1483P - Prospective observational study to assess the prophylactic effect of topical diclofenac in preventing the development of hand foot syndrome in patients with colorectal and gastric cancer on capecitabine therapy

Background

Hand-foot syndrome (HFS) is a prevalent adverse effect of capecitabine, primarily attributed to an inflammatory response driven by excess cyclooxygenase-2 activity. The D-TORCH study previously suggested that prophylactic application of topical diclofenac could mitigate the incidence of HFS compared to placebo. Our study aims to assess the effectiveness of topical diclofenac in preventing HFS in patients undergoing capecitabine treatment for colorectal and gastric cancers.

Methods

This prospective observational study included patients diagnosed with colorectal and stomach cancer who commenced capecitabine therapy between July 2023 and February 2024. We followed two cohorts: patients receiving topical diclofenac and a control group under observation. An impartial physician examined the participants at each visit. Exclusion criteria encompassed prior capecitabine treatment, concurrent use of anti-inflammatory drugs, dermatological disorders, and capecitabine treatment duration of less than three months.

Results

Of the initial 171 participants, 20 were excluded due to NSAID usage, leaving 151 who completed the study. Prophylactic diclofenac gel was administered to 71 patients (47%), while 80 patients (53%) received no additional treatment. In the diclofenac group, 12 patients (17%) experienced grade 2 or higher HFS, compared to 11 patients (14%) in the observation group (p = 0.199, HR: 1.741 [95% CI: 0.745-4.069]). The incidence of grade 3 side effects was similar in both groups (p: 0.479). HFS, manifested as early as week 3 and as late as week 18, with a median occurrence at 8.8 weeks. The dosage of capecitabine was identical in all groups, with a value of 2000mg/m².

Conclusions

The use of topical diclofenac did not significantly reduce the incidence of HFS in this study. These results provide valuable prospective data, underscoring the need for further studies to definitively evaluate the prophylactic utility of topical diclofenac in managing HFS.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.