Effects of sorafenib on symptoms and quality of life - Results from a large randomized placebo-controlled study in renal cancer

Introduction: The aim of the current study was to determine the impact of treatment with sorafenib versus placebo on renal cancer symptoms and quality of life (QOL). Methods: Symptoms were measured by the Functional Assessment of Cancer Therapy (FACT)-Kidney Cancer Symptom Index (FKSI) and QOL by the FACT-General (FACT-G). The FACT-G and FKSI were administered at baseline and day I of each cycle. Statistical analyses used a random coefficient model over 5 cycles for total score and individual items, using Memorial Sloan Kettering Risk Score (MSK) and treatment as factors and baseline score and treatment time as covariates. FKSI correlation to survival was based on a Cox proportional hazards model adjusting for treatment, age, and MSK. Results: At baseline and over time, there were no differences in mean scores for either the FACT-G or FKSI between the sorafenib and placebo groups. FKSI single-item analysis showed that sorafenib-treated patients reported significantly fewer symptoms and concerns versus placebo (eg, cough (P < 0.0001), fevers (P = 0.0015), shortness of breath (P <= 0.0312), ability to enjoy life (P = 0.0119), and worry that condition will get worse (P = 0.0004). Only concern about treatment side effects favored placebo (P < 0.0001). Baseline FKSI total score predicted overall survival (P < 0.0001). Conclusions: Sorafenib shows clinical benefit without adversely impacting overall QOL and has a positive impact on some individual symptoms and concerns. These findings are consistent with other clinical results from this trial of advanced renal cell carcinoma patients treated with sorafenib, which included significantly greater progression-free survival and low risk for treatment limited toxicities.