Capecitabine to Reduce Nonmelanoma Skin Carcinoma Burden in Solid Organ Transplant Recipients

BACKGROUND: Solidorgan transplant recipients (SOTRs) are at greater risk of nonmelanoma skin cancer (NMSC) than the general population, in large part because of their immunosuppression. Select individual SOTRs demonstrate a rate of tumor development at the upper end of their cohort. Capecitabine, a prodrug converted in the body to 5-fluorouracil (5-FU), may alter the risk for development of NMSC in an individual SOTR with a high rate of tumor development. OBJECTIVE: To report observations of a series of 10 SOTRs treated with capecitabine as adjuvant prevention for high-incidence NMSC. METHODS: Ten SOTRs were administered cycles of low-dose oral capecitabine (0.5-1.5 g/m(2) per day) for days 1 to 14 of a 21-day treatment cycle. Measurements (skin screenings, laboratory and toxicity monitoring) were performed every 1 to 3 months. Incidence rates of squamous cell carcinoma (SCC) before and during treatment were determined and compared using the Wilcoxon signed-rank test. RESULTS: The average incidence rate (mean ± SD) of SCC before treatment (0.56 ± 0.28 SCCs/month, range 0.17-1.17 SCCs/month) declined to 0.16 ± 0.11 SCCs/month (range 0-0.33 SCCs/month) during the first 12 months of treatment (mean reduction 68 ± 30.0%, range 0-100%, p < .005). Reduction in actinic keratosis was observed. Common side effects included fatigue, nausea, hand-and-foot syndrome, gout, and poor renal function. Seven of 10 participants required dose adjustment, and two of these were discontinued from the study drug because of side effects. LIMITATIONS: Case series design, small observational population. CONCLUSIONS: SOTRs experienced a clinically and statistically significant decline in incident SCCs during treatment with low-dose oral capecitabine, with varying degrees of side effects. Larger randomized trials will determine the dose and efficacy of capecitabine for adjuvant treatment of NMSC in SOTRs.