Abstract 4399
Background
Data on the efficacy and safety of all targeted therapies for metastatic renal cell carcinoma (mRCC) including sunitinib are collected in the Czech RENIS patient registry. RENIS thus provides a uniquely large sample of long-term effectiveness and prognostic data of sunitinib according to adverse/risk factors measured by the Memorial Sloan Kettering Cancer Center (MSKCC) score. The aim of this study was to analyze the long-term overall (OS) and progression-free survival (PFS) of sunitinib, when used as 1st line treatment, based on MSKCC risk group scores including MSKCC scores for two intermediate subgroups.
Methods
Data from mRCC patients treated using sunitinib in the 1st line were collected in RENIS between 06/2007 and 02/2018. OS/PFS were then stratified based on MSKCC scores: a) favorable risk (0 adverse factors (AF)), b) intermediate risk (pooled 1–2 AFs), and c) poor risk (3+ AFs). The OS/PFS of the intermediate risk group was further stratified into two subgroups: i) 1 AF and ii) 2 AFs. All OS/PFS data were analyzed using Kaplan-Meier estimates. Differences in OS/PFS between risk groups were assessed using median survival, 95% confidence intervals (CI), and the log-rank test. Then we assessed the OS/PFS for 1-, 3-, and 5-year survival.
Results
Over the 11-year follow-up, 2390 patients were treated using sunitinib with 806, 1450, and 134 patients in the favorable, intermediate, and poor MSKCC risk groups. The more favorable MSKCC risk group was accompanied by an improved OS and PFS (p < 0.001). Regarding the MSKCC for the two intermediate sub-groups, 1 AF was associated with improved survival compared to 2 AFs (p < 0.001) (Table).Table:
957P OS and PFS results for sunitinib treatment based on MSKCC risk groups
MSKCC favorable | MSKCC intermediate | MSKCC poor | MSKCC intermediate | All patients | ||
---|---|---|---|---|---|---|
1 AF | 2 AFs | |||||
Overall survival | ||||||
Median survival (95% CI) | 44.7months (40.9-50.5) | 24.1months (21.9-26.0) | 9.5months (7.2-14.1) | 28.2months (25.9-30.7) | 16.2months (14.5-20.2) | 28.5months (26.3-30.5) |
1-year survival (95% CI) | 85.0% (82.4-87.6) | 69.1% (66.6-71.7) | 44.3% (35.0-53.7) | 74.3% (71.4-77.2) | 58.0% (53.1-62.9) | 73.3% (71.4-75.2) |
3-year survival (95 %CI) | 57.3% (53.4-61.3) | 37.1% (34.1-40.1) | 9.6% (3.1-16.2) | 42.0% (38.3-45.7) | 26.3% (21.4-31.2) | 42.9% (40.5-45.2) |
5-year survival (95% CI) | 35.6% (31.2-40.1) | 23.4% (20.4-26.4) | 3.2% (0.0-8.8) | 26.5% (22.7-30.3) | 16.5% (11.8-21.2) | 26.8% (24.3-29.2) |
n | 806 | 1450 | 134 | 969 | 481 | 2390 |
Log-rank p-value | < 0.001 | < 0.001 | - | |||
Progression-free survival | ||||||
Median survival (95% CI) | 17.0months (15.4-18.8) | 9.0months (8.3-9.5) | 4.5months (3.9-6.1) | 10.1months (9.4-11.4) | 6.2months (5.5-7.5) | 10.6months (9.9-11.5) |
1-year survival (95% CI) | 61.8% (58.3-65.3) | 40.7% (38.0-43.4) | 20.8% (13.1-28.5) | 45.1% (41.8-48.4) | 31.6% (27.1-36.1) | 46.9% (44.7-49.0) |
3-year survival (95 %CI) | 25.1% (21.7-28.5) | 13.0% (11.0-15.1) | 1.8% (0.0-5.1) | 15.9% (13.2-18.6) | 7.0% (4.2-9.7) | 16.6% (14.9-18.4) |
5-year survival (95% CI) | 10.4% (7.7-13.2) | 8.0% (6.2-9.8) | 1.8% (0.0-5.1) | 9.7 (7.3-12.0) | 4.5% (2.1-6.9) | 8.4% (7.0-9.9) |
n | 806 | 1450 | 134 | 969 | 481 | 2390 |
Log-rank p-value | < 0.001 | < 0.001 | - |
Conclusions
Better MSKCC risk scores were associated with significantly longer OS and PFS. To our knowledge, this is the largest published sunitinib mRCC cohort described relative to MSKCC risk groups.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
J. Finek: Honoraria (self): Amgen; Honoraria (self): BMS; Honoraria (self): Roche; Honoraria (self): Bayer; Honoraria (self): Teva; Honoraria (self): MSD; Honoraria (self): Merck; Honoraria (self): Sanofi; Honoraria (self): Pierre Fabre. A. Poprach: Honoraria (self): Pfizer; Honoraria (self): Roche; Honoraria (self): Ipsen; Honoraria (self): Novartis; Honoraria (self): BMS; Honoraria (self): Bayer. B. Melichar: Honoraria (self): BMS; Honoraria (self): Merck; Honoraria (self): MSD; Honoraria (self): Roche; Honoraria (self): Novartis; Honoraria (self): Astellas Pharma; Honoraria (self): Pfizer; Honoraria (self): Bayer. J. Kopecky: Honoraria (self): BMS; Honoraria (self): Novartis; Honoraria (self): Pfizer. M. Zemanova: Advisory / Consultancy: Novartis; Honoraria (self): Eli Lilly; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: Boehringer Ingelheim. T. Buchler: Honoraria (self): Amgen; Honoraria (self): Roche; Honoraria (self): Novartis; Honoraria (self): Pfizer; Advisory / Consultancy: Roche; Advisory / Consultancy: BMS; Advisory / Consultancy: Pfizer; Travel / Accommodation / Expenses: Janssen. K. Kopeckova: Honoraria (self): Novartis; Travel / Accommodation / Expenses: Bayer; Travel / Accommodation / Expenses: Pfizer. T. Mlcoch: Full / Part-time employment: Value Outcomes. T. Dolezal: Full / Part-time employment: Value Outcomes. All other authors have declared no conflicts of interest.
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