Introduction Hand�foot syndrome (HFS) is a limiting toxicity of capecitabine, which is not life-threatening but could compromise capecitabine efficacy.
Materials and methods This phase II, multicenter, non-controlled study assessed the safety, particularly grade three HFS incidence, and efficacy of four capecitabine-based chemotherapy regimens [cisplatin/capecitabine (CX), epirubicin/cisplatin/capecitabine (ECX), epirubicin/oxaliplatin/capecitabine (EOX) and docetaxel/cisplatin/capecitabine (DCX)] as first-line treatment for advanced and/or metastatic gastric cancer.
Results One hundred and eight patients were assigned to one of the four treatment groups, according to investigator�s criteria, and grouped together for both safety and efficacy primary analyses. HFS was reported in 31 patients (19.6 %) and its first presentation occurred at a median of 72 days (range 19�209 days). Grade 3 HFS developed in 6.3, 5.2, 3.7 and 2.4 %, of patients receiving ECX, DCX, EOX or CX chemotherapy regimen, respectively. Capecitabine dose reduction/discontinuation due to HFS was required in 5.7 % of patients (9/158). The most common (>10 %) grade 3�4 treatment-related AEs were neutropenia (15.2 %), asthenia (12.0 %) and diarrhoea (11.4 %).
Conclusions A moderate incidence of HFS was reported in patients treated with capecitabine, which generally presented late and required dose reduction in <1/3 of patients. The results suggest that capecitabine may be useful in combination with standard fluorouracil-based regimens in patients with advanced and/or metastatic gastric cancer with favourable safety profile.
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