{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T03:01:04Z","timestamp":1790910064381,"version":"4.1.0"},"reference-count":27,"publisher":"Journal of Neurosurgery Publishing Group (JNSPG)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JNS"],"published-print":{"date-parts":[[2011,8]]},"abstract":"<jats:sec>\n<jats:title>Object<\/jats:title>\n<jats:p>The objective of the present study was analysis of results of the prospective clinical trial directed toward the evaluation of therapeutic efficacy of the administration of autologous formalin-fixed tumor vaccine (AFTV) concomitant with fractionated radiotherapy in cases of newly diagnosed glioblastoma multiforme.<\/jats:p><\/jats:sec>\n<jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>Twenty-four patients were enrolled into the clinical trial, while 2 cases were excluded from the final analysis of results. The treatment protocol included aggressive tumor resection, fractionated radiotherapy up to a total dose of 60 Gy, and 3 concomitant courses of AFTV administered with an interval of one week at the late stage of irradiation. Two delayed-type hypersensitivity (DTH) tests were done\u2014one 48 hours before the initial course of vaccination (DTH-1) and one 2 weeks after the third (DTH-2). All but one of the patients received salvage therapy at the time of tumor progression. The defined primary end point was overall survival; secondary end points were progression-free survival and safety of concomitant treatment.<\/jats:p><\/jats:sec>\n<jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>The median duration of overall survival was 19.8 months (95% CI 13.8\u201331.3 months). The actuarial 2-year survival rate was 40%. The median duration of progression-free survival was 7.6 months (95% CI 4.3\u201313.6 months). Overall survival showed a statistically significant association with recursive partitioning analysis class (p &lt; 0.05); progression-free survival showed a statistically significant association with p53 staining index (p &lt; 0.05) and size of DTH-2 response (p &lt; 0.001). AFTV injection concomitant with fractionated radiotherapy was well tolerated by all patients and in no case did treatment-related adverse effects exceed Grade 1 toxicity; adverse effects were limited to local erythema, induration, and swelling at the site of injection.<\/jats:p><\/jats:sec>\n<jats:sec>\n<jats:title>Conclusions<\/jats:title>\n<jats:p>The results of this study demonstrate that AFTV treatment concomitant with fractionated radiotherapy may be effective in patients with newly diagnosed glioblastoma. Further clinical testing is warranted.<\/jats:p><\/jats:sec>","DOI":"10.3171\/2011.4.jns10377","type":"journal-article","created":{"date-parts":[[2011,5,13]],"date-time":"2011-05-13T14:19:18Z","timestamp":1305296358000},"page":"248-255","source":"Crossref","is-referenced-by-count":53,"title":["Phase I\/IIa trial of autologous formalin-fixed tumor vaccine concomitant with fractionated radiotherapy for newly diagnosed glioblastoma"],"prefix":"10.3171","volume":"115","author":[{"given":"Yoshihiro","family":"Muragaki","sequence":"first","affiliation":[{"name":"Faculty of Advanced Techno-Surgery, Graduate School of Medicine,"},{"name":"Department of Neurosurgery, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Maruyama","sequence":"additional","affiliation":[{"name":"Faculty of Advanced Techno-Surgery, Graduate School of Medicine,"},{"name":"Department of Neurosurgery, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Iseki","sequence":"additional","affiliation":[{"name":"Faculty of Advanced Techno-Surgery, Graduate School of Medicine,"},{"name":"Department of Neurosurgery, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiko","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chie","family":"Shinohara","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kintomo","family":"Takakura","sequence":"additional","affiliation":[{"name":"Faculty of Advanced Techno-Surgery, Graduate School of Medicine,"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Tsuboi","sequence":"additional","affiliation":[{"name":"Graduate School of Comprehensive Human Science and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetsuya","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of Tsukuba;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akira","family":"Matsumura","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of Tsukuba;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masao","family":"Matsutani","sequence":"additional","affiliation":[{"name":"International Medical Center, Saitama Medical University, Saitama; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuyuki","family":"Karasawa","sequence":"additional","affiliation":[{"name":"Department of Radiology, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsunori","family":"Shimada","sequence":"additional","affiliation":[{"name":"STATZ Institute, Inc., Tokyo;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naohito","family":"Yamaguchi","sequence":"additional","affiliation":[{"name":"Department of Hygiene and Public Health II, Tokyo Women's Medical University;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoichi","family":"Nakazato","sequence":"additional","affiliation":[{"name":"Department of Human Pathology, Gunma University, Gunma, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiki","family":"Sato","sequence":"additional","affiliation":[{"name":"Cell-Medicine, Inc., Ibaragi;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Youji","family":"Uemae","sequence":"additional","affiliation":[{"name":"Cell-Medicine, Inc., Ibaragi;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadao","family":"Ohno","sequence":"additional","affiliation":[{"name":"Cell-Medicine, Inc., Ibaragi;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshikazu","family":"Okada","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomokatsu","family":"Hori","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, and"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1754","reference":[{"key":"b1-jns10377","series-title":"Cancer Res","first-page":"3937","article-title":"Intratumoral T-cell infiltrates and MHC class I expression in patients with stage IV melanoma","volume":"65","author":"Al-Batran","year":"2005"},{"issue":"Suppl","key":"b2-jns10377","series-title":"Neurol Med Chir (Tokyo)","first-page":"1","article-title":"Report of brain tumor registry of Japan (1969\u20131996), 11th edition","volume":"43","author":"Committee of Brain Tumor Registry of Japan","year":"2003"},{"key":"b3-jns10377","series-title":"J Natl Cancer 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(RPA) for glioblastoma multiforme (GBM) patients","volume":"57","author":"Shaw","year":"2003"},{"key":"b20-jns10377","series-title":"J Clin Oncol","first-page":"4272","article-title":"Antitumor vaccination of patients with glioblastoma multiforme: a pilot study to assess feasibility, safety, and clinical benefit","volume":"22","author":"Steiner","year":"2004"},{"key":"b21-jns10377","series-title":"Lancet Oncol","first-page":"459","article-title":"Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial","volume":"10","author":"Stupp","year":"2009"},{"key":"b22-jns10377","series-title":"N Engl J Med","first-page":"987","article-title":"Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma","volume":"352","author":"Stupp","year":"2005"},{"key":"b23-jns10377","series-title":"J Clin Oncol","first-page":"610","article-title":"Selective 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