Trial reportGynecologic oncology2025
A randomized phase II/III study of paclitaxel/carboplatin/metformin versus paclitaxel/carboplatin/placebo as initial therapy for measurable stage III or IVA, stage IVB, or recurrent endometrial cancer: An NRG oncology/GOG study.
Trial report in Gynecologic oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Efficacy of metformin as an adjuvant therapy in gynecologic malignancies: a meta-analysis of randomized controlled trials.Frontiers in pharmacology · 2026Pooled it
- Efficacy of metformin therapy in patients with cancer: a meta-analysis of 22 randomised controlled trials.BMC medicine · 2022Pooled it
- Beyond Weight Loss: A Comprehensive Review of Integrated Pharmacotherapy and Metabolic Bariatric Surgery in Endometrial Cancer Care.Medicina (Kaunas, Lithuania) · 2026Review
- Redefining the Treatment Landscape of Advanced Endometrial Cancer in the Era of Immunotherapy and Precision Oncology.Cancers · 2026Review
- Review
- Review
- Metabolic adaptations in cancer progression.Physiological reviews · 2026Review
- Comprehensive bioinformatics evaluation uncovers the possible oncogenic contribution of acrylamide to endometrial cancer.Discover oncology · 2025Article
- Updates and controversies in the management of uterine serous carcinoma and uterine carcinosarcoma.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2025Review
- A phase I study of temsirolimus in combination with metformin in patients with advanced or recurrent endometrial cancer.Gynecologic oncology · 2025Article
- Metformin in gynecological disorders: pathogenic insights and therapeutic implications.Frontiers in pharmacology · 2025Review
- Cancer biology in diabetes update: Focusing on antidiabetic drugs.Journal of diabetes investigation · 2024Review
- Accrual Suspensions in Seamless Phase II/III Trials: A Review of NRG Oncology Trials.JCO oncology advances · 2024Article
- Is it still worth pursuing the repurposing of metformin as a cancer therapeutic?British journal of cancer · 2023Review
- The Hippo pathway in endometrial cancer: a potential therapeutic target?Frontiers in oncology · 2023Review
- Review
- Diagnosis and management of an endometrial cancer patient with Cowden syndrome.Gynecologic oncology · 2021Article
- The Effects of NT-1044, a Novel AMPK Activator, on Endometrial Cancer Cell Proliferation, Apoptosis, Cell Stress andFrontiers in oncology · 2021Article
- The emerging role of molecular pathology in directing the systemic treatment of endometrial cancer.Therapeutic advances in medical oncology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
Abstract
introductionWe evaluated the efficacy of the addition of the anti-diabetic drug metformin to standard-of-care paclitaxel and carboplatin (PC) in patients with advanced and recurrent endometrial cancer (EC).
methodsIn this phase II/III trial, EC patients with chemotherapy-naïve stage III/IVA (with measurable disease) and stage IVB or recurrent (with or without measurable disease) disease were randomly assigned to PC/metformin (850 mg BID) versus PC/placebo. Metformin or placebo was continued as maintenance therapy after completion of PC until disease progression. The primary endpoint of phase II was progression-free survival (PFS). The primary endpoint of phase III was overall survival (OS). Secondary endpoints were objective response, duration of response, and toxicity.
resultsFrom 3/17/2014 to 12/22/2017, 448 patients were randomized to phase II/III studies, and the data were frozen for interim analysis. The phase II study deemed metformin worthy of further investigation in the phase III study. The interim phase III analysis stopped accrual for futility on 2/1/2018. The addition of metformin to PC had a slightly higher hazard of death compared to the PC regimen (HR = 1.088; 90% CI 0.803 to 1.475), which was sufficient to close the study early. The PFS had (HR = 0.814; 90% CI 0.635 to 1.043). At a median follow-up of 10 months and 121 deaths, median OS was not determined and 28 months, on PC/placebo and PC/metformin, respectively.
conclusionThe hazard ratios for PFS and OS endpoints was not sufficiently decreased with the addition of metformin to PC to justify continuing the trial.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.