Aim:
We sought to determine the efficacy and toxicity of checkpoint immunotherapy in cancer patients (pts) who have a poor performance status (PS).
Methods:
Pts with advanced solid malignancy and treated with anti-PD-1 monotherapy between January 2014 and February 2017, with an Eastern Cooperative Oncology Group (ECOG) PS ≥ 2 at treatment commencement were included. Pts with a melanoma diagnosis were excluded. Retrospective data were audited from medical records at five facilities.
Results:
Of the 49 pts eligible for inclusion, 37 (76%) pts had ECOG 2; 11 (22%) pts had ECOG 3; 1 (2%) pt had ECOG 4 status; 32 (65%) were male. Median age was 67 years. Of the 49 pts, 33 (67%) had non-small cell lung cancer. Twenty-seven (55%) had progress imaging; those without were assumed to have had progressive disease. There were no complete responses; four (8%) partial responses (PR); five (10%) with stable disease (SD); 40 (82%) with progressive disease. Median overall survival (mOS) was 4.9 months (95% confidence interval [CI] 3.6-6.3) with a mOS of 5.1 months (95%CI 3.1-7.1) in the ECOG 2 cohort; mOS of 4.3 months (95%CI 2.0-6.6) in the ECOG 3/4 cohort. The mOS of pts with PR/SD was 10.4 months (95%CI 6.2-14.6). Use of corticosteroids, hazard ratio (HR) 3.1 (95%CI 1.12-9.00); age less than 65, HR 2.3 (95%CI 1.17-4.63); and above median neutrophil-to-lymphocyte ratio, HR 4.48 (95%CI 1.46-13.73), were associated with decreased survival on univariate analysis. These prognostic factors were non-significant on multivariate analysis. Nine pts (18%) had immune related adverse events, three (6%) discontinued due to toxicity. Eight (16%) died within 30 days of initiation of treatment.
Conclusion:
Pts with poor PS treated with anti-PD-1 immunotherapy have worse survival compared to published clinical trial data. However, treatment appears well tolerated. Further research is warranted in this patient population.