Journal article
Metformin for patients with advanced stage ovarian cancer: A randomized phase II placebo-controlled trial
Gynecologic oncology, Vol.194, pp.18-24
03/2025
DOI: 10.1016/j.ygyno.2025.02.001
PMID: 39923680
Abstract
The primary aim of this study was to determine if metformin, an oral biguanide administered with first-line chemotherapy and continued as maintenance therapy, improves progression-free survival (PFS) for patients with advanced-stage ovarian cancer.
Patients with pathologically confirmed advanced-stage ovarian cancer undergoing primary debulking or neoadjuvant platinum-based chemotherapy followed by surgery were eligible to participate. Patients were randomized 1:1 to receive platinum/taxane-based chemotherapy with metformin 850 mg orally twice per day or placebo, followed by maintenance therapy (metformin or placebo) for two years from the date of randomization.
108 evaluable patients were enrolled; 54 were randomly assigned to metformin, and 54 to placebo. Sixty-six percent (n = 71) received neoadjuvant therapy, 31 % (n = 33) primary debulking surgery, and 88 % (n = 93) had tumors of high-grade serous histology. The primary endpoint, PFS, was not significantly different between the treatment groups (1-sided p-value = 0.31; adjusted hazard ratio [HR] = 0.87, 95 % confidence interval [CI]: 0.56-1.36). Median PFS was 15.4 months (95 % CI: 11.2-23,5) for metformin and 14.3 months (95 % CI: 11.6-18.0) for placebo. Overall survival (OS) was not significantly different (2-sided p-value = 0.21; adjusted HR = 1.49, 95 % CI: 0.86-2.59), with a median of 40.7 months (95 % CI: 28.0-48.2) for metformin versus 43.8 months (95 % CI: 35.3-57.2) for placebo. The addition of metformin was well tolerated, and there were no differences in toxicity between the two groups.
Although it was well-tolerated, adding metformin to first-line platinum/taxane-based therapy does not improve PFS or OS for patients with newly diagnosed advanced stage ovarian cancer.
Details
- Title: Subtitle
- Metformin for patients with advanced stage ovarian cancer: A randomized phase II placebo-controlled trial
- Creators
- Iris L Romero - University of ChicagoErnst Lengyel - University of ChicagoAndrea E Wahner Hendrickson - Mayo ClinicGustavo C Rodriguez - Department of Obstetrics and Gynecology, Endeavor Health, Evanston, IL, United StatesCharles A Leath III - University of Alabama at BirminghamRodney P Rocconi - University of Mississippi Medical CenterMichael J Goodheart - University of IowaSummer Dewdney - Rush University Medical CenterTheodore Karrison - Chicago Department of Public HealthGini F Fleming - University of ChicagoS Diane Yamada - University of Chicago
- Resource Type
- Journal article
- Publication Details
- Gynecologic oncology, Vol.194, pp.18-24
- Publisher
- ACADEMIC PRESS INC ELSEVIER SCIENCE
- DOI
- 10.1016/j.ygyno.2025.02.001
- PMID
- 39923680
- ISSN
- 0090-8258
- eISSN
- 1095-6859
- Grant note
- Harris Family FundMayo Clinic Ovarian Cancer SPORE: P50CA136393, CHI-208331-05 University of Chicago Cancer Center Support Grant: P30CA014599 NIH/NCI: 5U10CA180855, R35CA264619
The generous financial support of the Harris Family Fund sponsored this study. The pre-clinical work that laid the foundation for this clinical trial was supported as a project grant through the Mayo Clinic Ovarian Cancer SPORE (P50CA136393 (Kaufmann, S) Sub award #CHI-208331-05 to GFF, SDY, and EL) . Trial conduct and monitoring supported by University of Chicago Cancer Center Support Grant: P30CA014599. E.L. was supported NIH/NCI grant R35CA264619. CAL was supported in part by NIH/NCI funding (5U10CA180855) .
- Language
- English
- Date published
- 03/2025
- Academic Unit
- Obstetrics and Gynecology
- Record Identifier
- 9984790968902771
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