Capecitabine-induced Toxicity: An Outcome Study into Drug Safety

J. (Janneke) Baan, Monique MEM Bos*, Savita U Gonesh-Kisoensingh, IA (Iwan) Meynaar, Jelmer Alsma, Erik Meijer, Arnold G Vulto

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Background: The use of capecitabine has risen exponentially in the Netherlands since 2001. Clinical trials
describe a mild toxicity profile. Because circumstances in daily clinical practice can differ a lot from clinical trial
setting, we performed this retrospective analysis in a large community hospital to verify toxicity in a clinical situation.
Methods: A retrospective cohort study was conducted in patients with malignancies of the gastrointestinal tract
or breast treated with capecitabine in the period of January 2007 to January 2009. Primary study endpoint was the
incidence and severity of capecitabine-induced toxicity in daily clinical practice. Secondary endpoint concerned
determination of risk factors for toxicity due to capecitabine.
Results: Of 281 patients 92% experienced some degree of toxicity. Grade 3-4 toxicity occurred in 30% of
patients receiving monotherapy and in 47% with combination therapy. This was in accordance with the literature.
Type of toxicity varied, but gastro intestinal symptoms and hand foot syndrome were most commonly found. Risk of
toxicity increased with increasing age, independently of creatinine clearance.
Conclusions: Therapy with capecitabine monotherapy or capecitabine containing regiments in daily clinical
practice is accompanied by considerable toxicity, but frequency and severity are consistent with published clinical
trials. More toxicity can be expected with increasing age.
Original languageEnglish
JournalJournal of the Society for Integrative Oncology
Issue number1
Publication statusPublished - 2014


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