Discoveries in Genitourinary Cancer

Discoveries in Genitourinary Cancer

Source:

Motzer RJ, et al. Abstract 4502. Presented at: ASCO Annual Meeting; June 3-7, 2022; Chicago.

Disclosures: This study was supported by Bristol Myers Squibb in collaboration with Ono Pharmaceutical. Motzer reports serving in a consulting or advisory role for AstraZeneca, Calithera Biosciences, Eisai, EMD Serono, Exelixis, Genentech/Roche, Incyte, Lilly and Pfizer and receiving research funding to Motzer’s institution from Bristol Myers Squibb, Eisai, Exelixis, Genentech/Roche, Merck, Novartis and Pfizer.
June 22, 2022
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Quality of life associated with survival in RCC

Source:

Motzer RJ, et al. Abstract 4502. Presented at: ASCO Annual Meeting; June 3-7, 2022; Chicago.

Disclosures: This study was supported by Bristol Myers Squibb in collaboration with Ono Pharmaceutical. Motzer reports serving in a consulting or advisory role for AstraZeneca, Calithera Biosciences, Eisai, EMD Serono, Exelixis, Genentech/Roche, Incyte, Lilly and Pfizer and receiving research funding to Motzer’s institution from Bristol Myers Squibb, Eisai, Exelixis, Genentech/Roche, Merck, Novartis and Pfizer.
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CHICAGO — Better health-related quality of life was linked to longer survival in patients with intermediate- or poor-risk renal cell carcinoma, according to an analysis of the CheckMate 214 trial.

Results from the trial demonstrated OS, PFS and health-related quality-of-life benefits with nivolumab (Opdivo, Bristol Myers Squibb) plus ipilimumab (Yervoy, Bristol Myers Squibb) compared with sunitinib (Sutent, Pfizer) over long-term follow-up, Robert J. Motzer, MD, from Memorial Sloan Kettering Cancer Center, said during a presentation of the data at the ASCO Annual Meeting.

As prior studies have shown an association between quality of life and efficacy outcomes in RCC and other malignancies, Motzer and colleagues opted to “explore the prognostic ability of quality-of-life data to help inform on risk of progression or death in patients with advanced RCC.”

Assessing quality of life, survival

For the analysis, Motzer and colleagues used 5-year follow-up data from patients with intermediate- and poor-risk advanced RCC in the CheckMate 214 trial to assess the relationships between baseline and longitudinal health-related quality-of-life data and PFS and OS. To assess quality of life, the researchers used the Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) total score and the disease-related symptoms physical (DRS-P) subscale.

In the study, which included 425 patients in the nivolumab plus ipilimumab arm and 422 patients in the sunitinib arm, baseline quality of life referred to data collected before treatment at the time of randomization and longitudinal quality of life referred to data collected after randomization while patients were on study treatment as well as afterward. The researchers collected information on quality of life at baseline, on-treatment and at two timepoints after the last dose.

Two Cox proportional hazard models were fitted to time-to-event data, with PFS and OS as the dependent variable in each model. The baseline model evaluated the difference in PFS and OS between patients with meaningfully different quality-of-life scores before study treatment, whereas the longitudinal model evaluated whether improvement in quality-of- life scores over the course of study treatment were associated with better OS and PFS. Improvement was defined as five points for the FKSI-19 score and four points for the DRS-P score.

Prognostic potential of patient-reported outcomes

Overall, Motzer noted, results pointed to better survival outcomes with better health-related quality-of-life scores. For instance, increases in the FSKI-19 total scores and DRS-P scores were linked to decreases in the risk for progression or death in both the longitudinal and baseline models.

Regarding OS, in the baseline model, higher baseline quality-of-life scores were associated with a reduced risk for death for both the FKSI-19 total (HR = 0.83; 95% CI, 0.8-0.87) and the DRS-P scores (HR = 0.8; 95% CI, 0.76-0.84). The longitudinal model also showed that higher scores obtained while on study treatment were associated with longer OS, with HRs that were lower or stronger when compared with the baseline model, according to Motzer.

Additionally, in the longitudinal model, every five-point increase in the FKSI-19 total score was associated with a 31% reduction in the risk for death (HR = 0.69; 95% CI, 0.64-0.74), and every four-point increase in the DRS-P score was associated with a 35% reduction in the risk for death (HR = 0.65; 95% CI, 0.6-0.71).

In a landmark analysis for OS by quality-of-life response, the researchers observed OS benefits for responders — defined as patients with improvement in or maintenance of quality-of-life scores at the 6-month landmark vs. baseline — when compared with nonresponders. When assessed according to FKSI-19 total scores, the median survival time was longer for responders vs. nonresponders (67.8 vs. 32 months), with a 52% reduction in the risk for death for responders vs. nonresponders (HR = 048; 95% CI, 0.39-0.59). Similar results were found for the DRS-P score, according to Motzer.

Although the researchers pooled study arms for the current analysis, they also performed an analysis of each treatment arm separately and found OS benefits for responders in both treatment arms in the landmark analysis of OS by FKSI-19 total score. Specifically, there was a 61% reduction in the risk for death for responders vs. nonresponders in the nivolumab plus ipilimumab arm (HR = 0.39; 95% CI, 0.29-0.53) and a 43% reduction in risk for death for responders vs. nonresponders in the sunitinib arm (HR = 0.57; 95% CI, 0.43-0.76). Again, similar results were observed for the DRS-P score.

“These results highlight the value of patient-reported outcomes in measuring patients’ health-related quality of life as well as for prognostic modeling,” Motzer said.