460P - Evaluation of overall health status in patients with advanced squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 017

Date 20 December 2015
Event ESMO Asia 2015 Congress
Session Poster presentation 2
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Cancer Immunology and Immunotherapy
Presenter Martin Reck
Citation Annals of Oncology (2015) 26 (suppl_9): 125-147. 10.1093/annonc/mdv532
Authors M. Reck1, C. Coon2, F. Taylor3, M. Derosa2, J.R. Penrod4, H. Dastani4, L. Orsini5, R.J. Gralla6
  • 1Chefarzt Onkologischer Schwepunkt, LungenClinic Grosshansdorf, 22927 - Grosshansdorf/DE
  • 2Healthcare Analytics, Adelphi Values, Boston/US
  • 3Endpoint Development & Outcomes Assessment Practice, Adelphi Values, Boston/US
  • 4Outcomes Research, Oncology, Bristol-Myers Squibb, Princeton/US
  • 5Global Health Outcomes, Oncology, Bristol-Myers Squibb, Princeton/US
  • 6Department Of Medicine, Albert Einstein College of Medicine, Bronx/US

Abstract

Aim/Background

This phase 3 study evaluated efficacy and safety of second-line nivolumab (NIVO) vs docetaxel (DOC) in advanced squamous non-small cell lung cancer (NSCLC) patients. Overall survival was significantly superior and duration of treatment (Tx) longer for NIVO versus DOC.

Methods

Patient-reported health status was evaluated using the EQ-5D preference-based health state utility measure (EQ-5D index; scaled from 0-1) and visual analog scale (EQ-VAS; scaled from 0-100) for overall health status. Higher scores indicate better health status. The estimated minimally important difference (MID) was 0.08 for the EQ-5D index and 7 for the EQ-VAS. Assessment was every 4 and 3 weeks (wks) for NIVO and DOC, respectively, for the first 6 months on Tx; every 6 wks for the remaining Tx periods; and at 2 follow-up (FU) visits after Tx discontinuation. Baseline (BL) and the changes from BL at each assessment were summarized by Tx group.

Results

In the NIVO and DOC arms, 71.9% (97/135) and 64.2% (88/137) completed the EQ-5D at BL and ≥1 later assessment, respectively. BL mean [SD] EQ-VAS and EQ-5D index scores were similar for NIVO (63.7 [18.2] and 0.683 [0.208], respectively) and DOC (66.3 [20.5] and 0.663 [0.284], respectively). In the NIVO arm, the EQ-VAS score at wks 12, 20 to 36, and 48 was statistically higher (p ≤ 0.05) vs BL; differences at wks 24 to 36 and 48 were > MID. On-Tx assessments after wk 54 had <10 patients. Similarly, the EQ-5D index at wks 16 to 30 and wks 42 to 54 improved significantly vs BL (p ≤ 0.05); changes at wks 42 to 54 also >MID. The 2 FU assessments after NIVO discontinuation were not significantly different from BL for either assessment. In the DOC arm, the on-Tx EQ-VAS and EQ-5D index scores did not differ significantly from BL through wk 18, after which the sample had <10 patients. At FU visit 1, DOC patients' EQ-VAS, but not their EQ-5D index, showed a statistically and clinically significant deterioration from BL; at FU visit 2, their EQ-VAS and EQ-5D index scores were not statistically different from BL.

Conclusions

Improvements from BL in health status were statistically and clinically significant for squamous advanced NSCLC patients treated with nivolumab.

Clinical trial identification

NCT01642004

Disclosure

M. Reck: Advisory Board: Hoffmann-La Roche, Lilly, MSD, BMS, AstraZeneca, Boehringer-Ingelheim, Pfizer, Novartis; tobacco related remuneration. J.R. Penrod: employment and stock ownership with BMS. H. Dastani, L. Orsini: employment with BMS. R.J. Gralla: consultant to BMS. All other authors have declared no conflicts of interest.