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01-08-2018 | Original Article

Over-adherence to capecitabine: a potential safety issue in breast and colorectal cancer patients

Authors: Olivia Le Saux, Aurélie Bourmaud, Catherine Rioufol, Olivier Colomban, Jérôme Guitton, Vérane Schwiertz, Véronique Regnier, Benoit You, Florence Ranchon, Raymonde Maraval-Gaget, Pascal Girard, Franck Chauvin, Gilles Freyer, Michel Tod, Emilie Henin, Véronique Trillet-Lenoir

Published in: Cancer Chemotherapy and Pharmacology | Issue 2/2018

Abstract

Purpose

The aim of the OCTO clinical study was to measure patients’ adherence to capecitabine-based treatment.

Methods

A cohort of ambulatory patients treated with capecitabine monotherapy for either locally advanced or metastatic, breast or colorectal cancer was monitored for 6 cycles. Adherence was assessed in all patients by self-completed questionnaires on disease, pill-count and pharmacological dosage of FBAL (metabolite of capecitabine); and in half of the cohort by electronic medication event monitoring systems (MEMS™) recording the opening times of the device.

Results

Forty patients were enrolled between November 2008 and September 2011 and treated by capecitabine for an average of 4.75 cycles (range 1–6). Hand-foot syndrome (HFS) was the most frequently reported toxicity (35% patients), and to a lesser extent fatigue and/or asthenia (21%), nausea and/or vomiting (13%) and diarrhea (11%). In the MEMS™ cohort, 20 patients were included. Patients’ adherence was excellent with very few missing occasions (23/2272 records). Close analysis of MEMS™ data revealed unexpected medication patterns, such as patients taking extra days of medication beyond planned cycle, patients taking extra doses per day and patients missing a day of dosing and “compensating” by taking extra the following day (N = 7, 18%). A trend was found between over-adherence and high-grade toxicity (grades 3 and/or 4): OR 4.74 [0.65–45.2], p = 0.13 and higher AUC (p = 0.16). There was a trend towards increased AUC of FBAL in over-adherent patients (p = 0.16).

Conclusion

Adherence to oral anticancer chemotherapy was found excellent in this population suggesting over-adherence to capecitabine and potential safety implications for outpatients’ drugs.

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Title: Over-adherence to capecitabine: a potential safety issue in breast and colorectal cancer patients
Authors: Olivia Le Saux
Aurélie Bourmaud
Catherine Rioufol
Olivier Colomban
Jérôme Guitton
Vérane Schwiertz
Véronique Regnier
Benoit You
Florence Ranchon
Raymonde Maraval-Gaget
Pascal Girard
Franck Chauvin
Gilles Freyer
Michel Tod
Emilie Henin
Véronique Trillet-Lenoir
Publication date: 01-08-2018
Publisher: Springer Berlin Heidelberg
Published in: Cancer Chemotherapy and Pharmacology / Issue 2/2018
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-018-3612-x

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Abstract

Purpose

Methods

Results

Conclusion

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