A phase II study of docetaxel as salvage chemotherapy in advanced gastric cancer after failure of fluoropyrimidine and platinum combination chemotherapy
A phase II study of docetaxel as salvage chemotherapy in advanced gastric cancer after failure of fluoropyrimidine and platinum combination chemotherapy
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DOI：
10.1007/s00280-007-0516-6
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发表时间：
2008-04-01
影响因子：
3
通讯作者：
Kang, Yoon-Koo
中科院分区：
文献类型：
--
作者：
Lee, Jae-Lyun;Ryu, Min-Hee;Kang, Yoon-Koo
目的氟嘧啶（F）和铂（P）联合化疗已广泛应用于晚期胃癌（AGC）的一线治疗。多西他赛显示出对这种疾病有希望的活性。本研究旨在探讨多西他赛单药治疗F、P联合化疗失败的AGC患者的疗效和安全性。中位无治疗间隔为28.0天，81.6%的患者在一线化疗停药后4个月内发生癌症进展。多西他赛以75 mg/m2的剂量每3周静脉注射一次，同时预防性使用地塞米松。结果共使用多西他赛182个周期，中位周期为3个（范围1-9个）。意向治疗分析显示，8例患者达到客观缓解，缓解率为16.3%（95% CI，6.0-26.6）。中位缓解持续时间为4.7个月。共有20例患者显示疾病稳定，但17例患者出现疾病进展。存活患者的中位随访时间为11.3个月（范围6.3-18.8个月），至疾病进展的中位时间为2.5个月（95% CI，2.3-2.7），自多西他赛单药治疗开始后的中位总生存时间为8.3个月（95% CI，6.7-9.8）。18.4%的患者和5.4%的周期发生3/4级中性粒细胞减少和发热性中性粒细胞减少。3级及以上的非血液学毒性反应发生率为乏力32.7%、腹泻10.2%、周围感觉神经病变8.2%。结论多西他赛75 mg/m2对氟磷联合化疗后的AGC有较好的二线治疗作用。毒性特征为中度。
Purpose Fluoropyrimidine (F) and platinum (P) combination chemotherapy has been widely used as a first-line treatment of advanced gastric cancer (AGC). Docetaxel has shown promising activity against this disease. In this study, we explored the efficacy and safety of docetaxel monotherapy as salvage chemotherapy in AGC after F and P combination chemotherapy failed.Materials and methods From October 2004 to October 2005, 49 eligible patients were enrolled in this study. The median treatment-free interval was 28.0 days, and 81.6% of patients had suffered cancer progression within 4 months after the withdrawal of first-line chemotherapy. Docetaxel was given IV at a dose of 75 mg/m(2) every 3 weeks, together with dexamethasone prophylaxis.Results A total of 182 cycles of docetaxel were administered with a median of 3 (range 1-9) cycles. From an intention-to- treat analysis, eight patients achieved objective response with a response rate of 16.3% (95% CI, 6.0-26.6). The median response duration was 4.7 months. A total of 20 patients showed stable disease, but 17 patients suffered disease progression. At a median follow-up duration of 11.3 months for surviving patients (range 6.3-18.8 months), the median time to disease progression was 2.5 months (95% CI, 2.3-2.7) and the median overall survival time since the start of docetaxel monotherapy was 8.3 months (95% CI, 6.7-9.8). Grade 3/4 neutropenia and febrile neutropenia occurred in 18.4% of patients and in 5.4% of cycles. The incidence of non-hematologic toxicities of grade 3 or worse was asthenia 32.7%, diarrhea 10.2% and peripheral sensory neuropathy 8.2%.Conclusion Docetaxel at 75 mg/m(2) is active against AGC as second-line chemotherapy after prior exposure to F and P combination chemotherapy. The toxicity profile is moderate.