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E-Poster Display

204P - Metformin with neoadjuvant chemotherapy in stage II-III breast cancer: A phase II clinical trial

Date

17 Sep 2020

Session

E-Poster Display

Topics

Cytotoxic Therapy

Tumour Site

Breast Cancer

Presenters

Hend Azazy

Citation

Annals of Oncology (2020) 31 (suppl_4): S303-S339. 10.1016/annonc/annonc267

Authors

H.A. Azazy, N.M. Gado, D.A. Salem, W.R. El-Ghamry

Author affiliations

  • Clinical Oncology (ascod), Ain Shams University Hospital - Faculty of Clinical Medicine and Radiation Oncology, 11331 - Cairo/EG

Resources

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Abstract 204P

Background

Breast cancer is the most common cancer among women, with incidence increasing after the age of 35 until it reaches a peak at 55-64 years. Metformin has an anti-proliferative effect and diabetic patients on metformin have been shown to have a 30% reduction in lifetime risk of all cancers This anti-proliferative effect is the result of direct inhibition of mammalian target of rapamycin (mTOR) activity and direct activation of adenosine monophosphate-activated protein kinase (AMPK). We aimed at evaluating this anti-proliferative effect in terms of overall pathological response (partial and complete), concurrent with standard neoadjuvant chemotherapy in breast cancer.

Methods

Sixty non-diabetic breast cancer patients receiving neoadjuvant chemotherapy (fluorouracil, epirubicin, cyclophosphamide (FEC) then docetaxel ± trastuzumab) were randomized into two arms (thirty in each arm): Arm A: metformin (850 mg bid) starting with neoadjuvant chemotherapy. Arm B: control group receiving neoadjuvant chemotherapy alone.

Results

There was a significant difference between the metformin and control arm in terms of overall pathological complete response(pCR) and partial pathological response (pPR) versus no response (P=0.03). pCR was higher in Arm A, but didn’t reach significance due to the small sample size (P=0.09). Multivariate analysis showed a significantly more pronounced response in the Luminal B subtype of breast cancer (P=0.03) and in grade II tumours (P=0.03). There was no significant difference in overall toxicity or ≥ grade 3 adverse events between both arms; the most common toxicities were vomiting (53.6%), nausea (30.4%) and neutropenia (30.4%).

Conclusions

Metformin has a significant anti-proliferative effect which appears to result in increased pathological response in stage II-III breast cancer when given with neoadjuvant chemotherapy.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Ain Shams University Clinical Oncology Department (ASCOD).

Funding

Ain Shams University Clinical Oncology Department (ASCOD).

Disclosure

All authors have declared no conflicts of interest.

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