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

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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.

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Acknowledgments

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

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.

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Authors and Affiliations

  1. Department of Biostatistics and Computational Biology, Dana–Farber Cancer Institute, Boston, MA, 02215, USA

    Fengmin Zhao & Judith Manola

  2. Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA

    David Cella

  3. Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA

    Robert S. DiPaola

  4. Social Sciences & Health Policy Comprehensive Cancer Center, Wake Forest School of Medicine, Winston-Salem, NC, USA

    Lynne I. Wagner

  5. Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA

    Naomi S. B. Haas

Authors
  1. Fengmin Zhao
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  2. David Cella
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  3. Judith Manola
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  4. Robert S. DiPaola
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  5. Lynne I. Wagner
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  6. Naomi S. B. Haas
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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.

Corresponding author

Correspondence to Fengmin Zhao.

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The authors declare that they have no conflicts of interest.

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Zhao, F., Cella, D., Manola, J. et al. Fatigue among patients with renal cell carcinoma receiving adjuvant sunitinib or sorafenib: patient-reported outcomes of ECOG-ACRIN E2805 trial. Support Care Cancer 26, 1889–1895 (2018). https://doi.org/10.1007/s00520-017-4027-7

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  • DOI: https://doi.org/10.1007/s00520-017-4027-7

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