In the German AMBORA trial reported in the Journal of Clinical Oncology, Dürr et al found that an intensified clinical pharmacologic/pharmaceutical care initiative reduced medication errors and severe side effects, as well as improved treatment satisfaction, among patients receiving newer oral anticancer drugs.
The multicenter open-label trial included 202 patients (without restriction on tumor type) who were starting treatment with any oral anticancer drugs approved in 2001 or later. Patients were randomly assigned between November 2017 and January 2020 to receive intensified clinical pharmacologic/pharmaceutical care over 12 weeks (intensified-care group, n = 98) or standard of care (n = 104).
In addition to standard of care, the intensified-care group received four counseling sessions (in weeks 0, 1, 4 and 12) involving clinical pharmacologists and clinical pharmacists that focused on medication management, counseling and training, side-effect prevention and management, and adherence counseling. Patients received fact sheets on the oral drug they were receiving and brochures regarding common side effects and patient self-management.
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The primary endpoints were the number of antitumor drug–related problems (side effects and unresolved medication errors) and patient treatment satisfaction with therapy after 12 weeks as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)-convenience category (0–100 scale, 100 = highest satisfaction).
Drug-Related Problems
Drug-related problems were significantly reduced in the intensified-care group vs the control group at 12 weeks; the mean number of problems per patient was 3.85 vs 5.81 (adjusted ratio = 0.67, P < .001). Adjusted ratios were 0.70 (95% confidence interval [CI] = 0.59–0.83) for side effects and 0.10 (95% CI = 0.02–0.28) for unresolved medication errors.
Mean patient treatment satisfaction on the TSQM-convenience scale was 91.6 in the intensified-care group vs 74.4 in the control group (P < .001).
The intensified-care group had a significantly lower risk of the combined endpoint of severe side effects (grade ≥ 3), treatment discontinuation, unscheduled hospital admission, and death at 12 weeks, with a hazard ratio of 0.48 (95% CI = 0.32–0.71, P < .001). The adjusted ratio for severe side effects was 0.35 (95% CI = 0.22–0.54); 19% vs 31% of patients discontinued treatment; and 3% vs 14% had unscheduled hospitalizations (P = .004).
The investigators concluded: “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.”
Martin F. Fromm, MD, of the Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by a German Cancer Aid grant. For full disclosures of the study authors, visit ascopubs.org.
