The Effect of Metformin on Chemotherapy-Induced Toxicities in Non-diabetic Breast Cancer Patients: A Randomised Controlled Study

Manar A. Serageldin (), Amira B. Kassem, Yasser El-Kerm, Maged W. Helmy, Mahmoud M. El-Mas and Noha A. El-Bassiouny
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Manar A. Serageldin: Alexandria University
Amira B. Kassem: Damanhour University
Yasser El-Kerm: Alexandria University
Maged W. Helmy: Damanhour University
Mahmoud M. El-Mas: Alexandria University
Noha A. El-Bassiouny: Damanhour University

Drug Safety, 2023, vol. 46, issue 6, No 7, 587-599

Abstract: Abstract Background and Objective Breast cancer patients treated with adriamycin-cyclophosphamide plus paclitaxel (AC-T) are often challenged with serious adverse effects for which no effective therapies are available. Here, we investigated whether metformin, an antidiabetic drug with additional pleiotropic effects could favourably offset AC-T induced toxicities. Patients and Methods Seventy non-diabetic breast cancer patients were randomised to receive either AC-T (adriamycin 60 mg/m2 + cyclophosphamide 600 mg/m2 × 4 cycles Q21 days, followed by weekly paclitaxel 80 mg/m2 × 12 cycles) alone or AC-T plus metformin (1700 mg/day). Patients were assessed regularly after each cycle to record the incidence and severity of adverse events based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. Moreover, baseline echocardiography and ultrasonography were done and repeated after the end of neoadjuvant therapy. Results Addition of metformin to AC-T resulted in significantly less incidence and severity of peripheral neuropathy, oral mucositis, and fatigue (p 0.05). Conclusion Metformin offers a therapeutic opportunity for controlling toxicities caused by neoadjuvant chemotherapy in non-diabetic breast cancer patients. Trial Registration This randomised controlled trial was registered on November 20, 2019 in ClinicalTrials.gov under registration number: NCT04170465.

Date: 2023
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DOI: 10.1007/s40264-023-01305-4

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