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Purpose <p>Since hand-foot skin reaction (HFSR) is a dose-limiting toxicity associated with certain multikinase inhibitors, prophylactic measures to manage this adverse effect require improvement. This study aimed to evaluate the efficacy of depressurization using hydrocolloid dressing by comparing the effects of adding hydrocolloid dressing to standard prophylactic moisturizing versus moisturizing alone.</p> Methods <p>We conducted a phase 3 randomized self-controlled study for patients with unresectable colorectal cancer, gastrointestinal&#xa0;stromal tumors, or hepatocellular carcinoma who planned to receive either regorafenib or sorafenib. The primary endpoint was an incidence of grade 2 or higher HFSR (soles of the feet only) assessed using NCI CTCAE v.4.0. HFSR grading was performed according to pre-determined criteria, comprising a blinded central review of photographs of the foot, pain intensity (numerical rating scale), and patient-assessed interference score.</p> Results <p>Between January 2019 and January 2021, 50 patients were enrolled. 48/50 patients received regorafenib, and two received sorafenib. The incidence of grade 2 or higher HFSR was significantly lower in the hydrocolloid dressing group than in the control group (20% vs. 50%, <i>p</i> &lt; 0.0001, 95% CI of risk difference: [-42.7%, -17.3%]). Time to grade 2 or higher HFSR was significantly longer in the hydrocolloid dressing group (hazard ratio 0.32, <i>p</i> = 0.0017). The incidence of moderate, severe, or very severe in patient-reported HFSR, assessed using PRO-CTCAE, was also lower in the hydrocolloid dressing group (10% vs. 32%, <i>p</i> = 0.0002).</p> Conclusions <p>Our study showed that the prophylactic use of hydrocolloid dressing was effective for HFSR.</p> Trial Registration <p>J-SUPPORT1701, registered in December 2018 with the University Hospital Medical Information Network (UMIN000034853).</p>

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Efficacy of hydrocolloid dressing for hand-foot skin reaction: J-SUPPORT 1701 APRON trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月23日

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  • Asako Ryu,
  • Sadamoto Zenda,
  • Yoichi Shimizu,
  • Atsuo Takashima,
  • Arata Tsutsumida,
  • Akira Takahashi,
  • Michiko Arai,
  • Chigusa Morizane,
  • Takuhiro Yamaguchi,
  • Yusuke Takagi,
  • Tomoe Mashiko,
  • Tempei Miyaji,
  • Takashi Kawaguchi,
  • Naoya Yamazaki

摘要

Purpose

Since hand-foot skin reaction (HFSR) is a dose-limiting toxicity associated with certain multikinase inhibitors, prophylactic measures to manage this adverse effect require improvement. This study aimed to evaluate the efficacy of depressurization using hydrocolloid dressing by comparing the effects of adding hydrocolloid dressing to standard prophylactic moisturizing versus moisturizing alone.

Methods

We conducted a phase 3 randomized self-controlled study for patients with unresectable colorectal cancer, gastrointestinal stromal tumors, or hepatocellular carcinoma who planned to receive either regorafenib or sorafenib. The primary endpoint was an incidence of grade 2 or higher HFSR (soles of the feet only) assessed using NCI CTCAE v.4.0. HFSR grading was performed according to pre-determined criteria, comprising a blinded central review of photographs of the foot, pain intensity (numerical rating scale), and patient-assessed interference score.

Results

Between January 2019 and January 2021, 50 patients were enrolled. 48/50 patients received regorafenib, and two received sorafenib. The incidence of grade 2 or higher HFSR was significantly lower in the hydrocolloid dressing group than in the control group (20% vs. 50%, p < 0.0001, 95% CI of risk difference: [-42.7%, -17.3%]). Time to grade 2 or higher HFSR was significantly longer in the hydrocolloid dressing group (hazard ratio 0.32, p = 0.0017). The incidence of moderate, severe, or very severe in patient-reported HFSR, assessed using PRO-CTCAE, was also lower in the hydrocolloid dressing group (10% vs. 32%, p = 0.0002).

Conclusions

Our study showed that the prophylactic use of hydrocolloid dressing was effective for HFSR.

Trial Registration

J-SUPPORT1701, registered in December 2018 with the University Hospital Medical Information Network (UMIN000034853).