The Randomized AMBORA Trial: Impact of Pharmacological/Pharmaceutical Care on Medication Safety and Patient-Reported Outcomes During Treatment With New Oral Anticancer Agents

Abstract

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.

Medication Errors During Treatment with New Oral Anticancer Agents: Consequences for Clinical Practice Based on the AMBORA Study

“…For the present study, we performed a new, additional in‐depth analysis on the nature, types, and consequences of all medication errors of the previously published randomized, multicenter AMBORA trial 16 . In brief, the AMBORA trial investigated whether an intensified clinical pharmacological/pharmaceutical care over 12 weeks after therapy initiation with a new oral antitumor therapeutic can improve medication safety and patient‐reported outcomes compared with the standard of care.…”

“…It was conducted in nine independent outpatient clinics of a German university hospital and two oncological practices associated with the Comprehensive Cancer Center Erlangen‐EMN. A detailed description of the study design has previously been published 16 . In brief, patients were randomized in a 1:1 fashion using individual randomization lists for each oral antitumor agent.…”

“…In addition to oral antitumor agents, patients receive an average of approximately five drugs 14–16 . A retrospective study found a prevalence of 1.5 drug‐drug interactions per patient with the involvement of an oral anticancer drug in 47.4% of 898 patients 15 .…”

“…Medication errors related to the oral antitumor drug and the comedication represent a serious medication safety issue 13 and are important concerns in current guidelines 2,17 . Systematic concepts and interventions to detect and resolve problems are rather scarce 8,16 …”

“…In our recent prospective, randomized, multicenter AMBORA trial in patients starting new oral antitumor drugs independent of tumor entity, we showed that support by clinical pharmacologists and clinical pharmacists for both the patients and the treatment team considerably reduced (severe) side effects and medication errors directly related to the new oral antitumor drugs and thereby increased patient safety and patient‐reported outcomes 16 . To the best of our knowledge, this was the first trial with a broad spectrum of new oral antitumor agents that detected medication errors from prescription to drug intake by the patient.…”