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  • / Effect of metformin versus placebo on weight and metabolic factors in initial patients enrolled onto NCIC CTG MA.32, a multicenter adjuvant randomized controlled trial in early-stage breast cancer (BC).

Effect of metformin versus placebo on weight and metabolic factors in initial patients enrolled onto NCIC CTG MA.32, a multicenter adjuvant randomized controlled trial in early-stage breast cancer (BC).

Abstract Poster

Authors

null

Pamela Jean Goodwin

Samuel Lunenfeld Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada

Pamela Jean Goodwin , Wendy Parulekar , Karen A. Gelmon , Lois E. Shepherd , Jennifer A. Ligibel , Dawn L. Hershman , Priya Rastogi , Ingrid A. Mayer , Timothy J. Hobday , Julie Lemieux , Alastair Mark Thompson , Kathleen I. Pritchard , Timothy Joseph Whelan , Som Dave Mukherjee , Haji I. Chalchal , Conrad D. Oja , Katia Sonia Tonkin , Vanessa Bernstein , Bingshu E Chen , Vuk Stambolic

Organizations

Samuel Lunenfeld Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, NCIC Clinical Trials Group, Cancer Research Institute, Queen's University, Kingston, ON, Canada, NCIC Clinical Trials Group, British Columbia Cancer Agency, University of British Columbia, Vancouver, BC, Canada, Dana-Farber Cancer Institute/Harvard Medical School, Boston, MA, Columbia University Medical Center, New York, NY, National Surgical Adjuvant Breast and Bowel Project and University of Pittsburgh Cancer Institute, Pittsburgh, PA, Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, TN, Mayo Clinic College of Medicine, Rochester, MN, Centre de recherche du CHU de Québec, Unité de recherche en santé des populations Hôpital du Saint-Sacrement, Quebec, QC, Canada, National Cancer Research Institute Breast Clinical Studies Group, London, United Kingdom, Odette Cancer Centre, Sunnybrook Health Sciences Centre; University of Toronto, Toronto, ON, Canada, Juravinski Cancer Centre at Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada, Allan Blair Cancer Center, Regina, SK, Canada, British Columbia Cancer Agency, Fraser Valley Center, Surrey, BC, Canada, University of Alberta, Cross Cancer Institute, Edmonton, AB, Canada, British Columbia Cancer Agency, Vancouver Island Center, University of British Columbia, Vancouver, BC, Canada, Ontario Cancer Institute, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto, ON, Canada

Research Funding

Other

Background: MA.32 investigates effects of Metformin vs. Placebo, in addition to standard care, on invasive disease free survival and other outcomes. Metformin may improve obesity and metabolic factors [insulin, glucose, leptin, C-reactive protein (CRP)] that have been associated with poor BC outcomes. Maintaining blinding of investigators to outcomes, we conducted a planned, DSMB approved, analysis of the effect of Metformin vs. Placebo on weight and metabolic factors at 6 months, including examination of interactions with baseline body mass index (BMI), in the first 498 subjects with paired fasting plasma samples. Methods: 498 non-diabetic subjects with T1-3, N0-3, M0 BC meeting defined entry criteria who had completed surgery and adjuvant chemo (if given) provided fasting blood samples at randomization and 6 months (while on study drug). Glucose was measured locally; blood was aliquoted, frozen and stored at -80°C then shipped to NCIC CTG (Kingston, Canada). Paired plasma aliquots were shipped to Mount Sinai Hospital (Toronto, Canada) for analysis of Insulin (Dako), hsCRP (Roche Elecsys) and leptin (Luminex). Statistical analysis used the Wilcoxon signed rank test. Results: Mean age was 52.4 ±9.2 years. Arms were balanced for ER/PgR (63% pos), BMI, prior adjuvant chemo (89%), T and N status, grade, mastectomy/lumpectomy and radiation. Conclusions: Metformin significantly improved weight, insulin, glucose, leptin and CRP at 6 months. Effects did not vary by baseline BMI. Funded by: NIH, CCSRI, CBCF, BCRF, Apotex Canada (drug & placebo - in kind). Clinical trial information: NCT01101438.

Baseline
 Change
(6 months-baseline)
 Interaction
of change with
baseline BMI
Metformin Placebo P Metformin Placebo P P
Weight (kg) 75.6±15.4 76.3±16.7 0.88 -1.96±3.5 +0.37±3.1 <0.0001 0.42
BMI (kg/m2) 28.2±5.4 28.5±5.9 0.91 -0.74±1.3 +0.14±1.3 <0.0001 —
Glucose (mmol/L) 5.3±0.6 5.2±0.6 0.24 -0.1±7.0 0.03±0.61 <0.0001 0.74
Insulin (pmol/L) 67.7±51.8 71.3±63.4 0.88 -7.74±50.9 -1.46±55.5 0.017 0.98
Leptin (ng/ml) 15.7±13.2 16.2±13.2 0.78 -1.52±7.4 1.42±6.5 <0.0001 0.61
CRP (mg/L) 2.73±3.93 2.64±3.68 0.72 -0.20±4.0 0.80±7.8 0.007 0.23

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Abstract Details

Meeting

2013 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Breast Cancer - Triple-Negative/Cytotoxics/Local Therapy

Track

Breast Cancer

Sub Track

Triple-Negative Breast Cancer

Clinical Trial Registration Number

# NCT01101438

Citation

J Clin Oncol 31, 2013 (suppl; abstr 1033)

DOI

10.1200/jco.2013.31.15_suppl.1033

Abstract #

1033

Poster Bd #

25

Abstract Disclosures

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