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

David Cella*, Sally Elizabeth Jensen, Elizabeth A Hahn, Jennifer L. Beaumont, Beata Korytowsky, Helen Bhattacharyya, Robert Motzer

*Corresponding author for this work

Research output: Contribution to journalArticle

5 Citations (Scopus)

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. In a randomized trial comparing the sunitinib 4-week on/2-week off schedule to a continuous daily dose schedule, 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 the care for individuals with advanced renal cell carcinoma receiving intermittent dosing of sunitinib.

Original languageEnglish (US)
Pages (from-to)1353-1358
Number of pages6
JournalCancer medicine
Volume3
Issue number5
DOIs
StatePublished - Oct 1 2014

Fingerprint

Renal Cell Carcinoma
Fatigue
Appointments and Schedules
sunitinib
Patient Safety
Therapeutics

Keywords

  • Fatigue
  • Quality of life
  • Renal cell carcinoma
  • Sunitinib

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

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title = "Fatigue in patients with advanced renal cell carcinoma receiving sunitinib on an intermittent versus continuous dosing schedule in a randomized phase II trial",
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. In a randomized trial comparing the sunitinib 4-week on/2-week off schedule to a continuous daily dose schedule, 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 the care for individuals with advanced renal cell carcinoma receiving intermittent dosing of sunitinib.",
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Fatigue in patients with advanced renal cell carcinoma receiving sunitinib on an intermittent versus continuous dosing schedule in a randomized phase II trial. / Cella, David; Jensen, Sally Elizabeth; Hahn, Elizabeth A; Beaumont, Jennifer L.; Korytowsky, Beata; Bhattacharyya, Helen; Motzer, Robert.

In: Cancer medicine, Vol. 3, No. 5, 01.10.2014, p. 1353-1358.

Research output: Contribution to journalArticle

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T1 - Fatigue in patients with advanced renal cell carcinoma receiving sunitinib on an intermittent versus continuous dosing schedule in a randomized phase II trial

AU - Cella, David

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AU - Hahn, Elizabeth A

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AU - Motzer, Robert

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