Randomized phase II trial on mitomycin-C/cisplatin ± KLT in heavily pretreated advanced breast cancer
Randomized phase II trial on mitomycin-C/cisplatin ± KLT in heavily pretreated advanced breast cancer
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DOI：
10.1142/s0192415x08006132
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发表时间：
2008-01-01
影响因子：
5.7
通讯作者：
Hu, X. C.
中科院分区：
文献类型：
--
作者：
Guo, H. Y.;Cai, Y.;Hu, X. C.
本研究采用丝裂霉素（MMC）/顺铂（DDP）方案联合或不联合康莱特（KLT）作为挽救治疗晚期乳腺癌（ABC）的随机Ⅱ期临床研究。每三周一次的方案包括丝裂霉素（8 mg/m2）在第1天静脉给药，顺铂（25 mg/m2）在第1 - 3天静脉给药。KLT（100 ml）静脉滴注，第1 ~ 14天，每3周1次。在2006年4月至2007年7月期间，60例中位年龄为48岁的患者被随机分配到MMC/DDP组，接受或不接受KLT治疗。总体而言，客观缓解率（ORR）为17.5%。在ORR方面，实验和对照治疗之间没有显著差异（14.3% vs. 20.7%，p = 0.730），临床获益率（24.1% vs. 28.6%，p = 0.468）、中位至进展时间（TTP; 3.63 vs. 4.0，p = 0.872）和总生存期（OS; 7.17 vs.未达到，p = 0.120）。完全或部分缓解患者的中位TTP为6.0个月，但疾病稳定或进展患者的中位TTP仅为2.1个月（SD或PD; p = 0.028）。虽然未达到从化疗中获得临床获益的患者的中位OS，但SD不超过6个月或PD患者的中位OS仅为7.17个月（p = 0.004）。在ABC的治疗中，当KLT加入MMC/DDP双联时，没有额外的益处。从化疗中获得临床获益的患者的TTP和OS较长。
A randomized phase II study using mitomycin (MMC)/cisplatin (DDP) regimen with or without Kanglaite (KLT, a traditional Chinese medicine) as salvage treatment was conducted to exploit KLT's potential effects on patients with advanced breast cancer (ABC). Triweekly regimen consisted of mitomycin (8 mg/m(2)) administered intravenously on day 1, and cisplatin (25 mg/m(2)) intravenously on days 1 to 3. KLT (100 ml) was given intravenously per day on days 1 to 14 every 3 weeks. Between April 2006 and July 2007, 60 patients with a median age of 48 years were randomized into MMC/DDP with or without KLT treatment. In all, the objective response rate (ORR) was 17.5%. There were no significant differences between experimental and control treatments in terms of ORR (14.3% vs. 20.7%, p = 0.730), clinical benefit rates (24.1% vs. 28.6%, p = 0.468), median time to progression (TTP; 3.63 vs. 4.0, p = 0.872), and overall survival (OS; 7.17 vs. not reached, p = 0.120). The median TTP for patients with complete or partial responses was 6.0 months, but only 2.1 months for patients with stable or progressive disease (SD or PD; p = 0.028). While the median OS for patients who obtained clinical benefit from chemotherapy was not reached, that of patients with SD of no more than 6 months or PD was only 7.17 months (p = 0.004). There is no additional benefit when KLT is added to the MMC/DDP doublet in the management of ABC. Patients who obtained clinical benefit from chemotherapy had a longer TTP and OS.