Daily regorafenib better tolerated than intermittent dosing in GIST
Regorafenib at 120 mg daily is the preferred dosing pattern for gastrointestinal stromal tumour (GIST) compared to the standard intermittent dosing and yields comparable efficacy with better tolerability, a new study shows.
The study included 28 GIST patients (mean age at therapy 58±14.7 years; 60.7 percent male) who received regorafenib at a 120 mg continuous daily dosing schedule (79 percent; n=22) or at the standard intermittent dosing schedule (21 percent; n=6).
The Choi and Response Evaluation Criteria in Solid Tumours (RECIST) criteria were used to determine tumour response to treatment. Kaplan-Meier analysis was performed to determine overall survival (OS) and progression-free survival (PFS).
Over a median follow-up period of 26.8 months, 19 patients (n=68 percent) died. The median OS period after therapy initiation was 18.3 months. The median PFS after initiation of therapy was 9.4 months, and 89 percent (n=28) of the patients either died or progressed.
Stable disease was reported in 32 percent of the patients, and the treatment response rate was 39 percent.
In the RECIST criteria, the best overall response rate (ORR) was 4 percent (n=1) with a recorded time to response of 4 months. At the first follow-up 2 months after treatment initiation, the response rate was 0 percent. Disease control rate (DCR) was 71.4 percent (n=20).
In the Choi criteria, best ORR and DCR was 29 percent (n=8) and 71.4 percent (n=20), respectively. In both criteria, none of the responses recorded were complete responses.
Any-grade adverse events (AE) were reported in 93 percent (n=26) of the patients, while grade 3/4 AEs were reported in 43 percent (n=12). The most common any-grade AE was hand-foot syndrome, observed in 61 percent of patients. This was followed by fatigue (50 percent) and weight loss (43 percent).
Half of those on the intermittent dosing schedule discontinued therapy because of AEs, while only 14 percent in the continuous dosing group discontinued.