Immunotherapy represents a new standard of care in first and second line treatment of advanced NSCLC. Immune related adverse events (irAEs) have been proposed as an indicator of treatment efficacy.
Retrospective analysis of mNSCLC patients treated with anti-PD/anti-PDL1 with or without anti-CTLA4 therapy. Electronic patient records were reviewed; irAEs were identified and graded according to CTC AE v4.03 criteria. The association with survival was evaluated in uni- (UV) and multivariable (MV) Cox-regression models.
64 pts were identified; 41 (64.1%) were adenocarcinomas and 27 (42.2%) received immunotherapy in first-line. 44 pts (68.8%) received antiPD1/PDL1 monotherapy, and 20 pts (31.2%) received antiPDL1 + antiCTLA4. 15 pts (25%) developed irAEs: gastrointestinal (17.6%), endocrine (11.8%), cutaneous (17.6%), other (33.3%). Treatment was interrupted in 8 (53.3%) and suspended in 5 (33.3%) pts. 7 (50%) pts received high dose corticosteroids. No toxic deaths occurred. iRAEs were not significantly increased in pts receiving combination therapy (30% vs 20%, p = 0.377). Median OS was 6.5 m (95%CI: 0.24-12.7). Pts experiencing irAEs had a significantly higher OS (HR: 0.2; 95%CI: 0.07-0.58; p = 0.003) in UV analysis, and was independent of other prognostic factors in MV analysis (Table).Table: 1391P MV Cox-regression survival model
|irAE (yes vs no)||0.18 (0.06 – 0.53)||0.002|
|Histology||1.11 (0.99 – 1.24)||0.061|
|ECOG PS||0.82 (0.42 – 1.59)||0.551|
|Treatment line (first line vs second or further)||1.06 (0.52 – 2.18)||0.868|
|Treatment type (monotherapy vs combination)||2.25 (1.02 – 4.99)||0.045|
The development of irAEs may identify pts with a higher likelihood of benefitting from immunotherapy in NSCLC. These findings will require prospective validation in well-designed clinical trials.
Clinical trial identification
Legal entity responsible for the study
Instituto Investigación Sanitaria La Fe.
Has not received any funding.
All authors have declared no conflicts of interest.