Fatigue in patients with advanced renal cell carcinoma receiving sunitinib on an intermittent versus continuous dosing schedule in a randomized phase II trial

Cancer Medicine

David Cella¹  Sally E. Jensen¹  Elizabeth A. Hahn¹  Jennifer L. Beaumont¹  Beata Korytowsky³  Helen Bhattacharyya² 

[1] Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois;Statistics, Pfizer Specialty Care BU, New York City, New York;Global Health Economics and Outcomes Research, Pfizer Oncology, New York City, New York

关键词: Fatigue;    quality of life;    renal cell carcinoma;    sunitinib;   

DOI  :  10.1002/cam4.286

来源: Wiley

【 摘 要 】

Abstract

A phase II trial in advanced renal cell carcinoma (RCC) found no benefit in efficacy or safety between patients receiving oral sunitinib 50 mg/day for 4 weeks followed by 2-week off-treatment (Schedule 4/2) and those receiving 37.5 mg continuous daily sunitinib. We hypothesized that fatigue would have a more variable “on-off” effect with the 4/2 schedule. A total of 292 patients completed two fatigue-related items on Days 1 and 29 of each treatment cycle. Mean absolute slopes were compared across treatments. A planned analysis of item “I feel fatigued” demonstrated that the mean absolute slope was greater in Schedule 4/2 compared to continuous dosing (0.042 vs. 0.032, P = 0.003), and analysis based on the change from Day 1 to Day 29 (0.52 vs. 0.21, P = 0.002) and, separately, Day 29 to the next Day 1 (−0.38 vs. −0.05, P < 0.001) showed the changes to be significantly larger in Schedule 4/2 than continuous dosing. “I have a lack of energy” showed a similar pattern graphically, however, the planned analysis was not statistically significant based on the absolute slopes but was when Day 1 to Day 29 and Day 29 to Day 1 changes were analyzed separately. The 4/2 arm was associated with a greater degree of variability in fatigue reflecting a possible “on-off” effect whereby patients receiving the 4/2 schedule reported less fatigue at the beginning of each cycle compared to Day 29. The findings can inform care for individuals with advanced RCC receiving intermittent dosing of sunitinib.

【 授权许可】

CC BY   
© 2014 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.