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Quality of life in previously untreated patients with advanced renal cell carcinoma (aRCC) in CheckMate 214: updated results

  • D. Cella 1,
  • B. Escudier 2,
  • C. Ivanescu 3,
  • M. Mauer 4,
  • J. Lord-Bessen 5,
  • K. Gooden 6
1 Robert H. Lurie Comprehensive Cancer Center, Northwestern University, 60611 Chicago, USA 2 Medical Oncology, Gustave Roussy - Cancer Campus, 94805 Villejuif, France 3 Statistics, IQVIA, 181 Herikerbergweg, the Nethterlands 4 Oncology Clinical Development, Bristol-Myers Squibb, 08648 Lawrenceville, USA 5 Health Economics Outcomes Research, Bristol-Myers Squibb, 08648 Princeton, USA 6 Ww Heor, Bristol-Myers Squibb, 08540 Princeton, USA

Publication: , September 2019

https://oncologypro.esmo.org/Meeting-Resources/ESMO-2019-Congress/Quality-of-life-in-previously-untreated-patients-with-advanced-renal-cell-carcinoma-aRCC-in-CheckMate-214-updated-results

Background

The primary analysis of health-related quality of life (HRQoL) from CheckMate 214 have been published (Cella et al. Lancet Oncol. 2019). Nivolumab + ipilimumab (N+I) led to superior overall survival (OS) (HR: 0.63; p < 0.001) and more favorable HRQoL than sunitinib (S) as 1st-line treatment for intermediate/poor (I/P)-risk patients (pts) with aRCC. We report herein the HRQoL analyses from the 30-month follow-up.

Methods

Pts were randomized 1:1 to receive N 3 mg/kg + I 1 mg/kg every 3 wk for 4 doses then N 3 mg/kg every 2 wk, or S 50 mg/d orally for 4 wk (6-wk cycle). HRQoL was assessed on day 1 of wks 1 and 4 of the first 2 cycles, on day 1 of wks 1 and 5 of the next 2 cycles and on day 1 of wk 1 of subsequent cycles. An exploratory HRQoL analysis was conducted using the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19), Functional Assessment of Cancer Therapy-General (FACT-G) and EQ-5D instruments. The analyses included mixed-model repeated measures (MMRM) for change from baseline (BL) at 145 wks (while on-treatment), and time to deterioration (TTD).

Results

Table:
951P MMRM analysis (treatment differences at week 145) and time to deterioration for FKSI-19

aP < 0.05 CI, confidence interval; DRS, disease-related symptoms; HR, hazard ratio; LS, least square. A positive LS Mean favors N+I vs S. A HR < 1 favor N+I vs S.

1096 pts were randomized to N+I (I/P risk: 425; favorable [F] risk: 125) and S (I/P risk: 422; F risk: 124). HRQoL assessment completion rates were >78% in the first 145 wks. In the total and I/P-risk populations, N+I pts report improved FKSI-19 total scores over time to wk 145 while decrease is observed with S. At 145 wks (Table), the difference in change from BL between arms for FKSI-19 total, disease-related symptoms-physical and treatment side effects scores significantly benefited N+I vs S. TTD was statistically significantly longer with N+I for most domains in both populations. Similar results were observed for FACT-G and EQ-5D change from BL and TTD.

Conclusions

N+I significantly improved OS vs S without worsening HRQoL. N+I sustained long-term good HRQoL and significantly delayed TTD in both the total and I/P-risk populations.