Discussion
hand-foot, colorectal cancer, HFSR
COLORECTAL CANCER, SIDE EFFECT
The present study tested whether topical aluminum chloride, which suppresses sweating in the palms and soles, can prevent the development of regorafenib-related HFSR. The results demonstrated that the incidence of grade 3 HFSR, the study’s primary endpoint, was 7.4%, or well below the 20% threshold of previous clinical trials [The regorafenib dosage may be reduced or interrupted or the therapy may be permanently discontinued to manage treatment-related AEs, which typically occur within the first treatment cycle. In a phase III trial of colorectal cancer treatment, the median time to the first occurrence of AEs was 15 days [Previous clinical trials reported the time to HFSR development of any grade as two weeks or less, [The main side effect of topical, aluminum-based, antiperspirant therapy is local skin irritation, which is rarely severe and improves quickly with topical steroids [The present trial has several limitations, including its small sample size; non-randomized, open-label design; low ethnic diversity; and use of historical data to estimate study endpoints. Other important limitations include the lack of comparable data on the incidence of grade 3 HFSR in patients receiving reduced-dosage regorafenib (120 mg) in phase 3 trials; high frequency of regorafenib discontinuation for reasons other than HFSR; low proportion of patients completing the 12-week follow-up period; and assessment of HFSR using NCI-CTACE, version 4.0 without assessing QOL with tools, such as the hand-foot skin reaction and QOL questionnaire [