV2/ENGOT-ov17 Investigators and Pignata, S. Lorusso, D. Joly, F. Gallo, C. Colombo, N. Sessa, C. Bamias, A. Salutari, V. Selle, F. Frezzini, S. De Giorgi, U. Pautier, P. Bologna, A. Orditura, M. Dubot, C. Gadducci, A. Mammoliti, S. Ray-Coquard, I.L. Zafarana, E. Breda, E. Favier, L. Ardizzoia, A. Cinieri, S. Largillier, R. Sambataro, D. Guardiola, E. Lauria, R. Pisano, C. Raspagliesi, F. Scambia, G. Daniele, G. Perrone, F. Joly, F. Gallo, C. Colombo, N. Sessa, C. Bamias, A. Salutari, V. Selle, F. Frezzini, S. Bologna, A. Orditura, M. Dubot, C. Gadducci, A. Mammoliti, S. Zafarana, E. Breda, E. Favier, L. Ardizzoia, A. Cinieri, S. Largillier, R. Sambataro, D. Guardiola, E. Lauria, R. Pisano, C. Raspagliesi, F. Scambia, G. Daniele, G. Perrone, F. MITO16b/MANGO-OV2/ENGOT-ov17 Investigators

Abstract

Background: Bevacizumab is approved in combination with chemotherapy for the treatment of ovarian cancer, either in first-line therapy or for patients with recurrent disease not previously treated with the same drug. We aimed to test the value of continuing bevacizumab beyond progression after first-line treatment with the same drug. Methods: In our open-label, randomised, phase 3 trial done at 82 sites in four countries, we enrolled women (aged ≥18 years) who had previously received first-line platinum-based therapy including bevacizumab, and had recurrent (≥6 months since last platinum dose), International Federation of Gynaecology and Obstetrics stage IIIB–IV ovarian cancer with an Eastern Cooperative Oncology Group performance status 0–2. Patients were randomly assigned (1:1) to receive a carboplatin-based doublet intravenously (carboplatin area under the concentration curve [AUC] 5 on day 1 plus paclitaxel 175 mg/m2 on day 1, every 21 days; carboplatin AUC 4 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8, every 21 days; or carboplatin AUC 5 on day 1 plus pegylated liposomal doxorubicin 30 mg/m2 on day 1, every 28 days), or a carboplatin-based doublet plus bevacizumab (10 mg/kg intravenous every 14 days combined with pegylated liposomal doxorubicin–carboplatin, or 15 mg/kg every 21 days combined with gemcitabine–carboplatin or paclitaxel–carboplatin). Evaluable disease according to RECIST 1.1 guidelines was required before randomisation. Randomisation was done through the trial website with a minimisation procedure, stratified by centre, time of recurrence, performance status, and type of second-line chemotherapy. The primary endpoint was investigator-assessed progression-free survival, analysed on an intention-to-treat basis. Safety was assessed in all participants who received at least one dose. This trial is registered with ClinicalTrials.gov, NCT01802749 and EudraCT 2012-004362-17. Findings: Between Dec 6, 2013, and Nov 11, 2016, 406 patients were recr

Published
2021

6. Thromboembolic events and antithrombotic prophylaxis in advanced ovarian cancer patients treated with bevacizumab: secondary analysis of the phase IV MITO-16A/MaNGO-OV2A trial

Author

Di Liello, R, Arenare, L, Raspagliesi, F, Scambia, G, Pisano, C, Colombo, N, Frezzini, S, Tognon, G, Artioli, G, Gadducci, A, Lauria, R, Ferrero, A, Cinieri, S, De Censi, A, Breda, E, Scollo, P, De Giorgi, U, Lissoni, A, Katsaros, D, Lorusso, D, Salutari, V, Cecere, S, Lapresa, M, Nardin, M, Bogani, G, Distefano, M, Greggi, S, Gargiulo, P, Schettino, C, Gallo, C, Daniele, G, Califano, D, Perrone, F, Pignata, S, Piccirillo, M, Di Liello R., Arenare L., Raspagliesi F., Scambia G., Pisano C., Colombo N., Frezzini S., Tognon G., Artioli G., Gadducci A., Lauria R., Ferrero A., Cinieri S., De Censi A., Breda E., Scollo P., De Giorgi U., Lissoni A. A., Katsaros D., Lorusso D., Salutari V., Cecere S. C., Lapresa M., Nardin M., Bogani G., Distefano M., Greggi S., Gargiulo P., Schettino C., Gallo C., Daniele G., Califano D., Perrone F., Pignata S., Piccirillo M. C., Di Liello, R, Arenare, L, Raspagliesi, F, Scambia, G, Pisano, C, Colombo, N, Frezzini, S, Tognon, G, Artioli, G, Gadducci, A, Lauria, R, Ferrero, A, Cinieri, S, De Censi, A, Breda, E, Scollo, P, De Giorgi, U, Lissoni, A, Katsaros, D, Lorusso, D, Salutari, V, Cecere, S, Lapresa, M, Nardin, M, Bogani, G, Distefano, M, Greggi, S, Gargiulo, P, Schettino, C, Gallo, C, Daniele, G, Califano, D, Perrone, F, Pignata, S, Piccirillo, M, Di Liello R., Arenare L., Raspagliesi F., Scambia G., Pisano C., Colombo N., Frezzini S., Tognon G., Artioli G., Gadducci A., Lauria R., Ferrero A., Cinieri S., De Censi A., Breda E., Scollo P., De Giorgi U., Lissoni A. A., Katsaros D., Lorusso D., Salutari V., Cecere S. C., Lapresa M., Nardin M., Bogani G., Distefano M., Greggi S., Gargiulo P., Schettino C., Gallo C., Daniele G., Califano D., Perrone F., Pignata S., and Piccirillo M. C.

Abstract

INTRODUCTION: The use of routine antithrombotic prophylaxis is not recommended for advanced cancer patients receiving chemotherapy. The effect of bevacizumab-containing therapy on the risk of thromboembolic events remains controversial in ovarian cancer patients. We report on the incidence of thromboembolic events and the prevalence of antithrombotic therapy in patients enrolled in the single arm, phase IV, MITO-16A/MaNGO-OV2A trial. METHODS: In this trial, potential prognostic factors for patients with previously untreated ovarian cancer receiving a combination of platinum-based chemotherapy and bevacizumab were explored and the final analysis has already been reported. In this secondary analysis, the occurrence of thromboembolic events and the use of antithrombotic therapy were described according to the clinical characteristics of the patients. The prognostic role of thromboembolic events for progression-free and overall survival were also evaluated. RESULTS: From October 2012 to November 2014, 398 eligible patients were enrolled. 76 patients (19.1%) were receiving some type of anticoagulant or anti-aggregant treatment at baseline. Overall, 24 thromboembolic events were reported (cumulative incidence of 6.0%). The occurrence of thromboembolic events was not associated with baseline patient characteristics and was not modified by the use of antithrombotic prophylaxis (HR 0.60, 95% CI 0.18 to 2.0). Occurrence of thromboembolic events was not associated with progression-free survival (HR 1.34, 95% CI 0.83 to 2.15) or overall survival (HR 0.78, 95% CI 0.37 to 1.61). CONCLUSIONS: In our study, a 6.0% rate of thromboembolic events was reported during treatment with bevacizumab plus chemotherapy. Thromboembolic events were not associated with the clinical characteristics of the patients or with the use of antithrombotic prophylaxis, nor did they significantly affect the long-term prognosis. TRIAL REGISTRATION NUMBER: NCT01706120.

Published
2021

8. 105P CDK4/6 inhibitors in hormone receptor-positive, HER2-negative, locally advanced breast cancer (LABC): Biological and clinical activity, and post-surgical approaches

Author

Parola, S., primary, Di Lauro, V., additional, De Placido, P., additional, Forestieri, V., additional, Buono, G., additional, von Arx, C., additional, Pietroluongo, E., additional, Pagliuca, M., additional, Cianniello, D., additional, Lauria, R., additional, Caputo, R., additional, Arpino, G., additional, de Placido, S., additional, Giuliano, M., additional, De Laurentiis, M., additional, and De Angelis, C., additional

Published
2022
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9. Sharing real-world experiences to optimize the management of olaparib toxicities: a practical guidance from an Italian expert panel

Author

Lorusso, D, Bologna, A, Cecere, S, De Matteis, E, Scandurra, G, Zamagni, C, Arcangeli, V, Artioli, F, Bella, M, Blanco, G, Cardalesi, C, Casartelli, C, De Vivo, R, Di Napoli, M, Gisone, E, Lauria, R, Lissoni, A, Loizzi, V, Maccaroni, E, Mangili, G, Marchetti, C, Martella, F, Naglieri, E, Parolin, V, Ricciardi, G, Ronzino, G, Salutari, V, Scarfone, G, Secondino, S, Spagnoletti, I, Tasca, G, Tognon, G, Guarneri, V, Lorusso D., Bologna A., Cecere S. C., De Matteis E., Scandurra G., Zamagni C., Arcangeli V., Artioli F., Bella M., Blanco G., Cardalesi C., Casartelli C., De Vivo R., Di Napoli M., Gisone E. B., Lauria R., Lissoni A. A., Loizzi V., Maccaroni E., Mangili G., Marchetti C., Martella F., Naglieri E., Parolin V., Ricciardi G., Ronzino G., Salutari V., Scarfone G., Secondino S., Spagnoletti I., Tasca G., Tognon G., Guarneri V., Lorusso, D, Bologna, A, Cecere, S, De Matteis, E, Scandurra, G, Zamagni, C, Arcangeli, V, Artioli, F, Bella, M, Blanco, G, Cardalesi, C, Casartelli, C, De Vivo, R, Di Napoli, M, Gisone, E, Lauria, R, Lissoni, A, Loizzi, V, Maccaroni, E, Mangili, G, Marchetti, C, Martella, F, Naglieri, E, Parolin, V, Ricciardi, G, Ronzino, G, Salutari, V, Scarfone, G, Secondino, S, Spagnoletti, I, Tasca, G, Tognon, G, Guarneri, V, Lorusso D., Bologna A., Cecere S. C., De Matteis E., Scandurra G., Zamagni C., Arcangeli V., Artioli F., Bella M., Blanco G., Cardalesi C., Casartelli C., De Vivo R., Di Napoli M., Gisone E. B., Lauria R., Lissoni A. A., Loizzi V., Maccaroni E., Mangili G., Marchetti C., Martella F., Naglieri E., Parolin V., Ricciardi G., Ronzino G., Salutari V., Scarfone G., Secondino S., Spagnoletti I., Tasca G., Tognon G., and Guarneri V.

Abstract

Olaparib is the first poly(ADP-ribose) polymerase inhibitor approved as maintenance therapy of recurrent ovarian cancer (OC) patients with a BRCA mutation. To achieve the maximum clinical benefit, adherence to olaparib must be persistent. However, in clinical practice, this is challenged by the frequent suboptimal management of toxicities. In view of the expanding use of olaparib also in Italy, physicians must learn how to adequately and promptly manage drug toxicities not to unnecessarily interrupt or reduce the dose. The experts agreed that nausea,vomiting, anemia, and fatigue are the most frequent events experienced by OC patients on olaparib, and that these toxicities usually develop early during treatment, are mainly of grade 1–2 and transient and can be managed with simple non-pharmacological interventions. By sharing their real-world experiences, the panel prepared, for each toxicity, an algorithm organized by grade and besides the procedures indicated in the local label, included supportive care interventions based also on nutritional and lifestyle modifications and psycho-oncology consultation. Moreover, in view of the tablet entry into the Italian market, the full and reduced dosages of capsules and tablets were compared. This practical guidance is intended to be a tool to support especially less-experienced physicians in the management of these complex patients, with the aim to help preventing the worsening of patients’ conditions and the unnecessary interruption/reduction of olaparib dosage, which may jeopardize treatment efficacy.

Published
2020

10. Corrigendum to ‘Eribulin in combination with bevacizumab as second-line treatment for HER2-negative metastatic breast cancer progressing after first-line therapy with paclitaxel and bevacizumab: a multicenter, phase II, single arm trial (GIM11-BERGI)’: [ESMO Open Volume 6, Issue 2, April 2021, 100054]

Author

De Angelis, C., Bruzzese, D., Bernardo, A., Baldini, E., Leo, L., Fabi, A., Gamucci, T., De Placido, P., Poggio, F., Russo, S., Forestieri, V., Lauria, R., De Santo, I., Caputo, R., Cianniello, D., Michelotti, A., Del Mastro, L., De Laurentiis, M., Giuliano, M., De Placido, S., and Arpino, G.

Published
2021
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12. MITO16b/MANGO–OV2/ENGOT–ov17 Investigators. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial

Author

Pignata, S, Lorusso, D, Joly, F, Gallo, C, Colombo, N, Sessa, C, Bamias, A, Salutari, V, Selle, F, Frezzini, S, De Giorgi, U, Pautier, P, Bologna, A, Orditura, M, Dubot, C, Gadducci, A, Mammoliti, S, Ray-Coquard, I, Zafarana, E, Breda, E, Favier, L, Ardizzoia, A, Cinieri, S, Largillier, R, Sambataro, D, Guardiola, E, Lauria, R, Pisano, C, Raspagliesi, F, Scambia, G, Daniele, G, and Perrone, F

Published
2021

13. Cytoreductive surgery followed by chemotherapy and olaparib maintenance in BRCA 1/2 mutated recurrent ovarian cancer: A retrospective MITO group study

Author

Cecere, S. C., Musacchio, L., Bartoletti, M., Salutari, Vanda, Arenare, L., Lorusso, Domenica, Ronzino, G., Lauria, R., Cormio, G., Naglieri, E., Scollo, P., Marchetti, Claudia, Raspagliesi, F., Greggi, S., Cinieri, S., Bergamini, A., Orditura, M., Valabrega, G., Scambia, Giovanni, Martinelli, F., De Matteis, E., Cardalesi, C., Loizzi, V., Perniola, G., Carella, C., Scandurra, G., Giannone, G., Pignata, S., Salutari V., Lorusso D., Marchetti C. (ORCID:0000-0001-7098-8956), Scambia G. (ORCID:0000-0003-2758-1063), Cecere, S. C., Musacchio, L., Bartoletti, M., Salutari, Vanda, Arenare, L., Lorusso, Domenica, Ronzino, G., Lauria, R., Cormio, G., Naglieri, E., Scollo, P., Marchetti, Claudia, Raspagliesi, F., Greggi, S., Cinieri, S., Bergamini, A., Orditura, M., Valabrega, G., Scambia, Giovanni, Martinelli, F., De Matteis, E., Cardalesi, C., Loizzi, V., Perniola, G., Carella, C., Scandurra, G., Giannone, G., Pignata, S., Salutari V., Lorusso D., Marchetti C. (ORCID:0000-0001-7098-8956), and Scambia G. (ORCID:0000-0003-2758-1063)

Abstract

Introduction The role of cytoreductive surgery in the poly-ADP ribose polymerase inhibitors era is not fully investigated. We evaluated the impact of surgery performed prior to platinum-based chemotherapy followed by olaparib maintenance in platinum-sensitive BRCA-mutated recurrent ovarian cancer. Methods This retrospective study included platinum-sensitive recurrent ovarian cancer BRCA-mutated patients from 13 Multicenter Italian Trials in Ovarian cancer and gynecological malignancies centers treated between September 2015 and May 2019. The primary outcomes were progression-free survival and overall survival. Data on post-progression treatment was also assessed. Results Among 209 patients, 72 patients (34.5%) underwent cytoreductive surgery followed by platinum-based chemotherapy and olaparib maintenance, while 137 patients (65.5%) underwent chemotherapy treatment alone. After a median follow-up of 37.3 months (95% CI: 33.4 to 40.8), median progression-free survival in the surgery group was not reached, compared with 11 months in patients receiving chemotherapy alone (P<0.001). Median overall survival was nearly double in patients undergoing surgery before chemotherapy (55 vs 28 months, P<0.001). Post-progression therapy was assessed in 127 patients: response rate to chemotherapy was 29.2%, 8.8%, and 9.0% in patients with platinum-free interval >12 months, between 6 and 12 months, and <6 months, respectively. Conclusion Cytoreductive surgery performed before platinum therapy and olaparib maintenance was associated with longer progression-free survival and overall survival in BRCA-mutated platinum-sensitive relapsed ovarian cancer patients. In accordance with our preliminary results, the response rate to chemotherapy given after progression during olaparib was associated with platinum-free interval.

Published
2021

15. 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

16. Olaparib as maintenance therapy in patients with BRCA 1–2 mutated recurrent platinum sensitive ovarian cancer: Real world data and post progression outcome

Author

Cecere, S. C., Giannone, G., Salutari, Vanda, Arenare, L., Lorusso, Domenica, Ronzino, G., Lauria, R., Cormio, G., Carella, C., Scollo, P., Ghizzoni, Viola, Raspagliesi, F., Di Napoli, M., Mazzoni, E., Marchetti, Claudia, Bergamini, A., Orditura, M., Valabrega, G., Scambia, Giovanni, Maltese, G., De Matteis, Elisabetta, Cardalesi, C., Loizzi, V., Boccia, S., Naglieri, E., Scandurra, G., Pignata, S., Salutari V., Lorusso D., Ghizzoni V., Marchetti C. (ORCID:0000-0001-7098-8956), Scambia G. (ORCID:0000-0003-2758-1063), De Matteis E., Cecere, S. C., Giannone, G., Salutari, Vanda, Arenare, L., Lorusso, Domenica, Ronzino, G., Lauria, R., Cormio, G., Carella, C., Scollo, P., Ghizzoni, Viola, Raspagliesi, F., Di Napoli, M., Mazzoni, E., Marchetti, Claudia, Bergamini, A., Orditura, M., Valabrega, G., Scambia, Giovanni, Maltese, G., De Matteis, Elisabetta, Cardalesi, C., Loizzi, V., Boccia, S., Naglieri, E., Scandurra, G., Pignata, S., Salutari V., Lorusso D., Ghizzoni V., Marchetti C. (ORCID:0000-0001-7098-8956), Scambia G. (ORCID:0000-0003-2758-1063), and De Matteis E.

Abstract

Objectives: Olaparib is approved as maintenance therapy in patients with BRCA mutated platinum sensitive (PS) recurrent ovarian cancer (OC) after response to last platinum based therapy. Few data are available regarding the use out of the registration trials and on response to further treatments after progression. Materials ad methods: In this non interventional, retrospective study, patients treated with olaparib in 13 centers, according to the label, have been collected and analyzed. Primary objectives of the study are to describe effectiveness and safety of olaparib in a real world setting with a focus on post progression treatments and response. Results: 234 patients were analyzed. All patients were BRCA mutated and most of them had germline mutations. Around 50% of the patients received olaparib after 3 or more lines of platinum based chemotherapy achieving a radiologic complete (CR) or partial response. 12.4% patients with stable disease were also included. Median PFS was 14.7 months (95% CI:12.6–18), with statistically longer PFS in patients with normal serum Ca125 at baseline, a CR after last platinum based therapy and that received olaparib after second platinum based therapy. Median OS was not reached. Most frequent G3-G4 toxicity was anaemia (6%) with dose discontinuation and dose reduction in 11 (4.7%) and 49 (20.9%) of cases, respectively. Among 66 patients receiving further treatment after olaparib progression and evaluable for response, ORR was 22.2, 11.1% and 9.5% in patients with Platinum Free interval (PFI) of more than 12 months, between 6 and 12 months and less than 6 months, respectively. Conclusions: Olaparib is effective and safe in real world setting. Data on post-progression treatments seem to suggest cross resistance with chemotherapy and need to be confirmed in larger studies because of the potential importance in clinical practice decisions.

Published
2020

17. Sharing real-world experiences to optimize the management of olaparib toxicities: a practical guidance from an Italian expert panel

Author

Lorusso, Domenica, Bologna, A., Cecere, S. C., De Matteis, E., Scandurra, G., Zamagni, C., Arcangeli, V., Artioli, F., Bella, M., Blanco, G., Cardalesi, C., Casartelli, C., De Vivo, R., Di Napoli, M., Gisone, E. B., Lauria, R., Lissoni, A. A., Loizzi, V., Maccaroni, E., Mangili, G., Marchetti, Claudia, Martella, F., Naglieri, E., Parolin, V., Ricciardi, G., Ronzino, G., Salutari, Vanda, Scarfone, G., Secondino, S., Spagnoletti, I., Tasca, G., Tognon, G., Guarneri, V., Lorusso D., Marchetti C. (ORCID:0000-0001-7098-8956), Salutari V., Lorusso, Domenica, Bologna, A., Cecere, S. C., De Matteis, E., Scandurra, G., Zamagni, C., Arcangeli, V., Artioli, F., Bella, M., Blanco, G., Cardalesi, C., Casartelli, C., De Vivo, R., Di Napoli, M., Gisone, E. B., Lauria, R., Lissoni, A. A., Loizzi, V., Maccaroni, E., Mangili, G., Marchetti, Claudia, Martella, F., Naglieri, E., Parolin, V., Ricciardi, G., Ronzino, G., Salutari, Vanda, Scarfone, G., Secondino, S., Spagnoletti, I., Tasca, G., Tognon, G., Guarneri, V., Lorusso D., Marchetti C. (ORCID:0000-0001-7098-8956), and Salutari V.

Abstract

Olaparib is the first poly(ADP-ribose) polymerase inhibitor approved as maintenance therapy of recurrent ovarian cancer (OC) patients with a BRCA mutation. To achieve the maximum clinical benefit, adherence to olaparib must be persistent. However, in clinical practice, this is challenged by the frequent suboptimal management of toxicities. In view of the expanding use of olaparib also in Italy, physicians must learn how to adequately and promptly manage drug toxicities not to unnecessarily interrupt or reduce the dose. The experts agreed that nausea,vomiting, anemia, and fatigue are the most frequent events experienced by OC patients on olaparib, and that these toxicities usually develop early during treatment, are mainly of grade 1–2 and transient and can be managed with simple non-pharmacological interventions. By sharing their real-world experiences, the panel prepared, for each toxicity, an algorithm organized by grade and besides the procedures indicated in the local label, included supportive care interventions based also on nutritional and lifestyle modifications and psycho-oncology consultation. Moreover, in view of the tablet entry into the Italian market, the full and reduced dosages of capsules and tablets were compared. This practical guidance is intended to be a tool to support especially less-experienced physicians in the management of these complex patients, with the aim to help preventing the worsening of patients’ conditions and the unnecessary interruption/reduction of olaparib dosage, which may jeopardize treatment efficacy.

Published
2020

18. Abstract P2-08-15: Metabolic syndrome and early-stage breast cancer outcome: Results from a prospective observational study

Author

Buono, G, primary, Crispo, A, additional, Giuliano, M, additional, Rea, CG, additional, Forestieri, V, additional, Lauria, R, additional, De Placido, P, additional, De Laurentiis, M, additional, Pacilio, C, additional, Grimaldi, M, additional, Nocerino, F, additional, Montella, M, additional, De Placido, S, additional, and Arpino, G, additional

Published
2019
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19. Abstract P6-21-13: A phase II single arm trial evaluating the efficacy and safety of eribulin in combination with bevacizumab for second-line treatment of human epidermal growth factor receptor 2 (HER2)–negative metastatic breast cancer (MBC) progressing after first-line therapy with bevacizumab and paclitaxel

Author

De Placido, S, primary, De Laurentiis, M, additional, Bruzzese, D, additional, Bernardo, A, additional, Baldini, EE, additional, Montesarchio, V, additional, Fabi, A, additional, Gamucci, T, additional, De Placido, P, additional, Russo, S, additional, Lauria, R, additional, De Santo, I, additional, De Angelis, C, additional, Del Mastro, L, additional, Giuliano, M, additional, and Arpino, G, additional

Published
2019
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20. The HOBOE-2 multicenter randomized phase III trial in premenopausal patients with hormone-receptor positive early breast cancer comparing triptorelin plus either tamoxifen or letrozole or letrozole + zoledronic acid

Author

Perrone, F., primary, De Laurentiis, M., additional, de Placido, S., additional, Orditura, M., additional, Cinieri, S., additional, Riccardi, F., additional, Ribecco, A.S., additional, Putzu, C., additional, Del Mastro, L., additional, Rossi, E., additional, Daniele, B., additional, Mosconi, A.M., additional, Di Rella, F., additional, Landi, G., additional, Nuzzo, F., additional, Pacilio, C., additional, Lauria, R., additional, Arenare, L., additional, Piccirillo, M.C., additional, and Gallo, C., additional

Published
2018
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21. Laparoscopic surgery in the treatment of stage I adult granulosa cells tumors of the ovary: Results from the MITO-9 study

Author

Bergamini, A., primary, Ferrandina, G., additional, Candiani, M., additional, Cormio, G., additional, Giorda, G., additional, Lauria, R., additional, Perrone, A.M., additional, Scarfone, G., additional, Breda, E., additional, Savarese, A., additional, Frigerio, L., additional, Gadducci, A., additional, Mascilini, F., additional, Maneschi, F., additional, Cassani, C., additional, Marchetti, C., additional, Cecere, S.C., additional, Biglia, N., additional, De Giorgi, U., additional, Raspagliesi, F., additional, Lorusso, D., additional, and Mangili, G., additional

Published
2018
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22. Laparoscopic surgery in the treatment of stage I adult granulosa cells tumors of the ovary: Results from the MITO-9 study

Author

Bergamini, A., Ferrandina, G., Candiani, M., Cormio, G., Giorda, G., Lauria, R., Perrone, A. M., Scarfone, G., Breda, E., Savarese, A., Frigerio, L., Gadducci, A., Mascilini, F., Maneschi, F., Cassani, C., Marchetti, C., Cecere, S. C., Biglia, N., De Giorgi, U., Raspagliesi, F., Lorusso, D., Mangili, G., Ferrandina, G. (ORCID:0000-0003-4672-4197), Marchetti, C. (ORCID:0000-0001-7098-8956), Bergamini, A., Ferrandina, G., Candiani, M., Cormio, G., Giorda, G., Lauria, R., Perrone, A. M., Scarfone, G., Breda, E., Savarese, A., Frigerio, L., Gadducci, A., Mascilini, F., Maneschi, F., Cassani, C., Marchetti, C., Cecere, S. C., Biglia, N., De Giorgi, U., Raspagliesi, F., Lorusso, D., Mangili, G., Ferrandina, G. (ORCID:0000-0003-4672-4197), and Marchetti, C. (ORCID:0000-0001-7098-8956)

Abstract

Objective: Surgery represents the mainstay of treatment of stage I adult type granulosa cell tumors of the ovary (AGCTs). Because of the rarity and indolent course of the disease, no prospective trials are available. Open surgery has long been considered the traditional approach; oncological safety of laparoscopy is only supported by small series or case reports. The aim of this study was to compare the oncological outcomes between laparoscopic and open surgery in stage I AGCTs treated within the MITO (Multicenter Italian Trials in Ovarian cancer) Group. Methods: Data from patients with stage I AGCTs were retrospectively collected. Clinicopathological features were evaluated for association with relapse and death. Survival curves were calculated using the Kaplan-Meier method and compared with the log-rank test. The role of clinicopathological variables as prognostic factors for survival was evaluated using Cox's regression model. Results: 223 patients were identified. Stage 1A, 1B and 1C were 61.5%, 1.3% and 29.6% respectively. 7.6% were apparently stage I. Surgical approach was laparoscopic for 93 patients (41.7%) and open for 130 (58.3%). 5-years DFS was 84% and 82%, 10-years DFS was 68% and 64% for the laparoscopic and open-group (p = 0.6).5-years OS was 100% and 99%, 10 years OS was 98% and 97% for the laparoscopic and open-surgery group (p = 0.8). At multivariate analyses stage IC, incomplete staging, site of primary surgery retained significant prognostic value. Conclusion: The present study suggests that surgical route does not affect the oncological safety of patients with stage I AGCTs, with comparable outcomes between laparoscopic and open approach.

Published
2018

23. Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomised, multicentre, open-label, phase 3 trial

Author

Pignata, S, Scambia, G, Katsaros, D, Gallo, C, Pujade Lauraine, E, De Placido, S, Bologna, A, Weber, B, Raspagliesi, F, Panici, Pb, Cormio, G, Sorio, R, Cavazzini, Mg, Ferrandina, G, Breda, E, Murgia, V, Sacco, C, Cinieri, S, Salutari, V, Ricci, C, Pisano, C, Greggi, S, Lauria, R, Lorusso, D, Marchetti, C, Selvaggi, L, Signoriello, S, Piccirillo, Mc, DI MAIO, Massimo, Perrone, F, Multicentre Italian Trials in Ovarian cancer, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens et du sein, Mario Negri Gynecologic Oncology, European Network of Gynaecological Oncological Trial Groups, Gynecologic Cancer InterGroup Investigators, Pignata, S, Scambia, G, Katsaros, D, Gallo, C, Pujade-Lauraine, E, De Placido, S, Bologna, A, Weber, B, Raspagliesi, F, Panici, Pb, Cormio, G, Sorio, R, Cavazzini, Mg, Ferrandina, G, Breda, E, Murgia, V, Sacco, C, Cinieri, S, Salutari, V, Ricci, C, Pisano, C, Greggi, S, Lauria, R, Lorusso, D, Marchetti, C, Selvaggi, L, Signoriello, S, Piccirillo, Mc, Di Maio, M, and Perrone, F

Subjects
medicine.medical_specialty, Carboplatin plus Paclitaxel, medicine.medical_treatment, Phases of clinical research, law.invention, chemistry.chemical_compound, paclitaxel, Randomized controlled trial, law, Medicine, Chemotherapy, Intention-to-treat analysis, advanced ovarian cancer, business.industry, Hazard ratio, medicine.disease, Carboplatin, Surgery, Regimen, ovarian cancer, Settore MED/40 - GINECOLOGIA E OSTETRICIA, Oncology, chemistry, carboplatin, business, Febrile neutropenia
Abstract

Background: Carboplatin plus paclitaxel administered every 3 weeks is standard first-line chemotherapy for patients with advanced ovarian cancer. A weekly paclitaxel schedule combined with carboplatin every 3 weeks prolonged progression-free survival and overall survival in a Japanese phase 3 trial. The aim of our study was to assess whether a weekly schedule of carboplatin plus paclitaxel is more effective than the same drugs given every 3 weeks. Methods: We did a multicentre, randomised, phase 3 study at 67 institutions in Italy and France. Women with FIGO stage IC-IV ovarian cancer, an ECOG performance status of 2 or lower, and who had never received chemotherapy were randomly allocated in a 1:1 ratio to receive either carboplatin (AUC 6 mg/mL per min) plus paclitaxel (175 mg/m2) every 3 weeks for six cycles or carboplatin (AUC 2 mg/mL per min) plus paclitaxel (60 mg/m2) every week for 18 weeks. Randomisation was done by computer-based minimisation, stratified by centre, residual disease after surgery, and ECOG performance status. The study was not blinded. Coprimary endpoints were progression-free survival and quality of life (assessed by the Functional Assessment of Cancer Therapy Ovarian Trial Outcome Index [FACT-O/TOI] score), and analysis was by modified intention to treat. This report presents the final analysis. The study is registered with ClinicalTrials.gov, number NCT00660842. Findings: 822 patients were enrolled into the study between Nov 20, 2008, and March 1, 2012; 12 withdrew their consent immediately after randomisation and were excluded, and 810 were eligible for analysis. 404 women were allocated treatment every 3 weeks and 406 were assigned to the weekly schedule. After median follow-up of 22·3 months (IQR 16·2-30·9), 449 progression-free survival events were recorded. Median progression-free survival was 17·3 months (95% CI 15·2-20·2) in patients assigned to treatment every 3 weeks, versus 18·3 months (16·8-20·9) in women allocated to the weekly schedule (hazard ratio 0·96, 95% CI 0·80-1·16; p=0·66). FACT-O/TOI scores differed significantly between the two schedules (treatment-by-time interaction p

Published
2014

25. Tumor characteristics and prognosis in familial breast cancer

Author

Arpino, G., primary, Pensabene, M., additional, Condello, C., additional, Ruocco, R., additional, Cerillo, I., additional, Lauria, R., additional, Forestieri, V., additional, Giuliano, M., additional, De Angelis, C., additional, Montella, M., additional, Crispo, A., additional, and De Placido, S., additional

Published
2016
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26. A meta-analysis on the interactionbetween HER-2 expression and response to endocrine treatment in advanced breastcancer

Author

De Laurentiis M, Arpino G, Massarelli E, Ruggiero A, Carlomagno C, Tortora G, D'Agostino D, Caputo F, Cancello G, Montagna E, Malorni L, Zinno L, Lauria R, Bianco AR, De Placido S., CIARDIELLO, Fortunato, De Laurentiis, M, Arpino, G, Massarelli, E, Ruggiero, A, Carlomagno, C, Ciardiello, Fortunato, Tortora, G, D'Agostino, D, Caputo, F, Cancello, G, Montagna, E, Malorni, L, Zinno, L, Lauria, R, Bianco, Ar, and De Placido, S.

Published
2005

27. Adjuvant chemoendocrine therapy for early breast cancer: is it worthwhile?

Author

PERRONE F, DE PLACIDO S, CARLOMAGNO C, LAURIA R, BIANCO AR, GALLO, Ciro, Perrone, F., DE PLACIDO, Sabino, Gallo, C., Carlomagno, Chiara, Lauria, R., Bianco, ANGELO RAFFAELE, Perrone, F, DE PLACIDO, S, Gallo, Ciro, Carlomagno, C, Lauria, R, and Bianco, Ar

Subjects
breast cancer, adjuvant, endocrine therapy, chemotherapy
Published
1995

28. Topotecan compared with no terapy and carboplatin/paclitaxel in patients with ovarian cancer: Multicenter Italian Trials in Ovarian Cancer (MITO-1) randomized study

Author

DE PLACIDO S, SCAMBIA G, DI VAGNO G, NAGLIERI E, LOMBARDI A. V, BIAMONTE R, MARINACCIO M, CARTENI G, MANZIONE L, FEBBRARO A, DE MATTEIS A, DANESE S, PERRONE F, LAURIA R, DE LAURENTIS M, GREGGI S, GALLO C, PIGNATA S., VALERIO, Maria Rosaria, DE PLACIDO S, SCAMBIA G, DI VAGNO G, NAGLIERI E, LOMBARDI A V, BIAMONTE R, MARINACCIO M, CARTENI G, MANZIONE L, FEBBRARO A, DE MATTEIS A, VALERIO MR, DANESE S, PERRONE F, LAURIA R, DE LAURENTIS M, GREGGI S, GALLO C, and PIGNATA S

Published
2004

29. LBA14_PR - The HOBOE-2 multicenter randomized phase III trial in premenopausal patients with hormone-receptor positive early breast cancer comparing triptorelin plus either tamoxifen or letrozole or letrozole + zoledronic acid

Author

Perrone, F., De Laurentiis, M., de Placido, S., Orditura, M., Cinieri, S., Riccardi, F., Ribecco, A.S., Putzu, C., Del Mastro, L., Rossi, E., Daniele, B., Mosconi, A.M., Di Rella, F., Landi, G., Nuzzo, F., Pacilio, C., Lauria, R., Arenare, L., Piccirillo, M.C., and Gallo, C.

Published
2018
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31. SECOND-LINE CHEMOTHERAPY WITH A HYBRID-ALTERNATING REGIMEN OF BOLUS FLUOROURACIL MODULATED BY METHOTREXATE AND INFUSIONAL FLUOROURACIL MODULATED BY FOLINIC ACID IN PATIENTS WITH METASTATIC COLORECTAL CANCERPRETREATED WITH FLUOROURACIL. A PHASE II STUDY

Author

CARLOMAGNO C, DE LAURENTIIS, MICHELINO, LAURIA R, ARPINO, GRAZIA, MASSARELLI E, FERRARA C, MILANO A, VERNAGLIA LOMBARDI A, COSTANZO R, CATALANO G, BIANCO AR, DE PLACIDO, SABINO, Carlomagno, C, DE LAURENTIIS, Michelino, Lauria, R, Arpino, Grazia, Massarelli, E, Ferrara, C, Milano, A, VERNAGLIA LOMBARDI, A, Costanzo, R, Catalano, G, Bianco, Ar, and DE PLACIDO, Sabino

Published
2002

33. MITO (Multicentre Italian Trials in Ovarian cancer) - CERV 2 trial: a randomized phase II study of carboplatin and paclitaxel +/- cetuximab, in advanced and/or recurrent cervical cancer

Author

Piccirillo, M.C., primary, Scambia, G., additional, Lorusso, D., additional, De Giorgi, U., additional, Nicoletto, M.O., additional, Lauria, R., additional, Mosconi, A., additional, Sacco, C., additional, Omarini, C., additional, Tagliaferri, P., additional, Ferrandina, G., additional, Cinieri, S., additional, Pisano, C., additional, Cecere, S.C., additional, Di Napoli, M., additional, Salutari, V., additional, Daniele, G., additional, Gallo, C., additional, Perrone, F., additional, and Pignata, S., additional

Published
2015
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35. Extending the platinum-free interval with a non-platinum therapy in platinum-sensitive recurrent ovarian cancer. Results from the SOCRATES Retrospective Study

Author

Pignata, S., Ferrandina, G., Scarfone, G., Scollo, P., Odicino, F., Selvaggi, L., Katsaros, D., Frigerio, L., Mereu, L., Ghezzi, F., Manzione, L., Lauria, R., Breda, E., Marforio, G., Ballardini, M., Vernaglia Lombardi, A., Sorio, R., Tumolo, S., Costa, B., Magni, G., Perrone, F., and Favalli, G.

Subjects
Ovarian Neoplasms, Salvage Therapy, Time Factors, Drug Resistance, Antineoplastic Agents, Platinum Compounds, Middle Aged, Survival Analysis, Aged, Cohort Studies, Drug Resistance, Neoplasm, Female, Humans, Recurrence, Retrospective Studies, Treatment Outcome, Ovarian cancer, Chemotherapy, Neoplasm
Abstract

It has been proposed that extending the platinum-free interval with intervening non-platinum therapy increases the efficacy of a later re-treatment with platinum in platinum-sensitive recurrent ovarian cancer. This hypothesis is based on data from small series and although it has not been validated prospectively, this strategy has entered general practice in Italy in the last years. The SOCRATES study retrospectively assessed the pattern of care of a cohort of patients with recurrent platinum-sensitive ovarian cancer observed in the years 2000-2002 in 37 Italian centres. Data were collected between April and September 2005.Patients with recurrent ovarian cancer with a platinum-free interval6 months were eligible. 493 patient files were collected and 428 were eligible and analyzed.The interval from the end of the 1st line to relapse was 6-12 months in 164 patients (39.5%) and12 months in 251 cases (60.5%). Patients received a 2nd (100%), 3rd (80.1%), 4th (50.2%), 5th (28.3%), and 6th (11.9%) line of chemotherapy. At 2nd line 282 (65.9%) received platinum (group A), while 146 (34.1%) received non-platinum chemotherapy (group B). In the latter group, 67 patients received platinum at later progression (group B1), while 79 never received platinum (group B2). Median time to platinum re-treatment was 20 and 23.1 months in patients of groups A and B1, respectively. The response rate to the first platinum received was 74.4 and 57.4% in groups A and B1, respectively (p = 0.02). Group B2 was characterized by the worst response rate and survival. At multivariate analysis time of first platinum re-treatment (2nd line vs. later; p = 0.0132; OR = 2.34) and age (p = 0.0029; OR = 2.41) was independently associated with a higher possibility of response to platinum.With the limits of a retrospective study, our data question the hypothesis that extending the platinum-free interval with an intervening non-platinum therapy in patients with recurrent platinum-sensitive ovarian cancer improves the response rate of a further platinum re-treatment.

Published
2007

38. Prognostic significance of multifocality in primary breast cancer

Author

MORABITO A, PERRONE F, LAURIA R, CARLOMAGNO C, MARINELLI, Alessandra, DE LAURENTIIS M, MARTIGNETTI A, PETTINATO G, PANICO L, PETRELLA G, BIANCO AR, GALLO, Ciro, Morabito, A, Perrone, F, Lauria, R, Carlomagno, C, Marinelli, Alessandra, DE LAURENTIIS, M, Martignetti, A, Pettinato, G, Panico, L, Petrella, G, Gallo, Ciro, and Bianco, Ar

Published
1994

40. Abstract P4-01-21: Head to head comparison of standard echo doppler versus 3D speckle tracking echocardiography for early subclinical cardiotoxicity detection in breast cancer patients treated with anthracycline adjuvant chemotherapy

Author

Arpino, G, primary, Galderisi, M, additional, De Angelis, C, additional, Milano, M, additional, Gargiulo, P, additional, Santoro, A, additional, De Stefano, F, additional, Muscariello, R, additional, De Santo, I, additional, Lauria, R, additional, De Simone, G, additional, and De Placido, S, additional

Published
2013
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41. Manuale di Oncologia Clinica

Author

Bianco, A. R., Biondi, E., Carlomagno, C., Ciardiello, F., Contegiacomo, A., DE LAURENTIIS, M., DE PLACIDO, S., Lauria, R., Marinelli, A., Matano, E., Morabito, A., Palmieri, G., Pepe, S., Perrone, F., Tagliaferri, P., Tortora, Giampaolo, A.R.Bianco, Bianco, ANGELO RAFFAELE, E., Biondi, Carlomagno, Chiara, Ciardiello, Fortunato, Contegiacomo, Alma, DE LAURENTIIS, Michelino, DE PLACIDO, Sabino, Lauria, Rossella, Marinelli, Alfredo, Matano, Elide, A., Morabito, Palmieri, Giovannella, Pepe, Stefano, F., Perrone, P., Tagliaferri, and Tortora, Giampaolo

Subjects
clinica, testo universitario, Oncology, Oncologia, Immunology, Oncology, Immunology, Medicine, Medicine
Abstract

Manuale di Oncologia Clinica rivolto agli studenti delle Facoltà di Medicina e Chirurgia e agli specializzandi in Oncologia Medica

Published
1996

42. D01* - MITO (Multicentre Italian Trials in Ovarian cancer) - CERV 2 trial: a randomized phase II study of carboplatin and paclitaxel +/- cetuximab, in advanced and/or recurrent cervical cancer

Author

Piccirillo, M.C., Scambia, G., Lorusso, D., De Giorgi, U., Nicoletto, M.O., Lauria, R., Mosconi, A., Sacco, C., Omarini, C., Tagliaferri, P., Ferrandina, G., Cinieri, S., Pisano, C., Cecere, S.C., Di Napoli, M., Salutari, V., Daniele, G., Gallo, C., Perrone, F., and Pignata, S.

Published
2015
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45. Second-Line Chemotherapy with a Hybrid-Alternating Regimen of Bolus 5FU Modulated by Methotrexate and Infusional 5FU Modulated by Folinic Acid in Patients with Metastatic Colorectal Cancer Pretreated with 5FU

Author

Carlomagno, C., primary, Lauria, R., additional, De Laurentiis, M., additional, Arpino, G., additional, Massarelli, E., additional, Ferrara, C., additional, Milano, A., additional, Vernaglia Lombardi, A., additional, Costanzo, R., additional, Catalano, G., additional, Bianco, A.R., additional, and De Placido, S., additional

Published
2002
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47. The impact of schedule on acute toxicity and dose-intensity of high-dose chemotherapy with epirubicin and cyclophosphamide plus colony stimulating factors in advanced breast cancer.

Author

De Placido, S, primary, Lauria, R, additional, Carlomagno, C, additional, Perrone, F, additional, De Laurentiis, M, additional, Gallo, C, additional, Martignetti, A, additional, Bellelli, T, additional, Limite, G, additional, Petrella, G, additional, and Bianco, A R, additional

Published
1999
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50. Phase I study of carboplatin, cisplatin, and cyclophosphamide without and with lenograstim for the treatment of ovarian cancer

Author

Pignata, S, primary, Lauria, R, additional, Perrone, F, additional, Ferrari, E, additional, Biondi, E, additional, Maffeo, A, additional, Morabito, A, additional, Graziano, R, additional, Carlomagno, C, additional, DePlacido, G, additional, Gallo, C, additional, Bianco, A, additional, Pergola, M, additional, and DePlacido, S, additional

Published
1997
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