Abstract:
Background:Shorter duration of infusion of monoclonal antibody treatments may reduce treatment burden and improve healthcare resource utilization. Methods:This phase II study recruited Japanese patients with previously untreated CD20+ B-cell non-Hodgkin lymphoma. Patients received intravenous obinutuzumab 1000 mg by regular infusion on Days 1, 8 and 15 of Cycle 1, followed by 90-min shorter duration of infusion in up to seven subsequent cycles, provided they received ≥3 regular infusions without any grade ≥3 infusion-related reactions and had a lymphocyte count <5.0 × 109 cells/l. Standard cyclophosphamide, doxorubicin, vincristine and prednisolone chemotherapy was given in Cycles 1-6. The primary endpoints were as follows: incidence of grade ≥3 infusion-related reactions in Cycle 2 in patients who started shorter duration of infusion in Cycle 2, serum obinutuzumab concentrations and pharmacokinetic parameters and the time course of cytokine release. Adverse events and serious adverse events were monitored. Results:Of 35 patients treated, 28 completed eight cycles; 31 started shorter duration of infusion in Cycle 2 and two patients in subsequent cycles. Two patients discontinued before starting shorter duration of infusion. No grade ≥3 infusion-related reactions occurred in Cycle 2. Twenty-one infusion-related reactions (all grades 1-2) were reported in 17/35 (49%) patients overall, mostly in Cycle 1 (18/21 infusion-related reactions [86%]). Grade ≥3 AEs occurring in ≥10% of patients included neutropenia/neutrophil count decreased (66%) and leukopenia/white blood cell count decreased (23%). Steady-state pharmacokinetics of obinutuzumab were attained in Cycle 2 and were not affected by shorter duration of infusion. No relevant cytokine elevations were reported with shorter duration of infusion. Conclusions:Regular infusion and shorter duration of infusion of obinutuzumab have comparable tolerability and pharmacokinetics in Japanese patients.
journal_name
Jpn J Clin Oncoljournal_title
Japanese journal of clinical oncologyauthors
Ohmachi K,Ando K,Kinoshita T,Kumagai K,Hatake K,Ishikawa T,Teshima T,Kato K,Izutsu K,Ueda E,Nakai K,Kuriki H,Tobinai Kdoi
10.1093/jjco/hyy087subject
Has Abstractpub_date
2018-08-01 00:00:00pages
736-742issue
8eissn
0368-2811issn
1465-3621pii
5042867journal_volume
48pub_type
杂志文章,多中心研究abstract:BACKGROUND:In recent times, the possibility of detecting lung cancer using microsatellite alterations (microsatellite instability and loss of heterozygosity) in DNA of bronchial washings has been explored. However, no data regarding the presence of microsatellite alterations in lung cancer are available from India, a c...
journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章
doi:10.1093/jjco/hyh079
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journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章,meta分析
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journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章
doi:10.1093/jjco/28.5.323
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journal_title:Japanese journal of clinical oncology
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journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章,多中心研究
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journal_title:Japanese journal of clinical oncology
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journal_title:Japanese journal of clinical oncology
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:
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abstract::Expression of carcinoembryonic antigen (CEA) and nonspecific cross-reacting antigen (NCA) mRNAs were observed in malignant and nonmalignant colon tissues by Northern blot analysis. CEA mRNA was detected together with NCA mRNA in nine cultured cell lines, with the exception of the lung carcinoma A549 cell line, and in ...
journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章
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journal_title:Japanese journal of clinical oncology
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journal_title:Japanese journal of clinical oncology
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journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章,多中心研究
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journal_title:Japanese journal of clinical oncology
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doi:
更新日期:1987-06-01 00:00:00
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journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章
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pub_type: 杂志文章
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journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章,评审
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journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章,多中心研究
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journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章
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journal_title:Japanese journal of clinical oncology
pub_type: 临床试验,杂志文章
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pub_type: 杂志文章
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journal_title:Japanese journal of clinical oncology
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journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章,评审
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更新日期:2013-02-01 00:00:00
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journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章
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更新日期:2019-12-27 00:00:00
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journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章
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journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:Japanese journal of clinical oncology
pub_type: 临床试验,杂志文章
doi:
更新日期:1995-08-01 00:00:00
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journal_title:Japanese journal of clinical oncology
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journal_title:Japanese journal of clinical oncology
pub_type: 杂志文章
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