ArticleGynecologic oncology2025
A phase I study of temsirolimus in combination with metformin in patients with advanced or recurrent endometrial cancer.
Article in Gynecologic oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01529593 (Phase I Study of Temsirolimus in Combination With Metformin in Patients With Advanced Cancers), which is not on this map. Cited by 3 papers.
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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.
Phase I Study of Temsirolimus in Combination With Metformin in Patients With Advanced Cancers
Who cites it
3 citing papers in PubMed.
- Review
- Does immunotherapy hold great promise in endometrial cancer care?Frontiers in immunology · 2026Review
- From Inflammation to Malignancy: The Link Between Endometriosis and Gynecological Cancers.International journal of molecular sciences · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
Abstract
introductionMolecular alterations in the PI3K/AKT and Ras/Raf/MEK/ERK pathways are frequently observed in patients with endometrial cancers. However, mTOR inhibitors, such as temsirolimus, have modest clinical benefits. In addition to inducing metabolic changes in cells, metformin activates AMPK, which in turn inhibits the mTOR pathway. In this phase 1 clinical trial we hypothesized that combining metformin with temsirolimus would potentiate the antitumor activity against advanced or recurrent endometrial cancer.
methodsThe dose-expansion cohort used a Simon Minimax two-stage design. The objectives of the endometrial cancer expansion cohort were to evaluate the clinical tumor response, as indicated by the objective response and clinical benefit rates, as well as an ongoing safety assessment of the combination treatment.
resultsForty patients were enrolled in this study. The most common treatment-related adverse events (reported in 32 patients) were hypertriglyceridemia (n = 14), diarrhea (n = 13), mucositis (n = 13), anorexia (n = 12), and anemia (n = 10). The grade 3 adverse events were 2 instances each of anemia and thrombocytopenia and 1 instance each of mucositis, fatigue, weight loss, hypokalemia, hypophosphatemia, and increased aspartate aminotransferase and alanine transaminase levels. Among the 33 patients evaluable for response, objective response was seen in two (6 %; both partial responses), and 13 (39 %) patients had stable disease, including 11 for ≥4 months, representing a clinical benefit rate of 39 %.
conclusionsThe results of this single-center clinical trial showed that, in patients with advanced or recurrent endometrial cancer, metformin can be safely added to temsirolimus providing limited response without added safety concerns. CLINICAL TRIAL REGISTRATION NUMBER: NCT01529593.
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