Secord Angeles Alvarez, Havrilesky Laura J, Carney Michael E, Soper John T, Clarke-Pearson Daniel L, Rodriguez Gustavo C, Berchuck Andrew
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Box 3079, Duke University Medical Center, Durham, NC 27710, USA.
Int J Clin Oncol. 2007 Feb;12(1):31-6. doi: 10.1007/s10147-006-0619-9. Epub 2007 Feb 25.
The purpose of this study was to evaluate the toxicity profile of weekly low-dose paclitaxel and carboplatin in patients with gynecologic malignancies.
Patients had measurable disease defined by clinical examination or radiographic studies. Each cycle of treatment consisted of carboplatin at an AUC of 2 and paclitaxel at 80 mg/m2 on days 1, 8, and 15 of a 28-day cycle.
Twenty-eight patients with advanced or recurrent cervical and endometrial cancers were included in this study. The overall response rate (ORR) was 39% (2 CR, 9 PR). Among the 15 cervical cancers the ORR was 20%, while the 13 endometrial cancers had a 62% ORR. Median time to progression and overall survival was 3.4 and 7.6 months for those with cervical cancer and 5.5 and 15.4 months for those with endometrial cancer. Grade 3 or 4 hematologic toxicity was uncommon (7% grade 3 anemia, 21% grade 3 or 4 neutropenia, 7% grade 3 or 4 thrombocytopenia).
A regimen of weekly low-dose paclitaxel and carboplatin has an acceptable toxicity profile that is easily managed by dose adjustment and the use of erythropoietic therapy. This regimen appears to have activity in advanced or recurrent endometrial cancer which warrants further evaluation.
本研究旨在评估每周低剂量紫杉醇和顺铂对妇科恶性肿瘤患者的毒性特征。
患者具有通过临床检查或影像学研究确定的可测量疾病。每个治疗周期在28天周期的第1、8和15天由AUC为2的顺铂和80mg/m²的紫杉醇组成。
本研究纳入了28例晚期或复发性宫颈癌和子宫内膜癌患者。总缓解率(ORR)为39%(2例完全缓解,9例部分缓解)。在15例宫颈癌中,ORR为20%,而13例子宫内膜癌的ORR为62%。宫颈癌患者的中位进展时间和总生存期分别为3.4个月和7.6个月,子宫内膜癌患者分别为5.5个月和15.4个月。3级或4级血液学毒性不常见(3级贫血7%,3级或4级中性粒细胞减少21%,3级或4级血小板减少7%)。
每周低剂量紫杉醇和顺铂方案具有可接受的毒性特征,可通过剂量调整和使用促红细胞生成疗法轻松管理。该方案似乎对晚期或复发性子宫内膜癌有活性,值得进一步评估。