Literature DB >> 20215786

Adjuvant chemotherapy with etoposide, adriamycin and cisplatin compared with surgery alone in the treatment of gastric cancer: a phase III randomized, multicenter, clinical trial.

J Kulig1, P Kolodziejczyk, M Sierzega, L Bobrzynski, J Jedrys, T Popiela, J Dadan, M Drews, A Jeziorski, M Krawczyk, T Starzynska, G Wallner.   

Abstract

OBJECTIVE: The aim of this study was to evaluate the efficacy of adjuvant chemotherapy with etoposide, Adriamycin and cisplatin (EAP) after potentially curative resections for gastric cancer.
METHODS: After surgery, patients were randomly assigned to the EAP or control arm. Chemotherapy included 3 courses, administered every 28 days. Each cycle consisted of doxorubicin (20 mg/m(2)) on days 1 and 7, cisplatin (40 mg/m(2)) on days 2 and 8, and etoposide (120 mg/m(2)) on days 4, 5, and 6.
RESULTS: Of 309 eligible patients, 141 were allocated to chemotherapy and 154 to the supportive care group. Four (2.8%) treatment-related deaths were recorded, including 3 due to septic complications of myelosuppression and 1 due to cardiocirculatory failure. Grade 3 or 4 toxicities were found in 17 (22%) patients. According to the intention-to-treat analysis, the median survival was 41.3 months (95% confidence interval, 24.5-58.2) and 35.9 months (95% confidence interval, 25.5-46.3) in the chemotherapy and control group, respectively (p = 0.398). Subgroup analysis revealed survival benefit from chemotherapy in patients with tumors infiltrating the serosa and in those with 7-15 metastatic lymph nodes.
CONCLUSION: Three cycles of EAP regimen postoperatively offer no survival advantage in gastric cancer patients. Copyright 2010 S. Karger AG, Basel.

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Year:  2010        PMID: 20215786     DOI: 10.1159/000292360

Source DB:  PubMed          Journal:  Oncology        ISSN: 0030-2414            Impact factor:   2.935


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