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.
Adjuvant chemotherapy in completely resected gastric cancer: a randomized phase III trial conducted by GOIRC / Di Costanzo, F; Gasperoni, S; Manzione, L; Bisagni, G; Labianca, R; Bravi, S; Cortesi, E; Carlini, P; Bracci, R; Tomao, S; Messerini, L; Arcangeli, A; Torri, V; Bilancia, D; Floriani, I; Tonato, M; Italian Oncology Group for Cancer, Research; Dinota, A; Strafiuso, G; Corgna, E; Porrozzi, S; Boni, C; Rondini, E; Giunta, A; Monzio Compagnoni, B; Biagioni, F; Cesari, M; Fornarini, G; Nelli, F; Carboni, M; Cognetti, F; Enzo, Mr; Piga, A; Romiti, A; Olivetti, A; Masoni, L; De Stefanis, M; Dalla Mola, A; Camera, S; Recchia, F; De Filippis, S; Scipioni, L; Zironi, S; Luppi, G; Italia, M; Banducci, S; Pisani Leretti, A; Massidda, B; Ionta, Mt; Nicolosi, A; Canaletti, R; Biscottini, B; Grigniani, F; Di Costanzo, F; Rovei, R; Croce, E; Carroccio, R; Gilli, G; Cavalli, C; Olgiati, A; Pandolfi, U; Rossetti, R; Natalini, G; Foa, P; Oldani, S; Bruno, L; Cascinu, S; Catalano, G; Catalano, V; Lungarotti, F; Farris, A; Sarobba, Mg; Trignano, Mario; Muscogiuri, A; Francavilla, F; Figoli, F; Leoni, M; Papiani, G; Orselli, G; Antimi, M; Bellini, V; Cabassi, A; Contu, A; Pazzola, A; Frignano, M; Lastraioli, E; Saggese, M; Bianchini, D; Antonuzzo, L; Mela, M; Camisa, R.. - In: JOURNAL OF THE NATIONAL CANCER INSTITUTE. - ISSN 0027-8874. - 19:100(2008), pp. 388-398.
Adjuvant chemotherapy in completely resected gastric cancer: a randomized phase III trial conducted by GOIRC.
TRIGNANO, Mario;
2008-01-01
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
