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.; Dinota A.; Strafiuso G.; Corgna E.; Porrozzi S.; Boni C.; Rondini E.; Giunta A.; Barbara M.C.; Biagioni F.; Cesari M.; Fornarini G.; Nelli F.; Carboni M.; Francesco C.; Ruggeri E.M.; Andrea P.; Adriana R.; Alessandra O.; Luigi M.; De Stefanis M.; Dalla Mola A.; Salvatore C.; Francesco R.; De Filippis S.; Loreto S.; Sandra Z.; Gabriele L.; Maurizio I.; Stefano B.; Andrea P.L.; Bruno M.; Teresa I.M.; Angelo N.; Rodolfo C.; Bruno B.; Fausto G.; Di Costanzo F.; Rossella R.; Enrico C.; Rosalia C.; Germana G.; Carla C.; Angelo O.; Umberto P.; Riccardo R.; Giovanni N.; Paolo F.; Sabina O.; Lorenzo B.; Stefano C.; Giuseppina C.; Vincenzo C.; Ferdinando L.; Antonio F.; Mario T.; Antonio M.; Franco F.; Maurizio L.; Giorgio P.; Gianfranco O.; Mauro A.; Vincenzo B.; Alessandro C.; Antonio C.; Antonio P.; Mario F.; Lastraioli E.; Matilde S.; Diletta B.; Antonuzzo L.; Micol M.; Roberta C.. - In: JOURNAL OF THE NATIONAL CANCER INSTITUTE. - ISSN 0027-8874. - ELETTRONICO. - 100:(2008), pp. 388-398. [10.1093/jnci/djn054]

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

Di Costanzo F.;Bracci R.;Messerini L.;Arcangeli A.;Rondini E.;Giunta A.;Nelli F.;Salvatore C.;Gabriele L.;Di Costanzo F.;Antonio F.;Mario F.;Lastraioli E.;Antonuzzo L.;Micol M.;
2008

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.
100
388
398
Goal 3: Good health and well-being
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.; Dinota A.; Strafiuso G.; Corgna E.; Porrozzi S.; Boni C.; Rondini E.; Giunta A.; Barbara M.C.; Biagioni F.; Cesari M.; Fornarini G.; Nelli F.; Carboni M.; Francesco C.; Ruggeri E.M.; Andrea P.; Adriana R.; Alessandra O.; Luigi M.; De Stefanis M.; Dalla Mola A.; Salvatore C.; Francesco R.; De Filippis S.; Loreto S.; Sandra Z.; Gabriele L.; Maurizio I.; Stefano B.; Andrea P.L.; Bruno M.; Teresa I.M.; Angelo N.; Rodolfo C.; Bruno B.; Fausto G.; Di Costanzo F.; Rossella R.; Enrico C.; Rosalia C.; Germana G.; Carla C.; Angelo O.; Umberto P.; Riccardo R.; Giovanni N.; Paolo F.; Sabina O.; Lorenzo B.; Stefano C.; Giuseppina C.; Vincenzo C.; Ferdinando L.; Antonio F.; Mario T.; Antonio M.; Franco F.; Maurizio L.; Giorgio P.; Gianfranco O.; Mauro A.; Vincenzo B.; Alessandro C.; Antonio C.; Antonio P.; Mario F.; Lastraioli E.; Matilde S.; Diletta B.; Antonuzzo L.; Micol M.; Roberta C.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2158/1180501
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