Switch maintenance chemotherapy using S-1 with or without bevacizumab in patients with advanced non-small cell lung cancer: a phase II study
Switch maintenance chemotherapy using S-1 with or without bevacizumab in patients with advanced non-small cell lung cancer: a phase II study
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DOI：
10.1016/j.lungcan.2017.02.018
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发表时间：
2017-06-01
期刊：
影响因子：
5.3
通讯作者：
Goto, Koichi
中科院分区：
文献类型：
--
作者：
Niho, Seiji;Ohe, Yuichiro;Goto, Koichi
目的：我们进行了这项单中心、前瞻性、非随机、平行、两组II期研究，以评估晚期非小细胞肺癌（NSCLC）患者在接受以铂类为基础的方案诱导治疗后，使用S-1进行转换维持化疗的疗效和安全性。诱导期铂类化疗后未显示疾病进展的患者接受S-1，剂量为40 mg/m2，每日2次，连续14天，每3周一次，有或没有贝伐单抗（Bev），剂量为15 mg/kg。在诱导化疗方案包含Bev的情况下，适当时将Bev用作持续维持化疗。分别评价S-1和S-1 + Bev转换维持化疗的疗效和毒性。本研究的主要终点是S-1治疗开始后3个月的治疗成功率。结果：2010年7月至2014年1月，79例患者入组，其中78例符合纳入本研究的条件。S-1组3个月时的治疗成功率为28.2%（90%置信区间（CI），7.1-17.1%），S-1 + Bev组为64.1%（90% CI，50.0-76.8%）。S-1 + Bev组达到了主要终点。S-1组的中位PFS和OS分别为2.6个月和11.0个月，S-1 + Bev组分别为4.6个月和19.9个月。最常见的3级毒性是中性粒细胞减少症（S-1 + Bev组发生率为10%）。没有发热性中性粒细胞减少症的病例。结论：S-1的转换维持化疗与贝伐单抗的持续维持化疗相结合，产生了温和的疗效，轻度和可接受的毒性。(C)2017由Elsevier爱尔兰有限公司出版。
Objectives: We conducted this single-institute; prospective, non-randomized parallel two-arm phase II study to evaluate the efficacy and safety of switch maintenance chemotherapy with S-1 after induction therapy with a platinum-based regimen in patients with advanced non-small cell lung cancer (NSCLC).Patients and methods: Patients not showing disease progression after induction platinum-based chemotherapy received S-1 at the dose of 40 mg/m(2) twice daily for 14 consecutive days, every three weeks, with or without bevacizumab (Bev) at the dose of 15 mg/kg. In cases where the induction chemotherapy regimen contained Bev, Bev was used as continuation maintenance chemotherapy where appropriate. The efficacy/toxicity of switch maintenance chemotherapy with S-1 and S-1 + Bev was evaluated separately. The primary end point of this study was the treatment success rate at three months after the start of S-1 treatment.Results: Between July 2010 and January 2014, 79 patients were enrolled, of which 78 were found to be eligible for inclusion in this study. The treatment success rate at three months was 28.2% (90% confidence interval (CI), 7.1-17.1%) in the S-1 group and 64.1% (90% CI, 50.0-76.8%) in the S-1 + Bev group. The primary endpoint was met in the S-1 + Bev group. The median PFS and OS were 2.6 months and 11.0 months in the S-1 group, and 4.6 months and 19.9 months in the S-1 + Bev group, respectively. The most common grade three toxicity was neutropenia (10% incidence in the S-1 + Bev group). There were no cases of febrile neutropenia.Conclusions: Switch maintenance chemotherapy with S-1 in combination with continuation maintenance chemotherapy with bevacizumab yielded modest efficacy with mild and acceptable toxicities. (C) 2017 Published by Elsevier Ireland Ltd.