{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T04:32:28Z","timestamp":1775277148279,"version":"3.50.1"},"reference-count":26,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2017,2,14]],"date-time":"2017-02-14T00:00:00Z","timestamp":1487030400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007013","name":"F. Hoffmann-La Roche","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007013","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2017,7]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>The Phase Ib GERSHWIN study (NCT01680991) assessed the pharmacokinetic (PK) profile of obinutuzumab following multiple intravenous (i.v.) doses to Chinese patients with B\u2010cell lymphomas, and compared findings with previous obinutuzumab PK studies in mainly Caucasian (non\u2010Chinese) patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>GERSHWIN was an open\u2010label, single\u2010arm intervention study. Patients aged &gt;18 years with CD20+ relapsed\/refractory chronic lymphocytic leukaemia (CLL), diffuse large B\u2010cell lymphoma (DLBCL) or follicular lymphoma (FL) were enrolled from four centres in China. The treatment period was 24 weeks; patients received obinutuzumab 1000\u00a0mg i.v. on Days (D)1, 8 and 15 of Cycle (C)1 (CLL patients: first infusion split over 2 days) and on D1 of C2\u20138 (all cycles: 21 days). PK parameters were estimated using non\u2010compartmental analysis (NCA), and a population PK analysis was used to determine whether observed GERSHWIN PK data were in accordance with previous obinutuzumab PK studies in non\u2010Chinese patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The PK analysis population included 48 patients: 28 patients completed all treatment cycles. NCA showed a similar PK profile in Chinese patients with FL, DLBCL and CLL. Steady\u2010state concentrations of obinutuzumab appeared to be reached at the start of C2 irrespective of histology. There was no apparent relationship between body weight and systemic exposure. Most PK profiles observed in GERSHWIN lay within the 90% prediction interval of simulated profiles.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Obinutuzumab exposure was comparable in CLL, DLBCL and FL patients. NCA and population PK analysis indicate that PK characteristics of Chinese patients with B\u2010cell lymphomas are similar to those in non\u2010Chinese patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.13232","type":"journal-article","created":{"date-parts":[[2017,1,10]],"date-time":"2017-01-10T15:39:39Z","timestamp":1484062779000},"page":"1446-1456","source":"Crossref","is-referenced-by-count":8,"title":["Pharmacokinetics of obinutuzumab in Chinese patients with B\u2010cell lymphomas"],"prefix":"10.1111","volume":"83","author":[{"given":"John","family":"Zhai","sequence":"first","affiliation":[{"name":"Roche Innovation Center Shanghai  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yan","family":"Qin","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs National Cancer Center\/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) &amp; Peking Union Medical College (PUMC)  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun","family":"Zhu","sequence":"additional","affiliation":[{"name":"Department of Lymphoma, Beijing Cancer Hospital Peking University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuqin","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Lymphoma, Beijing Cancer Hospital Peking University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhixiang","family":"Shen","sequence":"additional","affiliation":[{"name":"Department of Hematology, Ruijin Homainlyspital Shanghai Jiaotong University  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xin","family":"Du","sequence":"additional","affiliation":[{"name":"Department of Hematology Guangdong General Hospital\/Guandong Academy of Medical Sciences  Guangzhou Guangdong China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Candice","family":"Jamois","sequence":"additional","affiliation":[{"name":"Roche Innovation Center Basel  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Brewster","sequence":"additional","affiliation":[{"name":"Roche Innovation Center Welwyn  Welwyn Garden City UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuankai","family":"Shi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs National Cancer Center\/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) &amp; Peking Union Medical College (PUMC)  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun","family":"Shi","sequence":"additional","affiliation":[{"name":"Roche Innovation Center Shanghai  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,2,14]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/gkv1037"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/bph.13347"},{"key":"e_1_2_11_4_1","unstructured":"LiXQ LiGD GaoZF ZhouXG ZhuXZ.The relative frequencies of lymphoma subtypes in China: a nationwide study of 10002 cases by the Chinese Lymphoma Study. 11th International Conference on Malignant Lymphoma Lugano 15\u201318 June2011. 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