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    Tumor mutational analysis of GOG248, a phase II study of temsirolimus or temsirolimus and alternating megestrol acetate and tamoxifen for advanced endometrial cancer (EC): An NRG Oncology/Gynecologic Oncology Group study

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    Authors
    Myers, Andrea P.
    Filiaci, Virginia L.
    Zhang, Yuping
    Pearl, Michael
    Behbakht, Kian
    Makker, Vicky
    Hanjani, Parviz
    Zweizig, Susan
    Burke, James J. 2nd
    Downey, Gordon
    Leslie, Kimberly K.
    Van Hummelen, Paul
    Birrer, Michael J.
    Fleming, Gini F.
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    UMass Chan Affiliations
    Department of Obstetrics and Gynecology
    Document Type
    Journal Article
    Publication Date
    2016-04-01
    Keywords
    Female Urogenital Diseases and Pregnancy Complications
    Maternal and Child Health
    Obstetrics and Gynecology
    Women's Health
    
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    Link to Full Text
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5119517/
    Abstract
    OBJECTIVE: Rapamycin analogs have reproducible but modest efficacy in endometrial cancer (EC). Identification of molecular biomarkers that predict benefit could guide clinical development. METHODS: Fixed primary tissue and whole blood were collected prospectively from patients enrolled on GOG 248. DNA was isolated from macro-dissected tumors and blood; next-generation sequence analysis was performed on a panel of cancer related genes. Associations between clinical outcomes [response rate (RR) 20%; progression-free survival (PFS) median 4.9months] and mutations (PTEN, PIK3CA, PIK3R1, KRAS, CTNNB1, AKT1, TSC1, TSC2, NF1, FBXW7) were explored. RESULTS: Sequencing data was obtained from tumors of 55 of the 73 enrolled pts. Mutation rates were consistent with published reports: mutations in PTEN (45%), PIK3CA (29%), PIK3R1 (24%), K-RAS (16%), CTNNB1 (18%) were common and mutations in AKT1 (4%), TSC1 (2%), TSC2 (2%), NF1 (9%) and FBXW7 (4%) were less common. Increased PFS (HR 0.16; 95% CI 0.01-0.78) and RR (response difference 0.83; 95% CI 0.03-0.99) were noted for AKT1 mutation. An increase in PFS (HR 0.46; 95% CI 0.20-0.97) but not RR (response difference 0.00, 95% CI -0.34-0.34) was identified for CTNNB1 mutation. Both patients with TSC mutations had an objective response. There were no statistically significant associations between mutations in PIK3CA, PTEN, PIK3R1, or KRAS and PFS or RR. CONCLUSIONS: Mutations in AKT1, TSC1 and TSC2 are rare, but may predict clinical benefit from temsirolimus. CTNNB1 mutations were associated with longer PFS on temsirolimus.
    Source
    Gynecol Oncol. 2016 Apr;141(1):43-8. doi: 10.1016/j.ygyno.2016.02.025. Link to article on publisher's site
    DOI
    10.1016/j.ygyno.2016.02.025
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/42779
    PubMed ID
    27016228
    Related Resources
    Link to Article in PubMed
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.ygyno.2016.02.025
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