PMID- 27848234 OWN - NLM STAT- MEDLINE DCOM- 20170503 LR - 20181113 IS - 1179-6901 (Electronic) IS - 1174-5886 (Print) IS - 1174-5886 (Linking) VI - 17 IP - 1 DP - 2017 Mar TI - Tolerability of Capecitabine Monotherapy in Metastatic Colorectal Cancer: A Real-World Study. PG - 117-124 LID - 10.1007/s40268-016-0154-8 [doi] AB - 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. FAU - Leicher, Laura W AU - Leicher LW AD - Isala Hospital, Dokter van Heesweg 2, PO Box 10400, 8000 GK, Zwolle, The Netherlands. FAU - de Graaf, Jacques C AU - de Graaf JC AD - Isala Hospital, Dokter van Heesweg 2, PO Box 10400, 8000 GK, Zwolle, The Netherlands. FAU - Coers, Wilko AU - Coers W AD - Meducom BV, Noordspierdijkerweg 185, Spierdijk, The Netherlands. FAU - Tascilar, Metin AU - Tascilar M AD - Isala Hospital, Dokter van Heesweg 2, PO Box 10400, 8000 GK, Zwolle, The Netherlands. FAU - de Groot, Jan Willem B AU - de Groot JW AD - Isala Hospital, Dokter van Heesweg 2, PO Box 10400, 8000 GK, Zwolle, The Netherlands. j.w.b.de.groot@isala.nl. LA - eng PT - Journal Article PL - New Zealand TA - Drugs R D JT - Drugs in R&D JID - 100883647 RN - 6804DJ8Z9U (Capecitabine) SB - IM MH - Aged MH - Aged, 80 and over MH - Capecitabine/administration & dosage/*adverse effects/*therapeutic use MH - Colorectal Neoplasms/*drug therapy/*pathology MH - Dose-Response Relationship, Drug MH - Drug Administration Schedule MH - Female MH - Humans MH - Male MH - Middle Aged MH - Neoplasm Metastasis/*drug therapy MH - Retrospective Studies PMC - PMC5318322 COIS- CONFLICT OF INTEREST: Jan Willem B. de Groot and Wilko Coers have received consulting fees and/or honorarium for writing support from Nordic Pharma International. Laura W. Leicher, Metin Tascilar, and Jacques C. de Graaf have not received any financial or other support. FUNDING: This study was made possible with financial support from Nordic Pharma International. EDAT- 2016/11/17 06:00 MHDA- 2017/05/04 06:00 PMCR- 2016/11/15 CRDT- 2016/11/17 06:00 PHST- 2016/11/17 06:00 [pubmed] PHST- 2017/05/04 06:00 [medline] PHST- 2016/11/17 06:00 [entrez] PHST- 2016/11/15 00:00 [pmc-release] AID - 10.1007/s40268-016-0154-8 [pii] AID - 154 [pii] AID - 10.1007/s40268-016-0154-8 [doi] PST - ppublish SO - Drugs R D. 2017 Mar;17(1):117-124. doi: 10.1007/s40268-016-0154-8.