J Cancer 2019; 10(10):2139-2144. doi:10.7150/jca.31217

Research Paper

Efficacy and Safety of Nivolumab in Patients with Advanced Non-small-cell Lung Cancer and Poor Performance Status

Hideyuki Katsura1, Yukio Suga2, Tomoyuki Araya3✉, Toshiyuki Kita3, Taro Yoneda4, Nobuyoshi Tanaka5, Ayumi Kawabata1, Sotoki Ishita1, Hiroki Mase6

1. Department of Pharmacy, Komatsu Municipal Hospital
2. Department of Clinical Drug Informatics, Faculty of Pharmacy, Institute of Medical, Pharmaceutical & Health Science, Kanazawa University
3. Department of Respiratory Medicine, National Hospital Organization Kanazawa Medical Center
4. Department of Respiratory Medicine, Komatsu Municipal Hospital
5. Department of Surgery, Komatsu Municipal Hospital
6. Department of Pharmacy, National Hospital Organization Kanazawa Medical Center

Abstract

Background: Nivolumab efficacy in patients with non-small-cell lung cancer (NSCLC) and performance status (PS) of 2-4 is unclear. We aimed to compare survival, treatment efficacy, and safety in patients with NSCLC with poor PS who received nivolumab plus best supportive care (BSC) with those in patients who received BSC alone in a palliative care unit (PCU).

Patients and methods: This retrospective study included 99 consecutive patients with NSCLC who received nivolumab plus BSC or BSC alone between December 2015 and March 2018.

Results: In total, 43 patients with PS of 0-1 (good PS group) and 20 patients with PS of 2-4 (poor PS group) received nivolumab plus BSC; the remaining 36 patients received BSC alone in the PCU (PC group). Median overall survival was 32 days [95% confidence interval (CI), 21-43] in the poor PS group and 31 days (95% CI, 25-37) in the PC group (hazard ratio, 0.653; 95% CI, 0.368-1.158; P = 0.137). Moreover, median overall survival in patients with PS of 3 or 4 among the poor PS group was not significantly longer than that in the PC group (HR, 1.235; 95% CI, 0.646-2.360; P = 0.516). The frequency of severe pneumonitis in the poor PS group was significantly higher than that in the good PS group (25% vs. 2%, P = 0.010).

Conclusion: Survival benefit of nivolumab in patients with NSCLC with poor PS, especially 3 or 4, was not confirmed. Further studies with larger numbers of patients are required to confirm our results.

Keywords: Clinical practice, Immune checkpoint inhibitor, Best supportive care, Overall survival, Pneumonitis

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How to cite this article:
Katsura H, Suga Y, Araya T, Kita T, Yoneda T, Tanaka N, Kawabata A, Ishita S, Mase H. Efficacy and Safety of Nivolumab in Patients with Advanced Non-small-cell Lung Cancer and Poor Performance Status. J Cancer 2019; 10(10):2139-2144. doi:10.7150/jca.31217. Available from http://www.jcancer.org/v10p2139.htm