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Serious fatigue with Sorafenib & Sunitinib by RCC patients
Sorafenib, and particularly sunitinib, worsened the severity of fatigue among patients with renal cell carcinoma (RCC) compared with placebo, according to a study published in Supportive Care in Cancer.
Tyrosine kinase inhibitors (TKIs) (eg, sorafenib and sunitinib) have demonstrated efficacy among patients with RCC and are being utilized with increased frequency. While TKIs improve outcomes, they are still associated with toxicities common with cancer therapies, such as fatigue.
A secondary endpoint of the randomized ECOG-ACRIN E2805 phase 3 study — which evaluated the impact of adjuvant sunitinib and sorafenib vs placebo on disease-free survival (DFS) for RCC — was patient-reported outcomes (PRO) with an emphasis on fatigue. Patients received oral sunitinib 37.5 mg once daily, sorafenib 400 mg once daily, or placebo once daily for 6 week cycles. The FACIT Fatigue scale was used to evaluate fatigue for 463 patients at baseline, week 10 (day 28 of cycle 2), and week 22 (day 28 of cycle 4).
A secondary objective of the study was to evaluate the psychometric properties of PROMIS Fatigue SF1 by comparing its performance with the FACIT Fatigue scale.
Results demonstrated that fatigue worsened among all patients after 2 treatment cycles, and particularly for patients who received sunitinib. The mean score for sunitinib was -9.6 (P < .001), -5.6 for sorafenib (P < .001), and -4.7 on placebo (P < .001). The fatigue level remained stable throughout week 10 and week 22. The difference in score change between the sorafenib, sunitinib, and placebo arms were not statistically significant.
The PROMIS Fatigue SF1 had good internal consistency and produced comparable results to the FACIT Fatigue scale score.
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