Patients undergoing treatment for breast or gastrointestinal cancers with the chemotherapy drug capecitabine (Xeloda®) may develop hand-foot syndrome (HFS). A common treatment side-effect, HFS can lead to redness, swelling, skin peeling, and sometimes painful blisters on the palms and soles. Although the syndrome is not life-threatening, it can cause significant discomfort and negatively impact a patient’s quality of life. As a result, doctors must sometimes reduce the capecitabine dose or stop the treatment altogether to manage this issue, which can lessen the drug’s effectiveness.
Traditional treatments like urea-based creams, topical steroids, and emollients have not always provided sufficient relief. Another option, celecoxib (Celebrex®), has shown potential to prevent severe cases of HFS, but its use has been limited due to the risk of serious side effects like heart problems and stomach bleeding.
Now, a groundbreaking international study called D-TORCH, presented at the 2023 American Society of Clinical Oncology annual meeting, investigated the efficacy of the topical solution diclofenac to prevent HFS in patients undergoing capecitabine treatment for breast and gastrointestinal cancers. In the study, 263 patients were split into two groups: one applied diclofenac 1% gel twice daily for three months after starting capecitabine, and the other used a placebo. Investigators then compared the rates of HFS between the two groups.
The results showed that the diclofenac group experienced significantly less HFS. Specifically, only 3.8% of patients in the diclofenac group developed painful blisters, skin peeling, and numbness (grade 2 or higher HFS), compared to 15.0% in the placebo group. Even overall cases of HFS were much lower in the diclofenac group at 6.1%, compared to 18.1% in the placebo group. This difference was observed regardless of patient gender or the type of cancer they had. An important point to note is that fewer patients in the diclofenac group needed to have their capecitabine dose reduced (3.8%) compared to the placebo group (15%), which can have significant implications for the patient’s cancer outcomes.
Given the findings showing a 75% reduction in the risk of developing grade 2 or higher HFS, the authors of the study suggested diclofenac could become the new standard of care for preventing HFS caused by capecitabine. It is worth mentioning that diclofenac was compared to a placebo and not to urea-based creams in the study, making it difficult to ascertain which may be the superior preventative choice in this clinical setting. Nonetheless, this represents a very good new option for patients that is both affordable and readily available over the counter in US pharmacies where it is sold under the brand name Voltaren or as a generic.
It is important to note that further studies are needed to see if diclofenac can prevent HFS caused by other cancer treatments like tyrosine kinase inhibitors (TKIs) or intravenous cytotoxic chemotherapy agents.
You can read more about the study here: Link to Study
