Cisplatin improves antitumor activity of weekly nab-paclitaxel in patients with metastatic breast cancer.
Cisplatin improves antitumor activity of weekly nab-paclitaxel in patients with metastatic breast cancer.
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DOI：
10.2147/ijn.s58275
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发表时间：
2014
影响因子：
8
通讯作者：
Hu X
中科院分区：
文献类型：
--
作者：
Sun S;Tang L;Zhang J;Lv F;Wang Z;Wang L;Zhang Q;Zheng C;Qiu L;Jia Z;Lu Y;Liu G;Shao Z;Wang B;Hu X
虽然纳米颗粒白蛋白结合紫杉醇（nab-paclitaxel）被批准每3周给予一次，但每周使用这种药物正在成为转移性乳腺癌（MBC）患者的新的护理标准。这项前瞻性II期研究旨在提高每周一次nab-紫杉醇联合顺铂治疗MBC患者的疗效。73名患有经常性或MBC的妇女有资格参加。每周给药nab -紫杉醇125 mg/m2，第1天、第8天和第15天，顺铂75 mg/m2，每28天重复一次，最多6个周期。主要目标是研究者评估的总缓解率（ORR）。ORR高达67.1%，一线患者的ORR为80.6%，未接受紫杉烷预处理的患者ORR为80%。在有客观反应的患者中，很大比例的患者（83.7%）在前两个周期内肿瘤迅速显著缩小。中位无进展生存期和总生存期分别为9.8个月和26.9个月。对于接受一线、二线和三线或以上治疗的患者，中位无进展生存期分别为11.7、7.7和7.6个月（P=0.005）。分子亚型与ORR或疾病进展无显著相关。4级中性粒细胞减少46例（63.0%），发热性中性粒细胞减少9例（12.3%）。3级周围神经病变是累积的剂量限制性毒性，发生在19例患者中（26.0%）。单周nab-紫杉醇联合顺铂治疗可提高疗效。该双药高效，反应快，毒性可控，在MBC患者中可能具有跨分子亚型的等效性。
Although nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is approved to be given every 3 weeks, weekly use of this drug is becoming a new standard of care in patients with metastatic breast cancer (MBC). This prospective Phase II study was conducted to improve the efficacy of weekly nab-paclitaxel with cisplatin in MBC patients. Seventy-three women with recurrent or MBC were eligible for participation. Nab-paclitaxel was administered weekly at a dose of 125 mg/m2 on day 1, day 8, and day 15, followed by cisplatin 75 mg/m2 on day 1, repeated every 28 days with a maximum of 6 cycles. The primary objective was investigator-assessed overall response rate (ORR). A high ORR of 67.1% was obtained, with rates of 80.6% for the first-line patients and 80% for patients not pretreated with taxanes. Among those who had objective responses, a large percentage of patients (83.7%) showed quickly remarkable tumor shrinkage during the first two cycles. The median progression-free and overall survival times were 9.8 and 26.9 months, respectively. For the patients receiving first-, second-, and third-line therapy or beyond, median progression-free survival was 11.7, 7.7, and 7.6 months, respectively (P=0.005). Molecular subtype was not significantly associated with ORR or disease progression. Grade 4 neutropenia occurred in 46 patients (63.0%), with febrile neutropenia found in 9 patients (12.3%). Grade 3 peripheral neuropathy was an accumulated dose-limiting toxicity occurring in 19 patients (26.0%). Efficacy of weekly nab-paclitaxel can be improved by adding cisplatin. The doublet is highly effective, with quick response, manageable toxicity, and possible equivalence across molecular subtypes in MBC patients.