Prevalence, Clinical Characteristics, and Factors Associated with Capecitabine-Induced Hand-Foot Syndrome in Patients with Cancer: Evidence from Sudan.

Abstract

Background: Hand‒foot syndrome (HFS) is a common cutaneous toxicity of capecitabine that can impair treatment continuity and quality of life. This study aimed to assess the prevalence, clinical characteristics, and factors associated with capecitabine-induced HFS.

Methods: A cross-sectional analytical study was conducted at Khartoum Oncology Hospital, Sudan (June-October 2022), among adult patients with cancer receiving capecitabine monotherapy. Hand‒foot syndrome was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events and a modified Black Patient Scale. Multivariable logistic regression was used to identify factors associated with HFS, with adjusted odds ratios (aORs) and 95% confidence intervals (CIs) reported. Data analysis was performed using SPSS version 27.

Results: A total of 135 patients were included in the analysis, 90 (66.7%) of whom were female and 52 (38.5%) were aged 56-70 years. The most common cancer type was breast cancer (n = 56) [41.5%]. The overall prevalence of HFS was 74 (54.8%), with 37 (50.0%) involving the hands only and 28 (37.8%) involving both the hands and feet. Onset occurred within 7-21 days in 47 (63.5%) patients. Pain was reported by 41 (30.4%), predominantly moderate by 20 (48.8). Grade I was the most frequent by National Cancer Institute criteria (n = 33) [44.5%] and the Black Patient Scale (n = 33) [44.5%]. Hand‒foot syndrome was more prevalent in female patients (n = 58) [64.4%, p = 0.001], patients with breast cancer (n = 35) [62.5%] (p = 0.049), and those receiving > 6 cycles (n = 6) [75%] (p = 0.006). After adjustment, female sex (aOR = 0.224, 95% CI 0.074-0.681; p = 0.008), patients without concomitant diseases (aOR = 2.389, 95% CI 1.011-5.646; p = 0.047), and patients receiving 4-6 cycles compared with those receiving 1-3 cycles (aOR = 0.359, 95% CI 0.155-0.828; p = 0.016) were independent predictors.

Conclusions: Capecitabine-induced HFS affects more than half of patients and generally occurs early in onset. After adjustment, female patients and those who received 4-6 chemotherapy cycles were less likely to experience HFS, whereas the absence of concomitant diseases was associated with a greater likelihood of developing HFS. Early monitoring and proactive supportive care remain essential to optimize treatment continuity.