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1. Final results of the real-life observational VICTOR-6 study on metronomic chemotherapy in elderly metastatic breast cancer (MBC) patients

Author

B. Trevisan, F. F. Pepe, I. Vallini, E. Montagna, D. Amoroso, R. Berardi, A. Butera, K. Cagossi, L. Cavanna, M. Ciccarese, S. Cinieri, E. Cretella, E. De Conciliis, A. Febbraro, F. Ferraù, A. Ferzi, A. Baldelli, A. Fontana, A. R. Gambaro, O. Garrone, V. Gebbia, D. Generali, L. Gianni, F. Giovanardi, A. Grassadonia, V. Leonardi, S. Sarti, A. Musolino, M. Nicolini, C. Putzu, F. Riccardi, D. Santini, M. G. Sarobba, M. G. Schintu, G. Scognamiglio, P. Spadaro, C. Taverniti, D. Toniolo, P. Tralongo, A. Turletti, R. Valenza, M. R. Valerio, P. Vici, L. Clivio, V. Torri, M. E. Cazzaniga, and The VICTOR Study Group

Subjects
Medicine, Science
Abstract

Abstract Nowadays, treatment of metastatic breast cancer (MBC) has been enriched with novel therapeutical strategies. Metronomic chemotherapy (mCHT) is a continuous and frequent administration of chemotherapy at a lower dose and so whit less toxicity. Thus, this strategy could be attractive for elderly MBC patients. Aim of this analysis is to provide insights into mCHT’s activity in a real-life setting of elderly MBC patients. Data of patients ≥ 75 years old included in VICTOR-6 study were analyzed. VICTOR-6 is a multicentre, Italian, retrospective study, which collected data on mCHT in MBC patients treated between 2011 and 2016. A total of 112 patients were included. At the beginning of mCHT, median age was 81 years (75–98) and in 33% of the patients mCHT was the first line choice. Overall Response Rate (ORR) and Disease Control Rate (DCR) were 27.9% and 79.3%, respectively. Median PFS ranged between 7.6 and 9.1 months, OS between 14.1 and 18.5 months. The most relevant toxicity was the hematological one (24.1%); severe toxicity (grade 3–4) ranged from 0.9% for skin toxicity up to 8% for hematologic one. This is a large study about mCHT in elderly MBC patients, providing insights to be further investigated in this subgroup of frail patients.

Published
2023
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2. Guideline Application in Real world: multi-Institutional Based survey of Adjuvant and first-Line pancreatic Ductal adenocarcinoma treatment in Italy. Primary analysis of the GARIBALDI survey

Author

M. Reni, E. Giommoni, F. Bergamo, M. Milella, L. Cavanna, M.C. Di Marco, M. Spada, S. Cordio, G. Aprile, G.G. Cardellino, E. Maiello, I. Bernardini, M. Ghidini, S. Bozzarelli, M. Macchini, G. Orsi, I. De Simone, Er. Rulli, L. Porcu, V. Torri, C. Pinto, Michele Reni, Marina Macchini, Giulia Orsi, Umberto Peretti, Mariamaddalena Valente, Elisa Giommoni, Lorenzo Antonuzzo, Francesco Di Costanzo, Francesca Bergamo, Vittorina Zagonel, Sara Lonardi, Federica Buggin, Michele Milella, Silvia Palmerio, Luigi Cavanna, Camilla Di Nunzio, Maria Cristina Di Marco, Elisa Grassi, Massimiliano Spada, Marco Messina, Stefano Cordio, Francesco Avola, Giuseppe Aprile, Salvatore Pagano, Francesca Simionato, Giovanni Gerardo Cardellino, Federica Majer, Evaristo Maiello, Tiziana Pia Latiano, Cinzia Chiarazzo, Fabrizio Artioli, Giorgia Razzini, Antonella Pasqualini, Michele Ghidini, Elisa Binda, Silvia Lazzarelli, Silvia Bozzarelli, Simona Sala, Gabriele Luppi, Elisa Pettorelli, Andrea Spallanzani, Giovanni Vicario, Flavia Salmaso, Marco Basso, Nicola Silvestris, Sabina Del Curatolo, Fable Zustovich, Francesca Bongiovanni, Ciro Longobardi, Ilenia Sandi, Caterina Fontanella, Silvia Montelatici, Monica Giordano, Giovanna Luchena, Micol Gilardoni, Emiliano Tamburini, Britt Rudnas, Barbara Venturini, Barbara Merelli, Giorgia Negrini, Elio Maria Vici, Alessandra Marabese, Cristina Garetto, Paola Curcio, Saverio Cinieri, Margherita Cinefra, Pasqualinda Ferrara, Maurizio Cantore, Patrizia Morselli, Guglielmo Fumi, Agnese Isidori, Giovanni Ciccarese, Giovanni Luca Paolo Frassineti, Flavia Pagan, Vanja Vaccaro, Chiara Spoto, Marianna Ferrara, Carlo Garufi, Marta Caporale, Enrico Vasile, Francesca Salani, Elisa Barone, Rossana Berardi, Azzurra Onofri, Zelmira Ballatore, Alessandra Lucarelli, Alessandra Barucca, Amedeo Pancotti, Teresa Scipioni, Katia Bencardino, Giovanna Marrapese, Laura Idotta, Fausto Petrelli, Veronica Lonati, Anna Ceribelli, Angelo Giuli, Cristina Zannori, Maria Bassanelli, Andrea Mambrini, Laura Ginocchi, Massimo Orlandi, Luigi Celio, Monica Niger, Lavinia Biamonte, Stefano Tamberi, Alessandra Piancastelli, Giorgio Papiani, Irene Valli, Paolo Allione, Maria Giovanna Boe, Mario Scartozzi, Eleonora Lai, Annagrazia Pireddu, Pina Ziranu, Laura Demurtas, Marco Puzzoni, Stefano Mariani, Andrea Pretta, Nicole Liscia, Clementina Savastano, Valentina Malaspina, Giuseppe Tonini, Teresa Grassani, Barbara Barco, Tagliaferri Pierosandro, Domenico Ciliberto, Antonella Ierardi, Natale Daniele Calandruccio, Vincenzo Minotti, Roberta Matocci, Valter Torri, Luca Porcu, Erica Rulli, Irene De Simone, Luciano Carlucci, Eliana Rulli, Davide Poli, Paola Tonto, Francesca Scellato, Carmine Pinto, and M. Reni, E. Giommoni , F. Bergamo , M. Milella , L. Cavanna , M. C. Di Marco , M. Spada , S. Cordio , G. Aprile , G. G. Cardellino, E. Maiello, I. Bernardini, M. Ghidini, S. Bozzarelli, M. Macchini , G. Orsi , I. De Simone, Er. Rulli, L. Porcu, V. Torri & C. Pinto, GARIBALDI Study Group

Subjects
Cancer Research, Oncology, pancreatic adenocarcinoma, adjuvant, first line, prospective survey, adherence to guidelines
Abstract

Background: Information about the adherence to scientific societies guidelines in the ‘real-world’ therapeutic management of oncological patients are lacking. This multicenter, prospective survey was aimed to improve the knowledge relative to 2017-2018 recommendations of the Italian Association of Medical Oncology (AIOM). Patients and methods: Treatment-naive adult patients with pancreatic adenocarcinoma were enrolled. Group A received adjuvant therapy, group B received primary chemotherapy, and group C had metastatic disease. The results on patients accrued until 31 October 2019 with a mature follow-up were presented. Results: Since July 2017, 833 eligible patients of 923 (90%) were enrolled in 44 Italian centers. The median age was 69 years (range 36-89 years; 24% >75 years); 48% were female; 93% had Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; group A: 16%, group B: 30%; group C: 54%; 72% Nord, 13% Center, 15% South. In group A, guidelines adherence was 68% [95% confidence interval (CI) 59% to 76%]; 53% of patients received gemcitabine and 15% gemcitabine þ capecitabine; median CA19.9 was 29 (range 0-7300; not reported 15%); median survival was 36.4 months (95% CI 27.5-47.3 months). In group B, guidelines adherence was 96% (95% CI 92% to 98%); 55% of patients received nab-paclitaxel þ gemcitabine, 27% FOLFIRINOX, 12% gemcitabine, and 3% clinical trial; median CA19.9 was 337 (range 0-20220; not reported 9%); median survival was 18.1 months (95% CI 15.6-19.9 months). In group C, guidelines adherence was 96% (95% CI 94% to 98%); 71% of patients received nabpaclitaxel þ gemcitabine, 16% gemcitabine, 8% FOLFIRINOX, and 4% clinical trial; liver and lung metastases were reported in 76% and 23% of patients, respectively; median CA19.9 value was 760 (range 0-1374500; not reported 9%); median survival was 10.0 months (95% CI 9.1-11.1 months). Conclusions: The GARIBALDI survey shows a very high rate of adherence to guidelines and survival outcome in line with the literature. CA19.9 testing should be enhanced; nutritional and psychological counseling represent an unmet need. Enrollment to assess adherence to updated AIOM guidelines is ongoing.

Published
2023

3. Fluorouracil and dose-dense adjuvant chemotherapy in patients with early-stage breast cancer (GIM2): end-of-study results from a randomised, phase 3 trial

Author

Lucia Del Mastro, Francesca Poggio, Eva Blondeaux, Sabino De Placido, Mario Giuliano, Valeria Forestieri, Michelino De Laurentiis, Adriano Gravina, Giancarlo Bisagni, Anita Rimanti, Anna Turletti, Cecilia Nisticò, Angela Vaccaro, Francesco Cognetti, Alessandra Fabi, Simona Gasparro, Ornella Garrone, Maria Grazia Alicicco, Ylenia Urracci, Mauro Mansutti, Paola Poletti, Pierpaolo Correale, Claudia Bighin, Fabio Puglisi, Filippo Montemurro, Giuseppe Colantuoni, Matteo Lambertini, Luca Boni, M Venturini, A Abate, S Pastorino, G Canavese, C Vecchio, M Guenzi, M Lambertini, A Levaggi, S Giraudi, V Accortanzo, C.A. Floris, E Aitini, G Fornari, S Miraglia, G Buonfanti, M.C. Cherchi, F Petrelli, A Vaccaro, E Magnolfi, A Contu, R Labianca, A Parisi, C Basurto, F Cappuzzo, M Merlano, S Russo, M Mansutti, E Poletto, M Nardi, D Grasso, A Fontana, L Isa, M Comandè, L Cavanna, S Iacobelli, S Milani, G Mustacchi, S Venturini, A.F. Scinto, M.G. Sarobba, P Pugliese, A Bernardo, I Pavese, M Coccaro, B Massidda, M.T. Ionta, A Nuzzo, L Laudadio, V Chiantera, R Dottori, M Barduagni, F Castiglione, F Ciardiello, V Tinessa, A Ficorella, L Moscetti, I Vallini, G Giardina, R Silva, M Montedoro, E Seles, F Morano, G Cruciani, V Adamo, A Pancotti, V Palmisani, A Ruggeri, E Cammilluzzi, F Carrozza, M D'Aprile, M Brunetti, P Gallotti, E Chiesa, F Testore, A D'Arco, A Ferro, A Jirillo, M Pezzoli, G Scambia, C Iacono, P Masullo, G Tomasello, G Gandini, A Zoboli, C Bottero, M Cazzaniga, G Genua, S Palazzo, M D'Amico, and D Perrone

Subjects
Oncology, Paclitaxel, Chemotherapy, Adjuvant, Antineoplastic Combined Chemotherapy Protocols, Humans, Female, Breast Neoplasms, Fluorouracil, Cyclophosphamide, Epirubicin
Abstract

Previous analyses of the GIM (Gruppo Italiano Mammella) 2 study showed that addition of fluorouracil to epirubicin, cyclophosphamide, and paclitaxel in patients with node-positive early breast cancer does not improve outcome, whereas dose-dense chemotherapy induces a significant improvement in both disease-free survival and overall survival as compared with a standard schedule. Here, we present long-term results of the study.In this 2 × 2 factorial, open-label, randomised, phase 3 trial, we enrolled patients aged 18-70 years with operable, node-positive, breast cancer with Eastern Cooperative Oncology Group performance status of 0-1 from 81 hospitals in Italy. Eligible patients were randomly allocated (1:1:1:1) to one of the four following study groups: four cycles of standard-interval intravenous EC (epirubicin 90 mg/mBetween April 24, 2003, and July 3, 2006, 2091 patients were randomly assigned to treatment: 545 to q3EC-P, 544 to q3FEC-P, 502 to q2EC-P, and 500 to q2FEC-P. 88 patients were enrolled in centres providing only standard interval schedule and were assigned only to q3FEC-P and q3EC-P; thus, 2091 patients were included in the intention-to-treat analysis for the comparison of EC-P (1047 patients) versus FEC-P (1044 patients) and 2003 patients were included in the intention-to-treat analysis for the comparison of dose-dense (1002 patients) versus standard interval analysis (1001 patients). After a median follow-up of 15·1 years (IQR 8·4-16·3), median disease-free survival was not significantly different between FEC-P and EC-P groups (17·09 years [95% CI 15·51-not reached] vs not reached [17·54-not reached]; unadjusted hazard ratio 1·12 [95% CI 0·98-1·29]; log-rank p=0·11). Median disease-free survival was significantly higher in the dose-dense interval group than the standard-interval group (not reached [95% CI 17·45-not reached] vs 16·52 [14·24-17·54]; 0·77 [95% CI 0·67-0·89]; p=0·0004). The most common grade 3-4 adverse events were neutropenia (200 [37%] of 536 patients in the q3EC-P group vs 257 [48%] of 533 in the q3FEC-P group vs 50 [10%] of 496 q2EC-P vs 97 [20%] of 492) and alopecia (238 [44%] vs 249 [47%] vs 228 [46%] vs 235 [48%]). During extended follow-up, no further grade 3-4 adverse events or deaths related to toxic-effects were reported. Treatment-related serious adverse events were reported in nine (2%) patients in the q3EC-P group, seven (1%) in the q3FEC-P group, nine (2%) in the q2EC-P group, and nine (2%) in the q2FEC-P group. No treatment-related deaths occurred.Updated results from the GIM2 study support that optimal adjuvant chemotherapy for patients with high-risk early breast cancer should not include fluorouracil and should use a dose-dense schedule.Bristol-Myers Squibb, Pharmacia, Dompè Biotec Italy, Italian Ministry of Health, Fondazione Italiana per la Ricerca sul Cancro, and Alliance Against Cancer.

Published
2022

4. Analysis of the humoral and cellular immune response after a full course of BNT162b2 anti-SARS-CoV-2 vaccine in cancer patients treated with PD-1/PD-L1 inhibitors with or without chemotherapy: an update after 6 months of follow-up

Author

A. Lasagna, D. Lilleri, F. Agustoni, E. Percivalle, S. Borgetto, N. Alessio, G. Comolli, A. Sarasini, F. Bergami, J.C. Sammartino, A. Ferrari, F. Zavaglio, F. Arena, S. Secondino, M. Falzoni, R. Schiavo, G. Lo Cascio, L. Cavanna, F. Baldanti, P. Pedrazzoli, and I. Cassaniti

Subjects
Cancer Research, Programmed Cell Death 1 Receptor, SARS-CoV-2, severe acute respiratory syndrome coronavirus 2, B7-H1 Antigen, 03 medical and health sciences, 0302 clinical medicine, Neoplasms, Humans, cancer, skin and connective tissue diseases, Immune Checkpoint Inhibitors, BNT162 Vaccine, IQR, interquartile range, 030304 developmental biology, Original Research, BNT162b2 anti-SARS-CoV-2 vaccine, Immunity, Cellular, 0303 health sciences, Spike-specific T cell response, SARS-CoV-2, PD-1/PD-L1 inhibitors, COVID-19, neutralizing antibody, NT Abs, NeuTralizing antibody, Immunity, Humoral, Oncology, IFNγ, interferon gamma, PBMC, peripheral blood mononuclear cells, 030220 oncology & carcinogenesis, Leukocytes, Mononuclear, third dose, Follow-Up Studies
Abstract

Background The durability of immunogenicity of SARS-CoV-2 vaccination in cancer patients remains to be elucidated. We prospectively evaluated the immunogenicity of the vaccine in triggering both the humoral and the cell-mediated immune response in cancer patients treated with anti PD-1/PD-L1 with or without chemotherapy six months after BNT162b2 vaccine. Patients and methods In the previous study, 88 patients were enrolled, while the analyses below refer to the 60 patients still on immunotherapy at the time of the follow up. According to previous SARS-CoV-2 exposure, patients were classified in SARS-CoV-2 naïve (without previous SARS-CoV-2 exposure) and SARS-CoV-2 experienced (with previous SARS-CoV-2 infection). Neutralizing antibody (NT Abs) titer against B.1.1 strain and total anti-Spike IgG concentration were quantified in serum samples. ELISpot assay was used for quantification of anti-Spike interferon gamma (IFNγ) producing cells/106 peripheral blood mononuclear cells (PBMC). Fifty patients (83.0%) were on immunotherapy alone, while ten patients (7%) were on chemo-immunotherapy. We analyzed separately patients on immunotherapy and patients on chemo-immunotherapy. Results Median T-cell response at six months was significantly lower than that measured at three weeks after vaccination (50 interquartile range (IQR) 20-118.8 vs 175IQR 67.5-371.3 IFNγ producing cells/106 PBMC;p

Published
2022
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5. Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study

Author

M.E. Cazzaniga, G. Pinotti, E. Montagna, D. Amoroso, R. Berardi, A. Butera, K. Cagossi, L. Cavanna, M. Ciccarese, S. Cinieri, E. Cretella, E. De Conciliis, A. Febbraro, F. Ferraù, A. Ferzi, G. Fiorentini, A. Fontana, A.R. Gambaro, O. Garrone, V. Gebbia, D. Generali, L. Gianni, F. Giovanardi, A. Grassadonia, V. Leonardi, P. Marchetti, E. Melegari, A. Musolino, M. Nicolini, C. Putzu, F. Riccardi, D. Santini, S. Saracchini, M.G. Sarobba, M.G. Schintu, G. Scognamiglio, P. Spadaro, C. Taverniti, D. Toniolo, P. Tralongo, A. Turletti, R. Valenza, M.R. Valerio, P. Vici, L. Clivio, V. Torri, F. Cicchiello, F. Riva, I. Vallini, M. Mazza, C. Bonfadini, E. Bordin, M. Canicattì, F. Cappuccio, E. Collovà, C. De Angelis, R. Desorte, S. Donati, G. Drudi, D. Galanti, C. Mocerino, L. Orlando, B. Pellegrino, L. Pizzuti, C. Ridolfi, A. Rocca, D. Sarti, I. Spagnoletti, N. Tinari, A. Vandone, L. Vizzini, Cazzaniga M.E., Pinotti G., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Fiorentini G., Fontana A., Gambaro A.R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Marchetti P., Melegari E., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Saracchini S., Sarobba M.G., Schintu M.G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M.R., Vici P., Clivio L., Torri V., Cicchiello F., Riva F., Vallini I., Mazza M., Bonfadini C., Bordin E., Canicatti M., Cappuccio F., Collova E., De Angelis C., Desorte R., Donati S., Drudi G., Galanti D., Mocerino C., Orlando L., Pellegrino B., Pizzuti L., Ridolfi C., Rocca A., Sarti D., Spagnoletti I., Tinari N., Vandone A., Vizzini L., Cazzaniga, M, Pinotti, G, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Fiorentini, G, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Marchetti, P, Melegari, E, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Saracchini, S, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Clivio, L, Torri, V, Cicchiello, F, Riva, F, Vallini, I, Mazza, M, Bonfadini, C, Bordin, E, Canicatti, M, Cappuccio, F, Collova, E, De Angelis, C, Desorte, R, Donati, S, Drudi, G, Galanti, D, Mocerino, C, Orlando, L, Pellegrino, B, Pizzuti, L, Ridolfi, C, Rocca, A, Sarti, D, Spagnoletti, I, Tinari, N, Vandone, A, and Vizzini, L

Subjects
Adult, Oncology, medicine.medical_specialty, Cyclophosphamide, Settore MED/06 - Oncologia Medica, Antineoplastic Agents, Breast Neoplasms, Vinorelbine, Drug Administration Schedule, Antineoplastic Agent, Efficacy, Capecitabine, 03 medical and health sciences, Breast cancer, 0302 clinical medicine, Retrospective Studie, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, 030212 general & internal medicine, Progression-free survival, Retrospective Studies, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocol, business.industry, Metronomic chemotherapy, General Medicine, Middle Aged, medicine.disease, Metastatic breast cancer, Metronomic Chemotherapy, Survival Rate, Methotrexate, Treatment Outcome, 030220 oncology & carcinogenesis, MED/06 - ONCOLOGIA MEDICA, Female, Surgery, business, Breast Neoplasm, Human, medicine.drug
Abstract

Metronomic chemotherapy (mCHT) refers to the minimum biologically effective dose of a chemotherapy agent given as a continuous dosing regimen, with no prolonged drug-free breaks, that leads to antitumor activity. Aim of the present study is to describe the use of mCHT in a retrospective cohort of metastatic breast cancer (MBC) patients in order to collect data regarding the different types and regimens of drugs employed, their efficacy and safety. Between January 2011 and December 2016, data of 584 metastatic breast cancer patients treated with mCHT were collected. The use of VRL-based regimens increased during the time of observation (2011: 16.8% - 2016: 29.8%), as well as CTX-based ones (2011: 17.1% - 2016: 25.6%), whereas CAPE-based and MTX-based regimens remained stable. In the 1st-line setting, the highest ORR and DCR were observed for VRL-based regimens (single agent: 44% and 88%; combination: 36.7% and 82.4%, respectively). Assuming VRL-single agent as the referee treatment (median PFS: 7.2 months, 95% CI: 5.3–10.3), the longest median PFS were observed in VRL-combination regimens (9.5, 95%CI 88.8–11.3, HR = 0.72) and in CAPE-single agent (10.7, 95%CI 8.3–15.8, HR = 0.70). The VICTOR-6 study provides new data coming from the real-life setting, by adding new information regarding the use of mCHT as an option of treatment for MBC patients.

Published
2019
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7. Evaluation of dexamethasone (DEX)-sparing regimens, administered with NEPA, a fixed combination of netupitant and palonosetron, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in older patients receiving high-dose cisplatin

Author

L. Celio, D. Cortinovis, A.A. Cogoni, L. Cavanna, O. Martelli, S. Carnio, E. Collovà, F. Bertolini, F. Petrelli, A. Cassano, R. Chiari, F. Zanelli, S. Pisconti, I. Vittimberga, A. Letizia, A. Misino, A. Gernone, E. Bonizzoni, S. Pilotto, S. De Placido, and E. Bria

Subjects
Oncology, Geriatrics and Gerontology
Published
2021
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8. Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial

Author

Gerardo Rosati, Sara Lonardi, Fabio Galli, Maria Di Bartolomeo, Monica Ronzoni, Maria G. Zampino, Maria Banzi, Alberto Zaniboni, Felice Pasini, Silvia Bozzarelli, Silvio K. Garattini, Daris Ferrari, Vincenzo Montesarchio, Andrea Mambrini, Libero Ciuffreda, Francesca Galli, Valeria Pusceddu, Chiara Carlomagno, Paolo Bidoli, Domenico Amoroso, Anna M. Bochicchio, Luca Frassineti, Domenico Corsi, Domenico Bilancia, Alessandro Pastorino, Alfonso De Stefano, Roberto Labianca, D. Bilancia, G. Rosati, V. Montesarchio, R.V. Iaffaioli, G. Nasti, B. Daniele, V. Zagonel, S. Lonardi, N. Pella, G. Aprile, F. Pasini, Roma P. Marchetti, A. Romiti, L. Ciuffreda, D. Ferrari, P. Foa, A. Zaniboni, R. Labianca, S. Mosconi, A. Sobrero, P. Bidoli, M. Cazzaniga, G.D. Beretta, D.C. Corsi, E. Cortesi, S. Barni, F. Petrelli, P. Allione, A.M. D'Arco, G. Valmadre, E. Piazza, E. Veltri, G. Vietti Ramus, L. Giustini, S. Tumulo, S. Cascinu, C. Granetto, F. Testore, M. Giordano, M. Moroni, M. Di Seri, A. Nuzzo, L. Angelelli, S. Gori, G. Farina, M. Aglietta, R. Franchi, M. Comandé, P. Giordani, G. Tonini, E. Bucci, A. Ballestrero, M. Benasso, C. Graiff, S. Bravi, O. Caffo, R.R. Silva, L. Frontini, S. Rota, L. Cozzi, M. Cantore, E. Maiello, S. Cinieri, N. Silvestris, S. Romito, V. Gebbia, M. Banzi, A. Santoro, F. Artioli, R. Mattioli, A. Contu, F. Di Costanzo, F. Leonardi, L. Cavanna, R. Passalacqua, D. Amoroso, P. Sozzi, M. D'Amico, D. Amadori, L. Frassineti, D. Turci, A. Ravaioli, E. Pasquini, A. Gambi, M. Faedi, G. Cruciani, E. Bajetta, M. Di Bartolomeo, L. Gianni, M. Ronzoni, M.T. Ionta, B. Massidda, M. Scartozzi, M.G. Zampino, A.M. Bochicchio, A. Ciarlo, A. Di Leo, S. Frustaci, G. Rangoni, A. Arizzoia, L. Pavesi, C. Verusio, G. Pinotti, A. Iop, S. De Placido, C. Carlomagno, V. Adamo, C. Ficorella, D. Natale, E. Greco, E. Rulli, F. Galli, D. Poli, L. Porcu, V. Torri, Rosati, G, Lonardi, S, Galli, F, Di Bartolomeo, M, Ronzoni, M, Zampino, M, Banzi, M, Zaniboni, A, Pasini, F, Bozzarelli, S, Garattini, S, Ferrari, D, Montesarchio, V, Mambrini, A, Ciuffreda, L, Pusceddu, V, Carlomagno, C, Bidoli, P, Amoroso, D, Bochicchio, A, Frassineti, L, Corsi, D, Bilancia, D, Pastorino, A, De Stefano, A, Labianca, R, Iaffaioli, R, Nasti, G, Daniele, B, Zagonel, V, Pella, N, Aprile, G, Marchetti, R, Romiti, A, Foa, P, Mosconi, S, Sobrero, A, Cazzaniga, M, Beretta, G, Cortesi, E, Barni, S, Petrelli, F, Allione, P, D'Arco, A, Valmadre, G, Piazza, E, Veltri, E, Ramus, G, Giustini, L, Tumulo, S, Cascinu, S, Granetto, C, Testore, F, Giordano, M, Moroni, M, Di Seri, M, Nuzzo, A, Angelelli, L, Gori, S, Farina, G, Aglietta, M, Franchi, R, Comande, M, Giordani, P, Tonini, G, Bucci, E, Ballestrero, A, Benasso, M, Graiff, C, Bravi, S, Caffo, O, Silva, R, Frontini, L, Rota, S, Cozzi, L, Cantore, M, Maiello, E, Cinieri, S, Silvestris, N, Romito, S, Gebbia, V, Santoro, A, Artioli, F, Mattioli, R, Contu, A, Di Costanzo, F, Leonardi, F, Cavanna, L, Passalacqua, R, Sozzi, P, D'Amico, M, Amadori, D, Turci, D, Ravaioli, A, Pasquini, E, Gambi, A, Faedi, M, Cruciani, G, Bajetta, E, Gianni, L, Ionta, M, Massidda, B, Scartozzi, M, Ciarlo, A, Di Leo, A, Frustaci, S, Rangoni, G, Arizzoia, A, Pavesi, L, Verusio, C, Pinotti, G, Iop, A, De Placido, S, Adamo, V, Ficorella, C, Natale, D, Greco, E, Rulli, E, Poli, D, Porcu, L, Torri, V, Rosati, G., Lonardi, S., Galli, F., Di Bartolomeo, M., Ronzoni, M., Zampino, M. G., Banzi, M., Zaniboni, A., Pasini, F., Bozzarelli, S., Garattini, S. K., Ferrari, D., Montesarchio, V., Mambrini, A., Ciuffreda, L., Pusceddu, V., Carlomagno, C., Bidoli, P., Amoroso, D., Bochicchio, A. M., Frassineti, L., Corsi, D., Bilancia, D., Pastorino, A., De Stefano, A., Labianca, R., Iaffaioli, R. V., Nasti, G., Daniele, B., Zagonel, V., Pella, N., Aprile, G., Marchetti, R. P., Romiti, A., Foa, P., Mosconi, S., Sobrero, A., Cazzaniga, M., Beretta, G. D., Cortesi, E., Barni, S., Petrelli, F., Allione, P., D'Arco, A. M., Valmadre, G., Piazza, E., Veltri, E., Ramus, G. V., Giustini, L., Tumulo, S., Cascinu, S., Granetto, C., Testore, F., Giordano, M., Moroni, M., Di Seri, M., Nuzzo, A., Angelelli, L., Gori, S., Farina, G., Aglietta, M., Franchi, R., Comande, M., Giordani, P., Tonini, G., Bucci, E., Ballestrero, A., Benasso, M., Graiff, C., Bravi, S., Caffo, O., Silva, R. R., Frontini, L., Rota, S., Cozzi, L., Cantore, M., Maiello, E., Cinieri, S., Silvestris, N., Romito, S., Gebbia, V., Santoro, A., Artioli, F., Mattioli, R., Contu, A., Di Costanzo, F., Leonardi, F., Cavanna, L., Passalacqua, R., Sozzi, P., D'Amico, M., Amadori, D., Turci, D., Ravaioli, A., Pasquini, E., Gambi, A., Faedi, M., Cruciani, G., Bajetta, E., Gianni, L., Ionta, M. T., Massidda, B., Scartozzi, M., Ciarlo, A., Di Leo, A., Frustaci, S., Rangoni, G., Arizzoia, A., Pavesi, L., Verusio, C., Pinotti, G., Iop, A., De Placido, S., Adamo, V., Ficorella, C., Natale, D., Greco, E., Rulli, E., Poli, D., Porcu, L., Torri, V., and Corsi, D. C.

Subjects
0301 basic medicine, Oncology, Male, Cancer Research, Colorectal cancer, Leucovorin, Efficacy, Older patient, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Stage (cooking), Aged, 80 and over, Colonic Neoplasm, Prognostic factor, Middle Aged, Prognosis, Colon cancer, Survival Rate, Oxaliplatin, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Colonic Neoplasms, Female, Fluorouracil, medicine.drug, Human, Compliance, Adult, medicine.medical_specialty, Prognosi, Adjuvant chemotherapy, Older patients, Prognostic factors, Subgroup analysis, Follow-Up Studie, 03 medical and health sciences, Internal medicine, Post-hoc analysis, medicine, Adjuvant therapy, Humans, Capecitabine, Cancer staging, Aged, Antineoplastic Combined Chemotherapy Protocol, business.industry, medicine.disease, 030104 developmental biology, Neoplasm Recurrence, Local, business, Follow-Up Studies
Abstract

Background: Previous studies on oxaliplatin and fluoropyrimidines as adjuvant therapy in older patients with stage III colon cancer (CC) produced conflicting results. Patients and methods: We assessed the impact of age on time to tumour recurrence (TTR), disease-free survival (DFS), cancer-specific survival (CSS), and overall survival (OS) in 2360 patients with stage III CC (1667 aged

Published
2021

9. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

D. Miles, E. Ciruelos, A. Schneeweiss, F. Puglisi, T. Peretz-Yablonski, M. Campone, I. Bondarenko, Z. Nowecki, H. Errihani, S. Paluch-Shimon, A. Wardley, J.-L. Merot, P. Trask, Y. du Toit, C. Pena-Murillo, V. Revelant, D. Klingbiel, T. Bachelot, K. Bouzid, I. Desmoulins, B. Coudert, I. Glogowska, E. Ciruelos Gil, F. Dalenc, F. Ricci, V. Dieras, B. Kaufman, A. Ferreira, M. Mano, H. Kalofonos, C. Andreetta, F. Montemurro, S. Barrett, Q. Zhang, D. Mavroudis, J. Matus, C. Villarreal Garza, C. Beato, G. Ismael, X. Hu, H. Abdel Azeem, R. Gaafar, C. Perrin, P. Kerbrat, J. Ettl, S. Paepke, E. Hitre, I. Lang, M. Trudeau, S. Verma, H. Li, O. Hoffmann, B. Aktas, A. Cariello, G. Cruciani, A. Tienghi, C. Tondini, T. Al-Twegieri, N. Loman, R. Laing, E. Brain, P. Fasching, M. Lux, A. Frassoldati, Z. Aziz, J. Salas, J. Streb, K. Krzemieniecki, A. Wronski, J. Garcia Garcia, S. Menjon Beltran, I. Cicin, P. Schmid, C. Gallagher, N. Turner, Z. Tong, K. Boer, B. Juhász, Z. Horvath, G. Bianchini, L. Gianni, G. Curigliano, A. Juarez Ramiro, S. Susnjar, E. Matos, E. Sevillano, L. Garcia Estevez, E. Gokmen, R. Uslu, H. Wildiers, F. Schutz, M. Cruz, H. Bourgeois, R. von Schumann, S. Stemmer, A. Dominguez, F. Morales-Vásques, M. Wojtukiewicz, J. Trifunovic, M.J. Echarri Gonzalez, J. Illarramendi Mañas, E. Martinez De Dueñas, N. Voitko, J. Hicks, S. Waters, P. Barrett-Lee, D. Wheatley, R. De Boer, V. Cocquyt, G. Jerusalem, C. Barrios, L. Panasci, J. Mattson, M. Tanner, M. Gozy, G. Vasilopoulos, C. Papandreou, J. Revesz, N. Battelli, G. Benedetti, L. Latini, C. Gridelli, J. Lazaro Leon, J. Alarcón Company, A. Arance Fernandez, A. Barnadas Molins, I. Calvo Plaza, R. Bratos, A. Gonzalez Martin, Y. Izarzugaza Peron, L. Klint, A. Kovalev, N. McCarthy, B. Yeo, D. Kee, J. Thomson, S. White, R. Greil, S. Wang, X. Artignan, I. Juhasz-Böess, A. Rody, R. Ngan, F. Dourleshter, H. Goldberg, L. Doni, F. Di Costanzo, F. Ferraù, M. Drobniene, E. Aleknavicius, K. Rashid, L. Costa, L. de la Cruz Merino, J. Garcia Saenz, R. López, O. Del Val Munoz, O. Ozyilkan, F. Azribi, H. Jaafar, R. Baird, M. Verrill, J. Beith, A. Petzer, J. Moreira de Andrade, V. Bernstein, N. Macpherson, D. Rayson, I. Saad Eldin, M. Achille, P. Augereau, V. Müller, A. Rasco, E. Evron, D. Katz, R. Berardi, S. Cascinu, A. De Censi, A. Gennari, N. El-Saghir, M. Ghosn, H.M. Oosterkamp, J. Van den Bosch, M. Kukulska, E. Kalinka, J. Alonso, E. Dalmau Portulas, M. Del Mar Gordon Santiago, I. Pelaez Fernandez, S. Aksoy, K. Altundag, H. Senol Coskun, H. Bozcuk, Y. Shparyk, L. Barraclough, N. Levitt, U. Panwar, S. Kelly, A. Rigg, M. Varughese, C. Castillo, L. Fein, L. Malik, R. Stuart-Harris, C. Singer, H. Stoeger, H. Samonigg, J. Feng, M. Cedeño, J. Ruohola, J.-F. Berdah, A. Goncalves, H. Orfeuvre, E.-M. Grischke, E. Simon, S. Wagner, G. Koumakis, K. Papazisis, N. Ben Baruch, G. Fried, D. Geffen, N. Karminsky, T. Peretz, L. Cavanna, P. Pedrazzioli, D. Grasso, E. Ruggeri, G. D’Auria, L. Moscetti, E. Juozaityte, J. Rodriguez Cid, H. Roerdink, N. Siddiqi, J. Passos Coelho, A. Arcediano Del Amo, E. Garcia Garre, M. García Gonzalez, A. Garcia-Palomo Perez, C. Herenandez Perez, P. Lopez Alvarez, M.H. Lopez De Ceballos, N. Martínez Jañez, M. Mele Olive, K. McAdam, T. Perren, G. Dunn, A. Humphreys, W. Taylor, R. Vera, L. Kaen, J. Andel, G. Steger, J. De Grève, M. Huizing, R. Hegg, A. Joy, P. Kuruvilla, S. Sehdev, S. Smiljanic, R. Kütner, J. Alexandre, J. Grosjean, P. Laplaige, R. Largillier, P. Maes, P. Martin, V. Pottier, B. Christensen, F. Khandan, H.-J. Lück, D.-M. Zahm, G. Fountzilas, V. Karavasilis, T. Safra, M. Inbar, L. Ryvo, A. Bonetti, E. Seles, A. Giacobino, Y. Chavarri Guerra, F. de Jongh, A. van der Velden, L. van Warmerdam, S. Vrijaldenhoven, C.H. Smorenburg, M. Cavero, R. Andres Conejero, A. Oltra Ferrando, A. Redondo Sanchez, N. Ribelles Entrena, S. Saura Grau, G. Viñas Vilaro, K. Bachmeier, M. Beresford, M. Butt, J. Joffe, C. Poole, P. Woodings, P. Chakraborti, G. Yordi, N. Woodward, A. Nobre, G. Luiz Amorim, N. Califaretti, S. Fox, A. Robidoux, E. Li, N. Li, J. Jiang, T. Soria, P. Padrik, O. Lahdenpera, H. Barletta, N. Dohollou, D. Genet, K. Prulhiere, D. Coeffic, T. Facchini, S. Vieillot, S. Catala, L. Teixeira, T. Hesse, T. Kühn, A. Ober, R. Repp, W. Schröder, D. Pectasides, G. Bodoky, Z. Kahan, I. Jiveliouk, O. Rosengarten, V. Rossi, O. Alabiso, M. Pérez Martínez, A.J. van de Wouw, J. Smok-Kalwat, M. Damasecno, I. Augusto, G. Sousa, A. Saadein, N. Abdelhafiez, O. Abulkhair, A. Antón Torres, M. Corbellas Aparicio, R. Llorente Domenech, J. Florián Jerico, J. Garcia Mata, M. Gil Raga, A. Galan Brotons, A. Llombart Cussac, C. Llorca Ferrandiz, P. Martinez Del Prado, C. Olier Garate, C. Rodriguez Sanchez, R. Sanchez Gomez, M. Santisteban Eslava, J. Soberino, M. Vidal Losada Garcia, D. Soto de Prado, J. Torrego Garcia, E. Vicente Rubio, M. Garcia, A. Murias Rosales, H. Granstam Björneklett, U. Narbe, M. Jafri, D. Rea, J. Newby, A. Jones, S. Westwell, A. Ring, I. Alonso, R. Rodríguez, Miles, D., Ciruelos, E., Schneeweiss, A., Puglisi, F., Peretz-Yablonski, T., Campone, M., Bondarenko, I., Nowecki, Z., Errihani, H., Paluch-Shimon, S., Wardley, A., Merot, J. -L., Trask, P., du Toit, Y., Pena-Murillo, C., Revelant, V., Klingbiel, D., Bachelot, T., Bouzid, K., Desmoulins, I., Coudert, B., Glogowska, I., Ciruelos Gil, E., Dalenc, F., Ricci, F., Dieras, V., Kaufman, B., Ferreira, A., Mano, M., Kalofonos, H., Andreetta, C., Montemurro, F., Barrett, S., Zhang, Q., Mavroudis, D., Matus, J., Villarreal Garza, C., Beato, C., Ismael, G., Hu, X., Abdel Azeem, H., Gaafar, R., Perrin, C., Kerbrat, P., Ettl, J., Paepke, S., Hitre, E., Lang, I., Trudeau, M., Verma, S., Li, H., Hoffmann, O., Aktas, B., Cariello, A., Cruciani, G., Tienghi, A., Tondini, C., Al-Twegieri, T., Loman, N., Laing, R., Brain, E., Fasching, P., Lux, M., Frassoldati, A., Aziz, Z., Salas, J., Streb, J., Krzemieniecki, K., Wronski, A., Garcia Garcia, J., Menjon Beltran, S., Cicin, I., Schmid, P., Gallagher, C., Turner, N., Tong, Z., Boer, K., Juhasz, B., Horvath, Z., Bianchini, G., Gianni, L., Curigliano, G., Juarez Ramiro, A., Susnjar, S., Matos, E., Sevillano, E., Garcia Estevez, L., Gokmen, E., Uslu, R., Wildiers, H., Schutz, F., Cruz, M., Bourgeois, H., von Schumann, R., Stemmer, S., Dominguez, A., Morales-Vasques, F., Wojtukiewicz, M., Trifunovic, J., Echarri Gonzalez, M. J., Illarramendi Manas, J., Martinez De Duenas, E., Voitko, N., Hicks, J., Waters, S., Barrett-Lee, P., Wheatley, D., De Boer, R., Cocquyt, V., Jerusalem, G., Barrios, C., Panasci, L., Mattson, J., Tanner, M., Gozy, M., Vasilopoulos, G., Papandreou, C., Revesz, J., Battelli, N., Benedetti, G., Latini, L., Gridelli, C., Lazaro Leon, J., Alarcon Company, J., Arance Fernandez, A., Barnadas Molins, A., Calvo Plaza, I., Bratos, R., Gonzalez Martin, A., Izarzugaza Peron, Y., Klint, L., Kovalev, A., Mccarthy, N., Yeo, B., Kee, D., Thomson, J., White, S., Greil, R., Wang, S., Artignan, X., Juhasz-Boess, I., Rody, A., Ngan, R., Dourleshter, F., Goldberg, H., Doni, L., Di Costanzo, F., Ferrau, F., Drobniene, M., Aleknavicius, E., Rashid, K., Costa, L., de la Cruz Merino, L., Garcia Saenz, J., Lopez, R., Del Val Munoz, O., Ozyilkan, O., Azribi, F., Jaafar, H., Baird, R., Verrill, M., Beith, J., Petzer, A., Moreira de Andrade, J., Bernstein, V., Macpherson, N., Rayson, D., Saad Eldin, I., Achille, M., Augereau, P., Muller, V., Rasco, A., Evron, E., Katz, D., Berardi, R., Cascinu, S., De Censi, A., Gennari, A., El-Saghir, N., Ghosn, M., Oosterkamp, H. M., Van den Bosch, J., Kukulska, M., Kalinka, E., Alonso, J., Dalmau Portulas, E., Del Mar Gordon Santiago, M., Pelaez Fernandez, I., Aksoy, S., Altundag, K., Senol Coskun, H., Bozcuk, H., Shparyk, Y., Barraclough, L., Levitt, N., Panwar, U., Kelly, S., Rigg, A., Varughese, M., Castillo, C., Fein, L., Malik, L., Stuart-Harris, R., Singer, C., Stoeger, H., Samonigg, H., Feng, J., Cedeno, M., Ruohola, J., Berdah, J. -F., Goncalves, A., Orfeuvre, H., Grischke, E. -M., Simon, E., Wagner, S., Koumakis, G., Papazisis, K., Ben Baruch, N., Fried, G., Geffen, D., Karminsky, N., Peretz, T., Cavanna, L., Pedrazzioli, P., Grasso, D., Ruggeri, E., D'Auria, G., Moscetti, L., Juozaityte, E., Rodriguez Cid, J., Roerdink, H., Siddiqi, N., Passos Coelho, J., Arcediano Del Amo, A., Garcia Garre, E., Garcia Gonzalez, M., Garcia-Palomo Perez, A., Herenandez Perez, C., Lopez Alvarez, P., Lopez De Ceballos, M. H., Martinez Janez, N., Mele Olive, M., Mcadam, K., Perren, T., Dunn, G., Humphreys, A., Taylor, W., Vera, R., Kaen, L., Andel, J., Steger, G., De Greve, J., Huizing, M., Hegg, R., Joy, A., Kuruvilla, P., Sehdev, S., Smiljanic, S., Kutner, R., Alexandre, J., Grosjean, J., Laplaige, P., Largillier, R., Maes, P., Martin, P., Pottier, V., Christensen, B., Khandan, F., Luck, H. -J., Zahm, D. -M., Fountzilas, G., Karavasilis, V., Safra, T., Inbar, M., Ryvo, L., Bonetti, A., Seles, E., Giacobino, A., Chavarri Guerra, Y., de Jongh, F., van der Velden, A., van Warmerdam, L., Vrijaldenhoven, S., Smorenburg, C. H., Cavero, M., Andres Conejero, R., Oltra Ferrando, A., Redondo Sanchez, A., Ribelles Entrena, N., Saura Grau, S., Vinas Vilaro, G., Bachmeier, K., Beresford, M., Butt, M., Joffe, J., Poole, C., Woodings, P., Chakraborti, P., Yordi, G., Woodward, N., Nobre, A., Luiz Amorim, G., Califaretti, N., Fox, S., Robidoux, A., Li, E., Li, N., Jiang, J., Soria, T., Padrik, P., Lahdenpera, O., Barletta, H., Dohollou, N., Genet, D., Prulhiere, K., Coeffic, D., Facchini, T., Vieillot, S., Catala, S., Teixeira, L., Hesse, T., Kuhn, T., Ober, A., Repp, R., Schroder, W., Pectasides, D., Bodoky, G., Kahan, Z., Jiveliouk, I., Rosengarten, O., Rossi, V., Alabiso, O., Perez Martinez, M., van de Wouw, A. J., Smok-Kalwat, J., Damasecno, M., Augusto, I., Sousa, G., Saadein, A., Abdelhafiez, N., Abulkhair, O., Anton Torres, A., Corbellas Aparicio, M., Llorente Domenech, R., Florian Jerico, J., Garcia Mata, J., Gil Raga, M., Galan Brotons, A., Llombart Cussac, A., Llorca Ferrandiz, C., Martinez Del Prado, P., Olier Garate, C., Rodriguez Sanchez, C., Sanchez Gomez, R., Santisteban Eslava, M., Soberino, J., Vidal Losada Garcia, M., Soto de Prado, D., Torrego Garcia, J., Vicente Rubio, E., Garcia, M., Murias Rosales, A., Granstam Bjorneklett, H., Narbe, U., Jafri, M., Rea, D., Newby, J., Jones, A., Westwell, S., Ring, A., Alonso, I., Rodriguez, R., Apollo - University of Cambridge Repository, Medical Genetics, Clinical sciences, and Laboratory for Medical and Molecular Oncology

Subjects
0301 basic medicine, Oncology, Receptor, ErbB-2, medicine.medical_treatment, chemistry.chemical_compound, paclitaxel, 0302 clinical medicine, Trastuzumab, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, skin and connective tissue diseases, HER2 positive, hormone receptor, metastatic breast cancer, overall survival, pertuzumab, Hematology, Metastatic breast cancer, Receptor, ErbB-2/genetics, Neoplasm Recurrence, Local/drug therapy, Treatment Outcome, Docetaxel, Paclitaxel, 030220 oncology & carcinogenesis, Female, Taxoids, Pertuzumab, medicine.drug, medicine.medical_specialty, Taxoids/therapeutic use, Breast Neoplasms, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Breast Neoplasms/drug therapy, Internal medicine, medicine, Humans, Trastuzumab/adverse effects, neoplasms, Chemotherapy, Taxane, business.industry, Antineoplastic Combined Chemotherapy Protocols/adverse effects, medicine.disease, 030104 developmental biology, chemistry, Neoplasm Recurrence, Local, business
Abstract

Background The phase III CLinical Evaluation Of Pertuzumab And TRAstuzumab (CLEOPATRA) trial established the combination of pertuzumab, trastuzumab and docetaxel as standard first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive locally recurrent/metastatic breast cancer (LR/mBC). The multicentre single-arm PERtUzumab global SafEty (PERUSE) study assessed the safety and efficacy of pertuzumab and trastuzumab combined with investigator-selected taxane in this setting. Patients and methods Eligible patients with inoperable HER2-positive LR/mBC and no prior systemic therapy for LR/mBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab and pertuzumab until disease progression or unacceptable toxicity. The primary endpoint was safety. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Prespecified subgroup analyses included subgroups according to taxane, hormone receptor (HR) status and prior trastuzumab. Exploratory univariable analyses identified potential prognostic factors; those that remained significant in multivariable analysis were used to analyse PFS and OS in subgroups with all, some or none of these factors. Results Of 1436 treated patients, 588 (41%) initially received paclitaxel and 918 (64%) had HR-positive disease. The most common grade ≥3 adverse events were neutropenia (10%, mainly with docetaxel) and diarrhoea (8%). At the final analysis (median follow-up: 5.7 years), median PFS was 20.7 [95% confidence interval (CI) 18.9-23.1] months overall and was similar irrespective of HR status or taxane. Median OS was 65.3 (95% CI 60.9-70.9) months overall. OS was similar regardless of taxane backbone but was more favourable in patients with HR-positive than HR-negative LR/mBC. In exploratory analyses, trastuzumab-pretreated patients with visceral disease had the shortest median PFS (13.1 months) and OS (46.3 months). Conclusions Mature results from PERUSE show a safety and efficacy profile consistent with results from CLEOPATRA and median OS exceeding 5 years. Results suggest that paclitaxel is a valid alternative to docetaxel as backbone chemotherapy. Exploratory analyses suggest risk factors that could guide future trial design.

Published
2021

10. 1697P Cancer patients’ perceptions, opinions and feelings during the COVID-19 epidemic in the most affected Italian areas: Serial cross-sectional study

Author

L. Buffoni, R. Maddalena, Caterina Caminiti, Angela Gobbi, F. A. Meriggi, C. Iridile, S. Piloni, Giulia Grizzi, Veronica Lonati, Giuseppe Maglietta, L. Cavanna, Francesco Campione, F. Gallina, Maria Bonomi, E. Gervasi, Margherita Ratti, Rodolfo Passalacqua, F. Barbin, L. Bonassi, and J. Saleri

Subjects
Coping (psychology), medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), business.industry, Cross-sectional study, media_common.quotation_subject, Hematology, Logistic regression, Article, Feeling, Oncology, Family medicine, Health care, Pandemic, Medicine, Anxiety, medicine.symptom, business, media_common
Abstract

Background: Risks associated with COVID outbreak and consequent restrictive measures taken by the Government can cause concern and anxiety The impact on cancer patients (pts) may be even greater We investigated the influence of COVID pandemic on pts’ perceptions, opinions and feelings during the peak of the epidemic and after the loosening of the Government restrictions Methods: Multicenter, serial cross-sectional study conducted in 11 cancer centers located in the hardest hit Italian areas The study is composed by 2 surveys administered to unselected adult pts receiving onsite oncologic treatments: the first during the enforcement of containment measures against COVID spread;the second upon the loosening of Government restrictions A self-administered questionnaire composed by 11 closed questions (only 1 answer) was used At least 1000 pts per each survey were deemed necessary Multivariable logistic regression models will be used to identify factors associated to recorded perceptions and opinions Main outcomes are: 1) perception of the pandemic effect on feelings 2) perception of changes in the relationship with the medical team 3) opinions on healthcare reorganization and on the information campaign This study has been approved by all Ethical Commettees of the centers Results: The first survey was conducted between March 16th and April 30th 1027 questionnaires were collected Mean age was 64 yrs (SD 11 7), 58% were women, 49% had low educational level 80% and 20% received i v and oral treatment, respectively As for pts feelings, 45 5% indicated that their fears related to cancer increased because hope in recovery diminished (23%) Courage of coping with tumor was increased in 26%, unchanged in 64%;95% perceived a high availability of healthcare facilities and 97 6% declared confidence in the treating teams, while 65 3% stated that the information received from the Government and local bodies was confusing Conclusions: Although half of the pts had more fears and concerns about the epidemic, they feel reassured, maintain trust in healthcare facilities and a good communication with doctors and nurses Due to the epidemic course, the second survey could not yet be performed and data will be available by June Legal entity responsible for the study: Azienda Istituti Ospitalieri di Cremona, Italy Funding: MEDEA, Medicina e Arte, Onlus, Cremona Disclosure: All authors have declared no conflicts of interest

Published
2020
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11. Immunogenicity and safety after the third dose of BNT162b2 anti-SARS-CoV-2 vaccine in patients with solid tumors on active treatment: a prospective cohort study

Author

A, Lasagna, F, Bergami, D, Lilleri, E, Percivalle, M, Quaccini, N, Alessio, G, Comolli, A, Sarasini, J C, Sammartino, A, Ferrari, F, Arena, S, Secondino, D, Cicognini, R, Schiavo, G, Lo Cascio, L, Cavanna, F, Baldanti, P, Pedrazzoli, and I, Cassaniti

Subjects
Vaccines, Synthetic, Cancer Research, COVID-19 Vaccines, Oncology, SARS-CoV-2, Immunoglobulin G, Neoplasms, COVID-19, Humans, Prospective Studies, mRNA Vaccines, Antibodies, Viral, BNT162 Vaccine
Abstract

Although a full course of coronavirus disease 2019 (COVID-19) vaccine is effective in cancer patients, the duration of the protection and the efficacy of a booster dose against the new variants remain unknown. We prospectively evaluated the immunogenicity of the third dose of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) BNT162b2 messenger RNA vaccine in cancer patients undergoing active treatment.Patients with solid cancer, vaccinated with a booster dose during active treatment, were enrolled in this study. Patients were classified into SARS-CoV-2 naïve (without previous COVID-19 infection) and SARS-CoV-2 experienced (with previous COVID-19 infection). Neutralizing antibody (NT Ab) titer and total anti-Spike immunoglobulin G (IgG) concentration were quantified in serum. Heparinized whole blood samples were used for SARS-CoV-2 Interferon Gamma Release Assay (IGRA). The primary endpoint was to assess the increase of IgG antibody level between baseline and 3 weeks after the booster.One hundred and forty-two consecutive patients were recruited. In SARS-CoV-2-naïve subjects, the median level of IgG was 157 BAU/ml [interquartile range (IQR) 62-423 BAU/ml] at T0 and reached a median of 2080 BAU/ml (IQR 2080-2080 BAU/ml) at 3 weeks after booster administration (T1; P0.0001). A median 16-fold increase of SARS-CoV-2 NT Ab titer (IQR 4-32) was observed in naïve subjects (from median 20, IQR 10-40, to median 640, IQR 160-640; P0.0001). Median interferon-γ level at T1 was significantly higher than that measured at T0 in SARS-CoV-2-naïve subjects (P = 0.0049) but not in SARS-CoV-2-experienced patients. The median level of SARS-CoV-2 NT Abs was 32-fold lower against Omicron compared to the wild-type strain (P = 0.0004) and 12-fold lower compared to the Delta strain (P = 0.0110).The third dose is able to trigger both the humoral and the cell-mediated immune response in cancer patients on active treatment. Our preliminary data about the neutralization of the SARS-CoV-2 vaccine against variants of concern seem to confirm the lower vaccine activity.

Published
2022
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13. Impact on Survival of Timing and Duration of Adjuvant Chemotherapy in Radically Resected Gastric Cancer

Author

Maria Di Bartolomeo, Filippo Pietrantonio, Eliana Rulli, Davide Poli, Rosa Berenato, Marta Caporale, Emilio Bajetta, Irene Floriani, E. Bajetta, M. Di Bartolomeo, L. Catena, M. Schiavo, G. Pinotti, I. Proserpio, G. Rosati, R. Bordonaro, S. Cordio, G. Burrafato, A.M. Bochicchio, M. Aieta, N. Fazio, F. Spada, V. Amoroso, G. Marini, H. Soto Parra, G. Novello, B. Massidda, M.T. Ionta, M. Comandè, R. Venezia, A. Bertolini, E. Menatti, L. Zanlorenzi, A. Colombo, A. Iop, S. Bonura, E. Mazza, M. Viganò, A. Ardizzoia, S. Dell'Oro, G. Lo Re, D. Santeufemia, A. Buonadonna, D. Luisi, G. Ucci, G. Di Lucca, A. Bonetti, F. Bergamo, M. Alù, F. Vastola, P. Marchetti, D.C. Corsi, E. Massa, G. Di Pinto, M. Duro, C. Oliani, M. Franchini, A. Inzoli, N. Gebbia, L. Repetto, S. Rota, L. Frontini, R. Labianca, S. Mosconi, A. Quadri, S. De Grossi, P. Bidoli, M.E. Cazzaniga, F. Villa, P. Foa, D. Ferrari, E. Aitini, C. Rabbi, S. Barni, F. Petrelli, M. Giordano, G. Luchena, M. Pirovano, A. Nasisi, V. Catalano, P. Giordani, A. Zaniboni, F. Leone, S. Ferrario, G.D. Beretta, E.T. Menichetti, D. Conte, D. Mari, R. Giannicola, C. Pierantoni, A.G. Luporini, A. Ragazzini, A. Ravaioli, D. Tassinari, M. Nicolini, D. Amadori, G.L. Frassineti, D. Turci, F. Zumaglini, S. Tamberi, A. Piancastelli, G. Cruciani, E. Bejtja, A. Falcone, L. Landi, G. Minuti, M. Cantore, M. Orlandi, A. Mambrini, A. Ciarlo, D. Cavaciocchi, F. Del Monte, S. Ricci, I.M. Brunetti, M. Lencioni, M. Sisani, P. Sozzi, C. Granetto, S. Chiara, A.S. Galetto, A.S. Ribecco, A. DeCensi, L. Ciuffreda, E.E. Baldini, R. Camisa, R. Todeschini, A. Santoro, L. Rimassa, C. Carnaghi, T. Pressiani, C. Boni, E. Rondini, R. Gnoni, F. Di Costanzo, S. Gasperoni, L. Cavanna, M.A. Palladino, R. Mattioli, G. Laici, F. Pucci, M.D. Alessio, I. Bernardini, G. Tomasello, G. Baldino, R. Rossetti, S. Giaquinta, C. Pinto, F. Di Fabio, F.L. Rijas Llimpe, A.A. Brandes, M. Marzola, A.O.G. Rummo Benevento, S. Competiello, V. Montesarchio, A. Rea, B. Daniele, G. Genua, M. Licenziato, R. Casaretti, L. Silvestro, M. Montano, M.G. Sarobba, G. Sanna, G. Filippelli, G. Dima, E. Greco, M. Roselli, D. Natale, G. Condemi, G. Fumi, S. Tafuto, P. Masullo, D. Nitti, A. Marchet, G. Tiberio, G. de Manzoni, S. Nobili, G. Fiorentini, R. Mazzanti, E. Perrotta, C. Carlomagno, A. De Stefano, G. Cartenì, and M. Otero

Subjects
Male, Oncology, Cancer Research, medicine.medical_specialty, Adjuvant chemotherapy, medicine.medical_treatment, Time-to-Treatment, 03 medical and health sciences, 0302 clinical medicine, Stomach Neoplasms, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Combined Modality Therapy, Aged, Neoplasm Staging, Proportional Hazards Models, Postoperative Care, Chemotherapy, Proportional hazards model, business.industry, Stomach, Cancer, General Medicine, Middle Aged, medicine.disease, medicine.anatomical_structure, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Adenocarcinoma, Female, 030211 gastroenterology & hepatology, business, Adjuvant
Abstract

Purpose Adjuvant chemotherapy improves survival of patients with gastric cancer. Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach (ITACA-S) was a phase III study comparing sequential FOLFIRI followed by docetaxel/cisplatin versus 5-fluorouracil monotherapy. The intensive regimen was not superior in terms of disease-free survival (DFS) and overall survival (OS). Methods The treatment was to be started within 8 weeks from surgery. This analysis evaluates the impact of time from surgery to chemotherapy start (TSC) on outcomes. Results Out of 1,106 randomized, 1,072 patients without major violations of eligibility criteria and receiving at least one treatment cycle were analyzed. Median TSC was 50 days. Chemotherapy was interrupted in 201 (18.8%) cases, whereas it was completed without or with modifications in 277 (25.8%) and 594 (55.4%), respectively. At a median follow-up of 56.9 months, 513 progressions and 472 deaths occurred. A longer TSC was significantly associated with longer DFS (hazard ratio [HR] 0.95; 95% confidence interval [CI] 0.89-1.00; p = 0.05) and OS (HR 0.91; 95% CI 0.86-0.97; p = 0.004), after adjustment for treatment arm, age, sex, primary tumor site, number of resected nodes, and tumor stage. Better treatment compliance was associated with improved survival. Conclusions Our findings suggest that longer TSC had at least no detrimental effect on DFS and OS, whereas treatment completion had a protective effect. Our findings need to be confirmed prospectively.

Published
2016
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14. Metformin plus chemotherapy versus chemotherapy alone in the first-line treatment of HER2-negative metastatic breast cancer. The MYME randomized, phase 2 clinical trial

Author

Andrea Rocca, Myme investigators, Paolo Bruzzi, F. Rosetti, Flavia Foca, A. De Censi, Patrizia Serra, Davide Corradengo, Luca Gianni, Alessandra Gennari, Dino Amadori, Laura Amaducci, Oriana Nanni, Alessandra Bologna, Andrea Freschi, Linda Valmorri, Samanta Sarti, L Cavanna, Nanni, O, Amadori, D, De Censi, A, Rocca, A, Freschi, A, Bologna, A, Gianni, L, Rosetti, F, Amaducci, L, Cavanna, L, Foca, F, Sarti, S, Serra, P, Valmorri, L, Bruzzi, P, Corradengo, D, Gennari, A, and Myme, Investigators

Subjects
0301 basic medicine, Cancer Research, medicine.medical_specialty, Receptor, ErbB-2, medicine.medical_treatment, Phases of clinical research, Breast Neoplasms, Neutropenia, Gastroenterology, Drug Administration Schedule, 03 medical and health sciences, HOMA index, 0302 clinical medicine, Breast cancer, Drug Therapy, Interquartile range, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Humans, Cyclophosphamide, Aged, Chemotherapy, business.industry, Insulin resistance, Middle Aged, medicine.disease, Metastatic breast cancer, Survival Analysis, Advanced breast cancer, Metformin, Progression-Free Survival, 030104 developmental biology, Treatment Outcome, Oncology, Doxorubicin, 030220 oncology & carcinogenesis, Female, business, medicine.drug
Abstract

Purpose: To investigate the efficacy of metformin (M) plus chemotherapy versus chemotherapy alone in metastatic breast cancer (MBC). Methods: Non-diabetic women with HER2-negative MBC were randomized to receive non-pegylated liposomal doxorubicin (NPLD) 60 mg/m2 + cyclophosphamide (C) 600 mg/m2 × 8 cycles Q21 days plus M 2000 mg/day (arm A) versus NPLD/C (arm B). The primary endpoint was progression-free survival (PFS). Results: One-hundred-twenty-two patients were evaluable for PFS. At a median follow-up of 39.6 months (interquartile range [IQR] 24.6-50.7 months), 112 PFS events and 71 deaths have been registered. Median PFS was 9.4 months (95% CI 7.8-10.4) in arm A and 9.9 (95% CI 7.4-11.5) in arm B (P = 0.651). In patients with HOMA index

Published
2018

15. The Prognostic Roles of Gender and O6-Methylguanine-DNA Methyltransferase Methylation Status in Glioblastoma Patients: The Female Power

Author

Enrico Franceschi, Alicia Tosoni, Santino Minichillo, Roberta Depenni, Alexandro Paccapelo, Stefania Bartolini, Maria Michiara, Giacomo Pavesi, Benedetta Urbini, Girolamo Crisi, Michele A. Cavallo, Luigino Tosatto, Claudio Dazzi, Claudia Biasini, Giuseppe Pasini, Damiano Balestrini, Francesca Zanelli, Vania Ramponi, Antonio Fioravanti, Ermanno Giombelli, Dario De Biase, Agostino Baruzzi, Alba A. Brandes, A. Baruzzi, F. Albani, F. Calbucci, R. D'Alessandro, R. Michelucci, A. Brandes, V. Eusebi, S. Ceruti, E. Fainardi, R. Tamarozzi, E. Emiliani, M. Cavallo, E. Franceschi, A. Tosoni, F. Fiorica, A. Valentini, R. Depenni, C. Mucciarini, G. Crisi, E. Sasso, C. Biasini, L. Cavanna, D. Guidetti, N. Marcello, A. Pisanello, A.M. Cremonini, G. Guiducci, S. de Pasqua, S. Testoni, R. Agati, G. Ambrosetto, A. Bacci, E. Baldin, A. Baldrati, E. Barbieri, S. Bartolini, E. Bellavista, F. Bisulli, E. Bonora, F. Bunkheila, V. Carelli, M. Crisci, P. Dall'Occa, D. de Biase, S. Ferro, C. Franceschi, G. Frezza, V. Grasso, M. Leonardi, G. Marucci, L. Morandi, B. Mostacci, G. Palandri, E. Pasini, M. Pastore Trossello, A. Pession, R. Poggi, P. Riguzzi, R. Rinaldi, S. Rizzi, G. Romeo, F. Spagnolli, P. Tinuper, C. Trocino, M. Dall'Agata, M. Frattarelli, G. Gentili, A. Giovannini, P. Iorio, U. Pasquini, G. Galletti, C. Guidi, W. Neri, A. Patuelli, S. Strumia, M. Faedi, M. Casmiro, A. Gamboni, F. Rasi, G. Cruciani, P. Cenni, C. Dazzi, A.R. Guidi, F. Zumaglini, A. Amadori, G. Pasini, M. Pasquinelli, E. Pasquini, A. Polselli, A. Ravasio, B. Viti, M. Sintini, A. Ariatti, F. Bertolini, G. Bigliardi, P. Carpeggiani, F. Cavalleri, S. Meletti, P. Nichelli, E. Pettorelli, G. Pinna, E. Zunarelli, F. Artioli, I. Bernardini, M. Costa, G. Greco, R. Guerzoni, C. Stucchi, C. Iaccarino, M. Ragazzi, R. Rizzi, G. Zuccoli, P. Api, F. Cartei, M. Colella, E. Fallica, M. Farneti, A. Frassoldati, E. Granieri, F. Latini, C. Monetti, A. Saletti, R. Schivalocchi, S. Sarubbo, S. Seraceni, M.R. Tola, B. Urbini, G. Zini, C. Giorgi, E. Montanari, D. Cerasti, P. Crafa, I. Dascola, I. Florindo, E. Giombelli, S. Mazza, V. Ramponi, F. Servadei, E.M. Silini, P. Torelli, P. Immovilli, N. Morelli, C. Vanzo, C. Nobile, Franceschi, Enrico, Tosoni, Alicia, Minichillo, Santino, Depenni, Roberta, Paccapelo, Alexandro, Bartolini, Stefania, Michiara, Maria, Pavesi, Giacomo, Urbini, Benedetta, Crisi, Girolamo, Cavallo, Michele A., Tosatto, Luigino, Dazzi, Claudio, Biasini, Claudia, Pasini, Giuseppe, Balestrini, Damiano, Zanelli, Francesca, Ramponi, Vania, Fioravanti, Antonio, Giombelli, Ermanno, De Biase, Dario, Baruzzi, Agostino, Brandes, Alba A., PERNO Study Group, Francesca, Bisulli, Valerio, Carelli, and Paolo, Tinuper

Subjects
Oncology, Adult, Male, medicine.medical_specialty, Multivariate analysis, Methyltransferase, Kaplan-Meier Estimate, DNA methyltransferase, Methylation, NO, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Biomarkers, Tumor, Medicine, Humans, DNA Modification Methylases, Aged, Proportional Hazards Models, Sex Characteristics, PERNO, business.industry, Brain Neoplasms, Standard treatment, Tumor Suppressor Proteins, Hazard ratio, Gender, DNA Methylation, Middle Aged, medicine.disease, Glioblastoma, MGMT, Prognosis, Confidence interval, DNA Repair Enzymes, 030220 oncology & carcinogenesis, Surgery, Neurology (clinical), Female, business, 030217 neurology & neurosurgery
Abstract

Background: Clinical and molecular factors are essential to define the prognosis in patients with glioblastoma (GBM). O6-methylguanine-DNA methyltransferase (MGMT) methylation status, age, Karnofsky Performance Status (KPS), and extent of surgical resection are the most relevant prognostic factors. Our investigation of the role of gender in predicting prognosis shows a slight survival advantage for female patients. Methods: We performed a prospective evaluation of the Project of Emilia Romagna on Neuro-Oncology (PERNO) registry to identify prognostic factors in patients with GBM who received standard treatment. Results: A total of 169 patients (99 males [58.6%] and 70 females [41.4%]) were evaluated prospectively. MGMT methylation was evaluable in 140 patients. Among the male patients, 36 were MGMT methylated (25.7%) and 47 were unmethylated (33.6%); among the female patients, 32 were methylated (22.9%) and 25 were unmethylated (17.9%). Survival was longer in the methylated females compared with the methylated males (P = 0.028) but was not significantly different between the unmethylated females and the unmethylated males (P = 0.395). In multivariate analysis, gender and MGMT methylation status considered together (methylated females vs. methylated males; hazard ratio [HR], 0.459; 95% confidence interval [CI], 0.242-0.827; P = 0.017), age (HR, 1.025; 95% CI, 1.002-1.049; P = 0.032), and KPS (HR, 0.965; 95% CI, 0.948-0.982; P < 0.001) were significantly correlated with survival. Conclusions: Survival was consistently longer among MGMT methylated females compared with males. Gender can be considered as a further prognostic factor.

Published
2018

16. Randomized Phase III Trial of Gemcitabine Plus Cisplatin Compared With Single-Agent Gemcitabine As First-Line Treatment of Patients With Advanced Pancreatic Cancer: The GIP-1 Study

Author

G. Colucci, R. Labianca, F. D. Costanzo, V. Gebbia, G. Cartenì, B. Massidda, E. Dapretto, L. Manzione, E. Piazza, M. Sannicolò, M. Ciaparrone, L. Cavanna, F. Giuliani, E. Maiello, A. Testa, P. Pederzoli, C. Gallo, M. D. Maio, F. Perrone, G. O. Italia Meridionale, G. I. per lo Studio dei Carcinomi dell'Apparato Digerente, G. O. Italiano di Ricerca Clinica, FALCONI , MASSIMO, G., Colucci, R., Labianca, F. D., Costanzo, V., Gebbia, G., Cartenì, B., Massidda, E., Dapretto, L., Manzione, E., Piazza, M., Sannicolò, M., Ciaparrone, L., Cavanna, F., Giuliani, E., Maiello, A., Testa, P., Pederzoli, Falconi, Massimo, C., Gallo, M. D., Maio, F., Perrone, G. O., Italia Meridionale, G. I., per lo Studio dei Carcinomi dell'Apparato Digerente, G. O., Italiano di Ricerca Clinica, Colucci, G., Labianca, R., DI COSTANZO, F., Gebbia, V., Cartenì, G., Massidda, B., Dapretto, E., Manzione, L., Piazza, E., Sannicolò, M., Ciaparrone, M., Cavanna, L., Giuliani, F., Maiello, E., Testa, A., Pederzoli, P., Falconi, V., Gallo, Ciro, DI MAIO, M., and Perrone, F.

Subjects
Adult, Male, Oncology, Cancer Research, medicine.medical_specialty, Pancreatic disease, medicine.drug_class, medicine.medical_treatment, Deoxycytidine, Antimetabolite, Pancreatic cancer, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Aged, Cisplatin, Chemotherapy, advanced pancreatic cancer, business.industry, gemcitabine, Cancer, Middle Aged, randomized clinical trial, medicine.disease, Female, Pancreatic Neoplasms, Gemcitabine, Surgery, Fluorouracil, business, medicine.drug
Abstract

Purpose Single-agent gemcitabine became standard first-line treatment for advanced pancreatic cancer after demonstration of superiority compared with fluorouracil. The Gruppo Italiano Pancreas 1 randomized phase III trial aimed to compare gemcitabine plus cisplatin versus gemcitabine alone (ClinicalTrials.gov ID NCT00813696). Patients and Methods Patients with locally advanced or metastatic pancreatic cancer, age 18 to 75 years, and Karnofsky performance status (KPS) ≥ 50, were randomly assigned to receive gemcitabine (arm A) or gemcitabine plus cisplatin (arm B). Arm A: gemcitabine 1,000 mg/m2 weekly for 7 weeks, and, after a 1-week rest, on days 1, 8, and 15 every 4 weeks. Arm B: cisplatin 25 mg/m2 added weekly to gemcitabine, except cycle 1 day 22. Primary end point was overall survival. To have 8% power of detecting a 0.74 hazard ratio (HR) of death, with bilateral α .05, 355 events were needed and 400 patients planned. Results Four hundred patients were enrolled (arm A: 199; arm B: 201). Median age was 63, 59% were male, 84% had stage IV, and 83% had KPS ≥ 80. Median overall survival was 8.3 months versus 7.2 months in arm A and B, respectively (HR, 1.10; 95% CI, 0.89 to 1.35; P = .38). Median progression-free survival was 3.9 months versus 3.8 months in arm A and B, respectively (HR, 0.97; 95% CI, 0.80 to 1.19; P = .80). The objective response rate was 10.1% in A and 12.9% in B (P = .37). Clinical benefit was experienced by 23.0% in A and 15.1% in B (P = .057). Combination therapy produced more hematologic toxicity, without relevant differences in nonhematologic toxicity. Conclusion The addition of weekly cisplatin to gemcitabine failed to demonstrate any improvement as first-line treatment of advanced pancreatic cancer.

Published
2010
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17. Characteristics of the case mix, organisation and delivery in cancer palliative care:a challenge for good-quality research

Author

Maria Nabal, L Cavanna, Koen Pardon, Michael I. Bennett, A. Caraceni, Nina Aass, Florian Strasser, A Noguera-Tejedor, E Rondini, Cinzia Brunelli, Gunnhild Jakobsen, Per Sjøgren, Erik Torbjørn Løhre, Marina Martínez, Luigi Piva, Adriana Turriziani, Dagny Faksvåg Haugen, Marianne Jensen Hjermstad, Stein Kaasa, F Rizzi, Alessandra Pigni, F Aielli, Josep Porta-Sales, M Feio, Barry Laird, K Fassbender, Family Medicine and Chronic Care, Faculty of Medicine and Pharmacy, and End-of-life Care Research Group

Subjects
Male, Palliative care, Survival, MULTICENTER, Integration, Medicine (miscellaneous), 0302 clinical medicine, Quality research, Cancer, Generalisability, Palliative Care, Patient characteristics, Neoplasms, Surveys and Questionnaires, Medicine and Health Sciences, Medicine, Prospective Studies, 030212 general & internal medicine, Aged, 80 and over, Oncology (nursing), PAIN, General Medicine, Middle Aged, CHEMOTHERAPY, Europe, Medical–Surgical Nursing, 030220 oncology & carcinogenesis, END, Female, Adult, medicine.medical_specialty, QUESTIONNAIRE, MINI-MENTAL-STATE, Young Adult, 03 medical and health sciences, Case mix index, Journal Article, Humans, Trial registration, Diagnosis-Related Groups, Aged, Performance status, business.industry, ONCOLOGY, LIFE, Family medicine, business, Nursing homes, Delivery of Health Care, Healthcare providers, SYMPTOM ASSESSMENT, Cancer palliative care
Abstract

ObjectivesPalliative care (PC) services and patients differ across countries. Data on PC delivery paired with medical and self-reported data are seldom reported. Aims were to describe (1) PC organisation and services in participating centres and (2) characteristics of patients in PC programmes.MethodsThis was an international prospective multicentre study with a single web-based survey on PC organisation, services and academics and patients' self-reported symptoms collected at baseline and monthly thereafter, with concurrent registrations of medical data by healthcare providers. Participants were patients ≥18 enrolled in a PC programme.Results30 centres in 12 countries participated; 24 hospitals, 4 hospices, 1 nursing home, 1 home-care service. 22 centres (73%) had PC in-house teams and inpatient and outpatient services. 20 centres (67%) had integral chemotherapy/radiotherapy services, and most (28/30) had access to general medical or oncology inpatient units. Physicians or nurses were present 24 hours/7 days in 50% and 60% of centres, respectively. 50 centres (50%) had professorships, and 12 centres (40%) had full-time/part-time research staff. Data were available on 1698 patients: 50% females; median age 66 (range 21–97); median Karnofsky score 70 (10–100); 1409 patients (83%) had metastatic/disseminated disease; tiredness and pain in the past 24 hours were most prominent. During follow-up, 1060 patients (62%) died; 450 (44%) 2 tests showed that hospice/nursing home patients were significantly older, had poorer performance status and had shorter survival compared with hospital-patients (pConclusionsThere is a wide variation in PC services and patients across Europe. Detailed characterisation is the first step in improving PC services and research.Trial registration numberClinicalTrials.gov Identifier: NCT01362816.

Published
2016
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18. Primary and secondary glomerulonephritis I

Author

N. Miyazaki, J. Matsumoto, F. Alberici, A. Palmisano, F. Maritati, E. Oliva, C. Buzio, A. Vaglio, G. Mjoen, G. E. Norby, B. E. Vikse, E. Svarstad, B. Rune, A. Knut, M. Szymczak, J. Kuzniar, W. Kopec, Z. Marchewka, M. Klinger, P. Arrizabalaga, R. Silvarino, F. Sant, G. Espinosa, M. Sole, R. Cervera, D. Gude, S. Chennamsetty, A. Demin, V. Kozlov, I. Lisukov, O. Kotova, A. Sizikov, V. Sergeevicheva, L. Demina, O. Borjesson, M. Wendt, A. Avik, A. R. Qureshi, J. Bratt, E. J. Miller, I. Gunnarsson, A. Bruchfeld, K. Sugiyama, M. Hasegawa, K. Yamamoto, H. Hayashi, S. Koide, K. Murakami, M. Tomita, S. Yoshida, Y. Yuzawa, S. Yew, D. Jayne, K. Westman, P. Hoglund, O. Flossman, A. Mahr, R. Luqmani, J. Robson, E. Thervet, C. Levi, E. Guiard, M. Roland, D. Nochy, C. Daniliuc, L. Guillevin, L. Mouthon, C. Jacquot, A. Karras, Y. Kimura, H. Morita, H. Debiec, H. Yamada, N. Miura, S. Banno, P. Ronco, H. Imai, D. H. Shin, D. Famee, H. M. Koo, S. H. Han, K. H. Choi, T.-H. Yoo, S.-W. Kang, C. Fofi, L. Scabbia, F. Festuccia, A. Stoppacciaro, P. Mene', A. Shimizu, M. Fukui, A. MII, T. Kaneko, Y. Masuda, Y. Iino, Y. Katayama, Y. Fukuda, A. Kuroki, K. Matsumoto, T. Akizawa, R. Jurubita, G. Ismail, R. Bobeica, E. Rusu, D. Zilisteanu, A. Andronesi, O. Motoi, V. Ditoiu, I. Copaci, M. Voiculescu, M. V. Irazabal, A. Eirin, J. C. Lieske, L. H. Beck, J. J. Dillon, P. H. Nachman, S. Sethi, S. B. Erickson, D. C. Cattran, F. C. Fervenza, B. Svobodova, Z. Hruskova, I. Janatkova, E. Jancova, V. Tesar, M. S. Seo, S. H. Kwon, E. B. Lee, J. Y. You, Y. K. Hyun, S. A. Woo, M. Y. Park, S. J. Choi, J. S. Jeon, H. Noh, J. G. Kim, D. C. Han, S. D. Hwang, T. Y. Choi, S. Y. Jin, E. Loiacono, D. Defedele, M. P. Puccinelli, R. Camilla, R. Gallo, L. Peruzzi, C. Rollino, G. Beltrame, M. Ferro, L. Vergano, F. Campolo, A. Amore, R. Coppo, T. Knoop, L. Bostad, T. Leivestad, R. Bjorneklett, J. Teranishi, R. Yamamoto, Y. Nagasawa, T. Shoji, H. Iwatani, N. Okada, T. Moriyama, A. Yamauchi, Y. Tsubakihara, E. Imai, H. Rakugi, Y. Isaka, F. M. Doh, S. J. Kim, D. S. Han, Y. Suzuki, K. Matsuzaki, H. Suzuki, K. Okazaki, H. Yanagawa, M. Maiguma, M. Muto, T. Sato, S. Horikoshi, J. Novak, O. Hotta, Y. Tomino, E. Gutierrez, I. Zamora, J. Ballarin, Y. Arce, S. Jimenez, C. Quereda, T. Olea, J. Martinez-Ara, A. Segarra, C. Bernis, A. Garcia, M. Goicoechea, S. Garcia de Vinuesa, J. Rojas, M. Praga, V. Ristovska, G. Petrushevska, L. Grcevska, K. Satake, Y. Shimizu, N. Mugitani, S. Honda, K. Shibuya, A. Shibuya, M. Papale, M. T. Rocchetti, S. DI Paolo, I. V. Suriano, A. D'apollo, G. Vocino, E. Montemurno, L. Varraso, G. Grandaliano, L. Gesualdo, A. Huerta, A. S. Bomback, P. A. Canetta, J. Radhakrishnan, L. Herlitz, B. Stokes, V. D'agati, G. Markowitz, G. B. Appel, H. Mouna, B. D. Nasr, I. Mrabet, L. Ahmed, A. Sabra, F. Mohamed Ammeur, E. Mezri, S. Habib, M. Innocenti, A. Pasquariello, G. Pasquariello, P. Mattei, A. Bottai, G. Fumagalli, L. Bozzoli, S. Samoni, A. Cupisti, B. Caldin, J. Hung, L. Repizo, D. M. Malheiros, R. Barros, V. Woronik, C. Giammarresi, L. Bono, A. Ferrantelli, C. Tortorici, G. Licavoli, U. Rotolo, X. Huang, Q. Wang, M. Shi, W. Chen, Z. Liu, R. Scarpioni, L. Cantarini, A. Lazzaro, M. Ricardi, V. Albertazzi, L. Melfa, C. Concesi, D. Vallisa, L. Cavanna, G. Gungor, H. Ataseven, A. Demir, Y. Solak, M. Biyik, B. Ozturk, I. Polat, A. Kiyici, O. Ozer Cakir, H. Polat, I. Castillo, V. Carreno, A. Aguilar, R. Madero, E. Hernandez, J. Bartolome, F. Gea, R. Selgas, H. A. M. El Aggan, H. S. El Banawy, E. Wagdy, N. Tchebotareva, O. LI, I. Bobkova, L. Kozlovskaya, V. Varshavskiy, E. Golicina, Y. Chen, Z. Gong, X. Chen, L. Tang, J. Zhou, X. Cao, R. Wei, E. H. Koo, J. H. Park, H. K. Kim, M. S. Kim, H. R. Jang, J. E. Lee, W. Huh, D. J. Kim, H. Y. Oh, Y.-G. Kim, O. Eskova, M. Shvetsov, E. Golytsina, O. Popova, M. Quaglia, S. Monti, R. Fenoglio, A. Menegotto, A. Airoldi, C. Izzo, M. A. Rizzo, U. Dianzani, P. Stratta, and D. Gianfreda

Subjects
Transplantation, Nephrology
Published
2012
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19. Are strong opioids equally effective and safe in the treatment of chronic cancer pain? A multicenter randomized phase IV 'real life' trial on the variability of response to opioids

Author

E. Molinari, L. Piva, V. Reina, M. Luzi, O. Corli, D. Valenti, F. Artioli, G. Lipari, M.T. Roy, S. Mameli, P. Preti, M. Diodati, F. Drudi, P.O. di Salemi, L.F. Nardi, M. Dauri, Irene Floriani, C. Crispino, A. Roberto, M. Lazzari, M. Mangiapia, T. Gamucci, G.A. Brunetti, G. Boscolo, L. Montanari, A. Caraceni, F. Formaglio, P. Ferrari, Maria Teresa Greco, L. Pavesi, R. Mistretta, G. Apolone, F. Narducci, C. Cartoni, G. Azzarello, L. Cavanna, T.A. Dragani, M. Montanari, M. Pizzuto, F. Fusco, M. Monfredo, E. Bandieri, F. Rizzi, M. Luzzani, V. Iorno, E. Zecca, C. Reale, D. Tassinari, A. Cupaiolo, Stein Kaasa, R. Di Gregorio, M. Pacchioni, G. Vasini, L. Orsi, and F. Galli

Subjects
Adult, Male, opioids in cancer pain, Drug-Related Side Effects and Adverse Reactions, Analgesic, Settore MED/41 - Anestesiologia, Fentanyl, 03 medical and health sciences, 0302 clinical medicine, Neoplasms, Medicine, Humans, neurotoxic effects, Aged, changes of therapy, variability of response, Morphine, business.industry, Hematology, Cancer Pain, Middle Aged, Discontinuation, Clinical trial, Analgesics, Opioid, Oncology, 030220 oncology & carcinogenesis, Anesthesia, Female, business, Cancer pain, Oxycodone, 030217 neurology & neurosurgery, medicine.drug, Buprenorphine
Abstract

Background Guidelines tend to consider morphine and morphine-like opioids comparable and interchangeable in the treatment of chronic cancer pain, but individual responses can vary. This study compared the analgesic efficacy, changes of therapy and safety profile over time of four strong opioids given for cancer pain. Patient and methods In this four-arm multicenter, randomized, comparative, of superiority, phase IV trial, oncological patients with moderate to severe pain requiring WHO step III opioids were randomly assigned to receive oral morphine or oxycodone or transdermal fentanyl or buprenorphine for 28 days. At each visit, pain intensity, modifications of therapy and adverse drug reactions (ADRs) were recorded. The primary efficacy end point was the proportion of nonresponders, meaning patients with worse or unchanged average pain intensity (API) between the first and last visit, measured on a 0–10 numerical rating scale. (NCT01809106). Results Forty-four centers participated in the trial and recruited 520 patients. Worst pain intensity and API decreased over 4 weeks with no significant differences between drugs. Nonresponders ranged from 11.5% (morphine) to 14.4% (buprenorphine). Appreciable changes were made in the treatment schedules over time. Each group required increases in the daily dose, from 32.7% (morphine) to 121.2% (transdermal fentanyl). Patients requiring adjuvant analgesics ranged from 68.9% (morphine) to 81.6% (oxycodone), switches varied from 22.1% (morphine) to 12% (oxycodone), discontinuation of treatment from 27% ( morphine) to 14.5% (fentanyl). ADRs were similar except for effects on the nervous system, which significantly prevailed with morphine. Conclusion The main findings were the similarity in pain control, response rates and main adverse reactions among opioids. Changes in therapy schedules were notable over time. A considerable proportion of patients were nonresponders or poor responders. Clinical Trial Registration NCT01809106 ( https://clinicaltrials.gov/ct2/show/NCT01809106?term=cerp&rank=2 ).

Published
2015

23. The thermometer of distress in oncology

Author

C. Di Nunzio, Chiara Citterio, L. Cavanna, Michela Monfredo, and P. Mordenti

Subjects
Distress, medicine.medical_specialty, Oncology, business.industry, Thermometer, medicine, Hematology, Intensive care medicine, business
Published
2017
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24. Final analysis of the phase III multicentric Italian study Short-HER: 9 weeks vs 1 year adjuvant trastuzumab for HER2+ early breast cancer

Author

P. Conte, G. Bisagni, A. Frassoldati, A. Brandes, L. Cavanna, F. Giotta, M. Aieta, V. Gebbia, A. Musolino, O. Garrone, M. Donadio, G. Cavazzini, A. Turletti, C. Zamagni, S. Danese, A. Ferro, F. Piacentini, S. Balduzzi, R. D'Amico, and V. Guarneri

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, business.industry, medicine.medical_treatment, Hematology, medicine.disease, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Pharmaceutical Adjuvants, Breast cancer, Trastuzumab, 030220 oncology & carcinogenesis, Internal medicine, medicine, business, Adjuvant, medicine.drug, Early breast cancer
Published
2017
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25. Pattern of care and effectiveness of treatment for glioblastoma patients in the real world: Results from a prospective population-based registry. Could survival differ in a high-volume center?

Author

Alba A. Brandes, Enrico Franceschi, Mario Ermani, Alicia Tosoni, Fiorenzo Albani, Roberta Depenni, Marina Faedi, Anna Pisanello, Girolamo Crisi, Benedetta Urbini, Claudio Dazzi, Luigi Cavanna, Claudia Mucciarini, Giuseppe Pasini, Stefania Bartolini, Gianluca Marucci, Luca Morandi, Elena Zunarelli, Serenella Cerasoli, Giorgio Gardini, Giovanni Lanza, Enrico Maria Silini, Silvio Cavuto, Agostino Baruzzi, A. Baruzzi, F. Albani, F. Calbucci, R. D'Alessandro, R. Michelucci, A. Brandes, V. Eusebi, S. Ceruti, E. Fainardi, R. Tamarozzi, E. Emiliani, M. Cavallo, E. Franceschi, A. Tosoni, F. Fiorica, A. Valentini, R. Depenni, C. Mucciarini, G. Crisi, E. Sasso, C. Biasini, L. Cavanna, D. Guidetti, N. Marcello, A. Pisanello, A.M. Cremonini, G. Guiducci, S. de Pasqua, S. Testoni, R. Agati, G. Ambrosetto, A. Bacci, E. Baldin, A. Baldrati, E. Barbieri, S. Bartolini, E. Bellavista, F. Bisulli, E. Bonora, F. Bunkheila, V. Carelli, M. Crisci, P. Dall'Occa, D. de Biase, S. Ferro, C. Franceschi, G. Frezza, V. Grasso, M. Leonardi, G. Marucci, V. Mazzocchi, L. Morandi, B. Mostacci, G. Palandri, E. Pasini, M. Pastore Trossello, A. Pession, M. Ragazzi, P. Riguzzi, R. Rinaldi, S. Rizzi, G. Romeo, F. Spagnolli, P. Tinuper, C. Trocino, S. Cerasoli, M. Dall'Agata, M. Faedi, M. Frattarelli, G. Gentili, A. Giovannini, P. Iorio, U. Pasquini, G. Galletti, C. Guidi, W. Neri, A. Patuelli, S. Strumia, M. Casmiro, A. Gamboni, F. Rasi, G. Cruciani, P. Cenni, C. Dazzi, AR. Guidi, F. Zumaglini, A. Amadori, G. Pasini, M. Pasquinelli, E. Pasquini, A. Polselli, A. Ravasio, B. Viti, M. Sintini, A. Ariatti, F. Bertolini, G. Bigliardi, P. Carpeggiani, F. Cavalleri, S. Meletti, P. Nichelli, E. Pettorelli, G. Pinna, E. Zunarelli, F. Artioli, I. Bernardini, M. Costa, G. Greco, R. Guerzoni, C. Stucchi, C. Iaccarino, R. Rizzi, G. Zuccoli, P. Api, F. Cartei, E. Fallica, E. Granieri, F. Latini, G. Lelli, C. Monetti, V. Ramponi, A. Saletti, R. Schivalocchi, S. Seraceni, M.R. Tola, B. Urbini, C. Giorgi, E. Montanari, D. Cerasti, P. Crafa, I. Dascola, I. Florindo, S. Mazza, F. Servadei, EM. Silini, P. Torelli, P. Immovilli, N. Morelli, C. Vanzo, Brandes, Alba A, Franceschi, Enrico, Ermani, Mario, Tosoni, Alicia, Albani, Fiorenzo, Depenni, Roberta, Faedi, Marina, Pisanello, Anna, Crisi, Girolamo, Urbini, Benedetta, Dazzi, Claudio, Cavanna, Luigi, Mucciarini, Claudia, Pasini, Giuseppe, Bartolini, Stefania, Marucci, Gianluca, Morandi, Luca, Zunarelli, Elena, Cerasoli, Serenella, Gardini, Giorgio, Lanza, Giovanni, Silini, Enrico Maria, Cavuto, Silvio, Baruzzi, Agostino, Calbucci, F, D'Alessandro, R, Michelucci, R, Eusebi, V, Ceruti, S, Fainardi, E, Tamarozzi, R, Emiliani, E, Cavallo, M, Fiorica, F, Valentini, A, Depenni, R, Mucciarini, C, Crisi, G, Sasso, E, Biasini, C, Cavanna, L, Guidetti, D, Marcello, N, Pisanello, A, Cremonini, A M, Guiducci, G, de Pasqua, S, Testoni, S, Agati, R, Ambrosetto, G, Bacci, A, Baldin, E, Baldrati, A, Barbieri, E, Bartolini, S, Bellavista, E, Bisulli, F, Bonora, E, Bunkheila, F, Carelli, V, Crisci, M, Dall'Occa, P, de Biase, D, Ferro, S, Franceschi, C, Frezza, G, Grasso, V, Leonardi, M, Marucci, G, Mazzocchi, V, Morandi, L, Mostacci, B, Palandri, G, Pasini, E, Pastore Trossello, M, Pession, A, Ragazzi, M, Riguzzi, P, Rinaldi, R, Rizzi, S, Romeo, G, Spagnolli, F, Tinuper, P, Trocino, C, Cerasoli, S, Dall'Agata, M, Faedi, M, Frattarelli, M, Gentili, G, Giovannini, A, Iorio, P, Pasquini, U, Galletti, G, Guidi, C, Neri, W, Patuelli, A, Strumia, S, Casmiro, M, Gamboni, A, Rasi, F, Cruciani, G, Cenni, P, Dazzi, C, Guidi, Ar, Zumaglini, F, Amadori, A, Pasini, G, Pasquinelli, M, Pasquini, E, Polselli, A, Ravasio, A, Viti, B, Sintini, M, Ariatti, A, Bertolini, F, Bigliardi, G, Carpeggiani, P, Cavalleri, F, Meletti, S, Nichelli, P, Pettorelli, E, Pinna, G, Zunarelli, E, Artioli, F, Bernardini, I, Costa, M, Greco, G, Guerzoni, R, Stucchi, C, Iaccarino, C, Rizzi, R, Zuccoli, G, Api, P, Cartei, F, Fallica, E, Granieri, E, Latini, F, Lelli, G, Monetti, C, Ramponi, V, Saletti, A, Schivalocchi, R, Seraceni, S, Tola, M R, Urbini, B, Giorgi, C, Montanari, E, Cerasti, D, Crafa, P, Dascola, I, Florindo, I, Mazza, S, Servadei, F, Silini, Em, Torelli, P, Immovilli, P, Morelli, N, and Vanzo, C

Subjects
Oncology, medicine.medical_specialty, medicine.medical_treatment, Population, Medicine (miscellaneous), temozolomide, NO, surgery, center volume, glioblastoma, radiotherapy, Internal medicine, Glioma, medicine, education, Prospective cohort study, education.field_of_study, Temozolomide, Neurologic Oncology, business.industry, Incidence (epidemiology), Articles, medicine.disease, nervous system diseases, Clinical trial, Radiation therapy, business, medicine.drug
Abstract

Background As yet, no population-based prospective studies have been conducted to investigate the incidence and clinical outcome of glioblastoma (GBM) or the diffusion and impact of the current standard therapeutic approach in newly diagnosed patients younger than aged 70 years. Methods Data on all new cases of primary brain tumors observed from January 1, 2009, to December 31, 2010, in adults residing within the Emilia-Romagna region were recorded in a prospective registry in the Project of Emilia Romagna on Neuro-Oncology (PERNO). Based on the data from this registry, a prospective evaluation was made of the treatment efficacy and outcome in GBM patients. Results Two hundred sixty-seven GBM patients (median age, 64 y; range, 29–84 y) were enrolled. The median overall survival (OS) was 10.7 months (95% CI, 9.2–12.4). The 139 patients ≤aged 70 years who were given standard temozolomide treatment concomitant with and adjuvant to radiotherapy had a median OS of 16.4 months (95% CI, 14.0–18.5). With multivariate analysis, OS correlated significantly with KPS (HR = 0.458; 95% CI, 0.248–0.847; P = .0127), MGMT methylation status (HR = 0.612; 95% CI, 0.388–0.966; P = .0350), and treatment received in a high versus low-volume center (HR = 0.56; 95% CI, 0.328–0.986; P = .0446). Conclusions The median OS following standard temozolomide treatment concurrent with and adjuvant to radiotherapy given to (72.8% of) patients aged ≤70 years is consistent with findings reported from randomized phase III trials. The volume and expertise of the treatment center should be further investigated as a prognostic factor.

Published
2014

26. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

E. Bajetta, I. Floriani, M. Di Bartolomeo, R. Labianca, A. Falcone, F. Di Costanzo, G. Comella, D. Amadori, C. Pinto, C. Carlomagno, D. Nitti, B. Daniele, E. Mini, D. Poli, A. Santoro, S. Mosconi, R. Casaretti, C. Boni, G. Pinotti, P. Bidoli, L. Landi, G. Rosati, A. Ravaioli, M. Cantore, F. Di Fabio, E. Aitini, A. Marchet, E. Rulli, M. Cropalato Di Tullio, F. Galli, E. Biagioli, I. De Simone, S. Mangano, M. Tonato, E. Zucca, M.G. Valsecchi, S. De Placido, L. Catena, M. Schiavo, I. Proserpio, R. Bordonaro, S. Cordio, G. Burrafato, A.M. Bochicchio, M. Aieta, N. Fazio, F. Spada, V. Amoroso, G. Marini, H. Soto Parra, G. Novello, B. Massidda, M.T. Ionta, M. Comandè, R. Venezia, A. Bertolini, E. Menatti, L. Zanlorenzi, A. Colombo, A. Iop, S. Bonura, E. Mazza, M. Viganò, A. Ardizzoia, S. Dell'Oro, G. Lo Re, D. Santeufemia, A. Buonadonna, D. Luisi, G. Ucci, G. Di Lucca, A. Bonetti, F. Bergamo, M. Alù, F. Vastola, P. Marchetti, D.C. Corsi, E. Massa, G. Di Pinto, M. Duro, C. Oliani, M. Franchini, A. Inzoli, N. Gebbia, L. Repetto, S. Rota, L. Frontini, A. Quadri, S. De Grossi, M.E. Cazzaniga, F. Villa, P. Foa, D. Ferrari, C. Rabbi, S. Barni, F. Petrelli, M. Giordano, G. Luchena, M. Pirovano, A. Nasisi, V. Catalano, P. Giordani, A. Zaniboni, F. Leone, S. Ferrario, G.D. Beretta, E.T. Menichetti, D. Conte, D. Mari, R. Giannicola, C. Pierantoni, A.G. Luporini, D. Tassinari, M. Nicolini, G.L. Frassineti, D. Turci, F. Zumaglini, S. Tamberi, A. Piancastelli, G. Cruciani, G. Minuti, M. Orlandi, A. Mambrini, A. Ciarlo, D. Cavaciocchi, F. Del Monte, S. Ricci, M.I. Brunetti, M. Lencioni, M. Sisani, P. Sozzi, C. Granetto, S. Chiara, A.S. Galetto, A.S. Ribecco, A. DeCensi, L. Ciuffreda, E.E. Baldini, R. Camisa, R. Todeschini, L. Rimassa, C. Carnaghi, T. Pressiani, E. Rondini, R. Gnoni, S. Gasperoni, L. Cavanna, M.A. Palladino, R. Mattioli, G. Laici, F. Pucci, M.D. Alessio, I. Bernardini, G. Tomasello, G. Baldino, R. Rossetti, S. Giaquinta, F.L. Rijas Llimpe, A.A. Brandes, M. Marzola, V. Montesarchio, A. Rea, G. Genua, L. Silvestro, M. Montano, M.G. Sarobba, G. Sanna, G. Filippelli, G. Dima, E. Greco, M. Roselli, D. Natale, G. Condemi, G. Fumi, S. Tafuto, P. Masullo, G. Tiberio, G. de Manzoni, G. Fiorentini, R. Mazzanti, A. De Stefano, G. Cartenì, M. Otero, Bajetta, E, Floriani, I, Di Bartolomeo, M, Labianca, R, Falcone, A, Di Costanzo, F, Comella, G, Amadori, D, Pinto, C, Carlomagno, Chiara, Nitti, D, Daniele, B, Mini, E, Poli, D, Santoro, A, Mosconi, S, Casaretti, R, Boni, C, Pinotti, G, Bidoli, P, Landi, L, Rosati, G, Ravaioli, A, Cantore, M, Di Fabio, F, Marchet, A, for the ITACA S., Study Group, Carlomagno, C, Aitini, E, and Valsecchi, M

Subjects
medicine.medical_specialty, SURGERY, Settore MED/06 - Oncologia Medica, adjuvant treatment, Docetaxel, Gastroenterology, LEUCOVORIN, adjuvant chemotherapy, gastric cancer, Folinic acid, Bolus (medicine), Stomach Neoplasms, randomized clinical trial, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, GASTRECTOMY, business.industry, Hazard ratio, gastric cancer, adjuvant treatment, adjuvant chemotherapy, randomized clinical trial, PHASE-III TRIAL, CHEMOTHERAPY, SURGERY, S-1, ADENOCARCINOMA, GASTRECTOMY, LEUCOVORIN, PHASE-III TRIAL, ADENOCARCINOMA, Hematology, S-1, CHEMOTHERAPY, Combined Modality Therapy, Surgery, Irinotecan, Regimen, Oncology, Fluorouracil, Chemotherapy, Adjuvant, FOLFIRI, Camptothecin, Taxoids, Cisplatin, business, medicine.drug
Abstract

Background: Some trial have demonstrated a benefit of adjuvant fluoropirimidine with or without platinum compounds compared with surgery alone. ITACA-S study was designed to evaluate whether a sequential treatment of FOLFIRI [irinotecan plus 5-fluorouracil/folinic acid (5-FU/LV)] followed by docetaxel plus cisplatin improves disease-free survival in comparison with 5-FU/LV in patients with radically resected gastric cancer. Patients and methods: Patients with resectable adenocarcinoma of the stomach or gastroesophageal junction were randomly assigned to either FOLFIRI (irinotecan 180 mg/m 2 day 1, LV 100 mg/m 2 as 2 h infusion and 5-FU 400 mg/m 2 as bolus, days 1 and 2 followed by 600 mg/m 2 /day as 22 h continuous infusion, q14 for four cycles) followed by docetaxel 75 mg/m 2 day 1, cisplatin 75 mg/m 2 day 1, q21 for three cycles (sequential arm) or De Gramont regimen (5-FU/LV arm). Results: From February 2005 to August 2009, 1106 patients were enrolled, and 1100 included in the analysis: 562 in the sequential arm and 538 in the 5-FU/LV arm. With a median follow-up of 57.4 months, 581 patients recurred or died (297 sequential arm and 284 5-FU/LV arm), and 483 died (243 and 240, respectively). No statistically significant difference was detected for both disease-free [hazard ratio (HR) 1.00; 95% confidence interval (CI): 0.85–1.17; P= 0.974] and overall survival (OS) (HR 0.98; 95% CI: 0.82–1.18; P= 0.865). Five-year disease-free and OS rates were 44.6% and 44.6%, 51.0% and 50.6% in the sequential and 5-FU/LV arm, respectively. Conclusions: A more intensive regimen failed to show any benefit in disease-free and OS versus monotherapy. Clinical trial registration: ClinicalTrials.gov Identifier: NCT01640782.

Published
2014

27. Amethyst NSCLC trial: Phase 2, parallel-arm study of receptor tyrosine kinase (RTK) inhibitor, MGCD265 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with activating genetic alterations in mesenchymal-epithelial transition factor (MET)

Author

Pasi A. Jänne, Richard C. Chao, Lyudmilla Bazhenova, D. Faltaos, M. Shum, Balazs Halmos, V. Tassell, J.-Y. Han, T. Nagy, Igor I. Rybkin, M. Schreeder, F. Badin, Dai Woo Kim, L. Cavanna, Ranee Mehra, Hoon-Kyo Kim, J. Christensen, Raul Mena, and Jung-Gon Lee

Subjects
Oncology, medicine.medical_specialty, biology, business.industry, non-small cell lung cancer (NSCLC), Hematology, Trial Phase, medicine.disease, Receptor tyrosine kinase, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, biology.protein, Medicine, Mesenchymal–epithelial transition, In patient, business, 030215 immunology
Published
2016
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28. palliative care Evaluation of effects of early palliative care on quality of life of advanced cancer patients. A multicenter controlled randomised clinical trial

Author

C. Degli Esposti, F. Ghisoni, Barbara Melotti, Gianpaolo Bacchini, Giuseppe Maglietta, C. Binovi, V. Scafuri, Erico Piva, Caterina Caminiti, Michela Monfredo, L. Cavanna, Vittorio Franciosi, G. Caruso, L. Bocchi, Raffaella Bertè, M. Sequino, Anita Rimanti, and P. Di Cesare

Subjects
Clinical trial, medicine.medical_specialty, Quality of life (healthcare), Palliative care, Oncology, business.industry, Medicine, Hematology, business, Intensive care medicine, Advanced cancer
Published
2016
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29. Midline for home palliative care

Author

F. Oleari, O. Grassi, P. Mordenti, M. Muroni, C. Gozzo, G. Cremona, S. Castellani, Maria Rosa Cordani, S. Bontini, S. Carini, and L. Cavanna

Subjects
Palliative care, Oncology, Nursing, business.industry, Medicine, Hematology, business
Published
2016
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30. Gastrointestinal stromal tumors associated with other malignancies. Chance phenomenon or causal relationship? A series of 75 patients

Author

E. Orlandi, P. Mordenti, L. Cavanna, Adriano Zangrandi, Elisabetta Nobili, E. zaffignani, R. delfanti, Rosa Porzio, P. capelli, and Elisa Maria Stroppa

Subjects
Oncology, medicine.medical_specialty, Series (stratigraphy), Stromal cell, business.industry, Internal medicine, Phenomenon, medicine, Hematology, business
Published
2016
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31. Effects of simultaneous care on quality of life of advanced cancer patients. A multicenter controlled randomised clinical trial

Author

F. Ghisoni, Michela Monfredo, L. Bocchi, G. Caruso, Vittorio Franciosi, Barbara Melotti, V. Scafuri, Giuseppe Maglietta, Erico Piva, Caterina Caminiti, C. Binovi, C. Degli Esposti, P. Di Cesare, M. Sequino, Anita Rimanti, Gianpaolo Bacchini, L. Cavanna, and Raffaella Bertè

Subjects
Clinical trial, medicine.medical_specialty, Quality of life (healthcare), Randomization, Oncology, business.industry, Medicine, Hematology, business, Intensive care medicine, Advanced cancer, Cancer advanced
Published
2016
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35. Painting the pain

Author

C. Di Nunzio, Elena Orlandi, L. Cavanna, Elena Zaffignani, and P. Mordenti

Subjects
medicine.medical_specialty, Referred pain, Oncology, business.industry, Physical therapy, medicine, Pain catastrophizing, Hematology, business
Published
2016
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36. A Multicenter Randomized Trial of Two Different ProMACE-CytaBOM Derived Protocols in Aggressive Non-Hodgkin's Lymphomas (NHL). A Preliminary Report

Author

M. Lombardo, V. Silingardi, N. Di Renzo, M. Brugiatelli, P. G. Gobbi, C. Mauri, Franco Narni, L. Baldini, L. Cavanna, G. Nicoletti, A. La Sala, G. Longo, Mario Carotenuto, V. Iannitto, Paolo Avanzini, and Massimo Federico

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Hodgkin s, Multicenter trial, PROMACE-CYTABOM, aggressive lymphomas, business.industry, Hematology, PROMACE-CytaBOM, law.invention, Randomized controlled trial, Preliminary report, law, Internal medicine, medicine, business
Published
1992
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37. Midline for apheresis of peripheral blood stem cells

Author

S. Carini, C. Gozzo, F. Oleari, Daniele Vallisa, O. Grassi, M.R. Cordani, M. Moretto, S. Castellani, L. Cavanna, P. Mordenti, C. Arbasi, L. Cappucciati, S. Bontini, and M. Muroni

Subjects
Pathology, medicine.medical_specialty, Apheresis, Oncology, business.industry, Medicine, Hematology, business, Peripheral Blood Stem Cells
Published
2015
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38. Effect of Mediterranean Diet on the prevalence of breast cancer relapse: preliminary results of the 'SETA PROJECT'

Author

Mara Negrati, L. Cavanna, C. Razza, Erminio Trevisi, Francesca Maria Cicognini, Maria Rosa Cordani, Manuela Fontana, Claudia Biasini, A. Pazzoni, C. Di Nunzio, Filippo Rossi, M. Confalonieri, C. Perri, and Massimo Ambroggi

Subjects
Oncology, medicine.medical_specialty, Pathology, Breast cancer, Mediterranean diet, business.industry, Internal medicine, medicine, Seta, Hematology, business, medicine.disease
Published
2015
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39. Redefining the pathways of care: the patient journey

Author

C. Di Nunzio, A. Soriani, M.L. Galli, L. Cavanna, Giuseppe Civardi, Luca Zanlari, P. Mordenti, B. Granelli, D. Terzoni, E. Marazzi, D.L. Capuano, R. Achilli, and S. Gandolfi

Subjects
medicine.medical_specialty, Oncology, Nursing, business.industry, Family medicine, Medicine, Hematology, business
Published
2015
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40. Tunnelled peripherally Inserted Central Catheters

Author

S. Bontini, S. Castellani, O. Grassi, P. Mordenti, M. Muroni, F. Oleari, L. Cavanna, M.R. Cordani, S. Carini, G. Cremona, and C. Gozzo

Subjects
medicine.medical_specialty, Oncology, business.industry, Medicine, Hematology, business, Surgery
Published
2015
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43. Central Nervous System metastastasis in gastric or gastro-esophageal junction cancer, correlation with human epidermal growth factor 2 (HER-2) status

Author

P. Mordenti, Emanuele Michieletti, Elisa Maria Stroppa, L. Cavanna, Adriano Zangrandi, Pietro Seghini, and C. Di Nunzio

Subjects
Nervous system, medicine.medical_specialty, Pathology, Human epidermal growth factor, business.industry, Gastro esophageal junction, Cancer, Hematology, medicine.disease, Endocrinology, medicine.anatomical_structure, Oncology, Internal medicine, medicine, business
Published
2015
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45. Central venous catheter care for the patients with cancer: ultrasound-guided insertion should be strongly recommended for internal jugular vein catheterization

Author

P. Mordenti, Raffaella Bertè, C. Di Nunzio, L. Cavanna, Giuseppe Civardi, and Daniele Vallisa

Subjects
medicine.medical_specialty, business.industry, medicine.medical_treatment, Cancer, Hematology, medicine.disease, Ultrasound guided, Catheterization, Surgery, Oncology, Neoplasms, medicine, Central Venous Catheters, Humans, Jugular Veins, business, Internal jugular vein, Central venous catheter, Ultrasonography
Published
2013
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46. Response to first-line chemotherapy and long-term survival in patients with multiple myeloma: results of the MM87 prospective randomised protocol

Author

A, Riccardi, O, Mora, C, Tinelli, C, Porta, M, Danova, S, Brugnatelli, D, Grasso, B, Tolcà, R, Spanedda, A, De Paoli, L, Barbarano, L, Cavanna, M, Giordano, C, Delfini, G, Nicoletti, C, Bergonzi, E, Rinaldi, L, Piccinini, and E, Ascari

Subjects
Male, Analysis of Variance, Survival Analysis, Software Design, Vincristine, Cause of Death, Antineoplastic Combined Chemotherapy Protocols, Drug Evaluation, Humans, Prednisone, Female, Prospective Studies, Multiple Myeloma, Melphalan, Peptichemio
Abstract

In this study we evaluated whether a good response to conventional chemotherapy, i.e. a significant tumour reduction, is a prerequisite for improved survival in multiple myeloma (MM). Between January 1987 and March 1990, 341 consecutive previously untreated patients with MM received chemotherapy within the prospective, multicentre, randomised Protocol MM87. Of these, 258 patients were evaluable for both response and long-term survival and 244 (94.6%) have died. The median survival of all patients was 40 months (6-162 months). The median survival did not differ between patients who had complete response (CR) (50 months (9-162 months)), partial response (PR) (46 months (8-147 months)) or stable disease (SD) (41 months (7-135 months)). The median survival was shorter (13.6 months (6-135 months)) (P0.0001) in patients whose disease progressed while they were receiving first induction chemotherapy. Causes of death were more frequently (P=0.04) related to MM in patients who had progressive disease (PD) than in patients who had a CR or PR or SD. The main clinical and laboratory characteristics were similar in the four groups. These data indicate that patients who maintain SD during first-line chemotherapy have a prognosis similar to that of patients who attain a response. Only patients whose disease progresses have a distinctly worse outcome.

Published
2002

47. Behind the disease, inside to the illness

Author

G. Civardi, Emanuele Bassi, Luca Zanlari, P. Mordenti, and L. Cavanna

Subjects
medicine.medical_specialty, Evidence-Based Medicine, business.industry, Humanism, Humans, Medicine, General Medicine, Disease, business, Intensive care medicine
Published
2014
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48. ALK positive lymphohistiocytic variant of anaplastic large cell lymphoma in an adult

Author

M, Paulli, D, Vallisa, A, Viglio, E, Boveri, S, Kindl, G, Vassallo, U, Magrini, and L, Cavanna

Subjects
Adult, Male, Histiocytosis, Non-Langerhans-Cell, Humans, Receptor Protein-Tyrosine Kinases, Anaplastic Lymphoma Kinase, Lymphoma, Large B-Cell, Diffuse, In Vitro Techniques, Protein-Tyrosine Kinases, Immunohistochemistry, Immunophenotyping
Abstract

The lymphohistiocytic (LH) variant of anaplastic large cell lymphoma (ALCL) has, for a long time, been considered typical of children and adolescents. The aim of this study is a detailed characterization of a case of this peculiar ALCL subtype affecting an adult patient.A 36-year old male presented with diffuse adenopathy and systemic symptoms (high fever, anorexia, asthenia); a diagnosis of CD30+/ALK+ ALCL, LH variant, was morphologically suspected and corroborated by immunohistochemistry that was crucial for the definitive diagnosis and subtyping.The neoplastic population consisted of cells highly variable in size and shape but more often isolated and largely obscured by a predominant reactive cellular infiltrate of histiocytes and plasma cells. The lymphoma cells exhibited a null non-B non-T antigenic profile, but reacted strongly for the Ber-H2/CD30, EMA, ALKc anti-TIA-1 monoclonal antibodies. The patient underwent chemotherapy plus bone marrow transplantation and, one year after diagnosis, he is well and in complete remission.Our findings provide additional evidence that: a) ALK+ lymphoma represents a single disease with a broad spectrum of morphology; b) clinicians and pathologists should be aware of the possible occurrence of LH variant of ALK+ ALCL also in adults in whom a favorable response to therapy may be expected despite systemic disease and an aggressive clinical presentation.

Published
2001

49. A novel HLA allele, B*4104, identified in a cord blood donor

Author

D M, Turner, G, Vlachos, S L, Cavanna, J, Brown, C, Brown, and C V, Navarrete

Subjects
Base Sequence, HLA-B Antigens, Histocompatibility Testing, Molecular Sequence Data, Humans, Blood Donors, Female, Sequence Analysis, DNA, Fetal Blood, Alleles
Abstract

Results from a number of HLA typing methods prompted the DNA sequencing (SBT) of a cord blood sample at the HLA-B locus. A novel HLA-B allele, B*4104, was identified. This was confirmed by sequencing the mother of the cord blood unit for HLA-B.

Published
2001

50. Ultrasound-guided fine needle biopsy of the spleen: high clinical efficacy and low risk in a multicenter Italian study

Author

G, Civardi, D, Vallisa, R, Bertè, A, Giorgio, C, Filice, M, Caremani, E, Caturelli, M, Pompili, I, De Sio, E, Buscarini, and L, Cavanna

Subjects
Adult, Male, Adolescent, Interventional, Splenic Neoplasms, Biopsy, Biopsy, Needle, Settore MED/09 - MEDICINA INTERNA, Middle Aged, Italy, Predictive Value of Tests, Needle, Humans, Female, Diagnostic Errors, Spleen, Ultrasonography, Interventional, Aged, Retrospective Studies, Splenic Diseases, Ultrasonography
Abstract

The aim of this study was to evaluate the clinical efficacy and safety of the ultrasound-guided fine needle biopsy (UG-FNB) of the spleen in a large population of patients. We collected retrospectively the findings concerning the application of UG-FNB of the spleen from eight Italian clinical centers that utilized this technique for at least ten years. A data schedule was sent to all centers to collect information about techniques, results, and complications of UG-FNB of the spleen. We analyzed 398 biopsy procedures both on focal lesions (257 cases) and on splenic parenchyma (141 cases). The overall accuracy was 90.9% for the series as a whole, 84.9% for cytological sampling, 88.3% for microhistological sampling, and 90.3% for both cytological and histological sampling (double biopsy). Tissue core biopsy yielded better overall accuracy in patients with suspected splenic involvement by lymphoma (90.9% vs. 68.5% for cytology). The complication rate was low (no death cases, less than 1% for major complications, and 5.2% for all complications). No predictive factors were able to detect high-risk situations. The operator's skill (higher number of performed procedures) was significantly related to better overall accuracy. Conversely, the complication rate was not affected. UG-FNB of the spleen is a very effective diagnostic procedure with low risk for the patient. Aspiration cytology and core needle biopsy showed similar diagnostic yields, except for the diagnosis of splenic lymphoma, in which core needle biopsy obtained better results.

Published
2001

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