Hem/Onc Speclst
Thomas Cosgriff , Lin Yang , Anna Alyasova , Dingwei Ye , Andrey Karpenko , Hanzhong Li , Boris Alekseev , Li-ping Xie , Ruben Dario Kowalyszyn , Oleg Karyakin , Yeni Verónica Neron , LaTonya Collins , Thomas Brechenmacher , Chinjune Lin , Liza Morgan , Robert J. Motzer
Background: The phase 2 RECORD-4 study assessed EVE in pts with mRCC who progressed after 1 prior anti-VEGF or cytokine (J Clin Oncol 2015;abstr 4518). At primary analysis, median progression-free survival (PFS, primary end point) in the overall population was 7.8 months (95% CI, 5.7-11.0). Here we present results of the final updated primary PFS and final overall survival (OS) analysis. Methods: RECORD-4 enrolled 134 pts with clear cell mRCC into 1 of 3 cohorts based on prior first-line therapy: sunitinib (cohort 1, n=58), other anti-VEGF (cohort 2, n=62: 23 sorafenib, 16 bevacizumab, 13 pazopanib, 10 other), or cytokines (cohort 3, n=14). Pts received EVE 10 mg/d until progression of disease (PD; RECIST, v1.0) or intolerance. Database lock for final analysis was June 26, 2015. Results: Demographics were balanced among cohorts; overall most pts were men (68%) and most had good/intermediate MSKCC prognosis (90%); median age was 59 yrs. Median duration of exposure was 5.8 mo. At the time of final analysis, study discontinuation was primarily due to disease progression (61%). In the overall population, median PFS (95% CI) was 7.4 (5.6-10.5) mo and median OS (95% CI) was 23.8 (17.0-not evaluable [NE]) mo (Table). Overall rate of grade 3 or 4 adverse events (AEs) was 56%. There were 13 on-treatment deaths; primary causes were disease progression, multi-organ failure, and respiratory failure (2.3% each). Conclusions: RECORD-4 final OS analysis supports EVE as a second-line option after sunitinib and other first-line therapies. EVE safety profile was consistent with previous experience. Clinical trial information: NCT01491672
Overall population N=134 | Prior therapy | |||
---|---|---|---|---|
Sunitinib N=58 | Other anti-VEGF N=62 | Cytokines N=14 | ||
Median PFS (95% CI), mo | 7.4 (5.6-10.5) | 5.6 (3.7-11.3) | 7.8 (5.7-11.0) | 12.9 (2.6-NE) |
Median OS (95% CI), mo | 23.8 (17.0-NE) | 23.8 (13.7-NE) | 17.2 (11.9-NE) | NE (15.9-NE) |
Safety set | N=133 | N=58 | N=61 | N=14 |
Grade 3/4 AEsa, n (%) | ||||
Overall | 74 (56) | 32 (55) | 32 (52) | 10 (71) |
Anemia | 17 (13) | 6 (10) | 7 (11) | 4 (29) |
Stomatitis/mouth ulceration | 9 (7) | 4 (7) | 3 (5) | 2 (14) |
Hyperglycemia | 6 (5) | 2 (3) | 4 (7) | 0 (0) |
Hypertriglyceridemia | 6 (5) | 3 (5) | 3 (5) | 0 (0) |
aCommonly reported (>4% in the overall population).
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Disclosures
2015 ASCO Annual Meeting
First Author: Robert Motzer
2018 Genitourinary Cancers Symposium
First Author: Paul L. de Souza
2023 ASCO Genitourinary Cancers Symposium
First Author: Jeffrey Thomas Yorio
2024 ASCO Genitourinary Cancers Symposium
First Author: Mehul Gupta