In advanced non-small cell lung cancer (NSCLC), immune checkpoint inhibitors (ICIs) significantly improved patients (pts) prognosis, even if many factors could impair their efficacy. The impact of steroids (well below the immunosuppressant dose) on ICIs outcomes is debatable, although a quite number of pts starts immunotherapy while on, or early recurs to steroids as supportive care medications or for mild AEs. Here, we aimed at assessing the impact of early steroids use on clinical outcomes of ICIs treatment in a series of pts with advanced NSCLC.
All consecutive pts with advanced NSCLC who started ICIs at our institution from Apr 2013 to Dec 2017 were retrospectively reviewed. Pts with at least one instrumental response assessment were included. Early use of steroids was defined as the use of a daily prednisone-equivalent dose ≥ 10 mg for at least 1 day within 28 days from ICIs initiation. Chi-square test or Fisher's exact test were used to analyze the association of early use of steroids with pts’ characteristics. The Kaplan-Meier method and the Cox proportional-hazards model were used for survival analyses.
Out of 151 pts included, 35 (23 %) made early use of steroids. Most of the pts (96%) received single agent anti PD-1/PD-L1, while 6 pts (4%) received combinatorial PD-L1+CTLA-4 blockade. Early use of steroids was negatively associated with disease control (OR 0,32; 95% CI 0.14-0.71, P = .006) and positively associated with ≥2 metastatic sites (OR 3,08, 95% CI 1.33-7.89; P = .01) and ECOG PS ³ 2 (OR 4.57; 95% CI 1.10-20.37; P = .03). With a median follow-up of 32.7 months, early use of steroids conferred a worse median progression-free survival (PFS) (1.98 vs 3.94 months; HR 1.80; 95% CI 1.20-2.80; P = .003). In the multivariable model including other covariates significantly associated with PFS (i.e. ECOG PS and PD-L1 status), the early use of steroids was confirmed to be independently associated with poorer PFS (HR 1.88; 95% CI 1.08-3.28; P = .03).
We found that the early use of steroids independently affects clinical outcomes in patients with advanced NSCLC treated with ICIs. If these findings will be further validated, such use in this setting should be carefully evaluated and avoided when not strictly needed.
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D. Signorelli: Consultancies: AstraZeneca, Boehringer Ingelheim, BMS. M.C. Garassino: Consultancies: MSD, BMS, AstraZeneca, Eli Lilly. C. Proto: Consultancies: MSD, BMS. All other authors have declared no conflicts of interest.