Pts with locoregional RCC at high risk (≥T3 and/or N+) of tumour recurrence post nephrectomy treated with adjuvant SU (50 mg daily; schedule 4/2) had significantly longer disease-free survival (DFS) vs. placebo (PBO; HR, 0.76; 95% CI, 0.59–0.98; P = 0.03). We report safety and therapy management data.
Reasons for SU treatment discontinuation (TDC), dose reduction (RED), dose interruption (INT), and pts TDC due to AEs by cycle, were summarized. Median time to SU TDC was calculated.
Of the 615 pts enrolled, 306 were treated with SU at a median (range) daily dose of 45.9 (8.9–52.6) mg. 71% of pts remained on SU treatment for 9 months (mo) and 56% completed the full 1-year treatment. Most common reasons for TDC were AEs (28.1%) and relapse (7.2%) in SU arm, and relapse (19.4%) and AEs (5.9%) in PBO arm. Common AEs leading to TDC, RED and INT are summarized in the Table. TDC due to AEs in cycles 1, 3, 6, and 9, respectively: 7.8%, 3.3%, 2.6%, and 1.6% in SU arm, and 0.3%, 1.3%, 0.3%, and 0% in PBO arm. In the 86 pts who DC SU, median time to TDC was 4.5 mo. Median time to first RED and INT in SU-treated pts was 2.9 and 3.0 mo, respectively. Mean change from baseline in most PRO measures including Global Health Status for SU vs PBO was not clinically meaningful (difference, -4.76; 95% CI, -6.82, -2.71). More data, including time on RED/INT, time to onset of common AEs, and the impact of AEs on pts quality of life, will be presented.Table:
855PD Most common AEs leading to TDC, dose RED and INT*
|Treatment DC||Dose RED||Dose INT|
|AE, %||SU||PBO||AE, %||SU||PBO||AE, %||SU||PBO|
Many of the AEs leading to DC and INT were grade 1/2 TDC=treatment discontinuation; RED=reduction; INT=interruption; PPE=palmar-plantar erythrodysesthesia syndrome.
No new safety signals were identified with sunitinib use in the adjuvant RCC setting. Effective therapy management, including dose RED/INT if necessary, is important as it optimizes the possibility of receiving effective treatment.
Clinical trial identification
Legal entity responsible for the study
M. Staehler: Received honoraria, consulting fees, and research grants from Pfizer, Bayer, GSK, Roche, Bristol-Myers Squib, Novartis, Exelixis and AVEO. R.J. Motzer: Received consulting fees from Pfizer, Novartis, Eisai and Exelixis. D.J. George: Received honoraria & consulting: Dendreon, Sanofi, Bayer; consulting: Medivation, Merck, Genentech, Clovis; grants: Genentech, Novartis, Janssen, Astellas, Celldex, Acerta; grants & consulting: Exelixis, Pfizer, Sanofi, Innocrin Pharma, Bristol-Myers Squib. H.S. Pandha: Received honoraria for advisory work from ipsen and Esai. F. Donskov: Received research funding from Pfizer, Novartis, and GSK. B. Escudier: Received consulting fees from Pfizer, Bristol-Myers Squib, Ipsen, ESU pharma and Novartis, and honoraria from Bayer, Roche, Pfizer, Genentech, Novartis, Bristol-Myers Squib, Eisai, Acceleron and Ipsen. A.J. Pantuck: AJ Pantuck has received consulting fees from Pfizer. L. Deannuntis, H. Bhattacharyya, X. Lin, M. Lechuga and L. Serfass: Employee of and owns stock in Pfizer. J-J. Patard: Received consulting fees from Pfizer and GSK. A. Ravaud: Member of RCC advisory boards in Pfizer, Novartis, GSK, Roche, and Bristol-Myers Squib; received institutional support grants from Pfizer and Novartis; housing and transportation for meetings and speeches by Pfizer, Novartis, Bristol-Myers Squib, Astra Zeneca and MSD. All other authors have declared no conflicts of interest.