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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Ganitumab and metformin plus standard neoadjuvant therapy in stage 2/3 breast cancer
npj Breast Cancer, Volume 7, No. 1, Article 131, Year 2021
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Description
I-SPY2 is an adaptively randomized phase 2 clinical trial evaluating novel agents in combination with standard-of-care paclitaxel followed by doxorubicin and cyclophosphamide in the neoadjuvant treatment of breast cancer. Ganitumab is a monoclonal antibody designed to bind and inhibit function of the type I insulin-like growth factor receptor (IGF-1R). Ganitumab was tested in combination with metformin and paclitaxel (PGM) followed by AC compared to standard-of-care alone. While pathologic complete response (pCR) rates were numerically higher in the PGM treatment arm for hormone receptor-negative, HER2-negative breast cancer (32% versus 21%), this small increase did not meet I-SPY’s prespecified threshold for graduation. PGM was associated with increased hyperglycemia and elevated hemoglobin A1c (HbA1c), despite the use of metformin in combination with ganitumab. We evaluated several putative predictive biomarkers of ganitumab response (e.g., IGF-1 ligand score, IGF-1R signature, IGFBP5 expression, baseline HbA1c). None were specific predictors of response to PGM, although several signatures were associated with pCR in both arms. Any further development of anti-IGF-1R therapy will require better control of anti-IGF-1R drug-induced hyperglycemia and the development of more predictive biomarkers. © 2021, The Author(s).
Authors & Co-Authors
Isaacs, Claudine J.
United States, Washington, D.c.
Georgetown University
Yau, Christina
United States, San Francisco
University of California, San Francisco
Wallace, Anne Marie
United States, La Jolla
University of California, San Diego
Pusztai, Lajos
United States, New Haven
Yale University
Tripathy, Debu
United States, Houston
The University of Texas Md Anderson Cancer Center
Petricoin, Emanuel F.
United States, Manassas
George Mason University - Science and Technology Campus
Falkson, Carla Isadora
United States, Rochester
University of Rochester Medical Center
Mukhtar, Rita A.
United States, San Francisco
University of California, San Francisco
Wulfkuhle, Julia D.
United States, Manassas
George Mason University - Science and Technology Campus
Buxton, Meredith Becker
United States, San Francisco
University of California, San Francisco
Sanil, Ashish
United States, Austin
Berry Consultants
Berry, Scott M.
United States, Austin
Berry Consultants
DeMichele, Angela M.
United States, Philadelphia
University of Pennsylvania
Rugo, Hope S.
United States, San Francisco
University of California, San Francisco
Symmans, William F Frasher
United States, Houston
The University of Texas Md Anderson Cancer Center
Berry, Donald A.
Unknown Affiliation
Esserman, Laura J.
United States, San Francisco
University of California, San Francisco
Statistics
Citations: 9
Authors: 17
Affiliations: 22
Identifiers
Doi:
10.1038/s41523-021-00337-2
ISSN:
23744677
Research Areas
Cancer