Patients beginning sunitinib treatment for advanced renal cell carcinoma (RCC) should be warned that fatigue is likely to occur early, but that it is unlikely to worsen over the course of treatment, suggest US researchers in Cancer.
The findings emerge from the retrospective analysis of a phase III trial that compared sunitinib with interferon (IFN)-α in 750 treatment-naive RCC patients with metastatic disease, who were asked to self-report their health-related quality of life (HRQoL) using three different questionnaires.
Patients treated with sunitinib who experienced the same grade of fatigue, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), as their IFN-α-treated peers generally had more favourable HRQoL scores, note David Cella, from Northwestern University Feinberg School of Medicine in Chicago, Illinois, and co-workers.
Patient-reported HRQoL was measured using the Functional Assessment of Cancer Therapy-Kidney Symptom Index–15-item (FKSI–15), the Functional Assessment of Cancer Therapy-General (FACT-G) and the EuroQoL Group's 5-dimension (EQ-5D) questionnaire. Higher scores on each of these measures represent better HRQoL.
Patients taking sunitinib reported the worst fatigue during the first cycle of treatment, when mean scores on the Disease-Related Symptoms subscale of the FKSI–15 dropped from 2.91 at baseline to 2.29, equating to an estimated effect size of 0.58, report Cella et al. Mean scores improved significantly in cycle two to 2.54 and were generally maintained at this level during subsequent cycles.
The researchers suggest that patients should therefore be given “upfront expectations” regarding the fatigue they could experience while on sunitinib, so that they “do not prematurely withdraw from treatment, thereby failing to take advantage of the potential clinical benefit of sunitinib.”
Overall, patients treated with sunitinib reported “noticeably” higher HRQoL scores than those treated with IFN-α on almost all questionnaires. For example, in patients with CTCAE grade 1 fatigue (mild fatigue vs baseline), those treated with sunitinib had a mean total FACT-G score of approximately 79.9 (out of a possible 108.0) versus approximately 75.5 for those treated with IFN-α.
Similar findings were seen for patients with CTCAE grade 0 fatigue (none), grade 2 (moderate or causing difficulty performing daily activities) and grade 3 (severe fatigue interfering with daily activities).
The team notes that fatigue must be considered in the context of the other risks and benefits of treatment, saying: “Use of HRQoL measures can be an important tool for the treating physician, in this regard, complementing CTCAE assessment.”
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