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Cancer Chemother Pharmacol ; 86(3): 435-444, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32852627


PURPOSE: The inclusion of the patient's perspective has become increasingly important when reporting adverse events and may assist in management of toxicity. The relationship between drug exposure and toxicity can be quantified by combining Markov elements with pharmacometric models. A minimal continuous-time Markov model (mCTMM) was applied to patient-reported outcomes using hand-foot syndrome (HFS) induced by capecitabine anti-cancer therapy as an example. METHODS: Patient-reported HFS grades over time of 150 patients from two observational studies treated with oral capecitabine were analyzed using a mCTMM approach. Grading of HFS severity was based on the Common Terminology Criteria for Adverse Events. The model was evaluated by visual predictive checks (VPC). Furthermore, a simulation study of the probability of HFS severity over time was performed in which the standard dosing regimen and dose adjustments according to HFS severity were investigated. RESULTS: The VPC of the developed dose-toxicity model indicated an accurate description of HFS severity over time. Individual absolute daily dose was found to be a predictor for HFS. The simulation study demonstrated a reduction of severe HFS using the recommended dose adjustment strategy. CONCLUSION: A minimal continuous-time Markov model was developed based on patient-reported severity of hand-foot syndrome under capecitabine. Thus, a modeling framework for patient-reported outcomes was created which may assist in the optimization of dosage regimens and adjustment strategies aiming at minimizing symptom burden during anti-cancer drug therapy.

Antimetabólitos Antineoplásicos/efeitos adversos , Capecitabina/efeitos adversos , Síndrome Mão-Pé/patologia , Cadeias de Markov , Neoplasias/tratamento farmacológico , Medidas de Resultados Relatados pelo Paciente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Síndrome Mão-Pé/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/patologia , Prognóstico , Estudos Prospectivos
Patient Educ Couns ; 83(3): 367-74, 2011 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-21482061


OBJECTIVE: This study was conducted to define the task allocation in multiprofessional cancer medication management (MCMM) with a special focus on the role of the pharmacist as well as patient education and counseling. The acceptance of the proposed task allocation and the perceptions on multiprofessional teamwork were explored on a national level. METHODS: We held local focus group meetings (University of Bonn with collaboration partners) to identify MCMM tasks. With the Delphi technique the tasks were allocated to physicians, pharmacists and nurses. Professionals (members of the German Cancer Society) were approached nationwide via an online questionnaire to evaluate the acceptance of the MCMM model and explore their perceptions on multiprofessional teamwork. RESULTS: The MCMM model comprised 38 tasks including 11 on patient education and counseling. It was rated to be reasonable (79%) and feasible (68%). Barriers and benefits of multiprofessional teamwork stated were patient-, team-, therapy-, structure-, and resources-related. CONCLUSIONS: The MCMM model integrates the pharmacist with responsibilities in patient education and counseling as well as prevention of drug-related problems. The approach was generally appreciated nationwide by the professions. PRACTICE IMPLICATIONS: The proposed model can serve as a tool to trigger changes in cancer medication management.

Aconselhamento , Conduta do Tratamento Medicamentoso/organização & administração , Equipe de Assistência ao Paciente/organização & administração , Farmacêuticos , Comportamento Cooperativo , Feminino , Grupos Focais , Alemanha , Humanos , Relações Interprofissionais , Masculino , Neoplasias/tratamento farmacológico , Enfermeiras e Enfermeiros , Educação de Pacientes como Assunto , Médicos , Inquéritos e Questionários
Support Care Cancer ; 19(7): 1009-18, 2011 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-20552377


PURPOSE: In this prospective multi-centre observational cohort study, we investigated the effect of an intensified multidisciplinary pharmaceutical care programme on the adherence of cancer patients treated with capecitabine, a prodrug of fluorouracil. PATIENTS AND METHODS: Twenty-four colorectal and 24 breast cancer patients participated in this study. Patients of the control group (n = 24) received standard care, patients of the intervention group (n = 24) received intensified pharmaceutical care consisting of written and spoken information. Adherence to capecitabine chemotherapy was measured using an electronic medication event monitoring system (MEMS™). RESULTS: Patients in the intervention group exhibited an enhanced but not significantly different mean overall adherence compared to the control group (97.9% vs 90.5%, p = 0.069). Mean daily adherence was significantly higher in the intervention group (96.8% vs 87.2%, p = 0.029). Variability of both adherence parameters was considerably reduced when pharmaceutical care was provided. At the end of the observation period of 126 days, the probability of still being treated with capecitabine was found to be 48% in the control group and 83% in the intervention group (p = 0.019, log-rank test). The relative risk for a deviating drug intake interval, i.e. <10 or >14 instead of 12 h, in the intervention group was found to be 0.51 (95% CI, 0.46-0.56) compared with the control group (p < 0.05, Chi-square test). CONCLUSIONS: The provision of intensified pharmaceutical care can enhance adherence to and prolong treatment with capecitabine. The results underline the importance of multidisciplinary care to assure the effectiveness of oral chemotherapy.

Antimetabólitos Antineoplásicos/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias Colorretais/tratamento farmacológico , Desoxicitidina/análogos & derivados , Fluoruracila/análogos & derivados , Adesão à Medicação/estatística & dados numéricos , Equipe de Assistência ao Paciente , Capecitabina , Intervalos de Confiança , Desoxicitidina/uso terapêutico , Feminino , Fluoruracila/uso terapêutico , Alemanha , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Estatística como Assunto , Estatísticas não Paramétricas