442O - Overall health status (HS) in patients (pts) with advanced (adv) non-squamous (NSQ) NSCLC treated with nivolumab (nivo) or docetaxel (doc) in Check...

Date 17 December 2016
Event ESMO Asia 2016 Congress
Session Thoracic cancers
Topics Cytotoxic agents
Non-Small-Cell Lung Cancer, Metastatic
Immunotherapy
Presenter Martin Reck
Citation Annals of Oncology (2016) 27 (suppl_9): ix139-ix156. 10.1093/annonc/mdw594
Authors M. Reck1, J. Brahmer2, B. Bennett3, F. Taylor4, J.R. Penrod5, M. Derosa4, H. Dastani5, R. Gralla6
  • 1Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), member of the German Center for Lung Research (DZL), 22927 - Grosshansdorf/DE
  • 2Department Of Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 21231 - Baltimore/US
  • 3Patient-centered Outcomes, Adelphi Values, SK10 5JB - Bollington/GB
  • 4Patient-centered Outcomes, Adelphi Values, 02210 - Boston/US
  • 5Health Economics And Outcomes Research, Bristol-Myers Squibb, 08536 - Princeton/US
  • 6Department Of Medicine (oncology), Albert Einstein College of Medicine, 10461 - Bronx/US

Abstract

Background

The CheckMate 057 randomized, open-label, phase III study evaluated the efficacy and safety of nivo vs doc in previously-treated pts with adv NSQ NSCLC. Overall survival was significantly improved with nivo vs doc, as were symptoms as assessed by the Lung Cancer Symptom Scale. Here we report the impact of nivo vs doc on overall pt-reported HS.

Methods

The EuroQoL-5 Dimensions visual analog scale (EQ-5D VAS) and EQ-5D utility index (UI) (scaled 0 to 100 and −0.594 to + 1, respectively) were assessed every other cycle (Q4W) for nivo and every cycle (Q3W) for doc for the first 6 mo on treatment (tx), then every 6 wks and at 2 post-tx follow-up visits. Changes from baseline (BL) at individual assessments (asmts), a mixed-effects model (MMRM) of change from BL over all on-tx asmts, and time to first deterioration (TTD) in HS were evaluated. The minimally important difference (MID) is ≥ 7 points for the EQ-5D VAS and ≥0.08 points for the UI.

Results

At on-tx asmts with >10 pts (through wk 78), EQ-5D VAS briefly worsened from BL in nivo pts at wk 4 (MID) at wks 24 and 36. There were no statistically significant changes from BL at any on-tx asmt in EQ-5D VAS scores for doc pts or in EQ-5D UI scores for nivo (apart from a worsening [

Conclusions

The EQ-VAS results from this phase III study showed that nivo pts with previously-treated adv NSQ NSCLC had improvements in on-tx HS while doc pts’ on-tx HS was stable. TTD in health status per the EQ-VAS was significantly longer in nivo- vs doc-treated pts.

Clinical trial indentification

NCT01673867

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

This study was funded by Bristol-Myers Squibb.

Disclosure

M. Reck: Served in a consulting or advisory role for Roche, Lilly, BMS, MSD, AZ, Pfizer, BI, and Celgene. Participated in a speakers\' bureau for Roche, Lilly, BMS, MSD, AZ, Pfizer, BI, and Celgene. J. Brahmer: Served in a consulting or advisory role for Celgene, Lilly, Merck, and BMS (BMS - uncompensated). Conducted research project(s) funded by BMS, MedImmune/AstraZeneca, and Merck. B. Bennett: Employed by AstraZeneca. Served in a consulting or advisory role at Adelphi Values. Conducted research project(s) funded by Adelphi Values. F. Taylor: Employee of Adelphi Values, a consultancy paid by BMS to analyze BMS’ clinical trial data. J.R. Penrod, H. Dastani: Employee of Bristol-Myers Squibb. Owned stock or held an ownership interest in Bristol-Myers Squibb. R. Gralla: Paid honoraria by Merck. Served in a consulting or advisory role at BMS, Merck, Lilly, BI. All other authors have declared no conflicts of interest.