A phase II randomized study of two taxanes and cisplatin for metastatic breast cancer after anthracycline: A final analysis

A phase II randomized study of two taxanes and cisplatin for metastatic breast cancer after anthracycline: A final analysis
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DOI:
10.1093/jjco/hyl124
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发表时间:
2007-01-01
影响因子:
2.4
通讯作者:
Liaw, Chaung-Chi
Liaw, Chaung-Chi
中科院分区:
医学4区
文献类型:
--
作者:
Lin, Yung-Chang;Chang, Hsien-Kun;Liaw, Chaung-Chi

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目的:本研究的目的是比较两种紫杉烷/顺铂联合治疗转移性乳腺癌在疾病进展时间、反应率和毒性方面的差异。方法:在2000年4月至2002年12月期间,101例晚期乳腺癌患者接受了蒽环类药物治疗,但未接受紫杉烷治疗。多西他赛60 mg/m(2) +顺铂50 mg/m(2)组50例,紫杉醇175 mg/m(2) +顺铂50 mg/m(2)组51例。每3周重复一个周期。结果:多西紫杉醇组总有效率为62.5%,紫杉醇组总有效率为42.6% (P = 0.06)。多西紫杉醇组和紫杉醇组到疾病进展的中位时间分别为9.8个月和6.5个月(P = 0.15)。多西紫杉醇组的中位总生存时间为22.7个月,紫杉醇组的中位总生存时间为22.4个月。3/4级关节痛/肌痛、感觉神经病变和贫血在紫杉醇组发生率更高,而粘膜炎、疲劳和中性粒细胞减少在多西紫杉醇组发生率更高。结论:紫杉烷/顺铂联合治疗晚期乳腺癌有效,而多西他赛/顺铂联合治疗似乎更有利。多西他赛/顺铂的毒性支持未来的一线临床试验。
Objective: The purpose of the study is to compare two taxanes/cisplatin combinations for metastatic breast cancer in terms of time to disease progression, response rates and toxicity.Methods: Between April 2000 and December 2002, 101 patients with advanced breast carcinoma, previously treated with an anthracycline but not with a taxane, were enrolled. Fifty patients were treated with docetaxel 60 mg/m(2) and cisplatin 50 mg/m(2), and 51 patients were treated with paclitaxel 175 mg/m(2) and cisplatin 50 mg/m(2). Each cycle repeated every 3 weeks.Results: The overall response rate was 62.5 and 42.6% in the docetaxel and palcitaxel groups respectively (P = 0.06). Median time to disease progression was 9.8 and 6.5 months in docetaxel and paclitaxel groups respectively (P = 0.15). The median overall survival time was 22.7 months in the docetaxel arm and 22.4 months in the paclitaxel arm. Grade 3/4 arthralgia/myalgia, sensory neuropathy and anemia occurred more frequently in the paclitaxel arm, while more mucositis, fatigue and neutropenia occurred in the docetaxel arm.Conclusion: Taxane/cisplatin combinations were active for advanced breast cancer, while there appeared to be evidence in favor of a docetaxel/cisplatin combination. The toxicity in favor of docetaxel/cisplatin warrants future first-line clinical trials.