Association of Immune-Related Adverse Events With Efficacy in Consolidation Nivolumab Plus Ipilimumab or Nivolumab Alone After Chemoradiation in Patients With Unresectable Stage III Nonsmall Cell Lung Cancer: An Exploratory Analysis From the Big 10 Cancer Research Consortium Study BTCRC LUN 16-081.
Cynthia X Wei, Sandra K Althouse, Hirva Mamdani, Nasser H Hanna, Greg A Durm
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引用次数: 0
Abstract
Background: Immunotherapy has been widely incorporated into the treatment of patients with non-small-cell lung cancer (NSCLC). Many of these patients will experience immune-related adverse events (irAEs) without decreased efficacy. We report a retrospective analysis of the association between irAEs and efficacy outcomes from the BTCRC LUN 16-081 randomized phase 2 trial of consolidation nivolumab (N) plus ipilimumab (IPI) vs N alone following chemoradiotherapy in unresectable Stage IIIA/IIIB NSCLC.
Results: A total of 105 patients enrolled from 9/2017 to 4/2021. In arm A (N alone), 65 % of patients developed irAEs with no difference in PFS or OS in patients with and without irAEs. In arm B (IPI+N), 84 % of patients developed irAE with no difference in OS in patients with and without irAEs, but longer PFS in those who experienced irAEs (30.9 vs. 6.8mo, P = .010). Patients in Arm A that discontinued treatment due to irAE (n = 8) had shorter PFS (8.2 vs. 31.9mo, P ≤ .0001) and OS (12.3mo vs. NE, P < .0001). Patients in Arm B that discontinued treatment due to irAEs (n = 18) had no difference in either PFS or OS.
Conclusions: The development of irAEs after chemoradiotherapy due to the use of Nivolumab alone or in combination with Ipilimumab did not result in reduced efficacy outcomes, with an observed improvement in PFS in the combination arm. If the irAEs resulted in discontinuation of treatment, this was associated with decreased efficacy outcomes in the N alone arm but not in the IPI + N arm.
背景：免疫疗法已被广泛纳入非小细胞肺癌（NSCLC）患者的治疗中。这些患者中的许多人将经历免疫相关不良事件（irAEs），但不会降低疗效。我们报告了一项回顾性分析，从BTCRC LUN 16-081随机2期试验中，在不可切除的IIIA/IIIB期非小细胞肺癌放化疗后，巩固性纳鲁单抗(N)加伊匹单抗（IPI）与单独使用N之间的irae和疗效结果之间的关联。结果：2017年9月至2021年4月共入组105例患者。在A组（仅N组）中，65%的患者发生了irAEs，有irAEs和没有irAEs的患者的PFS或OS没有差异。在B组（IPI+N）中，84%的患者发生了irAE，有irAE和没有irAE的患者的OS没有差异，但经历irAE的患者的PFS更长（30.9 vs 6.8mo, P = 0.010）。A组因irAE而停止治疗的患者（n = 8）的PFS （8.2 vs. 31.9mo, P≤0.0001）和OS （12.3mo vs. NE, P < 0.0001）较短。B组因irAEs而停止治疗的患者（n = 18）在PFS和OS方面没有差异。结论：放化疗后由于单独使用尼武单抗或联合使用伊匹单抗而发生的irAEs并没有导致疗效结果的降低，在联合组中观察到PFS的改善。如果irae导致停止治疗，这与单用N治疗组的疗效下降有关，但与IPI + N治疗组无关。
期刊介绍：
Clinical Lung Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of lung cancer. Clinical Lung Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of lung cancer. The main emphasis is on recent scientific developments in all areas related to lung cancer. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.
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