{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T11:24:18Z","timestamp":1788175458937,"version":"build-2803163510"},"reference-count":29,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,5,3]],"date-time":"2021-05-03T00:00:00Z","timestamp":1620000000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003769","name":"Eisai","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003769","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>E7777 is a recombinant cytotoxic fusion protein composed of the diphtheria toxin fragments A and B and human interleukin\u20102. It shares an amino acid sequence with denileukin diftitox, but has improved purity and an increased percentage of active monomer. We undertook a multicenter, single\u2010arm phase II study of E7777 in patients with relapsed or refractory peripheral T\u2010cell lymphoma (PTCL) and cutaneous T\u2010cell lymphoma (CTCL) to evaluate its efficacy, safety, pharmacokinetics, and immunogenicity. A total of 37 patients were enrolled, of which 17 and 19 patients had PTCL and CTCL, respectively, and one patient with another type of lymphoma (extranodal natural killer\/T\u2010cell lymphoma, nasal type), diagnosed by the Central Pathological Diagnosis Committee. Among the 36 patients with PTCL and CTCL, objective response rate based on the independent review was 36% (41% and 31%, respectively). The median progression\u2010free survival was 3.1\u00a0months (2.1\u00a0months in PTCL and 4.2\u00a0months in CTCL). The common adverse events (AEs) observed were increased aspartate aminotransferase (AST)\u00a0\/\u00a0alanine aminotransferase (ALT), hypoalbuminemia, lymphopenia, and pyrexia. Our results indicated that a 9\u00a0\u00b5g\/kg\/d dose of E7777 shows efficacy and a manageable safety profile in Japanese patients with relapsed or refractory PTCL and CTCL, with clinical activity observed across the range of CD25 expression. The common AEs were manageable, but increase in ALT\u00a0\/\u00a0AST, hypoalbuminemia, and capillary leak syndrome should be carefully managed during the treatment.<\/jats:p>","DOI":"10.1111\/cas.14906","type":"journal-article","created":{"date-parts":[[2021,3,31]],"date-time":"2021-03-31T23:14:25Z","timestamp":1617232465000},"page":"2426-2435","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":52,"title":["Phase II study of E7777 in Japanese patients with relapsed\/refractory peripheral and cutaneous T\u2010cell lymphoma"],"prefix":"10.1111","volume":"112","author":[{"given":"Hidetsugu","family":"Kawai","sequence":"first","affiliation":[{"name":"Department of Hematology and Oncology Tokai University School of Medicine Isehara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kiyoshi","family":"Ando","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Tokai University School of Medicine Isehara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0654-6920","authenticated-orcid":false,"given":"Dai","family":"Maruyama","sequence":"additional","affiliation":[{"name":"Department of Hematology, National Cancer Center Hospital National Cancer Center Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8588-8955","authenticated-orcid":false,"given":"Kazuhito","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Department of Hematology and Cell Therapy Aichi Cancer Center Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eiji","family":"Kiyohara","sequence":"additional","affiliation":[{"name":"Department of Dermatology Osaka University Hospital Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhito","family":"Terui","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology The Cancer Institute Hospital of JFCR Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriko","family":"Fukuhara","sequence":"additional","affiliation":[{"name":"Department of Hematology and Rheumatology Tohoku University Hospital Sendai Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomomitsu","family":"Miyagaki","sequence":"additional","affiliation":[{"name":"Department of Dermatology The University of Tokyo Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiki","family":"Tokura","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hamamatsu University School of Medicine Hamamatsu Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mamiko","family":"Sakata\u2010Yanagimoto","sequence":"additional","affiliation":[{"name":"Department of Hematology University of Tsukuba Hospital Tsukuba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadahiko","family":"Igarashi","sequence":"additional","affiliation":[{"name":"Department of Hematology Gunma Cancer Center Ota Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junya","family":"Kuroda","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology Kyoto Prefectural University of Medicine Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiro","family":"Fujita","sequence":"additional","affiliation":[{"name":"Department of Dermatology Osaka University Hospital Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiki","family":"Uchida","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Japanese Red Cross Nagoya Daini Hospital Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takayuki","family":"Ishikawa","sequence":"additional","affiliation":[{"name":"Department of Hematology Kobe City Medical Center General Hospital Kobe Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kentaro","family":"Yonekura","sequence":"additional","affiliation":[{"name":"Department of Dermatology Imamura General Hospital Kagoshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5815-4585","authenticated-orcid":false,"given":"Koji","family":"Kato","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Kyushu University Hospital Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadashi","family":"Nakanishi","sequence":"additional","affiliation":[{"name":"Eisai Co., Ltd. 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