González-Martín A J, Calvo E, Bover I, Rubio M J, Arcusa A, Casado A, Ojeda B, Balañá C, Martínez E, Herrero A, Pardo B, Adrover E, Rifá J, Godes M J, Moyano A, Cervantes A
Medical Oncology Service, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Ann Oncol. 2005 May;16(5):749-55. doi: 10.1093/annonc/mdi147. Epub 2005 Apr 7.
The aim of this study was to determine whether the response rate for the paclitaxel-carboplatin combination is superior to carboplatin alone in the treatment of patients with platinum-sensitive recurrent ovarian carcinoma.
Patients with recurrent ovarian carcinoma, 6 months after treatment with a platinum-based regimen and with no more than two previous chemotherapy lines, were randomized to receive carboplatin area under the curve (AUC) 5 (arm A) or paclitaxel 175 mg/m(2) + carboplatin AUC 5 (arm B). The primary end point was objective response, following a 'pick up the winner' design. Secondary end points included time to progression (TTP), overall survival, tolerability and quality of life (QoL).
Eighty-one patients were randomized and included in the intention-to-treat analysis. The response rate in arm B was 75.6% [26.8% complete response (CR) + 48.8% partial response (PR)] [95% confidence interval (CI) 59.7% to 87.6%] and 50% in arm A (20% CR + 30% PR) (95% CI 33.8% to 66.2%). No significant differences were observed in grade 3-4 hematological toxicity. Conversely, mucositis, myalgia/arthralgia and peripheral neurophaty were more frequent in arm B. Median TTP was 49.1 weeks in arm B (95% CI 36.9-61.3) and 33.7 weeks in arm A (95% CI 25.8-41.5). No significant differences were found in the QoL analysis.
Paclitaxel-carboplatin combination is a tolerable regimen with a higher response rate than carboplatin monotherapy in platinum-sensitive recurrent ovarian carcinoma.
本研究旨在确定在铂敏感复发性卵巢癌患者的治疗中，紫杉醇 - 卡铂联合方案的缓解率是否优于单纯卡铂。
接受铂类方案治疗6个月后复发且既往化疗线数不超过2线的卵巢癌患者，被随机分为接受卡铂曲线下面积（AUC）为5（A组）或紫杉醇175mg/m² + 卡铂AUC为5（B组）。主要终点为客观缓解，采用“选出胜者”设计。次要终点包括疾病进展时间（TTP）、总生存期、耐受性和生活质量（QoL）。
81例患者被随机分组并纳入意向性分析。B组的缓解率为75.6%[26.8%完全缓解（CR）+ 48.8%部分缓解（PR）][95%置信区间（CI）59.7%至87.6%]，A组为50%（20% CR + 30% PR）（95% CI 33.8%至66.2%）。3 - 4级血液学毒性无显著差异。相反，B组黏膜炎、肌痛/关节痛和周围神经病变更为常见。B组的中位TTP为49.1周（95% CI 36.9 - 61.3），A组为33.7周（95% CI 25.8 - 41.5）。生活质量分析未发现显著差异。
在铂敏感复发性卵巢癌中，紫杉醇 - 卡铂联合方案是一种耐受性良好的方案，缓解率高于卡铂单药治疗。
