Abstract 2300
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.
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.Table:
1367P
| Arm A n = 71 | Arm B n = 72 | |
|---|---|---|
| Safety | ||
| Primary endpoint, n (%) | 52/68 (76) | 54/70 (77) |
| P value | 0.9258 | |
| Grade ≥ 2 peripheral neuropathy | 25/68 (37) | 25/70 (36) |
| Grade ≥ 3 myelosuppression | 48/68 (71) | 45/70 (64) |
| Neutropenia | 39/68 (57) | 39/70 (56) |
| Anemia | 14/68 (21) | 17/70 (24) |
| Thrombocytopenia | 17/68 (25) | 12/70 (17) |
| Efficacy | ||
| Confirmed ORR, % | 24 | 40 |
| P value | 0.0376 | |
| PFS, median, months | 3.6 | 7.0 |
| P value | 0.0019 | |
| HR (95% CI) | 0.48 (0.30 - 0.76) | |
| OS, median, months | 15.2 | 16.2 |
| P value | 0.1966 | |
| HR (95% CI) | 0.72 (0.44 - 1.19) | |
| QoL | ||
| Mean maximum improvement from baseline, mm | ||
| LCSS Total score | 5.8 | 11.7 |
| LCSS Pulmonary symptom | 9.2 | 14.9 |
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.