Division of Medical Oncology, Ohio State University Wexner Medical Center, James Cancer Hospital and Solove Research Institute, Columbus, OH.
Center for Biostatistics, Ohio State University Wexner Medical Center, James Cancer Hospital and Solove Research Institute, Columbus, OH.
Clin Lung Cancer. 2018 Nov;19(6):e893-e900. doi: 10.1016/j.cllc.2018.08.008. Epub 2018 Aug 22.
The risk factors for immune-related adverse events (irAEs) remain undefined. Recently, a correlation between irAEs and clinical benefit was suggested. We examined the risk factors for irAEs and their effect on survival in patients with non-small-cell lung cancer (NSCLC) who had received immunotherapy.
We performed a retrospective review of patients with NSCLC treated with single-agent immunotherapy at our institution. irAEs were determined by treating physician diagnosis. A landmark analysis was performed at 3 months using log-rank tests and the Bonferroni method.
irAEs occurred in 27 of 91 patients (30%). The median overall survival (OS) for patients with irAEs was longer than that for patients without (24.3 vs. 5.3 months; hazard ratio, 2.75; 95% confidence interval, 1.54-4.92; P < .001). However, a landmark analysis of patients after 3 months of treatment revealed no difference in OS between patients with and without irAEs. No increased risk of pneumonitis was seen in patients with previous thoracic radiotherapy, although these patients had shorter survival (4.2 vs. 9.7 months; P = .004). Radiotherapy after the initiation of immunotherapy (n = 15) did not increase the risk of irAEs or pneumonitis; however, these patients had improved OS (17.3 vs. 6.0 months; P = .016).
The development of irAEs did not significantly correlate with survival when controlling for the duration of therapy in a landmark analysis. We found no increased risk of pneumonitis or irAEs in patients who had received radiotherapy. Radiotherapy before immunotherapy was associated with shorter survival, and radiotherapy after immunotherapy was associated with improved survival.
免疫相关不良事件（irAEs）的风险因素仍未确定。最近，有人提出 irAEs 与临床获益之间存在相关性。我们研究了接受免疫治疗的非小细胞肺癌（NSCLC）患者发生 irAEs 的风险因素及其对生存的影响。
我们对在我院接受单药免疫治疗的 NSCLC 患者进行了回顾性研究。irAEs 由治疗医生诊断确定。使用对数秩检验和 Bonferroni 方法在 3 个月时进行了里程碑分析。
91 例患者中有 27 例（30%）发生 irAEs。发生 irAEs 的患者中位总生存期（OS）长于未发生 irAEs 的患者（24.3 与 5.3 个月；风险比，2.75；95%置信区间，1.54-4.92；P<.001）。然而，治疗 3 个月后的里程碑分析显示，发生 irAEs 与未发生 irAEs 的患者之间的 OS 无差异。尽管这些患者的生存期更短（4.2 与 9.7 个月；P=.004），但有既往胸部放疗史的患者发生肺炎的风险并未增加。免疫治疗开始后进行放疗（n=15）并未增加 irAEs 或肺炎的风险，但这些患者的 OS 得到改善（17.3 与 6.0 个月；P=.016）。
在里程碑分析中，当控制治疗持续时间时，irAEs 的发生与生存无显著相关性。我们发现接受放疗的患者发生肺炎或 irAEs 的风险没有增加。免疫治疗前的放疗与较短的生存期相关，而免疫治疗后的放疗与改善的生存期相关。
