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Overall health status (HS) in patients (pts) with advanced (adv) non-squamous (NSQ) NSCLC treated with nivolumab (nivo) or docetaxel (doc) in CheckMate 057

2016; Elsevier BV; Volume: 27; Linguagem: Inglês

10.1093/annonc/mdw383.17

1569-8041

Martin Reck, Julie R. Brahmer, Bryan Bennett, Fiona Taylor, J.R. Penrod, Michael DeRosa, Homa Dastani, Richard J. Gralla,

Colorectal Cancer Treatments and Studies

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. 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. 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 [<MID] at wk 4) or doc pts. Between arms, there were no significant on-tx differences in EQ-5D VAS or UI scores at specific asmts. In the MMRM analysis of changes while on-tx, there was a significant improvement from BL for nivo pts compared to no change for doc pts in the EQ-VAS, with a significant difference between tx arms. The MMRM analysis for EQ-5D UI showed no differences from BL within or between tx arms. TTD in the EQ-5D VAS was delayed with nivo vs doc, with KM curves separating at ∼4 mo (HR, 0.76; 95% CI, 0.59–0.98). TTD per the EQ-5D UI was similar between arms. 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.