Cancer Res Treat.  2024 Oct;56(4):1050-1057. 10.4143/crt.2024.080.

Therapeutic Effect of Anti-inflammatory Tripeptide Cream in Hand-Foot Syndrome/Skin Reaction Related to Anticancer Drugs: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

• Yang Y
• Hahn JH
• Kim MS
• Jo M
• Lee YP
• Kim H
• Kim HK
• Kwon J
• Lee KH
• Han HS

• KMID: 2560239
• DOI: http://doi.org/10.4143/crt.2024.080

Abstract

Purpose
Hand-foot syndrome (HFS) and hand-foot skin reaction (HFSR) are relatively common toxicities that interfere with the quality of life (QoL) of patients with cancer. Anti-inflammatory tripeptide cream (ATPC) is a complex formulation of anti-inflammatory tripeptides, the CD99-agonist Binterin and the Wnt-antagonist Winhibin. The present study aimed to assess the therapeutic effects of ATPC in HFS/HFSR associated with anticancer drugs.
Materials and Methods
This was a single-center, randomized, double-blind, placebo-controlled trial. Patients who developed grade 1 HFS/HFSR after systemic anticancer treatments were enrolled, and randomly assigned to receive either ATPC or placebo cream (PC) and followed up at 3-week intervals for up to 9 weeks. Primary endpoint was the development of grade ≥ 2 HFS/HFSR.
Results
Between April 2019 and July 2022, 60 patients (31 in the ATPC and 29 in the PC group) completed the study. The incidence of grade ≥ 2 HFS/HFSR was significantly lower in the ATPC than in the PC group (25.8% vs. 51.7%, p=0.039). The ATPC showed trends towards a better QoL score, assessed by a HFSR and QoL questionnaire 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 over 9 weeks, though without statistical significance.
Conclusion
Our results showed that ATPC significantly decreased the development of grade ≥ 2 HFS/HFSR in patients already with HFS/HFSR. Therefore, ATPC may be an effective treatment for HFS/HFSR associated with anticancer drugs.

Keyword

Hand-foot syndrome; Hand-foot skin reaction; Anticancer drug; Anti-inflammatory tripeptide cream

Figure

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  Fig. 1. Study design. HF-QoL, hand-foot skin reaction and quality of life; HFS, hand-foot syndrome; HFSR, hand-foot skin reaction; MKI, multikinase inhibitor; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.

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  Fig. 2. Incidence of grade 2 or higher HFS/HFSR. ATPC, anti-inflammatory tripeptide cream; HFS, hand-foot syndrome; HFSR, hand-foot skin reaction; ns, not significant; PC, placebo cream. *p < 0.05.

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  Fig. 3. HF-QoL score of hands (A), feet (B), daily activities (C), and overall by treatment group (D). ATPC, anti-inflammatory tripeptide cream; HF-QoL, hand-foot skin reaction and quality of life; PC, placebo cream; SD, standard deviation.

Reference

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