Department of Radiotherapy, Yantai YuHuangDing Hospital, Yantai, Shandong, China.
Department of Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, 440 Jiyan Road, Jinan, 250117, Shandong, China.
Cancer Chemother Pharmacol. 2020 Jul;86(1):65-74. doi: 10.1007/s00280-020-04091-3. Epub 2020 Jun 12.
Doublet combination chemotherapy is commonly considered a second-line treatment for advanced non-small cell lung cancer (NSCLC) in China. This multi-institutional retrospective analysis evaluated and compared the efficacy between combination and mono-therapy after platinum-based first-line chemotherapy in Chinese patients with advanced NSCLC.
We retrospectively reviewed 335 patients who received second-line chemotherapy for advanced NSCLC. The primary endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS), response rate (RR) and toxicity. Treatment-free interval (TFI) was used for further stratification analysis. The Cox proportional hazards model was used for multivariate analysis.
Two hundred and fifty-three patients received doublet combination chemotherapy and 82 received single-agent chemotherapy. PFS was significantly prolonged in combination group compared to single-agent group (median 5.70 vs 3.70 months; HR 0.62; 95% CI 0.45-0.85; p < 0.001). The RR was significantly higher in the combination group than in the single-agent group (29.25% vs. 10.98%; p = 0.001). OS was also prolonged in combination group versus single-agent group (median 13.30 vs. 11.45 months, respectively; HR 0.70; 95% CI 0.52-0.95; p = 0.023). Among patients with TFI of ≥ 6 months, PFS and OS of the combination group were significantly increased than the single-agent group (median PFS, 6.67 vs. 3.80 months, p = 0.002; median OS, 13.60 vs. 11.45 months, p = 0.013). Grade III/IV toxicity was similar between the two groups (p = 0.113). Through multivariate analyses, we found that Eastern Cooperative Oncology Group (ECOG) score (p < 0.001), further-line treatment (p < 0.001) and combination chemotherapy (p = 0.024) were the independent prognostic factors.
Compared with mono-therapy, combination chemotherapy was a better second-line option for Chinese patients with good performance status, especially in those with TFI of ≥ 6 months.
在我国，对于晚期非小细胞肺癌（NSCLC），含铂双药化疗通常被认为是二线治疗选择。这项多机构回顾性分析评估并比较了中国晚期 NSCLC 患者在接受铂类为基础的一线化疗后，接受联合或单药治疗的疗效。
我们回顾性分析了 335 例接受二线化疗的晚期 NSCLC 患者。主要终点是总生存期（OS），次要终点是无进展生存期（PFS）、缓解率（RR）和毒性。无治疗间隔（TFI）用于进一步分层分析。采用Cox 比例风险模型进行多变量分析。
253 例患者接受了含铂双药联合化疗，82 例患者接受了单药化疗。与单药组相比，联合组的 PFS 显著延长（中位 5.70 个月 vs 3.70 个月；HR 0.62；95%CI 0.45-0.85；p<0.001）。联合组的 RR 显著高于单药组（29.25% vs 10.98%；p=0.001）。联合组的 OS 也长于单药组（中位 13.30 个月 vs 11.45 个月，HR 0.70；95%CI 0.52-0.95；p=0.023）。在 TFI≥6 个月的患者中，联合组的 PFS 和 OS 均显著长于单药组（中位 PFS，6.67 个月 vs 3.80 个月，p=0.002；中位 OS，13.60 个月 vs 11.45 个月，p=0.013）。两组的 3/4 级毒性相似（p=0.113）。通过多变量分析，我们发现东部肿瘤协作组（ECOG）评分（p<0.001）、进一步线治疗（p<0.001）和联合化疗（p=0.024）是独立的预后因素。
与单药治疗相比，对于 ECOG 评分良好的中国患者，尤其是 TFI≥6 个月的患者，联合化疗是一种更好的二线选择。
