Department of Oncology, Qingdao Central Hospital, Qingdao University, China.
Pingdu People's Hospital, Qingdao, China.
Cancer Control. 2020 Apr-Jun;27(2):1073274820932004. doi: 10.1177/1073274820932004.
Small-cell lung cancer (SCLC) is a recalcitrant cancer for its dismal prognosis although extensive research had been done. Four to 6 cycles platinum-based chemotherapy is the mainstay treatment for the extensive-stage disease; but the role of maintenance treatment is not fully understood. This is a phase 2, open-label study. Patients with extensive-stage SCLC reaching an objective response or stable disease (SD) after induction chemotherapy were randomly assigned (1:1) with a minimization procedure. One group received oral S-1 and the other group received placebo as maintenance treatment until disease progression or unacceptable toxicities. The primary end point of this study was progression-free survival (PFS), and the secondary end points were overall survival (OS), response rates, and toxicities. This study was based on earlier work, the preliminary results was reported on 2019 ASCO annual meeting. A total of 89 patients were enrolled, of whom 45 received S-1 maintenance therapy and 44 received placebo. The median PFS and OS were 6.35 months and 10.82 months in the S-1 group, as compared to 5.98 months and 10.09 months in the placebo group. The PFS was 7.2 months and 5.3 months, and OS was 12.9 months and 10.9 months in patients with an objective response compared to in patients with SD after induction chemotherapy, respectively. S-1 maintenance therapy did not prolong PFS or OS in patients with extensive-stage SCLC; tumor regression rate was the prognostic factor of PFS or OS. Further research with novel agents in the maintenance setting is warranted.
小细胞肺癌（SCLC）是一种预后极差的难治性癌症，尽管已经进行了广泛的研究。铂类药物为基础的化疗 4-6 个周期是广泛期疾病的主要治疗方法；但维持治疗的作用尚未完全了解。这是一项 2 期、开放标签的研究。诱导化疗后达到客观缓解或疾病稳定（SD）的广泛期 SCLC 患者，采用最小化程序随机分组（1:1）。一组患者接受口服 S-1 治疗，另一组患者接受安慰剂作为维持治疗，直到疾病进展或出现不可耐受的毒性。本研究的主要终点是无进展生存期（PFS），次要终点是总生存期（OS）、缓解率和毒性。这项研究是基于早期的工作，初步结果于 2019 年 ASCO 年会上报告。共有 89 名患者入组，其中 45 名患者接受 S-1 维持治疗，44 名患者接受安慰剂。S-1 组的中位 PFS 和 OS 分别为 6.35 个月和 10.82 个月，安慰剂组分别为 5.98 个月和 10.09 个月。在诱导化疗后有客观缓解和 SD 的患者中，PFS 分别为 7.2 个月和 5.3 个月，OS 分别为 12.9 个月和 10.9 个月。S-1 维持治疗并不能延长广泛期 SCLC 患者的 PFS 或 OS；肿瘤缓解率是 PFS 或 OS 的预后因素。在维持治疗中，需要进一步研究新型药物。
