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      Patients’ self-reported adherence to capecitabine on XELOX treatment in metastatic colorectal cancer: findings from a retrospective cohort analysis

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          Capecitabine plus oxaliplatin (XELOX) has been established as a first-line treatment for metastatic colorectal cancer. Adherence is particularly important with capecitabine to maintain appropriate curative effect. In this study, we monitored the adherence to capecitabine on XELOX treatment and investigated which factors might decrease compliance.


          The study included 242 consecutive patients who received XELOX treatment for metastatic colorectal cancer between October 2009 and March 2012. Adherence to capecitabine was checked by pharmacists with a patient-reported treatment diary at a pharmaceutical outpatient clinic. Adherence rate was defined as the number of times that a patient took capecitabine in a 14-day cycle/28 prescribed doses. We retrospectively surveyed median relative dose intensities of capecitabine and the factors deteriorating adherence across eight cycles from electronic patient records and examined differences in compliance rates according to age.


          The study included 144 male and 98 female patients. The overadherence rate was 1.5% (n=23). The median adherence rate was 93.5% (n=242) in the first cycle of XELOX treatment, which gradually rose to 96.1% (n=148) in the eighth cycle. The median relative dose intensity of capecitabine was 79.2%. The main factors contributing to decreased adherence to capecitabine were diarrhea (22.5%, 352 instances) and nausea/vomiting (13.8%, 215 instances). The rate of missed dose was 12.1%. Analysis of adherence issues in relation to patient age showed a trend toward worse adherence to capecitabine therapy in the group of patients aged ≥80 years (hazard ratio =3.83; 95% confidence interval 2.48–5.91, P<0.001 versus 70–80 years group and versus <70 years group, chi-square test).


          Patient-reported adherence to capecitabine on XELOX treatment in clinical practice is high but adversely affected by side effects. Patients aged 80 years or more exhibit a significant decrease in compliance compared with younger patients.

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          Most cited references 26

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          Patient adherence to treatment: three decades of research. A comprehensive review.

          Low compliance to prescribed medical interventions is an ever present and complex problem, especially for patients with a chronic illness. With increasing numbers of medications shown to do more good than harm when taken as prescibed, low compliance is a major problem in health care. Relevant studies were retrieved through comprehensive searches of different database systems to enable a thorough assessment of the major issues in compliance to prescribed medical interventions. The term compliance is the main term used in this review because the majority of papers reviewed used this term. Three decades have passed since the first workshop on compliance research. It is timely to pause and to reflect on the accumulated knowledge. The enormous amount of quantitative research undertaken is of variable methodological quality, with no gold standard for the measurement of compliance and it is often not clear which type of non-compliance is being studied. Many authors do not even feel the need to define adherence. Often absent in the research on compliance is the patient, although the concordance model points at the importance of the patient's agreement and harmony in the doctor-patient relationship. The backbone of the concordance model is the patient as a decision maker and a cornerstone is professional empathy. Recently, some qualitative research has identified important issues such as the quality of the doctor-patient relationship and patient health beliefs in this context. Because non-compliance remains a major health problem, more high quality studies are needed to assess these aspects and systematic reviews/meta-analyses are required to study the effects of compliance in enhancing the effects of interventions.
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            Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study.

            To compare the response rate, efficacy parameters, and toxicity profile of oral capecitabine with bolus intravenous (IV) fluorouracil plus leucovorin (5-FU/LV) as first-line treatment in patients with metastatic colorectal cancer. We prospectively randomized 605 patients to treatment with oral capecitabine for 14 days every 3 weeks or 5-FU/LV by rapid IV injection daily for 5 days in 4-week cycles. The overall objective tumor response rate among all randomized patients was significantly higher in the capecitabine group (24.8%) than in the 5-FU/LV group (15.5%; P =.005). In the capecitabine and 5-FU/LV groups, median times to disease progression were 4.3 and 4.7 months (log-rank P =.72), median times to treatment failure were 4.1 and 3.1 months (P =.19), and median overall survival times were 12.5 and 13.3 months (P =.974), respectively. Capecitabine, compared with bolus 5-FU/LV treatment, produced a significantly lower incidence (P <.0002) of diarrhea, stomatitis, nausea, and alopecia. Patients treated with capecitabine also displayed lower incidences of grade 3/4 stomatitis and grade 3/4 neutropenia (P <.0001) leading to significantly less neutropenic fever/sepsis. Grade 3 hand-foot syndrome (P <.00001) and grade 3/4 hyperbilirubinemia were the only toxicities more frequently associated with capecitabine than with 5-FU/LV treatment. Oral capecitabine was more active than 5-FU/LV in the induction of objective tumor responses. Time to disease progression and survival were at least equivalent for capecitabine compared with the 5-FU/LV arm. Capecitabine also demonstrated clinically meaningful benefits over bolus 5-FU/LV in terms of tolerability.
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              Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: the ADAGIO study.

              Imatinib mesylate (imatinib) has been shown to be highly efficacious in the treatment of chronic myeloid leukemia (CML). Continuous and adequate dosing is essential for optimal outcomes and with imatinib treatment possibly being lifelong, patient adherence is critical. The ADAGIO (Adherence Assessment with Glivec: Indicators and Outcomes) study aimed to assess prospectively over a 90-day period the prevalence of imatinib nonadherence in patients with CML; to develop a multivariate canonical correlation model of how various determinants may be associated with various measures of nonadherence; and to examine whether treatment response is associated with adherence levels. A total of 202 patients were recruited from 34 centers in Belgium, of whom 169 were evaluable. One-third of patients were considered to be nonadherent. Only 14.2% of patients were perfectly adherent with 100% of prescribed imatinib taken. On average, patients with suboptimal response had significantly higher mean percentages of imatinib not taken (23.2%, standard deviation [SD] = 23.8) than did those with optimal response (7.3%, SD = 19.3, P = .005; percentages calculated as proportions x 100). Nonadherence is more prevalent than patients, physicians, and family members believe it is, and therefore should be assessed routinely. It is associated with poorer response to imatinib. Several determinants may serve as alert signals, many of which are clinically modifiable.

                Author and article information

                Patient Prefer Adherence
                Patient Prefer Adherence
                Patient Preference and Adherence
                Patient preference and adherence
                Dove Medical Press
                09 April 2015
                : 9
                : 561-567
                [1 ]Department of Pharmacy, Hoshi University School of Pharmacy and Pharmaceutical Sciences, Tokyo, Japan
                [2 ]Gastroenterology Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Hoshi University School of Pharmacy and Pharmaceutical Sciences, Tokyo, Japan
                [3 ]Section for Practical Education, Hoshi University School of Pharmacy and Pharmaceutical Sciences, Tokyo, Japan
                Author notes
                Correspondence: Kazuyoshi Kawakami, Japanese Foundation for Cancer Research, Cancer Institute Hospital, Department of Pharmacy, 3-8-31 Ariake Koto-ku, Tokyo 135-8550, Japan, Email kazu.kawakami@ 123456jfcr.or.jp
                © 2015 Kawakami et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Original Research


                pharmaceutical outpatient clinic, oral anticancer drugs


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