Evaluation of patient-reported severity of hand-foot syndrome under capecitabine using a Markov modeling approach.

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.

Enhancing adherence to capecitabine chemotherapy by means of multidisciplinary pharmaceutical care.

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.

Minimising treatment-associated risks in systemic cancer therapy.

AIM OF THE REVIEW: To review the consequences of drug-related problems (DRP) in systemic cancer therapy and identify specific contributions of the pharmacist to minimise treatment-associated risks. METHOD: Searches in PubMed, Embase and the Cochrane Library were conducted. Bibliographies of retrieved articles were examined for additional references. Only papers in English between 1980 and 2007 were included. RESULTS: In systemic cancer therapy there is an enormous potential for DRP due to the high toxicity and the complexity of most therapeutic regimens. The most frequently reported DRP can be classified into adverse effects, drug-drug interactions, medication errors, and non-adherence. Pharmacists have enhanced efforts to assure quality and safety in systemic cancer therapy together with other health care providers. In consequence, oncology pharmacy has evolved as a novel specialist discipline. The endeavour to merge and co-ordinate individual activities and services of the pharmacist has led to pharmaceutical care concepts which aim at offering novel solutions to the various DRP. CONCLUSION: Pharmaceutical care for cancer patients should be developed within research projects and integrated into disease management programs in order to ensure broad implementation.

[Pharmacotherapy of a geriatric patient with Parkinson's disease]. / Pharmazeutische Betreuung einer Patientin mit primärem Parkinson- Syndrom.

Geriatric patients are often treated with a variety of drugs. Due to the complex pharmacotherapy there is a high potential of drug-related problems such as drug-drug interactions, adverse effects and medication errors. This article describes how the drug therapy of a geriatric patient with Parkinson's disease was optimized using SOAP notes.