“No problem” health-related quality of life (HRQoL) in patients treated with regorafenib (Reg) for relapsed metastatic colorectal cancer (mCRC).

Abstract

e15593 Background: REG has been shown to improve survival and delay time to quality of life deterioration over placebo (PBO) in two large randomized, double-blind, placebo-controlled multi-center phase III trials CORRECT and CONCUR for the treatment of relapsed mCRC. We report on findings of the five-dimensions of HRQoL in the two trials. Methods: The five key dimensions of HRQoL were captured in the CORRECT and CONCUR trials using EuroQol 5-Dimension questionnaire 3-level version (EQ-5D-3L). The 5 dimensions are mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, severe problems. We calculated the proportion of intent-to-treat (ITT) patients reporting “no problems” (NP) in each of the 5 dimensions by cycle and arm of treatment in the two trials. Results: Detailed descriptions of the trials have been reported previously. Due to space, data below focuses on CORRECT. ITT patients included 760 total in the CORRECT trial, 2:1 randomized to receive REG (N=505) and PBO (N=255). At baseline (BL), 95% of the ITT patients completed the questionnaire (Table), and patients reported the highest percentage of NP in self-care (87%) and lowest in pain/discomfort (35%). EQ-5D completion rates decline with each cycle of treatment, as are the percentages reporting NP in each dimension. The declines however appeared much more rapid for PBO than for REG. Both completion rate and percentages of NP were somewhat higher for PBO than for REG at BL, this continued until only cycle 2 and reversed completely from cycle 3 onward showing increasingly diminished proportion of those on PBO able to complete the questionnaire and reporting NP in each dimension. The differences between arms became larger with each cycle beginning cycle 3. Findings were similar for CONCUR (not shown). Conclusions: REG appeared to enable patients to maintain their mobility, self-care, usual activity, being pain-free and anxiety-free as well as their ability to complete the EQ-5D questionnaire, at much higher rates than PBO. Those whose EQ-5D were no longer available were likely poor performers that discontinued due to progression, death, toxicity or other unfavorable factors associated with their treatments. For PBO, toxicity was unlikely the reason. These findings suggest REG has a positive impact on quality of survival, as well as on length of survival. Further confirmatory analyses are needed.[Table: see text]