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Safety of generic capecitabine Kapetral as maintenance therapy in metastatic colorectal cancer

Maintenance therapy is continued use of less potent and toxic drugs when maximum response stabilizes after fi rst-line chemotherapy. It can signifi cantly prolong progression-free survival while maintain an acceptable safety profi le and improve QoL. Capecitabine is an oral chemotherapy prodrug that is enzymatically converted to 5-fl uorouracil, preferentially in tumor tissue through exploitation of higher intratumoral concentrations of thymidine phosphorylase. The aim of this study was to evaluate safety of generic capecitabine as maintenance therapy after fi rst-line chemotherapy in metastatic colorectal cancer. From 10/2016. - 3/2017. we followed and retrospectively analyzed data from 56 patients who were receiving Kapetral as maintenance therapy for metastatic colorectal cancer after 8 cycles of irinotecanbased induction chemotherapy. Initial capecitabine dose was 1250 mg/m2 taken twice daily during 14 days in three week cycle. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0, 2010). Dose of capecitabine was reduced according to spc recommendations. More then half patients receiving Kapetral had hand and foot syndrome (52%), 36% had diarrhea, 12, 5% hyperbilirubinemia, 14% abdominal cramps, 5% abdominal pain, 9% fatigue, 9% elevated transaminase, 5% hyperlacrimation and 4% of patients had chest tightness. Main dose limiting capecitabine monotherapy adverse events were hand and foot syndrome (34%) and diarrhea (12, 5%). Adverse events were more frequent in females and elderly patients (>65y). The most common dose- limiting capecitabine monotherapy adverse eff ects are hand-foot syndrome and diarrhea and they can signifi cantly diminish quality of life. It is very important to monitor and report adverse events in our everyday practice.

capecitabine, safety, maintenance therapy, colorectal cancer

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