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