1367P - 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 ≥ 3 myelosuppression. 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 13.8 mm (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.Table1367PArm A n = 71Arm B n = 72SafetyPrimary endpoint, n (%)52/68 (76)54/70 (77)P value0.9258Grade ≥ 2 peripheral neuropathy25/68 (37)25/70 (36)Grade ≥ 3 myelosuppression48/68 (71)45/70 (64)Neutropenia39/68 (57)39/70 (56)Anemia14/68 (21)17/70 (24)Thrombocytopenia17/68 (25)12/70 (17)EfficacyConfirmed ORR, %2440P value0.0376PFS, median, months3.67.0P value0.0019HR (95% CI)0.48 (0.30 - 0.76)OS, median, months15.216.2P value0.1966HR (95% CI)0.72 (0.44 - 1.19)QoLMean maximum improvement from baseline, mmLCSS Total score5.811.7LCSS Pulmonary symptom9.214.9 Open table in a new tab 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. NCT02151149. Clinical trial identification: NCT02151149 Legal entity responsible for the study: Celgene Corporation Funding: Celgene Corporation Disclosure: C.J. Langer: Consultant/Advisor Role: Celgene. J. Goldman, E. Kim: Research funding: Celgene. K. Konduri: Consultant/Advisory Role: Celgene, Boehringer Ingelheim, DAVA – Pharmaceuticals. A. Sanford, K. Amiri: Employment and stock ownership: Celgene. J. Weiss: Astellas: CME & company sponsored trials (CST); AZ, Biodesix, Clovis, Oncoples: consulting; Celgene: IIT support, CST support, SC; EMD Serono: DSMB member; GSK: IIT support; Medimmune, Pfizer: CST support, IIT support; Merck: CS Tsupport, IIT support. All other authors have declared no conflicts of interest.