Department of Gastroenterology/Gastrointestinal Oncology, Kitasato University East Hospital, 2-1-1 Asamizodai, Sagamihara, Kanagawa 228-8520, Japan.
Cancer Chemother Pharmacol. 2012 Feb;69(2):407-13. doi: 10.1007/s00280-011-1701-1. Epub 2011 Jul 28.
We conducted a phase II study to evaluate the efficacy and safety of a triplet regimen of docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer.
Docetaxel (40 mg/m(2)) and cisplatin (70 or 60 mg/m(2)) were given on day 1 of a 28-day cycle. S-1 (40 mg/m(2)) was given twice daily on days 1-14. Treatment with this regimen was continued for a maximum of 6 cycles. Subsequently, patients with no disease progression received a combination of docetaxel and S-1.
Fifty-nine patients were enrolled. The median number of administered cycles was 8 (range, 1-25). Because some patients had serious myelosuppression and renal dysfunction with 70 mg/m(2) of cisplatin, dose of cisplatin was reduced to 60 mg/m(2) after 19 patients had been treated. Common severe toxic effects of grade 3 or 4 were leukocytopenia (44%), neutropenia (72%), anemia (15%), and febrile neutropenia (14%). The overall response rate of this group was 81% (95% confidence interval (CI), 71-91%). The median overall survival and progression-free survival were 18.5 (95% CI, 15.6-21.5) and 8.7 (95% CI, 6.7-10.7) months, respectively.
Triplet of docetaxel, cisplatin, and S-1 is a well-tolerated and highly active regimen for advanced or recurrent gastric cancer. A 60 mg/m(2) of cisplatin is as effective as 70 mg/m(2) of cisplatin.
我们进行了一项 II 期研究，以评估多西他赛、顺铂和 S-1 三联方案在不可切除或复发性胃癌患者中的疗效和安全性。
多西他赛（40mg/m²）和顺铂（70 或 60mg/m²）于 28 天周期的第 1 天给药。S-1（40mg/m²）每天给药 2 次，第 1-14 天。该方案的治疗最多进行 6 个周期。随后，无疾病进展的患者接受多西他赛和 S-1 的联合治疗。
共纳入 59 例患者。中位治疗周期数为 8 个（范围，1-25）。由于 19 例患者在接受 70mg/m²顺铂治疗时出现严重骨髓抑制和肾功能不全，因此将顺铂剂量减少至 60mg/m²。3 或 4 级常见严重毒性反应为白细胞减少（44%）、中性粒细胞减少（72%）、贫血（15%）和发热性中性粒细胞减少（14%）。该组的总缓解率为 81%（95%置信区间（CI），71%-91%）。中位总生存期和无进展生存期分别为 18.5 个月（95%CI，15.6-21.5）和 8.7 个月（95%CI，6.7-10.7）。
多西他赛、顺铂和 S-1 的三联方案是一种耐受性良好且高度有效的晚期或复发性胃癌治疗方案。60mg/m²的顺铂与 70mg/m²的顺铂疗效相当。
