A Randomized, Open-label Phase III Trial of Mapisal® Versus an Urea Hand-foot Cream as Prophylaxis for Capecitabine-induced Hand-foot Syndrome in Patients With Gastrointestinal Tumors or Breast Cancer
Hand-foot syndrome (HFS) is a frequently occurring, often dose limiting, dermatologic
reaction associated with cytotoxic agents, such as capecitabine, liposomal doxorubicin, and
Adverse events affecting the integument have posed significant challenges to oncologists in
recent years in terms of selecting appropriate supportive therapies. Not only medications
that inhibit EGFR receptors such as erlotinib, gefitinib, panitumumab or cetuximab, but also
multiple-receptor tyrosine kinase inhibitors such as sunitinib and sorafenib and other
"older" medications such as capecitabine can often lead to skin-related adverse events that
can be difficult to manage.
These adverse events compromise skin-related quality of life and can lead to dose
compromises or even the termination of treatment.
To date, there are no side effects reported for the use of either Mapisal® or urea hand-foot
cream, making both treatments safe. Given the potential benefits of the treatments in
preventing HFS by reducing discomfort and impairment of quality of life, the conduct of the
trial is regarded as justifiable and there is no indication that patients are exposed to an
increased risk associated with study participation.
Deniz Gencer, Dr.
Germany: German Institute of Medical Documentation and Information