Introduction: This phase II study evaluated the efficacy and safety of the pan‐cyclin–dependent kinase inhibitor roniciclib with platinum‐based chemotherapy in patients with extensive‐disease SCLC. Methods: In this randomized, double‐blind study, unselected patients with previously untreated extensive‐disease SCLC received roniciclib, 5 mg, or placebo twice daily according to a 3 days–on, 4 days–off schedule in 21‐day cycles, with concomitant cisplatin or carboplatin on day 1 and etoposide on days 1 to 3. The primary end point was progression‐free survival. Other end points included overall survival, objective response rate, and safety. Results: A total of 140 patients received treatment: 70 with roniciclib plus chemotherapy and 70 with placebo plus chemotherapy. Median progression‐free survival times was 4.9 months (95% confidence interval [CI]: 4.2–5.5) with roniciclib plus chemotherapy and 5.5 months (95% CI: 4.6–5.6) with placebo plus chemotherapy (hazard ratio [HR] = 1.242, 95% CI: 0.820–1.881, p = 0.8653). Median overall survival times was 9.7 months (95% CI: 7.9–11.1) with roniciclib plus chemotherapy and 10.3 months (95% CI: 8.7–11.9) with placebo plus chemotherapy (HR = 1.281, 95% CI: 0.776–1.912, p = 0.7858). The objective response rates were 60.6% with roniciclib plus chemotherapy and 74.6% with placebo plus chemotherapy. Common treatment‐emergent adverse events in both groups included nausea, vomiting, and fatigue. Serious treatment‐emergent adverse events were more common with roniciclib plus chemotherapy (57.1%) than with placebo plus chemotherapy (38.6%). Conclusions: Roniciclib combined with chemotherapy demonstrated an unfavorable risk‐benefit profile in patients with extensive‐disease SCLC, and the study was prematurely terminated.

中文翻译：

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Roniciclib 联合顺铂/依托泊苷或卡铂/依托泊苷作为广泛病小细胞肺癌患者一线治疗的 II 期研究

简介：这项 II 期研究评估了泛细胞周期蛋白依赖性激酶抑制剂 roniciclib 与铂类化疗对广泛病 SCLC 患者的疗效和安全性。方法：在这项随机、双盲研究中，未经选择的先前未经治疗的广泛性疾病 SCLC 患者按照 3 天服用、4 天停药的时间表在 21 天的周期中每天两次接受 roniciclib、5 mg 或安慰剂，其中第 1 天同时使用顺铂或卡铂，第 1 天至第 3 天使用依托泊苷。主要终点是无进展生存期。其他终点包括总生存期、客观反应率和安全性。结果：共有 140 名患者接受治疗：70 名接受 roniciclib 加化疗，70 名接受安慰剂加化疗。中位无进展生存时间为 4.9 个月（95% 置信区间 [CI]：4.2–5.5) roniciclib 加化疗和 5.5 个月 (95% CI: 4.6–5.6) 安慰剂加化疗 (风险比 [HR] = 1.242, 95% CI: 0.820–1.881, p = 0.8653)。roniciclib 加化疗的中位总生存时间为 9.7 个月（95% CI：7.9-11.1），安慰剂加化疗为 10.3 个月（95% CI：8.7-11.9）（HR = 1.281，95% CI：0.776-1.912，p = 0.7858）。roniciclib 加化疗的客观缓解率为 60.6%，安慰剂加化疗的客观缓解率为 74.6%。两组常见的治疗中出现的不良事件包括恶心、呕吐和疲劳。与安慰剂加化疗 (38.6%) 相比，roniciclib 加化疗 (57.1%) 更常见严重的治疗紧急不良事件。结论：