Abstract：
UNASSIGNED: 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 BinterinTM and the Wnt-antagonist WinhibinTM. The present study aimed to assess the therapeutic effects of ATPC in HFS/HFSR associated with anticancer drugs.
UNASSIGNED: 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 nine weeks. Primary endpoint was the development of grade ≥ 2 HFS/HFSR.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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 nine weeks. Primary endpoint was the development of grade ≥ 2 HFS/HFSR.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
■手足综合征（HFS）和手足皮肤反应（HFSR）是相对常见的毒性，它们会干扰癌症患者的生活质量（QoL）。抗炎三肽乳膏（ATPC）是抗炎三肽的复杂配方，CD99激动剂BinterinTM和Wnt拮抗剂WinhibinTM。本研究旨在评估ATPC在与抗癌药物相关的HFS/HFSR中的治疗效果。
■这是一个单中心，随机化，双盲,安慰剂对照试验。纳入全身抗癌治疗后出现1级HFS/HFSR的患者，并随机分配接受ATPC或安慰剂乳膏（PC），并以3周的间隔进行随访，为期9周。主要终点是≥2级HFS/HFSR的发展。
■在2019年4月至2022年7月之间，有60名患者（ATPC组31名，PC组29名）完成了研究。ATPC组≥2级HFS/HFSR的发生率显着低于PC组（25.8％vs.51.7%,p=0.039)。ATPC显示出更好的QoL评分趋势，通过9周时的HFSR和QoL问卷评估（26.0vs.29.9，p=0.574），中断的频率较低，中断,或抗癌药物的剂量减少（51.6%vs.58.6%,p=0.586）比PC组超过9周，但没有统计学意义。
■我们的结果表明，在已经患有HFS/HFSR的患者中，ATPC显着降低了≥2级HFS/HFSR的发展。因此,ATPC可能是与抗癌药物相关的HFS/HFSR的有效治疗方法。
■这是一个单中心，随机化，双盲,安慰剂对照试验。纳入全身抗癌治疗后出现1级HFS/HFSR的患者，并随机分配接受ATPC或安慰剂乳膏（PC），并以3周的间隔进行随访，为期9周。主要终点是≥2级HFS/HFSR的发展。
■在2019年4月至2022年7月之间，有60名患者（ATPC组31名，PC组29名）完成了研究。ATPC组≥2级HFS/HFSR的发生率显着低于PC组（25.8％vs.51.7%,p=0.039)。ATPC显示出更好的QoL评分趋势，通过9周时的HFSR和QoL问卷评估（26.0vs.29.9，p=0.574），中断的频率较低，中断,或抗癌药物的剂量减少（51.6%vs.58.6%,p=0.586）比PC组超过9周，但没有统计学意义。
■我们的结果表明，在已经患有HFS/HFSR的患者中，ATPC显着降低了≥2级HFS/HFSR的发展。因此,ATPC可能是与抗癌药物相关的HFS/HFSR的有效治疗方法。
