A phase II study of amrubicin combined with carboplatin for elderly patients with small-cell lung cancer: North Japan Lung Cancer Study Group Trial 0405
A phase II study of amrubicin combined with carboplatin for elderly patients with small-cell lung cancer: North Japan Lung Cancer Study Group Trial 0405
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DOI：
10.1093/annonc/mdp384
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发表时间：
2010-04-01
影响因子：
50.5
通讯作者：
Nukiwa, T.
中科院分区：
文献类型：
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作者：
Inoue, A.;Ishimoto, O.;Nukiwa, T.
背景：氨柔比星是一种新的蒽环类药物，在以往的研究中显示出对小细胞肺癌（SCLC）的高活性。然而，氨柔比星和铂的联合方案很少被研究。方法：首次接受化疗的老年SCLC患者接受氨柔比星（35 mg/m2，d1 -3）和卡铂[曲线下面积（AUC）4.0，d1]，每3周1次。主要终点是总反应率（ORR），和次要终点是无进展生存期（PFS），总生存期和毒性profile.Results：从2005年1月至2007年11月，36例患者入组[中位年龄76（范围70-83）; ECOG体力状态为零和一个在17和19例患者，分别]。观察到1例完全缓解和31例部分缓解（ORR 89%）。中位PFS为5.8个月，中位生存时间为18.6个月。97%的患者出现3-4级中性粒细胞减少症，6例患者（17%）出现3-4级发热性中性粒细胞减少症。其他毒性反应是温和的，治疗相关的死亡是没有observed.Conclusions：氨柔比星联合卡铂是相当有效的小细胞肺癌与可接受的毒性作用，即使是老年人口。需要对该方案进行进一步评价。
Background: Amrubicin, a new anthracycline agent, has shown high activity for small-cell lung cancer (SCLC) in previous studies. However, a combination regimen with amrubicin and platinum has been investigated little. On the basis of previous phase I study, we conducted this study to evaluate the efficacy and the safety of amrubicin and carboplatin for elderly patients with SCLC.Methods: Chemotherapy-naive elderly patients with SCLC received amrubicin (35 mg/m(2), days 1-3) and carboplatin [area under the curve (AUC) 4.0, day1] every 3 weeks. The primary end point was overall response rate (ORR), and secondary end points were progression-free survival (PFS), overall survival and toxicity profile.Results: From January 2005 to November 2007, 36 patients were enrolled [median age 76 (range 70-83); ECOG performance status of zero and one in 17 and 19 patients, respectively]. One complete response and 31 partial responses were observed (ORR 89%). Median PFS was 5.8 months and median survival time was 18.6 months. Grade 3-4 neutropenia was observed in 97% of the patients and six patients (17%) suffered from grade 3-4 febrile neutropenia. Other toxic effects were moderate and treatment-related death was not observed.Conclusions: Amrubicin combined with carboplatin is quite effective for SCLC with acceptable toxic effects even for the elderly population. Further evaluation of this regimen is warranted.