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Jaleh Fallah, Haley Gittleman, Chana Weinstock, Elaine Chang, Sundeep Agrawal, Shenghui Tang, Richard Pazdur, Paul G Kluetz, Daniel L Suzman, Laleh Amiri-Kordestani, RE: Is it time to reconsider the role of upfront cytoreductive nephrectomy in metastatic renal cell carcinoma?, JNCI: Journal of the National Cancer Institute, Volume 116, Issue 9, September 2024, Page 1534, https://doi.org/10.1093/jnci/djae158
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In their editorial on the role of upfront cytoreductive nephrectomy (CN), Avery Braun and Maxwell Meng (1) note that the combination regimens that were approved on the basis of CheckMate-9ER, CLEAR, and KEYNOTE-426 have demonstrated improvements in overall survival, and they are common guideline-recommended first-line therapeutic options for metastatic renal cell carcinoma; analyses of pooled data limited to these trials can thus be informative. Here, we present the results of our exploratory pooled analyses of progression-free survival (PFS) by independent central review and overall survival (OS), using pooled data from these 3 trials (Table 1). Consistent with our prior analysis of the pool of 5 clinical trials, we demonstrate an association between CN prior to systemic treatment (with the combination of immune checkpoint inhibitor and anti-angiogenic therapy) and more favorable PFS and OS (2).
Treatment outcomes by status of cytoreductive nephrectomy, using pooled data from CheckMate-9ER, CLEAR, and KEYNOTE-426
| . | Cytoreductive nephrectomy (n = 332) . | No cytoreductive nephrectomy (n = 219) . |
|---|---|---|
| Progression-free survivala | ||
| Events, n (%) | 175 | 139 |
| Median (95% CI) | 20.3 (16.6 to 23.5) | 11.9 (9.8 to 13.7) |
| Unadjusted HR (95% CI) | 0.66 (0.52 to 0.82) | |
| Adjusted HRb (95% CI) | 0.69 (0.52 to 0.90) | |
| Overall survival | ||
| Events, n (%) | 142 | 126 |
| Median (95% CI) | 47.2 (44.4 to NE) | 32.9 (26.8 to 40.5) |
| Unadjusted HR (95% CI) | 0.60 (0.47 to 0.76) | |
| Adjusted HRb (95% CI) | 0.71 (0.54 to 0.95) | |
| . | Cytoreductive nephrectomy (n = 332) . | No cytoreductive nephrectomy (n = 219) . |
|---|---|---|
| Progression-free survivala | ||
| Events, n (%) | 175 | 139 |
| Median (95% CI) | 20.3 (16.6 to 23.5) | 11.9 (9.8 to 13.7) |
| Unadjusted HR (95% CI) | 0.66 (0.52 to 0.82) | |
| Adjusted HRb (95% CI) | 0.69 (0.52 to 0.90) | |
| Overall survival | ||
| Events, n (%) | 142 | 126 |
| Median (95% CI) | 47.2 (44.4 to NE) | 32.9 (26.8 to 40.5) |
| Unadjusted HR (95% CI) | 0.60 (0.47 to 0.76) | |
| Adjusted HRb (95% CI) | 0.71 (0.54 to 0.95) | |
Per RECIST v1.1 by independent central review. CI = confidence interval; HR = hazard ratio; NE = not estimable.
Stratified for study; and adjusted for age, sex, IMDC risk group, performance status, sarcomatoid component.
Treatment outcomes by status of cytoreductive nephrectomy, using pooled data from CheckMate-9ER, CLEAR, and KEYNOTE-426
| . | Cytoreductive nephrectomy (n = 332) . | No cytoreductive nephrectomy (n = 219) . |
|---|---|---|
| Progression-free survivala | ||
| Events, n (%) | 175 | 139 |
| Median (95% CI) | 20.3 (16.6 to 23.5) | 11.9 (9.8 to 13.7) |
| Unadjusted HR (95% CI) | 0.66 (0.52 to 0.82) | |
| Adjusted HRb (95% CI) | 0.69 (0.52 to 0.90) | |
| Overall survival | ||
| Events, n (%) | 142 | 126 |
| Median (95% CI) | 47.2 (44.4 to NE) | 32.9 (26.8 to 40.5) |
| Unadjusted HR (95% CI) | 0.60 (0.47 to 0.76) | |
| Adjusted HRb (95% CI) | 0.71 (0.54 to 0.95) | |
| . | Cytoreductive nephrectomy (n = 332) . | No cytoreductive nephrectomy (n = 219) . |
|---|---|---|
| Progression-free survivala | ||
| Events, n (%) | 175 | 139 |
| Median (95% CI) | 20.3 (16.6 to 23.5) | 11.9 (9.8 to 13.7) |
| Unadjusted HR (95% CI) | 0.66 (0.52 to 0.82) | |
| Adjusted HRb (95% CI) | 0.69 (0.52 to 0.90) | |
| Overall survival | ||
| Events, n (%) | 142 | 126 |
| Median (95% CI) | 47.2 (44.4 to NE) | 32.9 (26.8 to 40.5) |
| Unadjusted HR (95% CI) | 0.60 (0.47 to 0.76) | |
| Adjusted HRb (95% CI) | 0.71 (0.54 to 0.95) | |
Per RECIST v1.1 by independent central review. CI = confidence interval; HR = hazard ratio; NE = not estimable.
Stratified for study; and adjusted for age, sex, IMDC risk group, performance status, sarcomatoid component.
Data availability
The sharing of individual patient data from each participating trial will be subject to the policies and procedures of the institution(s) and group(s) who did the original studies.
Author contributions
Jaleh Fallah, MD (Conceptualization; Investigation; Methodology; Writing—original draft; Writing—review & editing), Haley Gittleman, PhD (Data curation; Formal analysis; Investigation; Writing—review & editing), Chana Weinstock, MD (Investigation; Writing—review & editing), Elaine Chang, MD (Investigation; Writing—review & editing), Sundeep Agrawal, MD (Investigation; Writing—review & editing), Shenghui Tang, PhD (Investigation; Supervision; Writing—review & editing), Richard Pazdur, MD (Supervision; Writing—review & editing), Paul G. Kluetz, MD (Investigation; Supervision; Writing—review & editing), Daniel L. Suzman, MD (Investigation; Supervision; Writing—review & editing), Laleh Amiri-Kordestani, MD (Investigation; Supervision; Writing—review & editing).
Funding
None declared.
Conflicts of interest
The authors declare no potential conflicts of interest.
References
Author notes
Jaleh Fallah and Haley Gittleman contributed equally to this work.
