PURPOSE Oral anticancer drugs (eg, kinase inhibitors) play an important role in cancer therapy. However, considerable challenges regarding medication safety of oral anticancer drugs have been reported. Randomized, controlled, multicenter studies on the impact of intensified clinical pharmacological/pharmaceutical care on patient safety and patient treatment perception are lacking. METHODS Patients were eligible for the randomized, multicenter AMBORA study, if they were newly started on any of the oral anticancer drugs approved in 2001 or later without restriction to certain tumor entities. Patients were randomly assigned to receive either standard of care (control group) or an additional, intensified clinical pharmacological/pharmaceutical care, which included medication management and structured patient counseling, over a period of 12 weeks (intervention group). Primary end points were the number of antitumor drug–related problems (ie, side effects and unresolved medication errors) and patient treatment satisfaction with the oral anticancer therapy after 12 weeks measured with the Treatment Satisfaction Questionnaire for Medication, category convenience. RESULTS Two hundred two patients were included. Antitumor drug–related problems were significantly lower in the intervention compared with the control group (3.85 v 5.81 [mean], P < .001). Patient treatment satisfaction was higher in the intervention group (Treatment Satisfaction Questionnaire for Medication, convenience; 91.6 v 74.4 [mean], P < .001). The hazard ratio for the combined end point of severe side effects (Common Terminology Criteria for Adverse Events ≥ 3), treatment discontinuation, unscheduled hospital admission, and death was 0.48 (95% CI, 0.32 to 0.71, P < .001) in favor of the intervention group. CONCLUSION Treatment with oral anticancer drugs is associated with a broad range of medication errors and side effects. An intensified clinical pharmacological/pharmaceutical care has considerable, positive effects on the number of medication errors, patient treatment perception, and severe side effects.

ore than 50 oral anti-cancer drugs have been licensed for use in Germany over the past 20 years. These agents are used for the treatment of a broad spectrum of solid tumors and hematological diseases (Table 1a and b). The anti-cancer properties of many substances are based on the inhibition of protein kinases, which are involved in cell growth and cell differentiation (Table 1a). In Germany, the protein kinase inhibitors have the second highest volume of sales among the group of oncological drugs (e1). Apart from the convenience of oral intake for patients, the research data for the clinical benefit of protein kinase inhibitors are-at least in part-highly convincing (1-3). However, approaches involving oral administration of anti-cancer drugs can present considerable challenges to both patient and treatment team. With intravenous chemotherapy, the entire dose reliably reaches the patient, but with oral intake this is less certain. Inadequate adherence must be assumed in a not inconsiderable proportion of patients: mean non-adherence rates of up to 54% have been described, which may endanger the success of treatment (4-6). About 50% of all oral anti-cancer drugs come with instructions regarding intake in relation to mealtimes, as substance absorption can be increased or decreased by food (7, e2, eTable 1). The patient has a special responsibility to follow the instructions accurately. Moreover, attention must be paid to a variety of potential drug-drug interactions. Many oral anticancer drugs are metabolized by CYP3A4. Inhibitors or inducers of CYP3A4 (see [8]) may reduce the therapeutic effect or elevate the risk of side effects. A retrospective study in the Netherlands found potential drug-drug interactions in 46% of around 900 patients treated with oral anti-cancer drugs; in 16% of patients these were classified as potentially major events (9). The potential consequences of interactions most frequently noted in this study were QT interval prolongation, gastrointestinal effects, or complications affecting the central nervous system (9). Medication errors therefore represent a serious problem in oral anti-cancer treatment (10-12). Characteristic side effects (affecting, for example, the skin, the cardiovascular system, and the gastrointestinal system) must be anticipated whenever oral anti-cancer drugs are used. The wide variety of Summary Background: Many oral anti-cancer drugs have come onto the market in the past 20 years. For example, kinase inhibitors, such as the BCR-ABL and BRAF inhibitors, have markedly improved the treatment of chronic myeloid leukemia and melanoma. In this review, we discuss the special challenges posed by poor adherence, drug-drug interactions with other substances, and side effects, among other problems, and the ways in which these challenges can be met. Methods: A selective search was carried out in PubMed for original and review articles on the safety of new oral anti-cancer drugs. Guidelines and current Summaries of Product Characteristics (SmPC) were also considered in the analysi...

The foundation was not involved in clinical study design, data collection, data analysis or interpretation.