Abstract:
:This phase I/II study was conducted to evaluate the safety and efficacy of tirapazamine in combination with cisplatin and vinorelbine for patients with advanced-stage IIIB/IV chemonaive non-small-cell lung cancer. Seventy patients with a Karnofsky performance status of > or = 60% were included. In the phase I part of the study, 21 patients were treated on day 1 with tirapazamine (escalating doses of 260, 330, or 390 mg/m(2)), cisplatin (75 or 100 mg/m(2)), and vinorelbine (25 or 30 mg/m(2)) for a maximum of 6 cycles every 4 weeks. Vinorelbine was repeated every week. In the phase II part of the study, 49 patients were treated on day 1 with tirapazamine 390 mg/m(2), cisplatin 100 mg/m(2), and vinorelbine 30 mg/m(2). The maximum tolerated dose was not reached. Muscle cramps, vomiting, nausea, tinnitus, neutropenia, and diarrhea were the most frequently reported adverse events in the phase I part of the study. Most of these events were grade 1 or 2. In the phase II part of the study, response rate was 47%, and median survival was 50 weeks. The most frequently reported adverse event was neutropenia. Asthenia, fever, anemia, vomiting, weight decrease, nausea, and muscle cramps were also noted. For patients treated at the maximum dose, dose reductions occurred 14% of tirapazamine cycles and in 4% of cisplatin cycles. The median number of cycles was 3. This regimen has a manageable toxicity profile. Response rate and median survival suggest that this combination might be more active than the cisplatin/vinorelbine combination. This triplet is currently being evaluated in a phase III study.
journal_name
Clin Lung Cancerjournal_title
Clinical lung cancerauthors
Gatineau M,Rixe O,Chevalier TLdoi
10.3816/clc.2005.n.008keywords:
subject
Has Abstractpub_date
2005-03-01 00:00:00pages
293-8issue
5eissn
1525-7304issn
1938-0690pii
S1525-7304(11)70223-6journal_volume
6pub_type
临床试验,杂志文章,多中心研究abstract:BACKGROUND:The programmed death 1/programmed death-ligand 1 (PD-L1) pathway reportedly is as an important factor determining effects of immunotherapy; however, its prognostic impact is controversial, and its association with the surrounding immune microenvironment has not yet been elucidated. PATIENTS AND METHODS:We r...
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doi:10.1016/j.cllc.2020.01.013
更新日期:2020-07-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章,随机对照试验
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更新日期:2015-11-01 00:00:00
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pub_type: 杂志文章
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pub_type: 杂志文章
doi:10.1016/j.cllc.2015.02.002
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journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2015.04.002
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journal_title:Clinical lung cancer
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cllc.2018.04.004
更新日期:2018-07-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2016.09.001
更新日期:2017-03-01 00:00:00
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pub_type: 杂志文章
doi:10.1016/j.cllc.2020.04.006
更新日期:2020-11-01 00:00:00
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pub_type: 杂志文章
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journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2017.05.013
更新日期:2018-01-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2014.10.003
更新日期:2015-03-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
doi:10.1016/j.cllc.2014.06.005
更新日期:2014-11-01 00:00:00
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journal_title:Clinical lung cancer
pub_type:
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更新日期:2009-09-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.3816/clc.2001.n.017
更新日期:2001-08-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
doi:10.3816/CLC.2006.n.037
更新日期:2006-09-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
doi:10.3816/CLC.2009.n.010
更新日期:2009-03-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
doi:10.3816/clc.2003.s.011
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journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2017.01.008
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journal_title:Clinical lung cancer
pub_type: 杂志文章
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journal_title:Clinical lung cancer
pub_type: 杂志文章
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journal_title:Clinical lung cancer
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
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journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.3816/clc.2001.n.025
更新日期:2001-11-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2012-11-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.3816/clc.2000.s.008
更新日期:2000-12-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章
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更新日期:1999-11-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章
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更新日期:2016-05-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章
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更新日期:2014-05-01 00:00:00
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journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
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更新日期:2015-09-01 00:00:00