Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
Efficacy of hydrocolloid dressing for hand-foot skin reaction: J-SUPPORT 1701 APRON trial.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Ryu Asako, Zenda Sadamoto, Shimizu Yoichi, Takashima Atsuo, Tsutsumida Arata, Takahashi Akira, Arai Michiko, Morizane Chigusa, Yamaguchi Takuhiro, Takagi Yusuke, Mashiko Tomoe, Miyaji Tempei, Kawaguchi Takashi, Yamazaki Naoya
Аннотация
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).
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).