Medizinische Klinik m. S. Hämatologie und Onkologie, Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin 13353, Germany.
Br J Cancer. 2011 Aug 9;105(4):505-12. doi: 10.1038/bjc.2011.278. Epub 2011 Jul 26.
No comparisons of different doses of docetaxel-capecitabine in patients with advanced gastric cancer have been performed.
Patients with previously untreated metastatic/locally advanced gastro-oesophageal or gastric adenocarcinoma were enrolled in a prospective multicentre phase II trial. Two sequential cohorts received docetaxel 75 mg m(-2) (day 1) plus capecitabine 1000 mg m(-2) twice daily (days 1-14) (cohort I) or docetaxel 60 mg m(-2) (day 1) plus capecitabine 800 mg m(-2) twice daily (days 1-14) (cohort II) every 3 weeks. The primary end point was confirmed overall response rate.
In all, 91 patients were enrolled (cohort I, n=40; cohort II, n=51) and 87 were evaluable for efficacy (n=38, 49, respectively). Overall response rate was 50.0% in cohort I and 23.5% in cohort II (exploratory analysis, P=0.014). Median times to tumour progression and overall survival were 5.6 and 10.1 months in cohort I and 3.7 and 7.2 months in cohort II, respectively. Dose reductions for docetaxel and capecitabine were required in 50.0% and 57.5% of patients in cohort I and 11.8% and 15.7% in cohort II, respectively.
Starting treatment with full doses and reducing promptly seems to be the more promisingly effective strategy than starting cautiously with lower doses. Docetaxel/capecitabine 75/2000 mg m(-2) is a manageable, convenient outpatient combination with promising efficacy against advanced gastric cancer.
尚未比较不同剂量多西紫杉醇-卡培他滨治疗晚期胃癌患者的疗效。
本前瞻性多中心 II 期临床试验纳入了未经治疗的转移性/局部晚期胃食管或胃腺癌患者。两个连续队列接受多西紫杉醇 75mg/m2（第 1 天）加卡培他滨 1000mg/m2，每日 2 次（第 1-14 天）（队列 I）或多西紫杉醇 60mg/m2（第 1 天）加卡培他滨 800mg/m2，每日 2 次（第 1-14 天）（队列 II），每 3 周 1 次。主要终点为确认总缓解率。
共纳入 91 例患者（队列 I，n=40；队列 II，n=51），87 例患者可评估疗效（分别为 n=38 和 n=49）。队列 I 的总缓解率为 50.0%，队列 II 为 23.5%（探索性分析，P=0.014）。队列 I 的中位肿瘤进展时间和总生存期分别为 5.6 个月和 10.1 个月，队列 II 分别为 3.7 个月和 7.2 个月。队列 I 中 50.0%和 57.5%的患者需要减少多西紫杉醇和卡培他滨的剂量，而队列 II 中分别为 11.8%和 15.7%。
起始时使用全剂量并迅速减量似乎比起始时使用低剂量更有效。多西紫杉醇/卡培他滨 75/2000mg/m2 是一种可行的、方便的门诊联合方案，对晚期胃癌有较好的疗效。
