E2805 was a phase III trial to test whether adjuvant sunitinib or sorafenib could improve disease-free survival compared to placebo in patients with renal cell carcinoma. Patient-reported outcomes (PRO), focusing on fatigue, were evaluated as a secondary endpoint.
A total of 463 patients participated in the PRO study. Fatigue was measured by the FACIT Fatigue scale and PROMIS Fatigue SF1 measure at baseline, week 10, and week 22. The primary endpoint was change in fatigue score from baseline to week 22, measured by the FACIT Fatigue scale. Secondarily, the psychometric properties of PROMIS Fatigue SF1 were assessed in relation to the FACIT Fatigue scale.
Fatigue got significantly worse on all arms after 2 cycles of treatment, and especially so in patients on sunitinib (- 9.6 vs. - 5.6 on sorafenib vs. - 4.7 on placebo). Fatigue remained stable during week 10 and week 22. Overall, the mean score change between baseline and week 22 was - 7.9 (p < 0.001) on sunitinib, - 6.4 (p < 0.001) on sorafenib and - 5.6 (p < 0.001) on placebo arm. The difference in score change was not statistically significant between the two experimental arms and the placebo arm (difference = - 2.34 [p = 0.110] and - 0.87 [p = 0.535] for sunitinib vs. placebo and sorafenib vs. placebo). PROMIS Fatigue SF1 had good internal consistency reliability and construct and criterion validity, and was highly correlated with the FACIT Fatigue scale score.
Fatigue got worse during study period, especially in patients on sunitinib. The PROMIS Fatigue SF1 was highly correlated with FACIT Fatigue and produced similar results.
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2017 Dec 23 [Epub ahead of print]
Fengmin Zhao, David Cella, Judith Manola, Robert S DiPaola, Lynne I Wagner, Naomi S B Haas
Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, 02215, USA. ., Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA., Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, 02215, USA., Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA., Social Sciences & Health Policy Comprehensive Cancer Center, Wake Forest School of Medicine, Winston-Salem, NC, USA., Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.