2081P - The therapeutic effect of anti-inflammatory tripeptide cream on hand-foot syndrome related to anticancer drugs: A prospective, randomized, placebo-controlled pilot trial

Background

Hand-foot syndrome (HFS) is a relatively common side effect that often interferes with the quality of life (QoL) in cancer patients. Anti-inflammatory tripeptide cream (ATPC) is a complex formulation of anti-inflammatory tripeptides, CD99 agonist Binterin^TM and Wnt antagonist Winhibin^TM. In the present study, we aimed to assess the therapeutic effects of ATPC on HFS associated with anticancer drugs.

Methods

This study was conducted as a single-center, prospective, randomized, placebo-controlled trial. Patients who developed grade 1 HFS by the National Cancer Institute Common Terminology Criteria for Adverse Events or World Health Organization after treatment with cytotoxic chemotherapeutic agents or multi-kinase inhibitors were enrolled. Patients were randomly assigned to receive ATPC or placebo cream (PC) and followed up with 3-weeks interval for up to 9 weeks. Primary endpoint was the development of grade ≥2 HFS. Secondary endpoints were QoL score assessed by Hand-Foot Skin Reaction and QoL (HF-QoL) questionnaire and the frequency of dose reduction or discontinuation of anticancer drugs related to HFS.

Results

From April 2019 to July 2022, 68 patients were randomized and 60 patients (31 in the ATPC group and 29 in the PC group) completed the study. The incidence of grade ≥2 HFS was significantly lower in the ATPC group than in the PC group (25.8% vs. 51.7%, P=0.039). The ATPC group showed trends towards a better HF-QoL score than at 9 weeks (26.0 vs. 29.9, P=0.574) and a lower frequency of discontinuation, interruption, or dose reduction of anticancer drugs (51.6% vs. 58.6%, P=0.586) than the PC group without statistical significance.

Conclusions

Our results showed that ATPC significantly decreased the development of grade ≥2 HFS in patients with HFS related to anticancer drugs. Therefore, ATPC can be effective treatment for HFS related to anticancer drugs. Further prospective large-scale randomized controlled trial is required to confirm the efficacy of ATPC in cancer patients with HFS.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Korean Society of Medical Oncology.

Disclosure

All authors have declared no conflicts of interest.