Background: To analyze the impact of sunitinib treatment on health-related quality of life (HRQOL) in Japanese patients with metastatic renal cell carcinoma (mRCC).
Methods: This study prospectively included 90 consecutive patients with mRCC treated with sunitinib for at least 3 months. HRQOL in these patients was assessed using the Medical Outcomes Study 36-Item Short Form (SF-36) consisting of 8 multi-item scales measuring health status.
Results: There were no significant differences in any of the 8 scores in these 90 patients between surveys conducted before and 3 months after sunitinib treatment. Three months after treatment, all 8 scores in patients who had some degree of tumor shrinkage were more favorable than those in the remaining patients, and there were significant differences in 2 of the 8 scale scores (role limitations because of emotional problems, mental health) between these two groups. However, there were no significant differences in any scale scores except one (social function) between patients with and without severe adverse events (AEs). Furthermore, a significant time-dependent improvement was observed in one score (body pain), while there were no significant differences in the remaining 7 scores 3, 6 and 12 months after sunitinib treatment in 29 patients who could be followed for at least 12 months.
Conclusions: Although this was a non-randomized study including a comparatively small number of patients, these findings suggest that efficacy rather than AE is likely to be associated with HRQOL in Japanese mRCC patients treated with sunitinib.