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Safety of programmed death–1 pathway inhibitors among patients with non–small-cell lung cancer and preexisting autoimmune disorders

Journal of Clinical Oncology Jul 04, 2018

Leonardi GC, et al. - Researchers determined if the use of programmed death (PD)-1 and PD-ligand 1 (PD-L1) inhibitors in patients with non–small-cell lung cancer (NSCLC) and underlying autoimmune disease (AID) is safe. They found that among patients with NSCLC with AID treated with a PD-(L)1 inhibitor, AID was exacerbated in a minority of patients. Compared to reported rates in clinical trials where patients with AID were excluded, a similar incidence of immune-related adverse events (irAEs) was reported in this study. Data showed generally manageable adverse events, which occasionally was the reason for immunotherapy being permanently discontinued.

Methods

  • Retrospective collection of clinicopathologic data from patients with NSCLC and a history of AID who received monotherapy with either a PD-1 or a PD-L1 (referred to as PD-[L]1) inhibitor, was accomplished as a part of a multi-institutional effort.
  • Qualifying AIDs included, but was not limited to: rheumatologic, neurologic, endocrine, GI, and dermatologic conditions.

Results

  • This study included 56 patients with NSCLC and an AID who received a PD-(L)1 inhibitor.
  • Active AID symptoms were present in 18% of patients and 20% were receiving immunomodulatory agents for their AID at the time of treatment initiation.
  • An AID flare and/or an immune-related adverse event (irAE) was experienced by 55% of patients.
  • A total of 13 patients (23% of the whole cohort) experienced exacerbation of the AID; systemic corticosteroids was needed for four of these patients.
  • Occurrence of immune-related adverse events was reported in 21 patients (38%).
  • Data showed that among irAEs, 74% were grade 1 or 2 and 26% were grade 3 or 4; eight patients required corticosteroids for irAE management.
  • Findings showed irAEs accounted for permanent discontinuation of PD-(L)1 therapy in eight patients (14%).
  • The overall response rate to immunotherapy was 22%.
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