Background: 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. Patients and methods: 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. Results: 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. Conclusions: 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.
|Number of pages||7|
|Journal||Supportive Care in Cancer|
|State||Published - Jun 1 2018|
Bibliographical noteFunding Information:
Funding This study was coordinated by the ECOG-ACRIN Cancer Research Group (Robert L. Comis, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following award numbers: CA180820, CA180794, CA189828. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government.
© 2017, Springer-Verlag GmbH Germany, part of Springer Nature.
- Adjuvant therapy
- Patient-reported outcome
- Renal cell carcinoma
ASJC Scopus subject areas