2.2. Regorafenib Administration and Safety
ADVERSE EVENTS
Regorafenib was administered as a second-line therapy; a total of 48 patients initiated at least one cycle of regorafenib. The average number of cycles initiated per patient was 5.65, and the median was 3. The mean duration of a cycle was 29.46 days per patient. The average duration of regorafenib treatment was 5.46 months. The lowest and highest treatment durations were 0.16 and 27.29 months, respectively.The total dose of regorafenib administered per cycle considering a 160 mg daily dose was 3360 mg, and the mean dose of regorafenib administered per cycle was 2258.01 mg. On average, the number of dose delays per cycle was 0.6 per patient. Treatment was never delayed for 8 (16.7%) patients. Thirty-one (31, 64.6%) out of 48 patients had no more than one dose delay per cycle, 6 (12.5%) had no more than two dose delays per cycle, and three (6.3%) had ≥3 dose delays per cycle. Over half of the dose delays were due to adverse events (AEs). Out of 48 patients, 9 (18.8%) had no more than one dose reduction per cycle, three patients (6.3%) had no more than two dose reductions per cycle, and one (2.1%) had ≥3 dose reductions per cycle. Regorafenib dose reduction was observed, on average, 0.24 times per cycle per patient. Thirty-five (72.9%) out of 48 patients had no dose reduction. Regorafenib dosage was reduced at least once for 9 (18.8%) patients. Three (6.3%) had a maximum of two dose reductions per cycle, and one (2.1%) had ≥3 dose delays per cycle. The number of dose escalations per cycle per patient is 0.14, and 7 (14.6%) patients had at least one dose escalation.