{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,8,29]],"date-time":"2024-08-29T12:33:18Z","timestamp":1724934798463},"reference-count":28,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2011,5,18]],"date-time":"2011-05-18T00:00:00Z","timestamp":1305676800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2011,7]]},"abstract":"<jats:p>In order to investigate better molecular\u2010target therapy for acute myeloid leukemia (AML), we conducted a phase I trial of a combination of gemtuzumab ozogamicin (GO) with conventional chemotherapy. Between January 2007 and December 2009, a total of 19 adult Japanese patients with relapsed or refractory CD33\u2010positive AML (excluding acute promyelocytic leukemia) were enrolled. All registered patients received a standard dose of cytarabine (Ara\u2010C) (100\u2003mg\/m<jats:sup>2<\/jats:sup>\u2003\u00d7\u20037\u2003days), combined with either idarubicin (IDR) (10\u201312\u2003mg\/m<jats:sup>2<\/jats:sup>\u2003\u00d7\u20033\u2003days) or daunorubicin (DNR) (50\u2003mg\/m<jats:sup>2<\/jats:sup>\u2003\u00d7\u20033\u20135\u2003days), and then GO (3\u20135\u2003mg\/m<jats:sup>2<\/jats:sup>), which was administered 1\u2003day after the last infusion of IDR (IAG regimen) or DNR (DAG regimen). While doses of both GO and IDR and the administration period of only DNR were increased, the dose\u2010limiting toxicity (DLT) was assessed. Among 19 patients (nine in the IAG regimen, 10 in the DAG regimen), the median age was 59\u2003years (range 33\u201364), and the relapsed\/refractory ratio was 13\/6. In the therapy using 3\u2003mg\/m<jats:sup>2<\/jats:sup> GO in the IAG or DAG regimen, grade 3\/4 leukopenia and neutropenia were observed in all patients, but none had grade 3\/4 non\u2010hematological toxicities, except febrile neutropenia. Three patients in the IAG regimen who were administered 5\u2003mg\/m<jats:sup>2<\/jats:sup> GO showed DLT. No patients had veno\u2010occlusive disease or sinusoidal obstructive syndrome. In conclusion, 3\u2003mg\/m<jats:sup>2<\/jats:sup> GO combined with Ara\u2010C and IDR or DNR can be safely administered, and phase II trials should be conducted to investigate the clinical efficacy of the combination therapy. (<jats:italic>Cancer Sci<\/jats:italic> 2011; 102: 1358\u20131365)<\/jats:p>","DOI":"10.1111\/j.1349-7006.2011.01957.x","type":"journal-article","created":{"date-parts":[[2011,4,22]],"date-time":"2011-04-22T10:08:35Z","timestamp":1303466915000},"page":"1358-1365","source":"Crossref","is-referenced-by-count":7,"title":["Phase I trial of gemtuzumab ozogamicin in intensive combination chemotherapy for relapsed or refractory adult acute myeloid leukemia (AML): Japan Adult Leukemia Study Group (JALSG)\u2010AML206 study"],"prefix":"10.1111","volume":"102","author":[{"given":"Noriko","family":"Usui","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akihiro","family":"Takeshita","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chiaki","family":"Nakaseko","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nobuaki","family":"Dobashi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroyuki","family":"Fujita","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hitoshi","family":"Kiyoi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yukio","family":"Kobayashi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toru","family":"Sakura","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuichi","family":"Yahagi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuyuki","family":"Shigeno","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chikako","family":"Ohwada","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasushi","family":"Miyazaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shigeki","family":"Ohtake","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shuichi","family":"Miyawaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomoki","family":"Naoe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazunori","family":"Ohnishi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"for the Japan Adult Leukemia Study Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2011,5,18]]},"reference":[{"key":"e_1_2_7_2_2","unstructured":"Acute myeloid leukemia in NCCN Clinical Guidelines in Oncology. 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