Phase II Trial of Ixabepilone As Second-Line Treatment in Advanced Endometrial Cancer: Gynecologic Oncology Group Trial 129-P
Phase II Trial of Ixabepilone As Second-Line Treatment in Advanced Endometrial Cancer: Gynecologic Oncology Group Trial 129-P
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DOI：
10.1200/jco.2008.20.6995
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发表时间：
2009-07-01
影响因子：
45.3
通讯作者：
Alvarez, Ronald D.
中科院分区：
文献类型：
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作者：
Dizon, Don S.;Blessing, John A.;Alvarez, Ronald D.
目的：进行一项II期研究，以确定伊沙epilone （BMS-247550，美国国家癌症研究所（NCI）提供的新药No. 59,699）在标准治疗后进展的持续性或复发性子宫内膜癌患者中的反应率。患者与方法入选的患者均为复发性或持续性子宫内膜癌及可测量疾病。允许先前的一个化疗方案，可以包括紫杉醇或多西紫杉醇。患者在21天周期的第1天接受伊沙epilone 40mg /m(2) 3小时输注。治疗一直持续到疾病进展或出现不可接受的毒性。结果52例患者进入研究，其中50例符合条件。中位年龄为64岁（范围40 - 83岁）。先前的治疗包括放射治疗21例（42%）和激素治疗8例（16%）。所有患者既往均有化疗，其中47例（94%）既往接受过紫杉醇治疗。总体应答率为12%；1例患者完全缓解（2%），5例部分缓解（10%）。30例患者（60%）病情稳定至少8周。中位无进展生存期（PFS）为2.9个月，6个月PFS为20%。主要的3级毒性是中性粒细胞减少（52%）、白细胞减少（48%）、胃肠道（24%）、神经系统（18%）、体质（20%）、感染（16%）和贫血（14%）。结论：在先前接受过紫杉醇治疗的晚期或复发子宫内膜癌女性队列中，伊沙epilone作为二线药物显示出有限持续时间的适度活性。
PurposeA phase II study was conducted to determine the response rate of ixabepilone (BMS-247550, National Cancer Institute (NCI)-supplied agent investigational new drug No. 59,699) in patients with persistent or recurrent endometrial cancer who have progressed despite standard therapy.Patients and MethodsEligible patients had recurrent or persistent endometrial cancer and measurable disease. One prior chemotherapeutic regimen, which could have included either paclitaxel or docetaxel, was allowed. Patients received ixabepilone 40 mg/m(2) as a 3-hour infusion on day 1 of a 21-day cycle. Treatment was continued until disease progression or until unacceptable toxicity occurred.ResultsFifty-two patients were entered on the study, and 50 of these were eligible. The median age was 64 years (range, 40 to 83 years). Prior treatment included radiation in 21 patients (42%) and hormonal therapy in eight patients (16%). All patients had prior chemotherapy, and 47 (94%) received prior paclitaxel therapy. The overall response rate was 12%; one patient achieved a complete remission (2%), and five achieved partial remission (10%). Stable disease for at least 8 weeks was noted in 30 patients (60%). The median progression-free survival (PFS) was 2.9 months, and the 6-month PFS was 20%. Major grade 3 toxicities were neutropenia (52%), leukopenia (48%), gastrointestinal (24%), neurologic (18%), constitutional (20%), infection (16%), and anemia (14%).ConclusionIn a cohort of women with advanced or recurrent endometrial cancer who were previously treated with paclitaxel, ixabepilone showed modest activity of limited duration as a second-line agent.