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Supportive Care in Cancer

, Volume 26, Issue 6, pp 1889–1895 | Cite as

Fatigue among patients with renal cell carcinoma receiving adjuvant sunitinib or sorafenib: patient-reported outcomes of ECOG-ACRIN E2805 trial

  • Fengmin ZhaoEmail author
  • David Cella
  • Judith Manola
  • Robert S. DiPaola
  • Lynne I. Wagner
  • Naomi S. B. Haas
Original Article

Abstract

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.

Keywords

Fatigue Patient-reported outcome Renal cell carcinoma Adjuvant therapy Sunitinib Sorafenib 

Notes

Acknowledgments

The authors thank all the patients who participated in the study.

Author contributions

FZ did the statistical analysis and wrote the first draft of the manuscript. DC and LW designed the quality of life proposal. JM and NBH designed the parent trial as the study statistician and study chair, respectively. RSD was the ECOG-ACRIN Genitourinary committee chair at the time. All authors interpreted the data, reviewed and edited the manuscript drafts, and approved the final version of the manuscript for submission.

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.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflicts of interest.

Supplementary material

520_2017_4027_MOESM1_ESM.docx (66 kb)
ESM 1 (DOCX 65 kb)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2017

Authors and Affiliations

  • Fengmin Zhao
    • 1
    Email author
  • David Cella
    • 2
  • Judith Manola
    • 1
  • Robert S. DiPaola
    • 3
  • Lynne I. Wagner
    • 4
  • Naomi S. B. Haas
    • 5
  1. 1.Department of Biostatistics and Computational BiologyDana–Farber Cancer InstituteBostonUSA
  2. 2.Department of Medical Social SciencesNorthwestern UniversityChicagoUSA
  3. 3.Rutgers Cancer Institute of New JerseyNew BrunswickUSA
  4. 4.Social Sciences & Health Policy Comprehensive Cancer CenterWake Forest School of MedicineWinston-SalemUSA
  5. 5.Abramson Cancer CenterUniversity of PennsylvaniaPhiladelphiaUSA

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