Health Management Center, Japan Community Health care Organization Yamatokoriyama Hospital, Yamatokoriyama, Japan.
Department of Biostatistics, Hyogo College of Medicine, Nishinomiya, Japan.
Thorac Cancer. 2023 Oct;14(29):2941-2949. doi: 10.1111/1759-7714.15080. Epub 2023 Aug 23.
This study evaluated the efficacy and safety of the combination chemotherapy of docetaxel plus S-1 in patients with previously treated non-small cell lung cancer (NSCLC) compared to docetaxel alone.
Patients with previously treated NSCLC were randomly assigned to docetaxel alone (arm A) or a combination of docetaxel and S-1 (arm B) for a maximum of four cycles. The primary endpoint was overall survival (OS).
The study was terminated early because of poor accrual. The number of patients evaluated were 74 and 77 in arm A and arm B, respectively. The median OS was 9.8 months (95% confidence interval [CI]: 6.8-15.2) and 12.3 months (95% CI: 9.2-14.5) in arms A and B, respectively. In arms A and B, the median progression-free survival was 3.5 months (95% CI: 2.7-4.0) and 4.1 months (95% CI: 3.2-4.7), respectively. No statistically significant difference was observed in OS (hazard ratio [HR]: 0.984, 95% CI: 0.682-1.419, p = 0.4569) or progression-free survival (HR: 0.823, 95% CI: 0.528-1.282, p = 0.0953). The major toxicity was myelosuppression. The incidence of grade 3 or more neutropenia was higher in arm A than in arm B (44.6% vs. 35.1%). However, the incidence of grade 3 or more febrile neutropenia and infection with neutropenia (12.2% vs. 22.1%) was more frequently observed in arm B.
The prematurely terminated study did not show the benefit of two cytotoxic agents over single-agent therapy for previously treated NSCLC patients.
本研究评估了多西他赛联合 S-1 化疗与多西他赛单药治疗既往治疗的非小细胞肺癌（NSCLC）患者的疗效和安全性。
既往治疗的 NSCLC 患者被随机分配至多西他赛单药组（A 组）或多西他赛联合 S-1 组（B 组），最多接受四个周期的治疗。主要终点为总生存期（OS）。
由于入组人数较少，该研究提前终止。A 组和 B 组分别有 74 例和 77 例患者接受了评估。A 组和 B 组的中位 OS 分别为 9.8 个月（95%CI：6.8-15.2）和 12.3 个月（95%CI：9.2-14.5）。A 组和 B 组的中位无进展生存期分别为 3.5 个月（95%CI：2.7-4.0）和 4.1 个月（95%CI：3.2-4.7）。OS（风险比[HR]：0.984，95%CI：0.682-1.419，p=0.4569）或无进展生存期（HR：0.823，95%CI：0.528-1.282，p=0.0953）无统计学差异。主要毒性为骨髓抑制。A 组的 3 级或以上中性粒细胞减少发生率高于 B 组（44.6% vs. 35.1%）。然而，B 组 3 级或以上发热性中性粒细胞减少和中性粒细胞减少感染的发生率（12.2% vs. 22.1%）更高。
提前终止的研究并未显示对于既往治疗的 NSCLC 患者，两种细胞毒性药物联合治疗并不优于单药治疗。
