Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer
Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer
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DOI：
10.1158/1078-0432.ccr-05-2425
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发表时间：
2006-06-01
影响因子：
11.5
通讯作者：
Nishiyama, Masahiko
中科院分区：
文献类型：
--
作者：
Yoshida, Kazuhiro;Ninomiya, Motoki;Nishiyama, Masahiko
用途：评价多西他赛联合新型口服5-氟尿嘧啶类似物S-1治疗晚期或复发性胃癌患者的疗效和毒性。患有晚期或复发性胃腺癌且既往接受过最多一种化疗方案的患者在第1天接受静脉注射多西他赛40 mg/m2，并口服S-1 80 mg/m2。结果：48例患者（中位年龄，65岁;范围，25-75岁）共接受了272个治疗周期（中位数，4;范围，1-17）。未观察到完全缓解和27例部分缓解，总缓解率为56.3% [95%置信区间（95% CI），38-66%]。18例患者（37.5%）的疾病稳定，3例患者（6.3%）的最佳缓解为疾病进展。肿瘤控制率（完全缓解+部分缓解+病情稳定）为93.8%（95% CI，83-98%）。中位总生存期为14.3个月（95% CI，10.7-20.3个月），中位至肿瘤进展时间为7.3个月（95% CI，4.3-10.0个月）。最常见的3 - 4级血液学毒性为中性粒细胞减少（58.3%）、白细胞减少（41.7%）、发热性中性粒细胞减少（8.3%）和贫血（8.3%）。最常见的3级非血液学毒性包括厌食（14.6%）、口腔炎（8.3%）和恶心（6.3%）。没有4级非血液学毒性的报告和所有治疗相关的毒性resolved.Conclusion：多西他赛/S-1组合是高度活跃和耐受性良好的晚期或复发性胃癌。需要在随机研究中进行进一步调查。
Purpose: To evaluate the efficacy and toxicity of docetaxel in combination with a novel oral 5-fluorouracil analogue S-1 for patients with advanced or recurrent gastric cancer.Experimental Design: Patients with advanced or recurrent adenocarcinoma of the stomach and up to one previous chemotherapy regimen were treated with i.v. docetaxel 40 mg/m(2) on day 1 and oral S-1 80 mg/m(2)/d on days 1 to 14 every 3 weeks.Results: Forty-eight patients (median age, 65 years; range, 25-75 years) received a total of 272 treatment cycles (median, 4; range, 1-17). No complete responses and 27 partial responses were observed for an overall response rate of 56.3% [95% confidence interval (95% Cl), 38-66%]. Eighteen patients (37.5%) had stable disease and three patients (6.3%) had progressive disease as best response. The tumor control rate (complete response + partial response + stable disease) was 93.8% (95% Cl, 83-98%). Median overall survival was 14.3 months (95% Cl, 10.7-20.3 months) and median time to tumor progression was 7.3 months (95% Cl, 4.3-10.0 months). The most common grade 3 to 4 hematologic toxicities were neutropenia (58.3%), leukopenia (41.7%), febrile neutropenia (8.3%), and anemia (8.3%). The most common grade 3 nonhematologic toxicities included anorexia (14.6%), stomatitis (8.3%), and nausea (6.3%). No grade 4 nonhematologic toxicities were reported and all treatment-related toxicities were resolved.Conclusion: Docetaxel/S-1 combination is highly active and well tolerated in advanced or recurrent gastric cancer. Further investigation in randomized studies is warranted.