Abstract 1458P
Background
In the CM 9ER trial, nivolumab plus cabozantinib (N+C) was associated with both increased survival and improved HRQoL in 1L aRCC patients (pts) at 23.5 months follow-up when compared to sunitinib (S). We investigated the association between HRQoL and overall survival (OS) and progression-free survival (PFS).
Methods
651 pts were assigned to N+C (n = 323) and S (n = 328), respectively. Patient function, symptoms, and HRQoL were assessed using the FKSI-19 instrument (Total Score [TS], Disease Related Symptoms [DRS], DRS-Physical [DRS-P], and Functional Well-Being [FWB]). Separate multivariate Cox regression models (adjusted for treatment, IMDC prognostic score, and region) were used to evaluate the prognostic significance of baseline and longitudinal HRQoL scores. Hazard ratios (HRs) were calculated as the risk of progression or death (P/D) per improvement in scores and defined with clinically meaningful score change thresholds (FKSI-19 TS = 5 points, DRS = 3, DRS-P = 4, FWB = 3).
Results
In both baseline and longitudinal analyses, OS and PFS were independently associated with HRQoL. Higher (better) baseline scores and improved longitudinal HRQoL were associated with significantly reduced risk of P/D (Table). Point estimates for HRs were mostly smaller in the longitudinal model versus the model including baseline values only. Table: 1458P
| PFS | OS | |||
| HR | 95% CI | HR | 95% CI | |
| Baseline | ||||
| FKSI-19 TS | 0.85 | 0.81 - 0.89 | 0.78 | 0.73 - 0.82 |
| DRS | 0.85 | 0.80 - 0.90 | 0.76 | 0.71 - 0.82 |
| DRS-P | 0.85 | 0.80 - 0.91 | 0.76 | 0.71 - 0.82 |
| FWB | 0.80 | 0.73 - 0.87 | 0.68 | 0.61 - 0.76 |
| Longitudinal | ||||
| FKSI-19 TS | 0.89 | 0.84 – 0.95 | 0.69 | 0.64 – 0.75 |
| DRS | 0.85 | 0.78 – 0.92 | 0.66 | 0.61 – 0.72 |
| DRS-P | 0.83 | 0.77 – 0.89 | 0.64 | 0.58 – 0.70 |
| FWB | 0.86 | 0.77 – 0.96 | 0.51 | 0.42 – 0.61 |
Baseline: lower HR indicates stronger association between higher PRO baseline score and lower risk of P/D.Longitudinal: lower HR indicates stronger association between greater improvement from baseline in PRO scores and lower risk of P/D.
Conclusions
Results demonstrate a positive relationship between HRQoL and clinical outcomes in 1L aRCC; baseline HRQoL scores are a potential predictor for survival and progression. The relationship between HRQOL and clinical outcomes is notable in patients whose HRQoL improved during the study, who were less likely to experience early disease progression or death.
Clinical trial identification
NCT03141177.
Editorial acknowledgement
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
D. Cella: Financial Interests, Personal, Advisory Role: AbbVie, GlaxoSmithKline, Pfizer, Astella Pharma, Novartis, Bristol Myers Squibb, Asahi Kasei, Ipsen, Mei Pharma; Financial Interests, Personal, Stocks/Shares: FACIT.org; Financial Interests, Institutional, Funding: Novartis, Ipsen, Pfizer, PledPharma, Bristol Myers Squibb, AbbVie, Regeneron, Clovis Oncology. C.G. Porta: Financial Interests, Invited Speaker: BMS. M. Hamilton: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. F. Ejzykowicz: Financial Interests, Personal, Other, BMS employee: BMS; Financial Interests, Personal, Full or part-time Employment, Flavia Ejzykowicz reports being employed by and owning stock in Bristol Myers Squibb: BMS; Financial Interests, Personal, Stocks/Shares: BMS; Financial Interests, Personal, Other, Flavia Ejzykowicz reports being employed by and owning stock in Bristol Myers Squibb: BMS; Non-Financial Interests, Other, reports being employed by and owning stock in Bristol Myers Squibb: BMS; Non-Financial Interests, Personal, Other, Flavia Ejzykowicz reports being employed by and owning stock in Bristol Myers Squibb: BMS. S.I. Blum: Financial Interests, Personal, Full or part-time Employment, Full-time Employee of Bristol Myers Squibb: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares, Stock shareholder of Bristol Myers Squibb: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares, Stock shareholder of GlaxoSmithKline: GlaxoSmithKline. C. Ivanescu: Financial Interests, Personal, Full or part-time Employment: IQVIA. C. Suarez Rodriguez: Financial Interests, Personal, Other: BMS. T.K. Choueiri: Financial Interests, Invited Speaker: BMS. R.J. Motzer: Financial Interests, Personal, Advisory Board: Pfizer, Novartis, Eisai, Exelixis, Merck, Genentech/Roche, Incyte, Lilly Oncology, AstraZeneca, EMD Serono, Aveo Pharmaceuticals, AVEO; Financial Interests, Institutional, Invited Speaker, funding for trial conduct from sponsor to my employer MSKCC: Pfizer, Eisai, Genentech/Roche, Merck, Bristol Myers Squibb, Exelixis, AVEO.