Quality of life (QoL) in patients (pts) with squamous (SCC) NSCLC treated with nab-paclitaxel with carboplatin (nab-P/C) induction therapy: Interim analysis of the phase III ABOUND.sqm study.

64 Background: Recent data on QoL in pts with advanced NSCLC treated with platinum-doublets are limited. This interim analysis evaluated QoL in pts with SCC NSCLC treated with nab-P/C during the induction part of the ABOUND.sqm study.

METHODS: In the ongoing phase III ABOUND.sqm study, pts with advanced SCC NSCLC are treated with first-line nab-P 100 mg/m(2) d 1, 8, 15 and C AUC 6 mg•min/mL d 1 (21-d cycles) for 4 cycles (induction). Pts not progressing after 4 cycles are randomized 2:1 to maintenance nab-P 100 mg/m(2)d 1 and 8 of each 21-d cycle + best supportive care (BSC) or BSC alone until progression. The primary endpoint is PFS from randomization to maintenance. QoL, an exploratory endpoint, was assessed using predefined PRO instruments, LCSS and EQ-5D-5L, on d 1 of each cycle. As the study is ongoing, this pre-planned analysis included data for QoL that were reported up to the cutoff date.

RESULTS: Of 128 pts included in this interim analysis, > 80% completed baseline (BL) + ≥ 1 post-BL PRO assessments. The median age was 68 years, 65% were male, and 99% had an ECOG PS of 0-1. Overall, the symptom burden index and average total score of the LCSS PRO were improved during induction therapy with nab-P/C; ≈ 50% of pts had clinically meaningful improvements (≥ 10 mm [VAS]) from BL in the composite LCSS items of cough, shortness of breath, and hemoptysis. More than 80% of pts maintained or improved each dimension of the EQ-5D-5L from BL, and a substantial proportion reported complete resolution of ≥ 1 specific dimension problem during induction (33%-48%; Table). No unusual safety signals were observed.

CONCLUSIONS: This interim analysis demonstrates that QoL was maintained or improved in pts with SCC NSCLC during nab-P/C induction therapy. For pts who reported problems in EQ-5D-5L dimensions at BL, many achieved complete resolution at least once during chemotherapy.

CLINICAL TRIAL INFORMATION: NCT02027428. [Table: see text].