Phase II Feasibility Study of Adjuvant S-1 plus Docetaxel for Stage III Gastric Cancer Patients after Curative D2 Gastrectomy
2011; Karger Publishers; Volume: 80; Issue: 5-6 Linguagem: Inglês
10.1159/000329090
ISSN1423-0232
AutoresShigeyuki Tamura, Kazumasa Fujitani, Yutaka Kimura, Takeshi Tsuji, Jin Matsuyama, Shöhei Iijima, Hiroshi Imamura, Kentaro Inoue, Kenji Kobayashi, Yukinori Kurokawa, Hiroshi Furukawa,
Tópico(s)Gastrointestinal Tumor Research and Treatment
Resumo<i>Objective:</i> The aim of this prospective study was to evaluate the feasibility and safety of adjuvant S-1 plus docetaxel in patients with stage III gastric cancer. <i>Methods:</i> We enrolled 53 patients with pathological stage III gastric cancer who underwent D2 gastrectomy. They received oral S-1 (80 mg/m<sup>2</sup>/day) administration for 2 consecutive weeks and intravenous docetaxel (40 mg/m<sup>2</sup>) on day 1, repeated every 3 weeks (1 cycle). The treatment was started within 45 days after surgery and repeated for 4 cycles, followed by S-1 monotherapy (4 weeks on, 2 weeks off) until 1 year after surgery. The feasibility of the 4 cycles of chemotherapy, followed by S-1 administration, was evaluated. <i>Results:</i> A total of 42 patients (79.2%, 95% CI 65.9–82.9) tolerated the planned 4 cycles of treatment with S-1 and docetaxel, and 34 patients (64.2%, 95% CI 49.8–76.9) completed subsequent S-1 monotherapy for 1 year. Grade 4 neutropenia was observed in 28% and grade 3 febrile neutropenia in 9% of the patients, while grade 3 nonhematological toxicities were relatively low. <i>Conclusions:</i> Adjuvant S-1 plus docetaxel therapy is feasible and has only moderate toxicity in stage III gastric cancer patients. We believe that this regimen will be a candidate for future phase III trials seeking the optimal adjuvant chemotherapy for stage III gastric cancer patients.
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