Quality of life (QoL) and overall survival (OS) in patients (pts) with advanced clear-cell renal cell carcinoma (aRCC) treated with nivolumab (NIVI) vs. everolimus (EVE) in the phase III CheckMate 025 study.

Authors

David Cella

David Cella

Northwestern University, Feinberg School of Medicine, Chicago, IL

David Cella , Viktor Gruenwald , Paul D. Nathan , Justin Doan , Homa Dastani , Fiona Taylor , Bryan Bennett , Michael DeRosa , Scott Berry , Kristine Broglio , Elmer Berghorn , Robert J. Motzer

Organizations

Northwestern University, Feinberg School of Medicine, Chicago, IL, Medical School of Hannover, Hannover, Germany, Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom, Bristol-Myers Squibb, Wallingford, CT, Bristol-Myers Squibb, Princeton, NJ, Adelphi Values, Boston, MA, Adelphi Values, Bollington, United Kingdom, Berry Consultants, LLC, Austin, TX, Memorial Sloan Kettering Cancer Center, New York, NY

Research Funding

Pharmaceutical/Biotech Company

Background: In the CheckMate 025 study (NCT01668784), pts treated with nivo had an OS benefit vs eve (hazard ratio=0.73; 98.5% CI, 0.57 to 0.93), and median scores on the Functional Assessment of Cancer Therapy–Kidney Symptom Index–Disease Related Symptoms (FKSI-DRS) scale increased from baseline (BL) and were significantly (P<0.05) improved with nivo vs eve through week 104 (NEJM 2015;373:1803–13). Here we present a full analysis of QoL in relation to OS. Methods: QoL was measured by the kidney-specific FKSI-DRS questionnaire at BL and every 4 weeks. Chi-square analyses were used to assess differences in the proportion of pts who experienced meaningful improvement (2-point change) with nivo vs eve. OS was assessed by subgroups of pts with FKSI-DRS improvement (≥2-point increase), no change (<2-point increase or decrease), and deterioration (≥2-point decrease) at week 8 using the Kaplan–Meier method. Results: BL QoL was collected for 86% of all randomized pts; 361/410 (nivo) and 343/411 (eve). Over the course of the study, 55% of pts experienced meaningful DRS improvement with nivo vs 37% with eve (P<0.001). Median (95% CI) time to improvement in DRS occurred at 4.7 (3.7–7.5) months with nivo and was not estimable (NE) with eve due to the limited number of pts who experienced improvement. Association of change in QoL at week 8 and OS is shown in the table. Results using the EQ-5D questionnaire of general health status will be presented. Conclusions: In this global study of pts with aRCC, treatment with nivo vs eve resulted in a significantly greater proportion of pts experiencing meaningful QoL improvement, and improvement or no change in QoL at 8 weeks was associated with an OS benefit with nivo vs eve. These results suggest that the assessment of QoL may be helpful for evaluating the extent of OS benefit in clinical practice. Clinical trial information: NCT01668784

FKSI-DRSNNivo
median OS (95% CI)
NEve
median OS (95% CI)
Hazard ratio (95% CI)
nivo vs eve
Improvement9128.1 (23.6–NE)4719.3 (14.5–NE)0.62 (0.37–1.06)
No change122NE (27.4–NE)95NE (19.3–NE)0.68 (0.44–1.05)
Deterioration8926.7 (17.3–NE)12824.3 (18.7–NE)0.99 (0.66–1.48)

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Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary (Nonprostate) Cancer

Track

Genitourinary Cancer—Kidney and Bladder

Sub Track

Kidney Cancer

Clinical Trial Registration Number

NCT01668784

Citation

J Clin Oncol 34, 2016 (suppl; abstr 4549)

DOI

10.1200/JCO.2016.34.15_suppl.4549

Abstract #

4549

Poster Bd #

171

Abstract Disclosures