Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: Results of a phase II trial
Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: Results of a phase II trial
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DOI：
10.1200/jco.2002.11.050
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发表时间：
2002-06-15
影响因子：
45.3
通讯作者：
Spriggs, DR
中科院分区：
文献类型：
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作者：
Hensley, ML;Maki, R;Spriggs, DR
目的：很少有化疗药物对平滑肌肉瘤（LMS）有效，特别是阿霉素治疗后进展的LMS。我们试图确定LMS患者对吉西他滨加多西他赛的反应。患有子宫（n = 29）或其他（n = 5）原发部位不可切除LMS且对0至2种既往化疗方案无反应的患者入选11期研究，第1天和第8天静脉注射（IV）吉西他滨900 mg/m2+多西他赛100 mg/m2第8天IV，第9 - 15天皮下给予粒细胞集落刺激因子，每21天给药一次。既往接受过盆腔放射治疗的患者接受的两种药物剂量均降低了25%。吉西他滨在第1和第2周期中在30或90分钟内给药，在所有后续周期中通过90分钟输注给药。药代动力学研究评估在体内的差异，吉西他滨浓度与不同的速度infration.Results：34例患者（中位年龄，55岁，范围，32至74岁）已入组。14人接受过盆腔放疗。34例患者中有16例在多柔比星治疗后进展; 18例既往未接受过化疗。在34例患者中，观察到3例患者完全缓解，15例患者部分缓解，总缓解率为53%（95%置信区间，35%至70%）。7例患者病情稳定。50%以前接受过阿霉素治疗的患者有反应。血液学毒性常见（中性粒细胞减少症：3级，15%; 4级，6%;血小板减少症：3级，26%; 4级，3%），但血小板减少性发热（6%）和出血事件（0%）罕见。中位进展时间为5.6个月（范围，4至10个月）。结论：吉西他滨联合多西他赛治疗和未治疗的LMS患者是耐受和高度活跃的。(C)2002年，美国临床肿瘤学会。
Purpose: Few chemotherapy agents are active in leiomyosarcoma (LMS), particularly LMS that has progressed after doxorubicin treatment. We sought to determine the response to gemcitabine plus docetaxel among patients with LMS.Patients and Methods: Patients with unresectable LMS of uterine (n = 29) or other (n = 5) primary sites who did not respond to zero to two prior chemotherapy regimens were enrolled onto a phase 11 study of gemcitabine 900 mg/m(2) intravenously (IV) on days I and 8 plus docetaxel 100 mg/m(2) IV on day 8 with granulocyte colony-stimulating factor given subcutaneously on days 9 to 15, delivered every 21 days. Patients with prior pelvic radiation received 25% lower doses of both agents. Gemcitabine was delivered over 30 or 90 minutes in cycles 1 and 2 and by 90-minute infusion in all subsequent cycles. Pharmacokinetic studies assessed in vivo differences in gemcitabine concentrations with different rates of infusion.Results: Thirty-four patients (median age, 55 years, range, 32 to 74 years) have enrolled. Fourteen had received prior pelvic radiation. Sixteen of 34 patients had progressed after doxorubicin-based therapy; 18 had no prior chemotherapy. Among 34 patients, complete response was observed in three patients and partial response in 15, for an overall response rate of 53% (95% confidence interval, 35% to 70%). Seven patients had stable disease. Fifty percent of patients previously treated with doxorubicin responded. Hematologic toxicity was common (neutropenia: grade 3, 15%; grade 4, 6%; thrombocytopenia: grade 3, 26%; grade 4, 3%), but neutropenic fever (6%) and bleeding events (0%) were rare. The median time to progression was 5.6 months (range, 4 to 10 months).Conclusion: Gemcitabine plus docetaxel is tolerable and highly active in treated and untreated patients with LMS. (C) 2002 by American Society of Clinical Oncology.