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CP-096 Adverse drug effects related to generic capecitabine in comparision with xeloda
  1. M Miarons1,
  2. R Querol2,
  3. Q Moreno1,
  4. S Marín1,
  5. L Campins1,
  6. T Gurrera1
  1. 1Mataro Hospital, Pharmacy Department, Mataro, Spain
  2. 2Mataro Hospital, Oncology Department, Mataro, Spain


Background 5-Fluorouracil (5-FU) is among the most commonly used chemotherapy drugs in oncology practice. Common toxicities of 5-FU and capecitabine include diarrhoea, mucositis and myelosuppression. Capecitabine (Xeloda) is an oral prodrug of 5-FU and is increasingly replacing infusional and bolus intravenous 5-FU.

Purpose The aim of this study s to assess the adverse drug effects (ADE) in all patients treated with generic capecitabine in our hospital compared with those reported for Xeloda.

Material and methods A retrospective observational study of patients treated with capecitabine for any indication over a period of 18 months (March 2014 to November 2015) was carried out. Data were collected from medical records which also stored patient characteristics, their disease, regimen received and ADE graded according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC-CTC).

Results 53 patients were included with a mean age of 68. 51% were women. 32 patients were receiving capecitabine monotherapy, 13 capecitabine and oxaliplatine, 3 bevacizumab, 4 radiotherapy and 3 mitomicine. Capecitabine was used to treat colorectal cancer in 39 patients (73.6%), breast cancer in 8 (15.1%), pancreatic cancer in 4 (7.5%), upper gastrointestinal cancer in 1 (1.9%) and ovarian cancer in 1 (1.9%). Regarding all patients, 8 (15.1%) had their dose reduced and 11 (20.8%) stopped treatment. Moreover, this occurred more frequently when capecitabine was associated with another chemotherapy. The main ADE were: diarrhoea 10 (19%), hand–foot syndrome grade 2 or more 8 (24.5%) and asthenia 5 (9%), whereas the most commonly reported adverse event (all grades) in all studies of Xeloda were hand–foot syndrome followed by diarrhoea and nausea and vomiting, and were generally slightly higher.

Conclusion We can conclude that: we saw slightly fewer ADE in our patients treated with capecitabine compared with what is reported for Xeloda; ADE occurred more frequently when capecitabine was associated with another chemotherapy; and capecitabine is a useful treatment, but careful monitoring during the first and subsequent cycles of treatment is recommended for all patients.

No conflict of interest

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