{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T21:37:24Z","timestamp":1777412244523,"version":"3.51.4"},"reference-count":18,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2017,9,4]],"date-time":"2017-09-04T00:00:00Z","timestamp":1504483200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Mundipharma K.K."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2017,10]]},"abstract":"<jats:p>\n                    Pralatrexate is a novel antifolate approved in the USA for the treatment of relapsed or refractory peripheral T\u2010cell lymphoma. To assess its safety, efficacy, and pharmacokinetics in Japanese patients with this disease, we undertook a phase I\/\n                    <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content>\n                    study. Pralatrexate was given i.v. weekly for 6\u00a0weeks of a 7\u2010week cycle. All patients received concurrent vitamin B\n                    <jats:sub>12<\/jats:sub>\n                    and folic acid. In phase I, three patients received pralatrexate 30\u00a0mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    and none experienced a dose\u2010limiting toxicity. In phase\n                    <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content>\n                    , we treated 22 additional patients with that dose. The median number of treatment cycles was 1 (range, 1\u20139). Nine of 20 evaluable patients (45%) achieved an objective response by central review, including two complete responses. All responses occurred within the first treatment cycle. At the time of data cut\u2010off, median progression\u2010free survival was 150\u00a0days. Median overall survival was not reached. In the total population, the most commonly reported adverse events included mucositis (88%), thrombocytopenia (68%), liver function test abnormality (64%), anemia (60%), and lymphopenia (56%). Grade 3\/4 adverse events included lymphopenia (52%), thrombocytopenia (40%), leukopenia (28%), neutropenia (24%), anemia (20%), and mucositis (20%). The pharmacokinetic profile showed no drug accumulation with repeat dosing. These results indicate that pralatrexate is generally well tolerated and effective in Japanese patients with relapsed or refractory peripheral T\u2010cell lymphoma. This trial was registered with ClinicalTrials.gov (\n                    <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>\n                    02013362).\n                  <\/jats:p>","DOI":"10.1111\/cas.13340","type":"journal-article","created":{"date-parts":[[2017,8,3]],"date-time":"2017-08-03T16:27:45Z","timestamp":1501777665000},"page":"2061-2068","source":"Crossref","is-referenced-by-count":36,"title":["Phase I\/\n                    <scp>II<\/scp>\n                    study of pralatrexate in Japanese patients with relapsed or refractory peripheral T\u2010cell lymphoma"],"prefix":"10.1111","volume":"108","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0654-6920","authenticated-orcid":false,"given":"Dai","family":"Maruyama","sequence":"first","affiliation":[{"name":"Department of Hematology National Cancer Center Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirokazu","family":"Nagai","sequence":"additional","affiliation":[{"name":"Department of Hematology National Hospital Organization Nagoya Medical Center Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshinobu","family":"Maeda","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Okayama University Hospital Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takahiko","family":"Nakane","sequence":"additional","affiliation":[{"name":"Hematology Graduate School of Medicine Osaka City University Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatsu","family":"Shimoyama","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomonori","family":"Nakazato","sequence":"additional","affiliation":[{"name":"Department of Hematology Yokohama Municipal Citizen's Hospital Yokohama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rika","family":"Sakai","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Kanagawa Cancer Center Yokohama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takayuki","family":"Ishikawa","sequence":"additional","affiliation":[{"name":"Department of Hematology Kobe City Medical Center General Hospital Kobe Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koji","family":"Izutsu","sequence":"additional","affiliation":[{"name":"Department of Hematology National Cancer Center Hospital Tokyo Japan"},{"name":"Department of Hematology Toranomon Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryuzo","family":"Ueda","sequence":"additional","affiliation":[{"name":"Department of Tumor Immunology Aichi Medical University School of Medicine Nagakute Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kensei","family":"Tobinai","sequence":"additional","affiliation":[{"name":"Department of Hematology National Cancer Center Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,9,4]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2008.16.4558"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-014-1520-3"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00277-016-2891-8"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2012.44.7524"},{"key":"e_1_2_8_6_1","unstructured":"National Comprehensive Cancer Network.NCCN clinical practice guidelines in oncology (NCCN Guidelines\u00ae): T\u2010cell lymphomas version 2.2017 \u2013 February 21 2017. [Cited 10 Mar 2017.] Available from URL:https:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/t-cell.pdf."},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2016.34.15_suppl.7542"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-10-1214"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.29.9024"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-12-2251"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-10-0671"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1080\/1042819031000077124"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-05-0331"},{"key":"e_1_2_8_14_1","volume-title":"WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues","author":"Swerdlow SH","year":"2008"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1999.17.4.1244"},{"key":"e_1_2_8_16_1","unstructured":"Folotyn\u00ae [USA package insert] 2016 Spectrum Pharmaceuticals"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2006.09.2403"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2008.20.8470"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.3109\/10428194.2013.779688"}],"container-title":["Cancer Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fcas.13340","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cas.13340","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cas.13340","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cas.13340","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T18:21:29Z","timestamp":1694110889000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/cas.13340"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,9,4]]},"references-count":18,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2017,10]]}},"alternative-id":["10.1111\/cas.13340"],"URL":"https:\/\/doi.org\/10.1111\/cas.13340","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.3410\/f.727876327.793539739","asserted-by":"object"}]},"ISSN":["1347-9032","1349-7006"],"issn-type":[{"value":"1347-9032","type":"print"},{"value":"1349-7006","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,9,4]]}}}