Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Cheello College of Medicine, Shandong University, Jiyan Road 440, Jinan, 250117, Shandong Province, People's Republic of China.
Department of Radiation Oncology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, Shandong, People's Republic of China.
J Cancer Res Clin Oncol. 2022 May;148(5):1253-1261. doi: 10.1007/s00432-021-03849-3. Epub 2021 Nov 23.
Growing numbers of clinical trials test the efficacy of radiotherapy (RT) plus immune checkpoint inhibitors (ICIs), but the number of irradiated sites is not uniform. We aimed to evaluate the efficacy of single-site RT plus immunotherapy in oligometastatic non-small cell lung cancer (NSCLC) with smaller disease burdens and low tumor heterogeneity.
We retrospectively identified oligometastatic NSCLC (< 4 metastatic sites) patients treated with PD-1 pathway inhibitors with or without RT to a single lesion in our institution between 2018 and 2020. The primary endpoints were the best objective response rate (ORR) and progression-free survival (PFS).
Of the 152 patients enrolled, 93 and 59 were identified as the ICI alone group and the ICI plus RT group, respectively. The addition of RT to ICI therapy significantly increased the best ORR from 31.2% to 50.8% (p = 0.015). The out-of-field (abscopal effect) response rate could reach 41.3% (95%CI 26.5%-56.1%) in the ICI plus RT group. Median PFS was 8.9 months (95%CI 4.7-13.1 months) with ICI alone versus 13.8 months (95%CI 9.5-18.1 months) with ICI plus radiotherapy (hazard ratio [HR] 0.556; p = 0.035). In an exploratory subgroup analysis of PFS, the addition of RT brought greater benefits in patients aged < 65 years (p = 0.016), patients with ECOG PS = 0 (p = 0.048), and patients with 1-2 metastatic sites (p = 0.024). No unexpected adverse events or significantly increased toxicities were observed in the experimental arm.
Single-site RT plus anti-PD-1 inhibitors significantly increased systemic responses and improved survival outcomes in oligometastatic NSCLC patients.
越来越多的临床试验测试了放疗（RT）联合免疫检查点抑制剂（ICI）的疗效，但照射部位的数量并不统一。我们旨在评估在疾病负担较小、肿瘤异质性较低的寡转移性非小细胞肺癌（NSCLC）中，单部位 RT 联合免疫治疗的疗效。
我们回顾性地确定了 2018 年至 2020 年间，在我们机构接受 PD-1 通路抑制剂治疗且 RT 照射单一病变的寡转移性 NSCLC（<4 个转移灶）患者。主要终点是最佳客观缓解率（ORR）和无进展生存期（PFS）。
在纳入的 152 例患者中，93 例和 59 例患者分别被确定为 ICI 单药组和 ICI 联合 RT 组。ICI 联合 RT 治疗显著提高了最佳 ORR，从 31.2%提高到 50.8%（p=0.015）。ICI 联合 RT 组的野外（远隔效应）缓解率可达到 41.3%（95%CI 26.5%-56.1%）。ICI 单药组的中位 PFS 为 8.9 个月（95%CI 4.7-13.1 个月），ICI 联合放疗组为 13.8 个月（95%CI 9.5-18.1 个月）（风险比 [HR] 0.556；p=0.035）。在 PFS 的探索性亚组分析中，RT 的加入在年龄<65 岁的患者（p=0.016）、ECOG PS=0 的患者（p=0.048）和 1-2 个转移灶的患者（p=0.024）中带来了更大的获益。在实验组中未观察到意外的不良事件或毒性显著增加。
单部位 RT 联合抗 PD-1 抑制剂显著提高了寡转移性 NSCLC 患者的全身反应和生存结局。
