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Poster display session

2300 - Quality of Life (QoL) in Elderly NSCLC Patients (pts) Treated with nab-Paclitaxel/Carboplatin (nab-P/C) in the ABOUND.70+ Trial

Date

09 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Cancers in Adolescents and Young Adults (AYA);  Geriatric Oncology;  Non-Small Cell Lung Cancer

Presenters

Corey Langer

Citation

Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380

Authors

C.J. Langer1, E. Anderson2, R. Jotte3, J. Goldman4, D. Haggstrom5, D. Smith6, C. Dahkil7, K. Konduri8, E. Kim8, A. Sanford9, K. Amiri9, J. Weiss10

Author affiliations

  • 1 Oncology/hematology, Abramson Cancer Center, 19104 - Philadelphia/US
  • 2 Oncology/hematology, Knight Cancer Institute, Portland/US
  • 3 Oncology/hematology, Rocky Mountain Cancer Center, Denver/US
  • 4 Medical Oncology, University of California-Los Angeles, Santa Monica/US
  • 5 Oncology/hematology, Levine Cancer Institute, Charlotte/US
  • 6 Oncology/hematology, Compass Oncology, Vancouver/US
  • 7 Oncology/hematology, Cancer Center of Kansas, Wichita/US
  • 8 Oncology/hematology, Baylor Charles A. Sammons Cancer Center, Dallas/US
  • 9 Oncology/hematology, Celgene Corporation, Summit/US
  • 10 Oncology/hematology, UNC Lineberger Comprehensive Cancer Center, Chapel Hill/US
More

Resources

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 = 71Arm B n = 72
Safety
Primary endpoint, n (%)52/68 (76)54/70 (77)
P value0.9258
Grade ≥ 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)
Efficacy
Confirmed ORR, %2440
P value0.0376
PFS, median, months3.67.0
P value0.0019
HR (95% CI)0.48 (0.30 - 0.76)
OS, median, months15.216.2
P value0.1966
HR (95% CI)0.72 (0.44 - 1.19)
QoL
Mean maximum improvement from baseline, mm
LCSS Total score5.811.7
LCSS Pulmonary symptom9.214.9

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.

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