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dc.contributor.authorFleming, Gini F.
dc.contributor.authorFiliaci, Virginia L.
dc.contributor.authorMarzullo, Brandon
dc.contributor.authorZaino, Richard J.
dc.contributor.authorDavidson, Susan A.
dc.contributor.authorPearl, Michael
dc.contributor.authorMakker, Vicky
dc.contributor.authorBurke, James J. 2nd
dc.contributor.authorZweizig, Susan L.
dc.contributor.authorVan Le, Linda
dc.contributor.authorHanjani, Parviz
dc.contributor.authorDowney, Gordon
dc.contributor.authorWalker, Joan L.
dc.contributor.authorReyes, Henry D.
dc.contributor.authorLeslie, Kimberly K.
dc.date2022-08-11T08:10:06.000
dc.date.accessioned2022-08-23T16:55:41Z
dc.date.available2022-08-23T16:55:41Z
dc.date.issued2014-03-01
dc.date.submitted2016-01-20
dc.identifier.citationGynecol Oncol. 2014 Mar;132(3):585-92. doi: 10.1016/j.ygyno.2014.01.015. Epub 2014 Jan 20. <a href="http://dx.doi.org/10.1016/j.ygyno.2014.01.015">Link to article on publisher's site</a>
dc.identifier.issn0090-8258 (Linking)
dc.identifier.doi10.1016/j.ygyno.2014.01.015
dc.identifier.pmid24456823
dc.identifier.urihttp://hdl.handle.net/20.500.14038/42762
dc.description.abstractOBJECTIVES: To determine the response, toxicities, and progression free survival of a regimen of temsirolimus with or without hormonal therapy in the treatment of advanced, or recurrent endometrial carcinoma. BACKGROUND: Preclinical evidence suggested that blockade of the PI3K/AKT/mTOR pathway might overcome resistance to hormonal therapy. METHODS: We performed a randomized phase II trial of intravenous temsirolimus 25mg weekly versus the combination of weekly temsirolimus with a regimen of megestrol acetate 80 mg bid for three weeks alternating with tamoxifen 20mg bid for three weeks in women with recurrent or metastatic endometrial carcinoma. RESULTS: There were 71 eligible patients who received at least one dose of therapy with 21 of these treated on the combination arm which was closed early because of an excess of venous thrombosis, with 5 episodes of deep venous thrombosis (DVT) and 2 pulmonary emboli. There were three responses observed in that arm (14%). A total of 50 eligible patients were treated on the single agent arm with 3 episodes of DVT and 11 responses (22%). Response rates were similar in patients with prior chemotherapy (7 of 29; 24%) and those with no prior chemotherapy (4 of 21; 19%). Two of four patients with clear cell carcinoma responded. CONCLUSIONS: Adding the combination of megestrol acetate and tamoxifen to temsirolimus therapy did not enhance activity and the combination was associated with an excess of venous thrombosis. Temsirolimus activity was preserved in patients with prior adjuvant chemotherapy.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=24456823&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC4063288/
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectDisease-Free Survival
dc.subjectDrug Administration Schedule
dc.subjectEndometrial Neoplasms
dc.subjectFemale
dc.subjectHumans
dc.subjectImmunohistochemistry
dc.subjectMegestrol Acetate
dc.subjectMiddle Aged
dc.subjectNeoplasm Metastasis
dc.subjectNeoplasm Recurrence, Local
dc.subjectSirolimus
dc.subjectderivatives
dc.subjectTamoxifen
dc.subjectEndometrial cancer
dc.subjectHormonal therapy
dc.subjectMegestrol acetate
dc.subjectTamoxifen
dc.subjectTemsirolimu
dc.subjectFemale Urogenital Diseases and Pregnancy Complications
dc.subjectMaternal and Child Health
dc.subjectNeoplasms
dc.subjectObstetrics and Gynecology
dc.subjectOncology
dc.subjectWomen's Health
dc.titleTemsirolimus with or without megestrol acetate and tamoxifen for endometrial cancer: a gynecologic oncology group study
dc.typeArticle
dc.source.journaltitleGynecologic oncology
dc.source.volume132
dc.source.issue3
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/obgyn_pp/117
dc.identifier.contextkey8028986
html.description.abstract<p>OBJECTIVES: To determine the response, toxicities, and progression free survival of a regimen of temsirolimus with or without hormonal therapy in the treatment of advanced, or recurrent endometrial carcinoma.</p> <p>BACKGROUND: Preclinical evidence suggested that blockade of the PI3K/AKT/mTOR pathway might overcome resistance to hormonal therapy.</p> <p>METHODS: We performed a randomized phase II trial of intravenous temsirolimus 25mg weekly versus the combination of weekly temsirolimus with a regimen of megestrol acetate 80 mg bid for three weeks alternating with tamoxifen 20mg bid for three weeks in women with recurrent or metastatic endometrial carcinoma.</p> <p>RESULTS: There were 71 eligible patients who received at least one dose of therapy with 21 of these treated on the combination arm which was closed early because of an excess of venous thrombosis, with 5 episodes of deep venous thrombosis (DVT) and 2 pulmonary emboli. There were three responses observed in that arm (14%). A total of 50 eligible patients were treated on the single agent arm with 3 episodes of DVT and 11 responses (22%). Response rates were similar in patients with prior chemotherapy (7 of 29; 24%) and those with no prior chemotherapy (4 of 21; 19%). Two of four patients with clear cell carcinoma responded.</p> <p>CONCLUSIONS: Adding the combination of megestrol acetate and tamoxifen to temsirolimus therapy did not enhance activity and the combination was associated with an excess of venous thrombosis. Temsirolimus activity was preserved in patients with prior adjuvant chemotherapy.</p>
dc.identifier.submissionpathobgyn_pp/117
dc.contributor.departmentDepartment of Obstetrics and Gynecology
dc.source.pages585-92


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