Frequent adverse events (AEs) experienced by patients receiving tyrosine kinase inhibitors (TKIs) are hand-foot syndrome and mucositis/stomatitis.
Clinicians need a reliable quality-of-life instrument that measure the functional consequences of treatments to determine appropriate interventions for those patients affected by AEs.
The Hand-Foot and Mucositis Symptom and Impact Questionnaire (HAMSIQ) was used to assess mouth/throat and hand/foot AEs and subsequent limitations in patients receiving pazopanib or sunitinib for metastatic renal cell carcinoma (mRCC) in two clinical trials: the COMPARZ trial (national clinical trial no. NCT00720941) and the PISCES study (clinicaltrials.gov NCT01064310).
In this analysis, published online ahead of print in Cancer, researchers from Northwestern Feinberg School of Medicine, Chicago, Illinois, and Novartis Pharma AG, Basel, Switzerland, sought to assess the feasibility, validity, and responsiveness of the HAMSIQ using data from the PISCES study.
Participants in the PISCES study who received pazopanib or sunitinib were asked to complete the HAMSIQ at baseline and every 2 weeks over two 10-week periods. The researchers used data from the first 10-week period in this analysis.
At least 85% of 169 patients completed the HAMSIQ, excluding an item concerning days off work. Among items within the same limitation subscale, correlations were high (Cronbach α ≥.80). HAMSIQ limitation scores were differentiated by patients’ baseline performance status and severity of soreness.
Compared with symptoms/limitations scores and changes from baseline scores using the Functional Assessment of Chronic Illness Therapy fatigue survey, small-to-moderate correlations were observed in patients’ scores with the HAMSIQ.
HAMSIQ results demonstrated responsiveness to changes in patients’ clinical status and the development of hand-foot syndrome AEs over time. The researchers found the instrument to be a reliable tool for assessing the impact of mouth/throat and hand/foot AEs in patients receiving TKIs.
1. Lai JS, Beaumont JL, Diaz J, et al. Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma [published online ahead of print October 12, 2015].