LAUSR

BACKGROUND An important issue for patients with cancer treated with novel therapeutics is how they weigh the effects of treatment on survival and quality-of-life (QOL). We compared QOL in patients enrolled to SWOG-1400I, a substudy of the LungMAP biomarker-driven master protocol. METHODS SWOG S1400I was a randomized phase III trial comparing nivolumab/ipilimumab vs nivolumab for treatment of immunotherapy-naïve disease in advanced squamous cell lung cancer. The primary endpoint was the MDASI-LC severity score at Week-7 and Week-13 with a target difference of 1.0 points, assessed using multivariable linear regression. A composite risk model for progression-free and overall survival was derived using best-subset selection. RESULTS Among 158 evaluable patients, median age was 67.6 years and most were male (66.5%). The adjusted MDASI-LC severity score was 0.04 points (95%-CI, -0.44 to 0.51, p=.89) at Week-7 and 0.12 points (95%-CI, -0.41 to 0.65, p=.66) at Week-13. A composite risk model showed that patients with high levels of both appetite loss and shortness-of-breath had a 3-fold increased risk of progression or death (HR = 3.06, 95%-CI, 1.88-4.98, p<.001) - and that those with high levels of both appetite loss and work limitations had a 5-fold increased risk of death (HR = 5.60, 95%-CI, 3.27-9.57, p<.001) - compared to those with neither risk category. CONCLUSIONS We found no evidence of a benefit of ipilimumab added to nivolumab compared to nivolumab alone for QOL in S1400I. A risk model identified patients at high risk of poor survival, demonstrating the prognostic relevance of baseline patient-reported outcomes even in those with previously-treated advanced cancer.