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nab-paclitaxel (nab-P) + carboplatin (C) induction therapy in patients (Pts) with squamous (SCC) NSCLC: Interim quality of life (QoL) outcomes from the phase 3 ABOUND.sqm study

Date

08 Oct 2016

Session

Poster Display

Presenters

Michael Thomas

Citation

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

Authors

M. Thomas1, S. Ponce Aix2, A. Ko3, R. Jotte4, T.J. Ong5, R. Page6, M. Socinski7, N. Trunova5, V. Villaflor8, D.R. Spigel9

Author affiliations

  • 1 Oncology, Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitätsklinikum Heidelberg, Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), 69120 - Heidelberg/DE
  • 2 Oncology, Unidad de Investigación Clínica de Cáncer Pulmón H12O-CNIO, Madrid/ES
  • 3 Biostats, Celgene Corporation, Summit/US
  • 4 Oncology, Rocky Mountain Cancer Centers U.S. Oncology Network, Denver/US
  • 5 Medical Affairs, Celgene Corporation, Summit/US
  • 6 Oncology, The Center for Cancer and Blood Disorders, Fort Worth/US
  • 7 Medical Oncology, University of Pittsburgh UPMC Cancer Pavilion, Pittsburgh/US
  • 8 Oncology, University of Chicago Medicine, Chicago/US
  • 9 Oncology, Sarah Cannon Research Institute, 37203 - Nashville/US
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Background

Limited QoL data exist for pts with advanced NSCLC treated with platinum-doublets, though these assessments can help interpret the clinical benefit of chemotherapy. Interim QoL outcomes in pts with SCC NSCLC treated with nab-P/C during the induction part of the ongoing ABOUND.sqm study are reported here.

Methods

Pts with advanced SCC NSCLC received first-line nab-P 100 mg/m2 d 1, 8, 15 + C area under the curve 6 d 1 (21-d cycles) for 4 cycles (induction). After 4 cycles, pts without progression continued to maintenance (randomized 2:1) nab-P 100 mg/m2 d 1 and 8 of each 21-d cycle + best supportive care (BSC) or BSC alone until progression or unacceptable toxicity. Progression-free survival from randomization into the maintenance part of the study is the primary endpoint. QoL (an exploratory endpoint of induction and maintenance parts) was assessed on d 1 of each cycle using the Lung Cancer Symptom Scale (LCSS) and Euro-QoL-5 Dimensions-5 Levels (EQ-5D-5L). This pre-planned analysis reports interim QoL data from induction to data cutoff.

Results

195 pts were included in this interim report; 90% completed baseline (BL) and ≥ 1 post-BL QoL assessments. The median age was 68 years, 65% were male, and 99% had 0-1 Eastern Cooperative Oncology Group performance status. During induction, the mean change from BL in LCSS symptom burden index and total score improved by ≥ 10.4% and ≥ 9.2%, respectively. Clinically meaningful improvements (≥ 10 mm [visual analog scale]) from BL in the individual LCSS items of cough, shortness of breath, and blood in sputum were observed in 59%, 47%, and 16% of all pts. Each dimension of the EQ-5D-5L was improved from BL in the majority of pts (81%-92%), and more than 33% of all pts reported complete resolution of ≥ 1 specific dimension problem reported at BL.

Conclusions

nab-P/C treatment maintained or improved QoL in pts with SCC NSCLC in the induction part of this trial. Clinically meaningful improvements were observed in several LCSS items, and many pts had complete resolution of problems reported at BL in some EQ-5D-5L dimensions. NCT02027428

Clinical trial identification

NCT02027428

Legal entity responsible for the study

N/A

Funding

Celgen Pharmaceutical

Disclosure

M. Thomas: Honoraria speaker/advisor from: Celgene, Astra Zeneca, Roche, BMS, MSD, Lilly, Novartis, MI. A. Ko, T.J. Ong, N. Trunova: Employee of Celgene and owns stock. M. Socinski: Hhonorarium from Celgene and member of their speakers' bureau. V. Villaflor: Research funding from Celgene and Novartis that is paid directly to the University of Chicago. D.R. Spigel: Consultant to Celgene, researching funding from Celgene and travel expenses. All other authors have declared no conflicts of interest.

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