Multicenter phase II trial of Genexol-PM, a novel Cremophor-free, polymeric micelle formulation of paclitaxel, with cisplatin in patients with advanced non-small-cell lung cancer
Multicenter phase II trial of Genexol-PM, a novel Cremophor-free, polymeric micelle formulation of paclitaxel, with cisplatin in patients with advanced non-small-cell lung cancer
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DOI：
10.1093/annonc/mdm374
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发表时间：
2007-12-01
影响因子：
50.5
通讯作者：
Heo, D. S.
中科院分区：
文献类型：
--
作者：
Kim, D. -W.;Kim, S. -Y.;Heo, D. S.
背景：Genexol-PM是紫杉醇(Taxol)的新型无CREL聚合物胶束制剂。这项多中心II期研究旨在评价Genexol-PM和顺铂联合治疗晚期非小细胞肺癌(NSCLC)的疗效和安全性。患者和方法：晚期NSCLC患者在3周周期的第一天给予Genexol-PM 230 mg/m(2)和顺铂60 mg/m(2)作为一线治疗。如果在第一个周期后没有观察到预先指定的毒性反应，则从第二个周期开始将Genexol-PM的患者内剂量递增到300 mg/m(2)。结果：69名患者进入本研究。总有效率为37.7%。中位进展时间为5.8个月，中位生存期为21.7个月。主要的非血液毒性反应包括3级周围感觉神经病(13.0%)和3/4级关节痛(7.3%)。4例(5.8%)出现3/4级过敏反应。主要血液学毒性反应为3/4度中性粒细胞减少症(分别为29.0%和17.4%)。结论：Genexol-PM联合顺铂化疗具有显著的抗肿瘤活性。与不含CrEL的紫杉醇聚合物胶束制剂相比，使用不含CrEL的聚合物胶束制剂可以在不显著增加毒性的情况下给药更高剂量的紫杉醇。
Background: Genexol-PM is a novel Cremophor EL (CrEL)-free polymeric micelle formulation of paclitaxel (Taxol). This multicenter phase II study was designed to evaluate the efficacy and safety of the combination of Genexol-PM and cisplatin for the treatment of advanced non-small-cell lung cancer (NSCLC).Patients and methods: Patients with advanced NSCLC received Genexol-PM 230 mg/m(2) and cisplatin 60 mg/m(2) on day 1 of a 3-week cycle as first-line therapy. Intrapatient dose escalation of Genexol-PM to 300 mg/m(2) was carried out from the second cycle if the prespecified toxic effects were not observed after the first cycle.Results: Sixty-nine patients were enrolled in this study. Overall response rate was 37.7%. The median time to progression was 5.8 months and the median survival period was 21.7 months. The major non-hematologic toxic effects included grade 3 peripheral sensory neuropathy (13.0%) and grade 3/4 arthralgia (7.3%). Four patients (5.8%) experienced grade 3/4 hypersensitivity reactions. The major hematological toxic effects were grade 3/4 neutropenia (29.0% and 17.4%, respectively).Conclusion: Genexol-PM plus cisplatin combination chemotherapy showed significant antitumor activity. The use of CrEL-free, polymeric micelle formulation of paclitaxel allowed administration of higher doses of paclitaxel compared with the CrEL-based formulation without significant increased toxicity.