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The development of new preventive measures and therapeutic methods in the management of hand-foot syndrome by multi-kinase inhibitors regorafenib (PMTMHFS)

The development of new preventive measures and therapeutic methods in the management of hand-foot syndrome by regorafenib (PMTMHFS)

28

Eligible patients were aged 20 to 99 years; Colorectal cancer patients who are scheduled to be on Regorafenib; Patients who are scheduled to be on the drugs started at 120 mg ; PS 0-1; Written informed consent for this study can be obtained from the patients. Patients were excluded they with fissure or erosion in the palmoplantar area; with a history of sympathectomy.

The target number of 28 patients to be enrolled was achieved. Of the 28 enrolled cases, 1 was untreated and 27 were treated cases. Of the 27 treated cases, treatment was interrupted in 21 cases due to deterioration of the primary disease, hand-foot syndrome or patient refusal of treatment, while treatment was completed in 6 cases.

There were 16 cases of aluminium chloride adverse events in all grades, with dry skin, desquamation and eczema as adverse events. One of these patients had grade 2 eczema. Grade 2 cases were mild with topical steroids only and treatment could be continued.

The primary endpoint, the incidence of Grade 3 hand-foot syndrome was 7.4% (80% confidence interval: 2.0%-18.5%) and the exact test (lower t-test) for the binomial proportion was statistically significant at p=0.0051, assuming a threshold (mother proportion in the null hypothesis) of 30%. The incidence of the secondary endpoint of all grade for hand-foot syndrome was 66.7% (95% confidence interval: 46.0%-83.5%), the incidence of hand-foot syndrome (Grade 1) was 22.2% (95% confidence interval: 9.6%-42.3%) The proportion of patients whose dose was reduced due to hand-foot syndrome, the proportion of patients whose dose was reduced due to hand-foot syndrome, and the proportion of patients whose medication was 0% (95% confidence interval not calculable), 7.4% (95% confidence interval: 0.9%-24.3%), 7.4% (95% confidence interval: 0.9%-24.3%) of cases discontinued due to hand-foot syndrome, 7.4% (95% confidence interval: 0.9%-24.3%) of cases discontinued due to hand-foot syndrome, 7.4% (95% confidence interval: 0.9%-24.3%) of cases from first regorafenib dose to hand-foot The proportion of cases of adverse reactions due to aluminium chloride up to withdrawal due to syndrome was 3.7% (95% confidence interval: 0.1%-19.0%), and no other defined adverse events (pruritus, bacterial skin infection, candidiasis, folliculitis, tinea, infectious impetigo, viral infection) occurred above Grade 1.

The primary endpoint, the incidence of Grade 3 hand-foot syndrome , was 7.4%, which was statistically significant assuming a threshold of 30%, and therefore the protocol treatment in the study was judged to be effective. However, the study was limited by the large number of patients who discontinued protocol treatment during the course of the study, and it is unclear whether the incidence of Grade 3 hand-foot syndrome would not increase even if those patients were able to continue to complete the protocol.

May. 31, 2022

No

no

https://jrct.niph.go.jp/latest-detail/jRCTs031180096

Nishizawa Aya

Japanese Foundation For Cancer Research

3-8-31 Ariake, Koto-ku, Tokyo 135-8550

aya.nishizawa@jfcr.or.jp

Nishizawa Aya

Japanese Foundation For Cancer Research

3-8-31 Ariake, Koto-ku, Tokyo 135-8550

+81-3-3520-0111

aya.nishizawa@jfcr.or.jp

Complete

Feb. 01, 2019

Interventional

single arm study

open(masking not used)

historical control

single assignment

prevention purpose

1)Colorectal cancer patients who are scheduled to be on Regorafenib
2)Patients are scheduled to be administered the drugs at a dose of 120mg
3) PS0-1
4) Written informed consent for this study can be obtained from the patients.

1) Patients with fissure or erosion in the palmoplantar area
2) Patients with a history of sympathectomy

Both

Colorectal cancer

Effectiveness of prevention of hand-foot syndrome associated with Regorafenib by using aluminum chloride and wound dressing

Incidence of Grade 3 HFS

Incidence of hand-foot syndrome including all grades, duration until the initial presentation of hand-foot syndrome, duration until the presentaion of hand-foot syndrome with more than grade 2, duration between the presentation of hand-foot syndrome with more than grade 2 and the improvement in the symptoms with the grade decreased to grade 1 or 0, the incidence of cases with reducing the dose of Regorafenib due to hand-foot syndrome, incidence of drug withdrawal due to hand-foot syndrome, the incidence of cases with treatment withdrawal due to hand-foot syndrome, incidence of discontinue medication of regorafenib due to hand-foot syndrome, incidence of side effects by alminum chloride

+81-3-5803-4575

Dec. 21, 2018

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