Abstract | PURPOSE: PATIENTS AND METHODS: A Simon two-stage design was employed. Women with ≤2 prior chemotherapy regimens for recurrence were eligible. Pretreatment biopsy was required, followed by everolimus 10 mg orally, letrozole 2.5 mg orally, and metformin 500 mg orally twice a day on a 4-week cycle. The primary endpoint was clinical benefit (CB), defined as complete response (CR), partial response (PR), or stable disease (SD) confirmed at 16 weeks. Patients were treated until progression or toxicity. RESULTS: Sixty-two patients were enrolled. Median age was 62 years (40-77) with 401 cycles completed, median of 6 cycles (1-31). Fifty-four patients were evaluable for response with a CB rate of 50% (27/54). Best overall response (OR) was PR 28% (15/54) and SD 22% (12/54). Thirteen patients received >12 cycles. Median follow-up was 17.9 months (2-47). Median progression-free survival was 5.7 [95% confidence interval (CI), 3.0-8.1] and OS was 19.6 months (95% CI, 14.2-26.3). Positive progesterone receptor expression was associated with CB (89.5% vs. 27.3%, P = 0.001). CONCLUSIONS:
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Authors | Pamela T Soliman, Shannon N Westin, David A Iglesias, Bryan M Fellman, Ying Yuan, Qian Zhang, Melinda S Yates, Russell R Broaddus, Brian M Slomovitz, Karen H Lu, Robert L Coleman |
Journal | Clinical cancer research : an official journal of the American Association for Cancer Research
(Clin Cancer Res)
Vol. 26
Issue 3
Pg. 581-587
(02 01 2020)
ISSN: 1557-3265 [Electronic] United States |
PMID | 31628143
(Publication Type: Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Comment)
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Copyright | ©2019 American Association for Cancer Research. |
Chemical References |
- Letrozole
- Metformin
- Everolimus
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Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
- Carcinoma, Endometrioid
- Everolimus
- Female
- Humans
- Letrozole
- Metformin
- Middle Aged
- Progression-Free Survival
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