Abstract

The landscape for first-line (1L) aRCC is rapidly evolving, with P+A and N+C recommended as standard of care irrespective of risk group by the European Association of Urology and the European Society for Medical Oncology. P+A and N+C have similar modes of action and demonstrated a significant efficacy benefit versus sunitinib (S), although no head-to-head data exist. As aRCC significantly impacts HRQoL, understanding HRQoL benefits of these 2 treatments is of interest to inform clinical decision making. An anchored MAIC was conducted using patient-level data from the CheckMate 9ER trial (NCT03141177; N+C vs S) and aggregate published data from the KEYNOTE-426 trial (NCT02853331; P+A vs S). Outcomes included Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index – Disease Related Symptoms (FKSI-DRS) and EQ-5D visual analog scale (EQ VAS) due to limited published HRQoL data from KEYNOTE-426. Hazard ratios for time to first and confirmed deteriorations (TTFD and TTCD, respectively) and baseline to week 30 least squares mean differences in these outcomes were re-estimated for CheckMate 9ER using a weighted population and indirectly compared with those in KEYNOTE-426 via a Bayesian framework. A total of 651 CheckMate 9ER patients (pts) were matched to 861 KEYNOTE-426 pts using age, region, risk group, sites of metastatic disease, and prior nephrectomy. Results from the MAIC favored N+C versus P+A in all outcomes with statistically significant differences for FKSI-DRS and TTFD in EQ VAS score (Table).Table: 668POutcomeMAIC results, N+C vs P+ATTFD, HR (95% CrI) EQ-5D VAS0.73 (0.55–0.96)aTTCD, HR (95% CrI) EQ-5D VAS0.72 (0.52–1.01) FKSI-DRS0.48 (0.33–0.69)aChange from baseline at week 30,LSMD (95% CrI) EQ-5D VAS2.55 (–0.88 to 5.98) FKSI-DRS1.85 (0.96–2.74)baThe 95% CrI does not contain 1. HR < 1 favors N+C over P+A. bThe 95% CrI does not contain 0. LSMD > 0 favors N+C over P+A. CrI, credible interval; HR, hazard ratio; LSMD, least squares mean difference. Open table in a new tab aThe 95% CrI does not contain 1. HR < 1 favors N+C over P+A. bThe 95% CrI does not contain 0. LSMD > 0 favors N+C over P+A. CrI, credible interval; HR, hazard ratio; LSMD, least squares mean difference. In pts with 1L aRCC, MAIC analyses indicate that compared with P+A, N+C demonstrated a significant improvement in DRS and significantly delayed deterioration in HRQoL. These results, combined with the efficacy and favorable safety profile of N+C, may further inform treatment decisions of clinicians and pts with 1L aRCC.

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