Oncology Department, Centre Catherine de Sienne, Nantes, France.
Ann Oncol. 2012 Feb;23(2):346-52. doi: 10.1093/annonc/mdr149. Epub 2011 May 11.
Platinum rechallenge or weekly topotecan in combination have not been evaluated in randomized trials for resistant recurrent ovarian cancer (ROC).
Patients with ROC after first- or second-line treatment including a platinum and taxane and progression within 6 months were randomized to weekly paclitaxel (wP, 80 mg/m(2)/week) alone or in combination with carboplatin (C, area under the curve of 5 mg/ml/min every 4 weeks) or weekly topotecan (wT, 3 mg/m(2)/week). Primary end point was progression-free survival (PFS) comparing wP and combination therapy.
Patients (n = 165) received a median three cycles in each arm. Nonhematologic toxicity was not different, except increased hypersensitivity reactions with wP + C. Grade 3-4 hematologic toxic effects with wP, wP + C, and wP + wT, respectively, were neutropenia in 13%, 54%, and 42%; febrile neutropenia in 0%, 4%, and 5%; and anemia in 6%, 19%, and 29%. Response rates were 35%, 37%, and 39%, and median PFS times were 3.7, 4.8, and 5.4 months, respectively. PFS was not significantly different among the treatment arms [hazard ratio (HR) 0.922; 95% confidence interval (CI) 0.765-1.111; P = 0.46] or between monotherapy and combination therapy (HR 0.951; 95% CI 0.686-1.318; P = 0.76).
Combination chemotherapy in platinum-resistant ROC was more toxic than weekly paclitaxel and did not significantly prolong PFS.
铂类药物再挑战或每周拓扑替康联合治疗在抵抗复发性卵巢癌（ROC）的随机试验中尚未得到评估。
一线或二线治疗（包括铂类和紫杉烷）后出现 ROC 且在 6 个月内进展的患者，按随机分组接受每周紫杉醇（wP，80mg/m²/周）单药或联合卡铂（C，每 4 周一次，曲线下面积为 5mg/ml/min）或每周拓扑替康（wT，3mg/m²/周）治疗。主要终点为比较 wP 和联合治疗的无进展生存期（PFS）。
每组患者（n=165）中位接受了三周期治疗。非血液学毒性无差异，wP+C 组过敏反应增加。wP、wP+C 和 wP+wT 组的 3-4 级血液学毒性效应分别为中性粒细胞减少症 13%、54%和 42%；发热性中性粒细胞减少症 0%、4%和 5%；贫血症 6%、19%和 29%。缓解率分别为 35%、37%和 39%，中位 PFS 时间分别为 3.7、4.8 和 5.4 个月。各治疗组之间 PFS 无显著差异[风险比（HR）0.922；95%置信区间（CI）0.765-1.111；P=0.46]或单药与联合治疗之间（HR 0.951；95% CI 0.686-1.318；P=0.76）。
铂类耐药 ROC 的联合化疗比每周紫杉醇更具毒性，且并未显著延长 PFS。
