Division of Respiratory Medicine, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.
Respiratory Center, Matsusaka Municipal Hospital, Matsusaka, Japan.
Thorac Cancer. 2020 Jun;11(6):1559-1565. doi: 10.1111/1759-7714.13429. Epub 2020 Apr 14.
Ramucirumab plus docetaxel (RAM+DOC) is expected to prolong survival in patients with advanced non-small cell lung cancer (NSCLC); however, the efficacy and safety for older patients remains unknown. The objective of this study was to evaluate the efficacy and safety of RAM+DOC in patients 75 years and older.
We retrospectively reviewed consecutive patients with advanced NSCLC who had received RAM+DOC treatment at three institutions. We compared the efficacy and safety in patients 75 years and older to those under 75 years of age.
A total of 114 patients were identified. The median progression-free survival, time to treatment failure and overall survival was 3.6 (95% CI: 0.4-6.7), 3.1 (95% CI: 2.4-3.9) and 11.2 months (95% CI: 5.6-16.8) in the older group (N = 23), and 4.2 (95% CI: 3.3-5.0), 3.4 (95% CI: 3.3-5.0) and 12.2 months (95% CI: 9.1-15.4) in the younger group (N = 91), respectively. Survival curves were similar for each group, while the objective response rate was 30.4% (95% CI: 13.2-52.9%) in older patients and 35.2% (95% CI, 25.4-45.9%) for the younger group. A total of 22 older patients (95.7%) and 73 (80.2%) younger patients received primary prophylactic pegylated-granulocyte-colony stimulating factor (PEG-G-CSF). Four older patients (17.3%) and 14 younger patients (15.3%) discontinued RAM+DOC due to adverse events.
RAM+DOC is expected to be efficacious and tolerable in older patients when supported with prophylactic PEG-G-CSF therapy.
Significant findings of the study ・PFS, OS, and ORR in older patients were similar to those under 75 years of age. ・Safety of RAM+DOC was well tolerated in older patients with prophylactic PEG-G-CSF. ・Prophylactic PEG-G-CSF with RAM+DOC may contribute to better efficacy. What this study adds ・This study suggests that RAM+DOC with prophylactic PEG-G-CSF is expected to be a useful option in older patients with advanced NSCLC.
雷莫芦单抗联合多西他赛（RAM+DOC）有望延长晚期非小细胞肺癌（NSCLC）患者的生存时间；然而，对于年龄较大的患者的疗效和安全性尚不清楚。本研究的目的是评估 RAM+DOC 在 75 岁及以上患者中的疗效和安全性。
我们回顾性分析了在三所机构接受 RAM+DOC 治疗的晚期 NSCLC 连续患者。我们比较了 75 岁及以上患者与 75 岁以下患者的疗效和安全性。
共纳入 114 例患者。在年龄较大的组（N=23）中，中位无进展生存期、治疗失败时间和总生存期分别为 3.6（95%CI：0.4-6.7）、3.1（95%CI：2.4-3.9）和 11.2 个月（95%CI：5.6-16.8），而在年龄较小的组（N=91）中，中位无进展生存期、治疗失败时间和总生存期分别为 4.2（95%CI：3.3-5.0）、3.4（95%CI：3.3-5.0）和 12.2 个月（95%CI：9.1-15.4）。两组的生存曲线相似，而客观缓解率在年龄较大的患者中为 30.4%（95%CI：13.2-52.9%），在年龄较小的患者中为 35.2%（95%CI，25.4-45.9%）。共有 22 名年龄较大的患者（95.7%）和 73 名年龄较小的患者（80.2%）接受了培非格司亭预防性治疗。有 4 名年龄较大的患者（17.3%）和 14 名年龄较小的患者（15.3%）因不良反应而停止使用 RAM+DOC。
在预防性 PEG-G-CSF 治疗的支持下，RAM+DOC 有望对年龄较大的患者有效且耐受。
研究的重要发现：
老年患者的 PFS、OS 和 ORR 与 75 岁以下患者相似。
预防性 PEG-G-CSF 治疗的 RAM+DOC 安全性在老年患者中得到良好耐受。
RAM+DOC 联合预防性 PEG-G-CSF 可能有助于提高疗效。
本研究的意义：
该研究表明，在年龄较大的晚期 NSCLC 患者中，RAM+DOC 联合预防性 PEG-G-CSF 有望成为一种有用的选择。
