Abstract 63P
Background
Pembrolizumab is the standard first-line option for patients with metastatic non-small cell lung cancer (NSCLC) with programmed death-ligand 1 (PD-L1) expression of ≥50%. Clinicopathological correlates of effectiveness in real-life populations remain unclear.
Methods
This study is a single-center retrospective analysis of patients (pts) with stage IV NSCLC treated with pembrolizumab in routine practice. Inclusion criteria included good performance status (ECOG 0–1), no active brain metastases, and no EGFR or ALK alterations. The median progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. The log-rank test and Cox regression model were used for uni- multivariate analysis.
Results
A group of 240 pts was included, of whom 20% were >75 years old, 10% had brain and 14% liver metastases. The ORR was 34%, 23% of pts had progressive disease, while 17% of pts has before the first radiological assessment. Median PFS and OS were 8.4 months (95% CI 4.9–11.8; 153 events) and 13.8 months (95% CI 10.47–17.12; 141 events), respectively. Adverse events (AEs) were reported in 28% of pts, including irAE in 18.8%. AEs led to treatment discontinuation in 10.3% of pts, and resulted in death in 2%. In the univariate analysis, tumor burden <110 mm (p < 0.04), neutrophils/lymphocytes ratio (NLR) <2.64 (p < 0.009), platelet/lymphocyte ratio (PLR) <256 (p < 0.024), monocyte/lymphocyte ratio (MLR) <37 (0.030), and Systemic Inflammatory Index <1309 (p < 0.003) and the Lung Immune Prognostic Index (LIPI) of 0 (p < 0.038) had a favorable impact on OS. Other pretreatment evaluated factors- age >75 years included- were not relevant. Early PD was a negative prognostic factor, with substantially shorter OS (p < 0.001). In multivariate analysis, the trend for a negative impact on OS of larger tumor burden was observed (p < 0.090, HR 1.35 95% CI 0.95–1.9).
Conclusions
The results of treatment with pembrolizumab in real-life are not as favorable as those obtained in the clinical trial setting. Taking into account additional factors - such as tumor burden and inflammatory indices - may be helpful in identifying the optimal patient population.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
M. Knetki-Wroblewska: Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb, Roche, MSD, Takeda, Amgen, AstraZeneca, Boehringer Ingelheim, Ipsen; Financial Interests, Personal, Advisory Board: Takeda, Boehringer Ingelheim, Bristol Myers Squibb. S. Tabor: Financial Interests, Personal, Invited Speaker: MSD. A. Płużański: Financial Interests, Personal, Invited Speaker: BMS, MSD, AstraZeneca, Roche, Takeda, Pfizer; Financial Interests, Personal, Advisory Board: BMS, Takeda, MSD. K. Winiarczyk: Financial Interests, Personal, Invited Speaker: MSD, BMS, Pfizer. P. Sobczuk: Financial Interests, Personal, Other, Travel grant: Novartis; Financial Interests, Personal, Other, Travel Grant: MSD, Pierre Fabre, BMS; Financial Interests, Personal, Invited Speaker: Swixx BioPharma, BMS, Gilead; Financial Interests, Personal, Stocks/Shares: CelonPharma; Non-Financial Interests, Personal, Leadership Role, Board Member, Chair of Young Oncologists Section: Polish Society of Clinical Oncology. A. Piórek: Financial Interests, Personal, Invited Speaker: MSD, BMS. K. Zajda: Financial Interests, Personal, Invited Speaker: MSD, BMS, Roche. M. Zaborowska-Szmit: Financial Interests, Personal, Invited Speaker: MSD, BMS, Pfizer, Roche. P. Badurak: Financial Interests, Personal, Invited Speaker: BMS, MSD, Roche. D.M. Kowalski: Financial Interests, Personal, Invited Speaker: MSD, BMS, Roche, Pfizer, Takeda, AstraZeneca; Financial Interests, Personal, Advisory Board: BMS, MSD, Takeda. M. Krzakowski: Financial Interests, Personal, Advisory Board: BMS, Roche, Amgen, MSD, AstraZeneca; Financial Interests, Personal, Other, Travel grant: BMS, Roche, AstraZeneca. All other authors have declared no conflicts of interest.