Quality of life (QoL) in elderly NSCLC patients (pts) treated with nab-paclitaxel/carboplatin (nab-P/C) in the ABOUND.70+ trial

Abstract

Background: Treatment of elderly pts with advanced NSCLC remains challenging, and the impact of therapies on QoL can be an important factor in clinical decisions. nab-P/ C demonstrated efficacy in a subset of pts ≥ 70 yrs with NSCLC in a phase 3 trial. ABOUND.70+was designed to determine whether a 1-wk break can further improve tolerability of nab-P/C in these patients. QoL outcomes are reported here. Methods: Pts ≥ 70 yrs with locally advanced/metastatic NSCLC were randomized 1:1 to first-line nab-P 100 mg/m2 on d 1, 8, and 15+ C AUC 6 on d 1 of a 21-day cycle (Arm A) or the same regimen with a 1-week break between cycles (Arm B). Primary endpoint: percentage of pts with grade ≥ 2 peripheral neuropathy or grade ≥ 3myelosuppression. Key secondary endpoints: PFS, ORR, OS for which statistical analyses do not control for type I error (P values unadjusted). QoL (exploratory endpoint) was assessed using Lung Cancer Symptom Scale (LCSS) and EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) at d 1 of each cycle. Results: At interim evaluation, primary endpoint was similar across arms, resulting in early closure of enrollment. In Arms A and B, 78% and 79% completed a baseline and ≥ 1 postbaseline QoL assessment. LCSS item of cough improved with each cycle; at the end of cycle 6, mean change from baseline in Arms A and B was 25.4 and 13.8mm(visual analog scale). For cough, median time to deterioration (TTD) was 4.4 and 4.7 mos (P=0.7003). For the composite LCSS pulmonary symptom items of cough, shortness of breath, and hemoptysis, the median TTD was 4.4 and 6.0 mos (P=0.3347). Mean maximum improvement (at any point during treatment) in EQ-5D-5L visual analog scale was 10.1 and 12.8 points. Table lists key safety, efficacy and QoL data. Conclusions: These results support nab-P/C as a treatment option in elderly pts with NSCLC. Safety (primary endpoint) and OS were similar across the two arms, while there was a signal of improvement in ORR, PFS, and QoL with a 1-wk break. (Table Presented).