吉西他滨用于铂类预处理的晚期上皮性卵巢癌患者的II期研究。
A phase II study of gemcitabine in platinum pre-treated patients with advanced epithelial ovarian cancer.
作者信息
Friedlander M, Millward M J, Bell D, Bugat R, Harnett P, Moreno J A, Campbell L, Varette C, Ripoche V, Kayitalire L
机构信息
Prince of Wales Hospital, Randwick, Australia.
出版信息
Ann Oncol. 1998 Dec;9(12):1343-5. doi: 10.1023/a:1008469212268.
BACKGROUND
Most patients with advanced ovarian cancer will relapse following platinum-based combination chemotherapy and be considered for second-line treatment. Gemcitabine, a nucleoside analogue, is active against a range of solid tumors. This phase II study investigated the activity of single-agent gemcitabine in patients with recurrent ovarian cancer.
PATIENTS AND METHODS
Thirty-eight patients with FIGO stage III (34%) or IV (64%) ovarian cancer who were previously treated with platinum-containing regimens were enrolled. Patients received 1200 mg/m2 gemcitabine on days 1, 8 and 15 of a 28-day cycle.
RESULTS
Patients completed an average of 3.6 cycles. Two complete and three partial responses were seen in 36 evaluable patients, for an overall response rate of 13.9% (95% CI: 4.7%-29.5%). The median survival time was 6.7 months. Toxicities were generally mild. The most common were grade 3-4 neutropenia and grade 3 leukopenia reported in 23.7% and 10.5% of patients, respectively. One patient had grade 4 pulmonary toxicity.
CONCLUSION
Single-agent gemcitabine is active and well tolerated in patients with recurrent ovarian cancer.
背景
大多数晚期卵巢癌患者在接受铂类联合化疗后会复发，并需考虑二线治疗。吉西他滨是一种核苷类似物，对多种实体瘤具有活性。这项II期研究调查了单药吉西他滨对复发性卵巢癌患者的活性。
患者和方法
38例FIGO III期（34%）或IV期（64%）卵巢癌患者入组，这些患者此前接受过含铂方案治疗。患者在28天周期第1、8和15天接受1200mg/m²吉西他滨治疗。
结果
患者平均完成3.6个周期。36例可评估患者中观察到2例完全缓解和3例部分缓解，总缓解率为13.9%（95%CI：4.7%-29.5%）。中位生存时间为6.7个月。毒性一般较轻。最常见的是3-4级中性粒细胞减少和3级白细胞减少，分别在23.7%和10.5%的患者中报告。1例患者有4级肺部毒性。
结论
单药吉西他滨对复发性卵巢癌患者具有活性且耐受性良好。
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