Patient reported outcomes in a phase 2 trial of SU11248 for metastatic renal cell carcinoma

Abstract

8167 Background: SU11248 is a novel, oral multi-targeted tyrosine kinase inhibitor with both anti-angiogenic and anti-tumor activity. In a phase 2 study (014) of SU11248 for the treatment of metastatic renal cell carcinoma following failure of 1 prior cytokine treatment, a 40% tumor response rate (25/63) has been reported (Motzer et al., ASCO 2005, submitted). This analysis describes the patient reported outcomes (PROs) in this trial. Methods: PROs were assessed using the FACIT-Fatigue scale (FACIT-Fatigue, score range = 0–52) and the EQ-5D health status visual analogue scale (EQ-VAS, score range = 0–100) in the first four 6-week cycles (4 weeks on treatment, 2 weeks off), weekly for FACIT-Fatigue and at the start and end of each 4-week treatment period for EQ-VAS. Of 63 patients enrolled, 62 participated in the baseline PRO assessment and 37 (59%) provided complete or near-complete data across four 6-week cycles. Results: At baseline, FACIT-Fatigue and EQ-VAS scores of these patients were slightly lower than those of the general population. Baseline FACIT-Fatigue and EQ-VAS scores were associated with baseline performance status (FACIT-Fatigue p<0.001; EQ-VAS, p=0.001) and, marginally, with subsequent response to therapy (partial response/stable disease was associated with less fatigue or better health state; FACIT-Fatigue p=0.169; EQ-VAS p=0.033). FACIT-Fatigue and EQ-VAS scores declined across these four cycles (average change from baseline: FACIT-Fatigue = -2.2, EQ-VAS = -5.87) but these changes are smaller than what is considered ‘minimally important’ for these measures. A pattern of decline and recovery coincided with the 4-week on/2-week off periods in each cycle. Average change from baseline in FACIT-Fatigue and EQ-VAS scores did not differ with response to therapy. Conclusions: SU11248 did not cause significant changes in PROs in this group of patients, although FACIT-Fatigue and EQ-VAS scores declined slightly while patients were on treatment and improved while they were off treatment in the first four cycles. These changes were not correlated with tumor response. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer Pfizer Pfizer