Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer
Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer
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DOI：
10.1200/jco.2001.19.22.4216
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发表时间：
2001-11-15
影响因子：
45.3
通讯作者：
Patel, R
中科院分区：
文献类型：
--
作者：
Perez, EA;Vogel, CL;Patel, R
目的：我们在一项II期多中心临床试验中评估了每周紫杉醇治疗转移性乳腺癌的安全性和有效性。进入标准是相对自由的，以反映在临床practice.Patients和方法的异质性转移性乳腺癌：患者有组织学证实和可测量的转移性乳腺癌。允许最多2种既往转移性疾病化疗方案，包括既往蒽环类和紫杉烷类治疗以及既往高剂量治疗。Paclitaxel 80 mg/m2每周给药一次，每4周为1周期，共4周。结果：共纳入212例患者，211例可评价毒性，177例可评价反应。90%的患者既往接受过化疗（辅助化疗、转移性化疗或两者兼有），46%的患者有三个或更多的转移部位，60%的患者有内脏优势疾病。答复记录了两次，并进行了独立审查。总体缓解率（完全缓解加部分缓解）为21.5%（95%置信区间，15.4%至27.5%），41.8%的患者病情稳定。中位进展时间为4.7个月，所有212例患者的总生存期为12.8个月。治疗耐受性良好，3/4级血液学毒性发生率为15%，3级神经毒性发生率为9%;其他严重毒性罕见。在34%的患者大于或等于65岁的反应率和毒性档案是类似的年轻patients.Conclusion：每周紫杉醇治疗耐受性良好，并表现出合理的活动，在这个相对较重的预处理人口与先进的疾病。每周紫杉醇联合治疗的进一步研究是必要的。(C)2001年，美国临床肿瘤学会。
Purpose We evaluated the safety and efficacy of weekly paclitaxel therapy in women with metastatic breast cancer in a phase II multicenter trial. Entry criteria were relatively liberal to reflect the heterogeneity of metastatic breast cancer in clinical practice.Patients and Methods: Patients had histologically confirmed and measurable metastatic breast cancer. Up to two prior chemotherapy regimens for metastatic disease, including prior therapy with anthracyclines and taxanes and prior high-dose therapy, were allowed. Paclitaxel 80 mg/m(2) was administered weekly for 4 weeks per 4-week cycle.Results: We enrolled 212 patients, 211 were assessable for toxicity and 177 were assessable for response. Ninety percent of patients had received prior chemotherapy (adjuvant, metastatic, or both), 46% of patients had three or more involved metastatic sites, and 60% of patients had visceral-dominant disease. Responses were documented on two occasions and were independently reviewed. The overall response rate (complete plus partial response) was 21.5% (95% confidence interval, 15.4% to 27.5%), with 41.8% of patients having disease stabilization. Median time to progression was 4.7 months, and overall survival in all 212 patients enrolled was 12.8 months. Therapy was well tolerated, with a 15% incidence of grade 3/4 hematologic toxicity and a, 9% incidence of grade 3 neurotoxicity; other serious toxicities were rare. The response rate and toxicity profile in the 34% of patients greater than or equal to 65 years of age were similar to that of younger patients.Conclusion: Weekly paclitaxel therapy was well tolerated and demonstrated reasonable activity in this relatively heavily pretreated population with advanced disease. Further study of weekly paclitaxel, in combination therapy is warranted. (C) 2001 by American Society of Clinical Oncology.