{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T17:51:33Z","timestamp":1785520293892,"version":"3.56.0"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2023,1,17]],"date-time":"2023-01-17T00:00:00Z","timestamp":1673913600000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100012634","name":"Novocure","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100012634","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,4,29]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Tumour-treating fields therapy is a locoregional, anti-cancer treatment. Efficacy and safety of tumour-treating fields therapy in adults with newly diagnosed glioblastoma were demonstrated in the pivotal phase 3 EF-14 study (NCT00916409). Here, we report post-approval data of tumour-treating fields therapy in Japanese patients with newly diagnosed glioblastoma.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Unsolicited post-marketing surveillance data from Japanese patients with newly diagnosed glioblastoma treated with tumour-treating fields therapy (December 2016\u2013June 2020) were retrospectively analysed. The primary endpoints were skin, neurological and psychiatric adverse events. The secondary endpoints were 1- and 2-year overall survival rates, and the 6-month progression-free survival. adverse events were analysed using MedDRA v24.0. The overall survival and progression-free survival were assessed using the Kaplan\u2013Meier survival analysis (log-rank testing). The Cox proportional hazard regression analyses were also performed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Forty patients with newly diagnosed glioblastoma were enrolled (62.5% male; median age 59\u00a0years; median baseline Karnofsky Performance Scale score 90). The most common tumour-treating-fields-therapy-related adverse event was beneath-array local skin reaction (60% of patients). The adverse events were mostly mild to moderate in severity. Neurological disorders were observed in 2.5% patients (one patient reported dysesthesia). No psychiatric disorders were reported. The 1- and 2-year overall survival rates were 77.9% (95% CI 60.6\u201388.3) and 53.6% (35.5\u201368.7%), respectively. The 6-month progression-free survival was 77.5% (61.2\u201387.6%). These survival rates compare favourably with those in the EF-14 trial (1- and 2-year overall survival rates: 73% [69\u201377%] and 43% [39\u201348%], respectively; 6-month progression-free survival rate: 56% (51\u201361%).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>This post-approval, real-world evidence study revealed no new safety signals and suggests the safety and efficacy of tumour-treating fields therapy in Japanese patients with newly diagnosed glioblastoma.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyad001","type":"journal-article","created":{"date-parts":[[2023,1,17]],"date-time":"2023-01-17T07:37:27Z","timestamp":1673941047000},"page":"371-377","source":"Crossref","is-referenced-by-count":24,"title":["Safety and efficacy of tumour-treating fields (TTFields) therapy for newly diagnosed glioblastoma in Japanese patients using the Novo-TTF System: a prospective post-approval study"],"prefix":"10.1093","volume":"53","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5617-8068","authenticated-orcid":false,"given":"Ryo","family":"Nishikawa","sequence":"first","affiliation":[{"name":"Department of Neuro-Oncology\/Neurosurgery, Saitama Medical University International Medical Center , Saitama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0164-6295","authenticated-orcid":false,"given":"Fumiyuki","family":"Yamasaki","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Hiroshima University Hospital , Hiroshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4626-4645","authenticated-orcid":false,"given":"Yoshiki","family":"Arakawa","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Kyoto University Graduate School of Medicine , Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihiro","family":"Muragaki","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Tokyo Women\u2019s Medical University Hospital , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4303-6006","authenticated-orcid":false,"given":"Yoshitaka","family":"Narita","sequence":"additional","affiliation":[{"name":"National Cancer Center Hospital Department of Neurosurgery and Neuro-Oncology, , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shota","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, The University of Tokyo Hospital , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shigeru","family":"Yamaguchi","sequence":"additional","affiliation":[{"name":"Hokkaido University Hospital Department of Neurosurgery, , Sapporo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akitake","family":"Mukasa","sequence":"additional","affiliation":[{"name":"Kumamoto University Hospital Department of Neurosurgery, , Kumamoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masayuki","family":"Kanamori","sequence":"additional","affiliation":[{"name":"Tohoku University Hospital Department of Neurosurgery, , Sendai, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,1,16]]},"reference":[{"key":"2023050106125448600_ref1","doi-asserted-by":"crossref","first-page":"9","DOI":"10.2176\/nmc.sup.2017-0001","article-title":"Brain tumor registry of Japan (2005-2008)","volume":"57","author":"Brain Tumor Registry of Japan","year":"2017","journal-title":"Neurol Med Chir (Tokyo)"},{"key":"2023050106125448600_ref2","doi-asserted-by":"crossref","first-page":"1073","DOI":"10.1093\/neuonc\/noaa106","article-title":"Glioblastoma in adults: a Society for Neuro-Oncology (SNO) and European Society of Neuro-Oncology (EANO) consensus review on current management and future directions","volume":"22","author":"Wen","year":"2020","journal-title":"Neuro Oncol"},{"key":"2023050106125448600_ref3","doi-asserted-by":"crossref","first-page":"iv1","DOI":"10.1093\/neuonc\/noaa200","article-title":"CBTRUS statistical report: primary brain and other central nervous system Tumors diagnosed in the United States in 2013-2017","volume":"22","author":"Ostrom","year":"2020","journal-title":"Neuro Oncol"},{"key":"2023050106125448600_ref4","volume-title":"Adult glioblastoma (GBM) guidelines - CQ6 how to treat adult recurrent glioblastoma?","author":"The Japan Society for Neuro-Oncology","year":"2016"},{"key":"2023050106125448600_ref5","article-title":"Optune\u00ae: instructions for use","author":"Novocure","year":"2019"},{"key":"2023050106125448600_ref6","article-title":"Optune\u00ae: instructions for use (EU)","author":"Novocure","year":"2020"},{"key":"2023050106125448600_ref7","doi-asserted-by":"crossref","first-page":"1191","DOI":"10.1007\/s00262-020-02534-7","article-title":"Tumor-treating fields (TTFields) induce immunogenic cell death resulting in enhanced antitumor efficacy when combined with anti-PD-1 therapy","volume":"69","author":"Voloshin","year":"2020","journal-title":"Cancer Immunol Immunother"},{"key":"2023050106125448600_ref8","doi-asserted-by":"crossref","first-page":"3016","DOI":"10.3390\/cancers12103016","article-title":"Tumor treating fields (TTFields) hinder cancer cell motility through regulation of microtubule and acting dynamics","volume":"12","author":"Voloshin","year":"2020","journal-title":"Cancers (Basel)"},{"key":"2023050106125448600_ref9","doi-asserted-by":"crossref","first-page":"10152","DOI":"10.1073\/pnas.0702916104","article-title":"Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors","volume":"104","author":"Kirson","year":"2007","journal-title":"Proc Natl Acad Sci U S A"},{"key":"2023050106125448600_ref10","doi-asserted-by":"crossref","first-page":"3288","DOI":"10.1158\/0008-5472.CAN-04-0083","article-title":"Disruption of cancer cell replication by alternating electric fields","volume":"64","author":"Kirson","year":"2004","journal-title":"Cancer Res"},{"key":"2023050106125448600_ref11","doi-asserted-by":"crossref","first-page":"633","DOI":"10.1007\/s10585-009-9262-y","article-title":"Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs","volume":"26","author":"Kirson","year":"2009","journal-title":"Clin Exp Metastasis"},{"key":"2023050106125448600_ref12","doi-asserted-by":"crossref","first-page":"18046","DOI":"10.1038\/srep18046","article-title":"Mitotic spindle disruption by alternating electric fields leads to improper chromosome segregation and mitotic catastrophe in cancer cells","volume":"5","author":"Giladi","year":"2015","journal-title":"Sci Rep"},{"key":"2023050106125448600_ref13","doi-asserted-by":"crossref","first-page":"54","DOI":"10.1016\/j.pan.2013.11.009","article-title":"Mitotic disruption and reduced clonogenicity of pancreatic cancer cells in vitro and in vivo by tumor treating fields","volume":"14","author":"Giladi","year":"2014","journal-title":"Pancreatology"},{"key":"2023050106125448600_ref14","doi-asserted-by":"crossref","first-page":"697","DOI":"10.1038\/s41416-020-01136-5","article-title":"Tumor Treating Fields therapy for glioblastoma: current advances and future directions","volume":"124","author":"Rominiyi","year":"2021","journal-title":"Br J Cancer"},{"key":"2023050106125448600_ref15","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1038\/s41420-018-0130-x","article-title":"Tumor treating fields increases membrane permeability in glioblastoma cells","volume":"4","author":"Chang","year":"2018","journal-title":"Cell Death Discov"},{"key":"2023050106125448600_ref16","doi-asserted-by":"crossref","first-page":"1074","DOI":"10.1038\/s41419-018-1085-9","article-title":"AMPK-dependent autophagy upregulation serves as a survival mechanism in response to tumor treating fields (TTFields)","volume":"9","author":"Shteingauz","year":"2018","journal-title":"Cell Death Dis"},{"key":"2023050106125448600_ref17","doi-asserted-by":"crossref","first-page":"206","DOI":"10.1186\/s13014-017-0941-6","article-title":"Tumor treating fields (TTFields) delay DNA damage repair following radiation treatment of glioma cells","volume":"12","author":"Giladi","year":"2017","journal-title":"Radiat Oncol"},{"key":"2023050106125448600_ref18","article-title":"Optune\u00ae: instructions for use for unrescetable malignant pleural mesothelioma","author":"Novocure","year":"2021"},{"key":"2023050106125448600_ref19","doi-asserted-by":"crossref","first-page":"CT201","DOI":"10.1158\/1538-7445.AM2019-CT201","article-title":"Final results of phase II STELLAR trial: TTFields with chemotherapy in unresectable malignant pleural mesothelioma","volume":"79","author":"Ceresoli","year":"2019","journal-title":"Cancer Res"},{"key":"2023050106125448600_ref20","doi-asserted-by":"crossref","first-page":"1702","DOI":"10.1016\/S1470-2045(19)30532-7","article-title":"Tumor Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial","volume":"20","author":"Ceresoli","year":"2019","journal-title":"Lancet Oncol"},{"key":"2023050106125448600_ref21","doi-asserted-by":"crossref","first-page":"8551","DOI":"10.1200\/JCO.2019.37.15_suppl.8551","article-title":"Radiological response patterns in the phase 2 STELLAR trial of TTFields with chemotherapy for first-line treatment of malignant pleural mesothelioma (MPM)","volume":"37","author":"Grosso","year":"2019","journal-title":"J Clin Oncol"},{"key":"2023050106125448600_ref22","doi-asserted-by":"crossref","first-page":"2306","DOI":"10.1001\/jama.2017.18718","article-title":"Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial","volume":"318","author":"Stupp","year":"2017","journal-title":"JAMA"},{"key":"2023050106125448600_ref23","doi-asserted-by":"crossref","first-page":"2192","DOI":"10.1016\/j.ejca.2012.04.011","article-title":"NovoTTF-100A versus physician\u2019s choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality","volume":"48","author":"Stupp","year":"2012","journal-title":"Eur J Cancer"},{"key":"2023050106125448600_ref24","doi-asserted-by":"crossref","first-page":"185","DOI":"10.2217\/cns-2016-0049","article-title":"Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial","volume":"6","author":"Kesari","year":"2017","journal-title":"CNS Oncol"},{"key":"2023050106125448600_ref25","doi-asserted-by":"crossref","first-page":"671972","DOI":"10.3389\/fonc.2021.671972","article-title":"Efficacy and safety of tumor treating fields (TTFields) in elderly patients with newly diagnosed glioblastoma: subgroup analysis of the phase 3 EF-14 clinical trial","volume":"11","author":"Ram","year":"2021","journal-title":"Front Oncol"},{"key":"2023050106125448600_ref26","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.1053\/j.seminoncol.2014.03.011","article-title":"Characterization and management of dermatologic adverse events with the NovoTTF-100A system, a novel anti-mitotic electric field device for the treatment of recurrent glioblastoma","volume":"41","author":"Lacouture","year":"2014","journal-title":"Semin Oncol"},{"key":"2023050106125448600_ref27","doi-asserted-by":"crossref","first-page":"1045","DOI":"10.3389\/fonc.2020.01045","article-title":"Prevention and management of dermatologic adverse events associated with tumor treating fields in patients with glioblastoma","volume":"10","author":"Lacouture","year":"2020","journal-title":"Front Oncol"},{"key":"2023050106125448600_ref28","doi-asserted-by":"crossref","first-page":"489","DOI":"10.1007\/s11060-020-03540-6","article-title":"Global post-marketing safety surveillance of Tumor Treating Fields (TTFields) in patients with high-grade glioma in clinical practice","volume":"148","author":"Shi","year":"2020","journal-title":"J Neurooncol"},{"key":"2023050106125448600_ref29","doi-asserted-by":"crossref","first-page":"S4","DOI":"10.1053\/j.seminoncol.2014.09.010","article-title":"Clinical practice experience with NovoTTF-100A\u2122 system for glioblastoma: the patient registry dataset (PRiDe)","volume":"41","author":"Mrugala","year":"2014","journal-title":"Semin Oncol"},{"key":"2023050106125448600_ref30","doi-asserted-by":"crossref","first-page":"S25","DOI":"10.1053\/j.seminoncol.2014.09.008","article-title":"Post hoc analyses of intention-to-treat population in phase III comparison of NovoTTF-100A\u2122 system versus best physician\u2019s choice chemotherapy","volume":"41","author":"Kanner","year":"2014","journal-title":"Semin Oncol"},{"key":"2023050106125448600_ref31","doi-asserted-by":"crossref","first-page":"467","DOI":"10.1007\/s11060-018-03057-z","article-title":"Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial","volume":"141","author":"Toms","year":"2019","journal-title":"J Neurooncol"}],"container-title":["Japanese Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jjco\/article-pdf\/53\/5\/371\/50138002\/hyad001.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jjco\/article-pdf\/53\/5\/371\/50138002\/hyad001.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,5,1]],"date-time":"2023-05-01T06:13:17Z","timestamp":1682921597000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jjco\/article\/53\/5\/371\/6988105"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,1,16]]},"references-count":31,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2023,1,16]]},"published-print":{"date-parts":[[2023,4,29]]}},"URL":"https:\/\/doi.org\/10.1093\/jjco\/hyad001","relation":{},"ISSN":["1465-3621"],"issn-type":[{"value":"1465-3621","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2023,5]]},"published":{"date-parts":[[2023,1,16]]}}}