{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T04:16:24Z","timestamp":1791000984129,"version":"4.1.0"},"reference-count":22,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2019,7,5]],"date-time":"2019-07-05T00:00:00Z","timestamp":1562284800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Gynecologic Cancer Center of Excellence","award":["HU0001-16-2-0006"],"award-info":[{"award-number":["HU0001-16-2-0006"]}]},{"name":"Gynecologic Cancer Center of Excellence","award":["W81XWH-11-2-0131"],"award-info":[{"award-number":["W81XWH-11-2-0131"]}]},{"name":"Gynecologic Cancer Center at Walter Reed Army Medical Center","award":["W81XWH-9-2-0051"],"award-info":[{"award-number":["W81XWH-9-2-0051"]}]},{"name":"the Gynecologic Cancer Translational Research Center of Excellence","award":["W81XWH-10-2-0018"],"award-info":[{"award-number":["W81XWH-10-2-0018"]}]},{"name":"United States Army Medical Research Acquisition Activity for the Gynecologic Disease Program","award":["W81XWH-05-2-0005"],"award-info":[{"award-number":["W81XWH-05-2-0005"]}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2019,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>E39, an HLA\u2010A2\u2010restricted, immunogenic peptide derived from the folate\u2010binding protein (FBP), is overexpressed in multiple malignancies. We conducted a phase I\/IIa trial of the E39\u00a0+\u00a0GM\u2010CSF vaccine with booster inoculations of either E39 or E39\u2032 (an attenuated version of E39) to prevent recurrences in disease\u2010free endometrial and ovarian cancer patients(pts). Here, we present the final 24\u2010month landmark analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and methods<\/jats:title><jats:p>HLA\u2010A2\u00a0+\u00a0patients receiving E39\u00a0+\u00a0GM\u2010CSF were included in the vaccine group (VG), and HLA\u2010A2\u2010 pts (or HLA\u2010A2\u00a0+\u00a0patients refusing vaccine) were followed as the control group (CG). VG group received 6 monthly inoculations as the primary vaccine series (PVS) and were randomized to receive either E39 or E39\u2032 booster inoculations. Demographic, safety, immunologic, and disease\u2010free survival (DFS) data were collected and evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Fifty\u2010one patients were enrolled; 29 in the VG and 22 in the CG. Fourteen patients received &lt;1000\u00a0\u03bcg and 15 received 1000\u00a0\u03bcg of E39. There were no clinicopathologic differences between VG and CG or between dose groups. E39 was well tolerated. At the 24\u00a0months landmark, DFS was 55.5% (VG) vs 40.0% (CG), <jats:italic>P\u00a0<\/jats:italic>=\u00a00.339. Patients receiving 1000\u00a0\u03bcg and boosted patients also showed improved DFS (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.03). DFS was improved in the 1000\u00a0\u03bcg group after treatment of primary disease (90.0% vs CG:42.9%, <jats:italic>P<\/jats:italic>\u00a0=\u00a00.007), but not in recurrent patients. In low\u2010FBP expressing patients, DFS was 100.0% (1000\u00a0\u03bcg), 50.0% (&lt;1000\u00a0\u03bcg), and 25.0% (CG), <jats:italic>P<\/jats:italic>\u00a0=\u00a00.029.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This phase I\/IIa trial reveals that E39\u00a0+\u00a0GM\u2010CSF is safe and may be effective in preventing recurrence in high\u2010risk ovarian and endometrial cancer when optimally dosed (1000\u00a0\u03bcg) to FBP low patients being treated for primary disease.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.2378","type":"journal-article","created":{"date-parts":[[2019,7,5]],"date-time":"2019-07-05T09:23:31Z","timestamp":1562318611000},"page":"4678-4687","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":35,"title":["Final analysis of a phase I\/IIa trial of the folate\u2010binding protein\u2010derived E39 peptide vaccine to prevent recurrence in ovarian and endometrial cancer patients"],"prefix":"10.1002","volume":"8","author":[{"given":"Tommy A.","family":"Brown","sequence":"first","affiliation":[{"name":"Department of Surgery San Antonio Military Medical Center San Antonio Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Byrd","sequence":"additional","affiliation":[{"name":"National Capital Consortium Fellowship in Gynecologic Oncology Walter Reed National Military Medical Center Bethesda Bethesda Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4593-7502","authenticated-orcid":false,"given":"Timothy J.","family":"Vreeland","sequence":"additional","affiliation":[{"name":"Department of Surgical Oncology The University of Texas MD Anderson Cancer Center Houston Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5962-3876","authenticated-orcid":false,"given":"Guy T.","family":"Clifton","sequence":"additional","affiliation":[{"name":"Department of Surgery San Antonio Military Medical Center San Antonio Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doreen O.","family":"Jackson","sequence":"additional","affiliation":[{"name":"Department of Surgery San Antonio Military Medical Center San Antonio Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane F.","family":"Hale","sequence":"additional","affiliation":[{"name":"Department of Surgery San Antonio Military Medical Center San Antonio Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Garth S.","family":"Herbert","sequence":"additional","affiliation":[{"name":"Department of Surgery San Antonio Military Medical Center San Antonio Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John W.","family":"Myers","sequence":"additional","affiliation":[{"name":"Department of Surgery San Antonio Military Medical Center San Antonio Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia M.","family":"Greene","sequence":"additional","affiliation":[{"name":"Department of Surgery San Antonio Military Medical Center San Antonio Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John S.","family":"Berry","sequence":"additional","affiliation":[{"name":"Department of Surgery Womack Army Medical Center Fayetteville North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Martin","sequence":"additional","affiliation":[{"name":"Cancer Vaccine Development Program San Antonio Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John C.","family":"Elkas","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Inova Fairfax Hospital Annandale Virginia"},{"name":"Mid\u2010Atlantic Gynecologic Oncology and Pelvic Surgical Associates Annandale 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