Phase II study of a 4-week capecitabine regimen in advanced or recurrent gastric cancer
Phase II study of a 4-week capecitabine regimen in advanced or recurrent gastric cancer
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DOI：
10.1097/00001813-200602000-00016
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发表时间：
2006-02-01
影响因子：
2.3
通讯作者：
Koizumi, W
中科院分区：
文献类型：
--
作者：
Sakamoto, J;Chin, K;Koizumi, W
我们的目的是评估卡培他滨对化疗未行手术的晚期或转移性胃癌患者的疗效和安全性。一项开放标记的多中心11期研究针对以前未接受治疗的进展期或转移性胃癌患者进行。卡培他滨828 mg/m(2)口服，每日2次，第1~21天，每4周1次。入选的60例患者的基线特征为：男性/女性49/11，中位年龄(28-74岁)，98%的患者表现良好(ECOG0-1)，27例患者(45%)接受过胃切除术。中位数为4个治疗周期(范围1-37)。5名患者被排除在疗效分析之外，因为他们不符合资格标准。在可评估的患者群体(n=55)中，总体应答率为26%[95%可信区间(95%CI)15-39%]，另外29%的患者病情稳定。意向治疗人群(n=60)的总体RR为23%(95%可信区间13-36.0%)。可评估患者群体的中位进展时间为3.4个月(95%可信区间为1.8-6.1)，意向治疗人群的总体生存时间为10.0个月(95%可信区间为6.4-13.6)。最常见的3/4级药物相关不良事件是手足综合征(13%)，但这很容易通过中断治疗和减少剂量来控制。无1例发生3/4级药物相关性腹泻、呕吐、白细胞减少或血小板减少。我们得出结论，这种为期4周的卡培他滨方案显示了良好的活性，并作为晚期/转移性胃癌的一线治疗方案具有良好的耐受性。有必要对这种疗法进行进一步的研究。
Our objective was to evaluate the efficacy and safety of capecitabine in chemotherapy-naive patients with unresectable advanced or metastatic gastric cancer. An open-label multicenter phase 11 study was conducted for previously untreated patients with advanced or metastatic gastric cancer. Oral capecitabine 828 mg/m(2) twice daily was given on days 1-21 every 4 weeks. Baseline characteristics of 60 enrolled patients were: male/female 49/11, median age 64 years (range 28-74), good performance status (ECOG 0-1) in 98% of patients and 27 patients had prior gastrectomy (45%). A median of 4 treatment cycles were administered (range 1-37). Five patients were excluded from the efficacy analysis because they did not meet eligibility criteria. The overall response rate MR) in the evaluable patient population (n=55) was 26% [95% confidence interval (95% CI) 15-39%] and a further 29% of patients had stable disease. The overall RR in the intent-to-treat population (n=60) was 23% (95% CI 13-36.0%). Median time to progression in the evaluable patient population was 3.4 months (95% CI 1.8-6.1) and overall survival time in the intent-to-treat population was 10.0 months (95% CI 6.4-13.6). The most frequent grade 3/4 drug-related adverse event was hand-foot syndrome (13%), but this was readily managed by treatment interruption and dose reduction. No patients developed grade 3/4 drug-related diarrhea, vomiting, leukopenia or thrombocytopenia. We conclude that this 4-week regimen of capecitabine showed promising activity and was well tolerated as first-line therapy for advanced/metastatic gastric cancer. Further investigation of this regimen is warranted.