Concomitant botanical medicine use among patients participating in commercial prostate cancer trials

J K Roydhouse; L A Menapace; H Xia; P Song; T Berman; R Agarwal; D L Suzman; K Wright; J A Beaver; P G Kluetz

doi:10.1016/j.ctim.2020.102549

Concomitant botanical medicine use among patients participating in commercial prostate cancer trials

Complement Ther Med. 2020 Nov:54:102549. doi: 10.1016/j.ctim.2020.102549. Epub 2020 Aug 29.

Authors

J K Roydhouse¹, L A Menapace², H Xia³, P Song³, T Berman⁴, R Agarwal⁵, D L Suzman⁴, K Wright⁶, J A Beaver⁴, P G Kluetz⁷

Affiliations

¹ ORISE Fellow, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, Food and Drug Administration (US FDA), Silver Spring, MD, USA; Menzies Institute for Medical Research, University of Tasmania, Hobart TAS, Australia. Electronic address: jessica.roydhouse@utas.edu.au.
² Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA; National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
³ Division of Clinical Pharmacology, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
⁴ Office of Oncologic Diseases, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
⁵ New Drug Products Branch II, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
⁶ Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
⁷ Oncology Center of Excellence, US FDA, Silver Spring, MD, USA.

PMID: 33183667
DOI: 10.1016/j.ctim.2020.102549

Abstract

Objectives: Patients with cancer frequently use botanical medications. The concomitant use of such medications by patients on commercial trials has not been well-described, despite the importance of these trials for evaluating the safety and efficacy of new agents. We sought to describe the use of botanical medications taken by patients with prostate cancer enrolled on global commercial trials.

Design: Retrospective study.

Setting: Regulatory repository of commercial clinical trial data.

Interventions: Anti-cancer therapy.

Main outcome measures: Botanical and medication use data were pooled across six international commercial randomized trials for metastatic prostate cancer with detailed information on medication and indications. Botanical products were considered to have potential for drug interaction if they led to a change in drug exposure in human trials. Potential for interaction was ascertained by PubMed review. Descriptive statistics were used for analysis.

Results: Of 7318 enrolled patients, 700 (10 %) reported botanical use at any time and 653 (9%) reported use of botanical products while on trial. Nearly half of botanical product types were not classified by plant (43 %). The highest proportion of botanical use was among patients in Asian countries (32 %), followed by patients in North America (13 %). Eighty-six different types of botanical products were used; of these, nineteen had a patient-reported anti-cancer indication.

Conclusions: Botanical medicine use among patients with prostate cancer in commercial trials is moderate, although it varies by region. Practitioners should be aware of the use of botanical interventions in a clinical trial context.

Keywords: Botanical; Clinical trial; Concomitant; Prostate cancer.

MeSH terms

Complementary Therapies / methods*
Complementary Therapies / statistics & numerical data*
Drug Therapy, Combination
Humans
Male
Phytotherapy / methods*
Phytotherapy / statistics & numerical data*
Plant Preparations*
Prostatic Neoplasms / drug therapy*
Randomized Controlled Trials as Topic
Retrospective Studies

Substances

Plant Preparations