ASSET: Alternative schedule sunitinib in metastatic renal cell carcinoma (RCC)—Cardiopulmonary exercise testing (CPET).

• DOI: 10.1200/jco.2021.39.6_suppl.300
• Publication Date: 2021-03-02T17:06:00Z
• Authors: Michael Roger Har...; David Bartlett; Tian Zhang; Andrew J. Armstrong; Aubrie Coburn; Brian Coyne; Monika Anand; Taofik Oyekunle; Yuan Wu; Michel Khouri; Daniel J. George
• Keywords: Clinical endpoint

300 Background: Sunitinib (SUN) is a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) approved for treatment of advanced RCC and high risk after nephrectomy. Evidence suggests that 2 week (wk) on, 1 wk off schedule (2/1) SUN administration may be more tolerable than the standard 4 (4/2). We investigated changes in cardiopulmonary function related parameters over time patients treated with both schedules SUN. Methods: Patients starting RCC, KPS ≥80 normal organ marrow function, were enrolled randomized 1:1 to 4/2 or 2/1. Subjects required able walk jog on treadmill complete an acceptable CPET at baseline (BL). Primary endpoint was change peak oxygen uptake (VO peak) 12 from BL. Key secondary endpoints BL in: left ventricular ejection fraction (LVEF), upper lower body strength (1-RM), functional measures (chair stand, timed up-and-go [TUG], 6-minute test [6MWT], quality life (QOL; FACT-Fatigue, FKSI-19), anxiety depression (HADS) exercise behavior (Godin Leisure Score). ANCOVA models controlling values used analyze primary endpoints. Results: Between 11/20/2017 6/24/2019, 9 out planned 30 consented participate Duke. Two declined 7 study: Arm A 3 B. All completed study. Median age, BMI, VO 65 yrs, 30.5 kg/m , 19.2 ml kg −1 min . observed no difference between arms (p=0.84). report scores all (Table). In addition, mean (SE) QOL by FACIT-Fatigue FKSI-19 -2.88 (1.5) 1.2 [9.8]; HADS 1.14 (1.3); physical activity (1.7). Conclusions: non-significant declines most fitness during first To our knowledge, this reported study these RCC. Given VEGF TKI, alone immune checkpoint inhibitor, remains care metastatic ccRCC, studies should undertaken examine whether training can prevent function. Clinical trial information: NCT03109015 [Table: see text]