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

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.

Efficacy and safety of nivolumab for advanced gastric cancer patients with poor performance statuses

“…Katsura H et al studied the efficacy and safety of nivolumab among NSCLC patients with poor PS. The OS durations of patients with PS 0-1 and 2-4 were 412 and 32 days, respectively (p < 0.001) [14]. Our study is the first to focus on nivolumab for AGC patients with poor PS.…”

“…In a previous study of NSCLC (CheckMate 153 trial), irAEs were similar for the overall population (6%) and patients with an ECOG PS of 2 (9%) [11]. Katsura H et al reported that the incidence of pneumonitis in the group with poor PS was significantly higher than that in the group with good PS (35% vs. 9%, p = 0.028) [14]. Fujimoto D et al reported that the incidence rates of severe irAEs were similar between those with good PS scores (0-1) and poor PS scores (2-4) within 2 months after commencing nivolumab therapy (6.1% vs. 6.3%, respectively; p = 0.918).…”

Efficacy and safety of nivolumab for advanced gastric cancer patients with poor performance statuses

“…Although, there were few studies of nivolumab in patients with poor PS. were 412 and 32 days, respectively (p < 0.001) [11]. Our study is the first to focus on nivolumab for AGC patients with poor PS.…”

“…In a previous study of NSCLC (CheckMate 153 trial), irAEs were similar for the overall population (6%) and patients with an ECOG PS of 2 (9%) [8]. Katsura H et al reported that the incidence of pneumonitis in the group with poor PS was significantly higher than that in the group with good PS (35% vs. 9%, p = 0.028) [11]. Fujimoto D et al reported that the incidence rates of severe irAEs were similar between those with good PS scores (0-1) and poor PS scores (2-4) within 2 months after commencing nivolumab therapy (6.1% vs. 6.3%, respectively; p = 0.918).…”

“…Kato K et al reported that nivolumab was more beneficial than irinotecan among AGC patients with slow growing tumours [11]. In their study, patients were classified into slow-(SG) and rapid-(RG)…”