Quality of life (QoL) in elderly patients (pts) with advanced NSCLC treated with nab-paclitaxel (nab-P) + carboplatin (C): Interim results from the ABOUND.70+ study

Date

08 Oct 2016

Session

Poster Display

Presenters

Jared Weiss

Citation

Annals of Oncology (2016) 27 (6): 416-454. 10.1093/annonc/mdw383

Authors

J. Weiss1, E. Kim2, K.I. Amiri3, E. Anderson4, S. Dakhil5, D. Haggstrom2, R. Jotte6, K. Konduri7, M. Modiano8, T.J. Ong3, A. Sanford9, D. Smith10, M. Socoteanu11, J. Goldman12, C. Langer13

Author affiliations

  • 1 Oncology, Lineberger Comprehensive Cancer Center, 27514 - Chapel Hill/US
  • 2 Oncology, Levine Cancer Institute, Charlotte/US
  • 3 Medical Affairs, Celgene Corporation, Summit/US
  • 4 Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland/US
  • 5 Hematology, Cancer Center of Kansas, Wichita/US
  • 6 Oncology, Rocky Mountain Cancer Centers U.S. Oncology Network, Denver/US
  • 7 Oncology, Baylor Charles A. Sammons Cancer Center, Dallas, TX; Texas Oncology PA, Dallas/US
  • 8 Oncology, ACRC/Arizona Clinical Research Center and Arizona Oncology, Tucson/US
  • 9 Biostats, Celgene Corporation, Summit/US
  • 10 Oncology, Compass Oncology, Vancouver/US
  • 11 Oncology, Texas Oncology Tyler/Longview, Longview/US
  • 12 Oncology, University of California, Los Angeles/US
  • 13 Oncology, Abramson Cancer Center, University of Pennsylvania, Philadelphia/US
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Resources

Background

The lack of QoL assessment in elderly pts receiving chemotherapy for NSCLC is an important issue that potentially hinders treatment decisions. We report interim QoL outcomes in elderly pts with advanced NSCLC treated with nab-P/C in the ABOUND.70+ study.

Methods

Pts ≥ 70 years of age with locally advanced/metastatic NSCLC were randomized 1:1 to first-line nab-P 100 mg/m2 d 1, 8, 15 + C area under the curve 6 d 1 every 21 days (arm A) or the same nab-P/C regimen followed by a 1-week break between cycles (arm B, every 28 days). The percentage of pts with either grade ≥ 2 peripheral neuropathy or grade ≥ 3 myelosuppression adverse events is the primary endpoint. QoL (an exploratory endpoint) was assessed using the Lung Cancer Symptom Scale (LCSS) and Euro-QoL-5 Dimensions-5 Levels (EQ-5D-5L) on d 1 of each cycle.

Results

Of 119 pts included in this report, > 85% completed baseline (BL) and > 70% completed BL +≥ 1 post-BL QoL assessments. The median age was 76 years (range, 70 - 93 years), 56% were male, and 99% had an Eastern Cooperative Oncology Group performance status of 0-1. In general, LCSS symptom burden index and average total scores improved during the first 4 cycles. In the LCSS item of cough, a mean change from BL to end of cycle 4 of 18.98 mm was observed on the visual analog scale (VAS; 95% CI, 8.42 - 29.54). Clinically meaningful improvements (≥ 10 mm [VAS]) from BL in the composite LCSS items of cough, shortness of breath, and hemoptysis were observed in 50% of pts. More than 80% of pts maintained or improved each dimension of the EQ-5D-5L from BL. In pts with radiological stable disease or better (75/108 evaluable had BL +≥ 1 post-BL assessment), ≥ 77% of pts reported stability/improvement in 1 or more individual EQ-5D-5L items from BL during the first 4 cycles of therapy; 95% of pts reported stability/improvement in their anxiety/depression score at least once.

Conclusions

These interim results from the ABOUND.70+ study suggest that nab-P/C treatment resulted in clinically meaningful QoL improvements in elderly pts with NSCLC. The study is ongoing, and efficacy and safety data will be reported at future meetings. NCT02151149

Clinical trial identification

NCT02151149

Legal entity responsible for the study

N/A

Funding

Celgene Corporation

Disclosure

E. Kim: Grant reseach and speakers bureau. K.I. Amiri, T.J. Ong, A. Sanford: Employee of Celgene and owns stock. K. Konduri: Consultant/ Advisory Board: Boehringer Ingelheim; DAVA- Pharmaceuticals, Celgene. J. Goldman: Research funding from Celgene. C. Langer: Consultant/research Celgene. All other authors have declared no conflicts of interest.

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