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Cancer Chemother Pharmacol. 2018 Aug;82(2):319-327. doi: 10.1007/s00280-018-3612-x. Epub 2018 Jun 15.

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

Le Saux O1,2,3,4, Bourmaud A5,6,7, Rioufol C5,8,7,9, Colomban O5,7, Guitton J5,7, Schwiertz V8,9, Regnier V5,6,7, You B5,10,7,9, Ranchon F5,8,7,9, Maraval-Gaget R10,9, Girard P5,7,11, Chauvin F5,6,7, Freyer G5,10,7,9, Tod M5,7, Henin E5,7, Trillet-Lenoir V5,10,7,9.

Author information

1
EMR3738, Ciblage Thérapeutique en Oncologie, Faculté de Médecine et de Maïeutique Lyon-Sud Charles Mérieux, Université Claude Bernard, Oullins, France. olivia.le-saux@chu-lyon.fr.
2
Service d'Oncologie Médicale, Centre Hospitalo-Universitaire Lyon-Sud, Pierre-Bénite, France. olivia.le-saux@chu-lyon.fr.
3
Université de Lyon, Lyon, France. olivia.le-saux@chu-lyon.fr.
4
Hospices Civils de Lyon, Lyon, France. olivia.le-saux@chu-lyon.fr.
5
EMR3738, Ciblage Thérapeutique en Oncologie, Faculté de Médecine et de Maïeutique Lyon-Sud Charles Mérieux, Université Claude Bernard, Oullins, France.
6
Hygée center, Lucien Neuwirth Cancer institut, and CIC 14 08 INSERM, Saint Etienne, France.
7
Université de Lyon, Lyon, France.
8
Service pharmaceutique - Unité de pharmacie clinique oncologique, Centre Hospitalo-Universitaire Lyon-Sud, Pierre Bénite, France.
9
Hospices Civils de Lyon, Lyon, France.
10
Service d'Oncologie Médicale, Centre Hospitalo-Universitaire Lyon-Sud, Pierre-Bénite, France.
11
Merck Institute for Pharmacometrics, Merck Serono S.A., Switzerland, a Subsidiary of Merck KGaA, Darmstadt, Germany.

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.

KEYWORDS:

Adherence; Breast cancer; Capecitabine; Colorectal cancer; Oral anticancer drugs; Over-adherence

PMID:
29948022
DOI:
10.1007/s00280-018-3612-x

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