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Clinical Trial
. 2023 Apr 11;115(4):437-446.
doi: 10.1093/jnci/djad003.

Quality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I

Joseph M Unger  1   2 , Lu Qian  1   2 , Mary W Redman  1   2 , Susan S Tavernier  3 , Lori Minasian  4 , Ellen V Sigal  5 , Vassiliki A Papadimitrakopoulou  6   7 , Michael Leblanc  1   2 , Charles S Cleeland  6 , Samuel A Dzingle  8 , Thomas J Summers  9 , Herta Chao  10 , Sheshadri Madhusudhana  11 , Liza Villaruz  12 , Jeffrey Crawford  13 , Jhanelle E Gray  14 , Karen L Kelly  15 , David R Gandara  15 , Lyudmila Bazhenova  16 , Roy S Herbst  17 , Scott N Gettinger  17 , Carol M Moinpour  18
Affiliations
Clinical Trial

Quality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I

Joseph M Unger et al. J Natl Cancer Inst. .

Abstract

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 S1400I, a substudy of the LungMAP biomarker-driven master protocol.

Methods: SWOG S1400I was a randomized phase III trial comparing nivolumab plus ipilimumab vs nivolumab for treatment of immunotherapy-naïve disease in advanced squamous cell lung cancer. The primary endpoint was the MD Anderson Symptom Inventory-Lung Cancer 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 MD Anderson Symptom Inventory-Lung Cancer severity score was 0.04 points (95% confidence interval [CI] = -0.44 to 0.51 points; 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 appetite loss and shortness of breath had a threefold increased risk of progression or death (hazard ratio [HR] = 3.06, 95% CI = 1.88 to 4.98; P < .001) and that those with high levels of both appetite loss and work limitations had a fivefold increased risk of death (HR = 5.60, 95% CI = 3.27 to 9.57; P < .001)-compared with those with neither risk category.

Conclusions: We found no evidence of a benefit of ipilimumab added to nivolumab compared with 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.

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Figures

Figure 1.
Figure 1.
Consort diagram. MDASI-LC = MD Anderson Symptom Inventory–Lung Cancer; QOL = quality of life.
Figure 2.
Figure 2.
Bar plots of adjusted mean differences between nivolumab plus ipilimumab vs nivolumab alone. The vertical lines indicate the 95% confidence limits. MDASI-LC = MD Anderson Symptom Inventory–Lung Cancer.
Figure 3.
Figure 3.
Linear mixed model regression results. Blue = nivolumab plus ipilimumab; red = nivolumab alone. The boxes indicate the model-derived point estimates, connected by solid lines. The dashed lines indicate the 95% confidence regions. CI = confidence interval; MDASI-LC = MD Anderson Symptom Inventory–Lung Cancer.
Figure 4.
Figure 4.
Forest plot of hazard ratio comparing risk of progression-free or overall survival by prognostic risk category. The boxes indicate the hazard ratios and the horizontal lines show the 95% confidence intervals. Results for the best 2-variable models are shown in red. MDASI-LC = MD Anderson Symptom Inventory–Lung Cancer.
Figure 5.
Figure 5.
Progression-free and overall survival by risk score.
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