Dataset Information

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

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) compared to control arm. Moreover, the left ventricular ejection fraction (LVEF%) in the control arm dropped from a mean of 66.69 ± 4.57 to 62.2 ± 5.22% (p = 0.0004) versus a preserved cardiac function in the metformin arm (64.87 ± 4.84 to 65.94 ± 3.44%, p = 0.2667). Furthermore, fatty liver incidence was significantly lower in metformin compared with control arm (8.33% vs 51.85%, p = 0.001). By contrast, haematological disturbances caused by AC-T were preserved after concurrent metformin administration (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.

SUBMITTER: Serageldin MA

PROVIDER: S-EPMC10220128 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Serageldin Manar A MA Kassem Amira B AB El-Kerm Yasser Y Helmy Maged W MW El-Mas Mahmoud M MM El-Bassiouny Noha A NA

Drug safety 20230502 6

<h4>Background and objective</h4>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.<h4>Patients and methods</h4>Seventy non-diabetic breast cancer patients were randomised to receive either AC-T (adriamycin 60 mg/m<sup> ...[more]

PMID: 37131014

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Dataset Information

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

Background and objective

Patients and methods

Results

Conclusion

Trial registration

Publications

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

Similar Datasets

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