Adjuvant chemotherapy in completely resected gastric cancer: a randomized phase III trial conducted by GOIRC

Francesco Di Costanzo, Silvia Gasperoni, Luigi Manzione, Giancarlo Bisagni, Roberto Labianca, Stefano Bravi, Enrico Cortesi, Paolo Carlini, Raffaella Bracci, Silverio Tomao, Luca Messerini, Annarosa Arcangeli, Valter Torri, Domenico Bilancia, Irene Floriani, Maurizio Tonato, Angelo Dinota, Gennaro Strafiuso, Enrichetta Corgna, Stella Porrozzi, Corrado Boni, Ermanno Rondini, Alessandro Giunta, Barbara Monzio Compagnoni, Franco Biagioni, Maurizio Cesari, Giuseppe Fornarini, Fabrizio Nelli, Manlio Carboni, Francesco Cognetti, Maria Ruggeri Enzo, Andrea Piga, Adriana Romiti, Alessandra Olivetti, Luigi Masoni, Marinella De Stefanis, Angelo Dalla Mola, Salvatore Camera, Francesco Recchia, Sandro De Filippis, Loreto Scipioni, Sandra Zironi, Gabriele Luppi, Maurizio Italia, Stefano Banducci, Andrea Pisani Leretti, Bruno Massidda, Maria Teresa Ionta, Angelo Nicolosi, Rodolfo Canaletti, Bruno Biscottini, Fausto Grigniani, Federica Di Costanzo, Rossella Rovei, Enrico Croce, Rosalia Carroccio, Germana Gilli, Carla Cavalli, Angelo Olgiati, Umberto Pandolfi, Riccardo Rossetti, Giovanni Natalini, Paolo Foa, Sabina Oldani, Lorenzo Bruno, Stefano Cascinu, Giuseppina Catalano, Vincenzo Catalano, Ferdinando Lungarotti, Antonio Farris, Maria Giuseppina Sarobba, Mario Trignano, Antonio Muscogiuri, Fontana Francavilla, Franco Figoli, Maurizio Leoni, Giorgio Papiani, Gianfranco Orselli, Mauro Antimi, Vincenzo Bellini, Alessandro Cabassi, Antonio Contu, Antonio Pazzola, Mario Frignano, Elena Lastraioli, Matilde Saggese, Diletta Bianchini, Lorenzo Antonuzzo, Micol Mela, Roberta Camisa
Journal of the National Cancer Institute 2008 March 19, 100 (6): 388-98

BACKGROUND: Complete surgical resection of gastric cancer is potentially curative, but long-term survival is poor.

METHODS: Patients with histologically proven adenocarcinoma of the stomach of stages IB, II, IIIA and B, or IV (T4N2M0) and treated with potentially curative surgery were randomly assigned to follow-up alone or to intravenous treatment with four cycles (repeated every 21 days) of PELF (cisplatin [40 mg/m(2), on days 1 and 5], epirubicin [30 mg/m(2), days 1 and 5], L-leucovorin [100 mg/m(2), days 1-4], and 5-fluorouracil [300 mg/m(2), days 1-4] in a hospital setting. Frequencies and severity of adverse events were determined. Overall survival (OS) and disease-free survival (DFS) were compared between the treatment arms using Kaplan-Meier analysis and a Cox proportional hazards regression model. All statistical tests were two-sided.

RESULTS: From January 1995 through September 2000, 258 patients were randomly assigned to chemotherapy (n = 130) or surgery alone (n = 128). Patient characteristics were well balanced between the two arms. Among those who received chemotherapy, grade 3 or 4 toxic effects including vomiting, mucositis, and diarrhea were experienced by 21.1%, 8.4%, and 11.8% of patients, respectively. Leucopenia, anemia, and thrombocytopenia of grade 3 or 4 were experienced by 20.3%, 3.3%, and 4.2% of patients, respectively. After a median follow-up of 72.8 months, 128 patients (49.6%) experienced recurrence and 139 (53.9%) deaths were observed, one toxicity-related. Relative to treatment with surgery alone, adjuvant chemotherapy did not increase disease-free survival (hazard ratio [HR] of recurrence = 0.92; 95% confidence interval [CI] = 0.66 to 1.27) or overall survival (HR of death = 0.90; 95% CI = 0.64 to 1.26).

CONCLUSIONS: Our results failed to provide proof of an effect of adjuvant chemotherapy with PELF on overall survival or disease-free survival. The estimated effect of chemotherapy (10% reduction in the hazard of death or relapse) is modest and consistent with the results of meta-analyses of adjuvant chemotherapy without platinum agents.

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