Background
Treatment efficacy of nivolumab in patients with advanced NSCLC has been demonstrated for patients with a good performance status (ECOG ≤1), but efficacy in the setting of poorer performance status (PS) has not been proven.
Methods
A retrospective analysis of patients treated with nivolumab for advanced NSCLC between May 2015 and June 2017 was performed. ECOG PS at the time of starting nivolumab was captured. The primary objective of the study was to evaluate the ‘real world’ application of nivolumab, assess toxicity and measure survival outcomes for treated patients. We also aimed to evaluate the impact of PS on overall survival (OS) and response to nivolumab.
Results
66 patients were identified (33 male, 33 female) with median age 68.5 years, 85% current/former smokers and 17 (26%) patients had brain metastasis. 39 (59%) patients received at least 1 prior line of systemic therapy and 27 (41%) had ≥ 2 prior therapies. Median duration of nivolumab therapy was 2.5 months and 14 (21%) patients died within 30 days of treatment commencement. 26 patients started treatment with a PS ≥2 with 2 (7%) achieving a partial response, 4 (15%) stable disease and 14 (54%) disease progression. 20% of patients experienced Grade ≥ 3 treatment related adverse events (TRAEs), most commonly pneumonitis, hepatitis and colitis. 13 TRAEs led to treatment discontinuation. Median OS was 7.4 months (95%CI 8.1- 12.8). OS of patients with PS ≥ 2 during treatment was 3.5 months (95%CI 3.5- 8.5) as compared to 10.9 months (95%CI 10.1 -16.7) with PS ≤ 1.
Conclusions
Despite lack of clinical evidence to support this practice, we found that 39% of patients that commenced nivolumab had a PS ≥ 2. In this retrospective, single institute analysis patients with poor PS treated with nivolumab for advanced NSCLC had worse survival as compared to patients with good PS with only 7 % achieving a partial response.