Abstract 1329P
Background
The introduction of Immunotherapy (IO) has improved the prognosis of patients (pts) with Non-Small Cell Lung Cancer (NSCLC). However, data in poor ECOG performance status (PS) pts remains scant due to their exclusion from randomized trials.
Methods
We retrospectively analyzed data about pts with stage IV NSCLC treated with IO between Apr 2013 and Feb 2020 in two Italian Centers, to evaluate the impact of PS (0-1 vs 2) on disease control rate (DCR), median progression free survival (mPFS) and overall survival (mOS). Chi-square test was used to compare demographic and clinical-pathological variables including Charlson score (0-7; 8-10; >10), antibiotics and steroids exposure. Their impact on survival was evaluated through Cox proportional hazard models. Exploratory endpoints were the analysis of systemic inflammation parameters at baseline (Neutrophil to Lymphocyte Ratio (NLR) (200), LDH (
Results
Among 404 pts included, PS was 0 in 137 (33.9%), 1 in 208 (51.4%) and 2 in 59 (14.6%) pts; 143 were female and 90 had squamous NSCLC. Clinical-pathological variables were uniformly distributed except for higher liver metastasis and steroids exposure in PS2 pts (p= 0.046 and 0.03). DCR was 50.3% and 21.8% in pts with PS 0-1 and 2 (p= 0.001). At a median follow-up of 29 months (mos) mPFS was 3.0 mos (95% CI 2.7-4.0) and 2.0 mos (95% CI 1.6-3.0) (p< 0.0001) and mOS was 13.2 mos (95% CI 11.0-15.8) and 4.0 mos (95% CI 2.8-5.7) (p< 0.0001) in pts with PS 0-1 and 2 respectively. PS2 status, PDL1 expression <1%, IO line ≥2 and steroids exposure were associated with worse PFS and OS at univariate and multivariate analysis. Higher NLR, PLR and LDH value correlated with significantly worst PFS and OS in the whole population. Subgroup analysis confirmed poor outcomes in PS2 pts with high LDH and steroid therapies. The incidence of Grade 3/4 adverse events was 11.1% in PS 0-1 and 11.9% in PS 2 pts (p= 0.87).
Conclusions
Our data confirm reduced efficacy of IO in pts with poor PS even though a good safety. Despite PS remains the most powerful independent prognostic factor for NSCLC, LDH levels and steroids exposure could support the decision making in PS2 pts.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
D. Signorelli: Advisory/Consultancy: AstraZeneca; Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS; Research grant/Funding (institution), Travel/Accommodation/Expenses: MSD; Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer. C. Proto: Honoraria (self), Travel/Accommodation/Expenses: MSD International GmbH; Honoraria (self), Travel/Accommodation/Expenses: BMS; Honoraria (self), Travel/Accommodation/Expenses: Eli Lilly. A. Prelaj: Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: AstraZeneca; Honoraria (self): BMS. F.G.M. De Braud: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Amgen; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Eli Lilly; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: F. Hoffmann-La Roche; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Ignyta; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck Sharp and Dohme; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck Serono; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer. F. Morgillo: Advisory/Consultancy: MSD; Advisory/Consultancy: Lilly; Research grant/Funding (institution): AstraZeneca. M.C. Garassino: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: MSD International GmbH; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Boehringer Ingelheim Italia S.p.A; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Celgene; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Eli Lilly; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Ignyta; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Incyte; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Inivata; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: MedImmune; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Honoraria (institution), Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Takeda; Research grant/Funding (institution): Tiziana; Research grant/Funding (institution): Foundation Medicine; Research grant/Funding (institution): AIRC; Research grant/Funding (institution): AIFA; Research grant/Funding (institution): Italian Moh; Research grant/Funding (institution): TRANSCAN. G. Lo Russo: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD International GmbH; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb. All other authors have declared no conflicts of interest.