Capecitabine Induced Hand-Foot Syndrome: A Systematic Review of Case Reports

Background Hand-foot syndrome is a common adverse effect of 5-fluorouracil infusion or oral capecitabine. Several types of research have shown that clinical presentations of hand-foot syndrome vary by ethnicity, so we tried to look at the incidence and severity of hand-foot syndrome in individuals receiving infusional 5-fluorouracil or oral capecitabine at a tertiary care hospital in central Kerala, India. Aim To determine the incidence and severity of hand-foot syndrome in cancer patients receiving infusional 5-fluorouracil or oral capecitabine chemotherapy regimen. Methodology A prospective cohort study was conducted at the oncology department of a tertiary care hospital in Kerala, India. Our study subjects were those who underwent chemotherapy with infusional 5-fluorouracil or oral capecitabine and later developed hand-foot syndrome. The patients who developed hand-foot syndrome after chemotherapy were assessed to determine the incidence of hand-foot syndrome. Also, the severity of hand-foot syndrome among cancer patients was estimated using CTCAE version 5.0. Results Out of 104 study participants, 76.90% ( N = 80) of the patients had hand-foot syndrome, whereas 23.07% ( N = 24) did not. The onset of hand-foot syndrome symptoms varied depending on the patient. Most patients (60%) displayed grade-one symptoms in their third cycle. The remaining patients showed grade-one symptoms in cycle one (3.75%), cycle two (17.5%), and cycle four (18.75%). The study also showed t no association between the incidence of hand-foot syndrome and the type of regimen. Conclusion The majority of the patients suffered from hand-foot syndrome. As well, most of the patients were afflicted by grade one hand-foot syndrome.

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Randomized double-blind, placebo-controlled study of topical diclofenac in the prevention of hand-foot syndrome in patients receiving capecitabine (the D-TORCH study)

Santhosh

Kumar

Pramanik

et al. 2022

Trials

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Introduction Hand-foot syndrome (HFS) is a common cutaneous side effect of capecitabine therapy. Apart from oral cyclooxygenase-2 (COX-2) inhibitor (celecoxib), there are no proven strategies for the prevention of HFS. However, celecoxib is associated with significant cardiotoxicity. To date, no study has evaluated the role of topical COX inhibitor, diclofenac. In this study, we aim to compare topical 1% diclofenac gel with placebo in the prevention of capecitabine-induced HFS. Methods This is a randomized, placebo-controlled, double-blind, parallel-group superiority trial: the Diclofenac Topical in Reducing Capecitabine induced HFS (D-TORCH) study. A total of 264 patients with breast and gastrointestinal malignancies will be randomly allocated (stratified by sex and type of therapy [monotherapy or combination regimen with capecitabine]) to receive either 1% topical diclofenac or placebo that will be applied over the palmar and dorsal surface of the hands twice daily whilst taking capecitabine for 12 weeks. The patients will be followed up until the end of four cycles. The primary objective of this study is to compare the effect of topical diclofenac with placebo in preventing HFS (incidence of NCI CTCAEv5.0 grade 2 or higher HFS). The secondary objective is to compare the effect of topical diclofenac with placebo on preventing all grades of HFS (incidence of NCI CTCv5.0 all grade HFS), time to develop HFS (from the start of capecitabine), patient-reported outcomes (PROs) (HF-HRQoL questionnaire), adherence with the application (self-reported), capecitabine dose changes (number of patients with dose modifications due to HFS) and safety profile (NCICTCv5.0 all grade HFS) Discussion The D-TORCH study aims to determine if 1% topical diclofenac reduces the incidence of grade 2 or higher HFS in patients receiving capecitabine. To date, there have been a lot of trials for hand-foot syndrome prevention using agents like pyridoxine, vitamin E, carvedilol, and various polyherbal formulations, but none has been found successful. If the trial meets the primary end point, 1% topical diclofenac will be the new standard of care for HFS prevention. Trial registration Clinical Trials Registry of India CTRI/2021/01/030592. Prospectively registered on January 19, 2021

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Capecitabine Induced Hand-Foot Syndrome: A Systematic Review of Case Reports

Cited by 3 publications

References 26 publications

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Performance of capecitabine in novel combination therapies in colorectal cancer

Incidence and severity of hand-foot syndrome in cancer patients receiving infusional 5-fluorouracil or oral capecitabine-containing chemotherapy regimens

Randomized double-blind, placebo-controlled study of topical diclofenac in the prevention of hand-foot syndrome in patients receiving capecitabine (the D-TORCH study)

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