Maintenance therapy with pemetrexed versus docetaxel after induction therapy with carboplatin and pemetrexed in chemotherapy-naïve patients with advanced non-squamous non-small-cell lung cancer: a randomized, phase II study
Maintenance therapy with pemetrexed versus docetaxel after induction therapy with carboplatin and pemetrexed in chemotherapy-naïve patients with advanced non-squamous non-small-cell lung cancer: a randomized, phase II study
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晚期非鳞状非小细胞肺癌初治患者接受卡铂和培美曲塞诱导治疗后培美曲塞与多西他赛维持治疗的比较：一项随机 II 期研究
DOI：
10.1007/s00280-013-2218-6
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发表时间：
2013
影响因子：
3
通讯作者：
K. Chida
中科院分区：
文献类型：
--
作者：
M. Karayama;N. Inui;Shigeki Kuroishi;K. Yokomura;M. Toyoshima;T. Shirai;M. Masuda;Takashi Yamada;Kazumasa Yasuda;T. Suda;K. Chida
目的维持化疗的最佳策略存在争议。我们评估了培美曲塞继续维持和多西他赛切换维持治疗晚期非鳞状非小细胞肺癌（NSCLC）的有效性和安全性。MethodsChemotherapy-naïve非鳞状NSCLC患者被纳入这项随机II期研究。在卡铂（AUC 6）和培美曲塞（500mg /m2）诱导治疗4个周期后达到疾病控制的患者随机接受培美曲塞（500mg /m2）或多西他赛（60mg /m2）维持治疗。主要终点是无毒性生存期，定义为从开始维持治疗到出现任何3/4级毒性或任何原因导致的死亡的时间。结果共有85例患者进入诱导期，其中26例患者被分配到培美曲塞维持治疗，25例患者被分配到多西他赛维持治疗。培美曲塞组的无毒性生存期（中位20.8个月，95%可信区间（CI） 0.7 -不可估计）明显高于多西他赛组（中位0.5个月，95% CI 0.2-2.0，风险比0.36,95% CI 0.17-0.74）。结论对于卡铂和培美曲塞诱导治疗后病情得到控制的非鳞状NSCLC患者，培美曲塞继续维持可能是一种可行的治疗选择。多西他赛切换维持也可能有效，但经常引起严重的血液学毒性。
PurposeThe optimal strategy for maintenance chemotherapy is controversial. We evaluated the efficacy and safety of continuation maintenance with pemetrexed and switch maintenance with docetaxel in advanced non-squamous non-small-cell lung cancer (NSCLC).MethodsChemotherapy-naïve patients with non-squamous NSCLC were enrolled in this randomized phase II study. Patients who achieved disease control after four cycles of induction therapy with carboplatin (AUC 6) and pemetrexed (500 mg/m2) were randomized to maintenance therapy with pemetrexed (500 mg/m2) or docetaxel (60 mg/m2). The primary endpoint was survival without toxicity, defined as the time from the initiation of maintenance therapy to the first date of any grade 3/4 toxicity or death due to any cause.ResultsA total of eighty-five patients were enrolled in the induction phase, and 26 patients were assigned to the pemetrexed maintenance therapy and 25 patients were assigned to the docetaxel maintenance therapy. Survival without toxicity was significantly longer in the pemetrexed group (median 20.8 months, 95 % confidence interval (CI) 0.7–not estimable) than in the docetaxel group (median 0.5 months, 95 % CI 0.2–2.0, hazard ratio 0.36, 95 % CI 0.17–0.74).ConclusionsContinuation maintenance with pemetrexed may be a feasible treatment option for patients with non-squamous NSCLC who have achieved disease control after induction therapy with carboplatin and pemetrexed. Switch maintenance with docetaxel may also be efficacious but frequently causes severe hematologic toxicity.