Tolerability of Capecitabine Monotherapy in Metastatic Colorectal Cancer: A Real-World Study

• Published in: Drugs in R&D Vol. 17; no. 1; pp. 117 - 124
• Main Authors: Leicher, Laura W., de Graaf, Jacques C., Coers, Wilko, Tascilar, Metin, de Groot, Jan Willem B.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.03.2017; Springer Nature B.V
• Subjects: Aged; Aged, 80 and over; Capecitabine - administration & dosage; Capecitabine - adverse effects; Capecitabine - therapeutic use; Colorectal cancer; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - pathology; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Internal Medicine; Male; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Metastasis - drug therapy; Original; Original Research Article; Pharmacology/Toxicology; Pharmacotherapy; Retrospective Studies; Relative Dose Intensity; Dose Reduction; Hematological Adverse Event; Capecitabine Monotherapy; Capecitabine
• ISSN: 1174-5886; 1179-6901
• DOI: 10.1007/s40268-016-0154-8

Background Capecitabine monotherapy is a treatment option for selected patients with metastatic colorectal cancer (mCRC) and is administered to up to 17% of patients. Data are limited with regard to adverse events and dosing practices associated with capecitabine monotherapy in real-world situations. Objectives The aim of this study was to provide real-world data on adverse event rates and dose adjustments/discontinuations associated with capecitabine monotherapy in patients with mCRC. Methods This retrospective study analyzed data from CRC patients scheduled to receive up to eight planned cycles of capecitabine monotherapy between 2009 and 2013 at a single large community hospital in The Netherlands. Data on adverse events (hand-foot syndrome [HFS], gastrointestinal (GI) events, hematological adverse events, and cardiotoxicity), as well as relative dose intensities (RDIs), dose reductions, and discontinuations, were evaluated. Results Data from 86 patients (45 females; mean age at the start of treatment, 69 years) were included. A total of 46.5% of patients experienced HFS and 44.2% experienced a GI event at some time during treatment. Hematological events and cardiotoxicity were rare. Most patients (77%) started at below the recommended dose, and patients at the lowest dose also had the lowest median RDIs. Dose reductions and discontinuations occurred in 15–25% of patients who experienced HFS or GI event over the course of eight cycles. Conclusions HFS and GI events were very common in patients treated with capecitabine monotherapy in a real-world clinical setting. Most patients started treatment at below the recommended dose, and 15–25% of patients who had HFS or a GI event had a dose reduction or discontinuation.