Abstract:
:BNP7787 (disodium 2,2'-dithio-bis-ethane sulphonate; Tavocept) is a novel agent developed to protect against cisplatin (cis-diammine-dichloroplatinum(II))-associated chronic toxicities. In this study, we determined the recommended dose of BNP7787 when preceding a fixed dose of cisplatin, the pharmacokinetics (PKs) and the possible reduction of saline hydration. Patients with advanced solid tumours received BNP7787 in escalating doses of 4.1-41 g m(-2) as a 15-min intravenous (i.v.) infusion followed by cisplatin 75 mg m(-2) as a 60-min i.v. infusion together with pre- and postcisplatin saline hydration in a volume of 2200 ml; cycles were repeated every 3 weeks. PK was carried out using BNP7787, cisplatin and the combination. Twenty-five patients were enrolled in stage I of the study to determine the recommended dose of BNP7787. No dose-limiting toxicity was reached. The highest dose level of 41 g m(-2) resulted in a low incidence of grade 2 toxicities, being nausea and vomiting, dry mouth or bad taste and i.v. injection site discomfort. Doses of BNP7787 > or = 18.4 g m(-2) did not show a drug interaction between BNP7787 and cisplatin. In stage II of the study, patients received a fixed dose of BNP7787 of 18.4 g m(-2) preceding cisplatin and were entered in prespecified reduced saline hydration steps. A total of 21 patients in cohorts of six to nine patients received reduced saline hydration of 1600 ml (step A), 1000 ml (step B) and 500 ml (step C). In step C, two out of six evaluable patients experienced grade 1 nephrotoxicity. Cisplatin acute toxicities in all 46 patients were as expected. Only five patients complained of paresthesias grade 1 and six developed slight audiometric changes. Partial tumour response was observed in four patients and stable disease in 15 patients. In conclusion, BNP7787 was tolerated well up to doses of 41 g m(-2). The recommended dose of 18.4 g m(-2) enabled safe reduction of the saline hydration schedule for cisplatin to 1000 ml. Further studies will assess whether BNP7787 offers protection against platinum-related late side effects.
journal_name
Br J Cancerjournal_title
British journal of cancerauthors
Boven E,Westerman M,van Groeningen CJ,Verschraagen M,Ruijter R,Zegers I,van der Vijgh WJ,Giaccone Gdoi
10.1038/sj.bjc.6602553subject
Has Abstractpub_date
2005-05-09 00:00:00pages
1636-43issue
9eissn
0007-0920issn
1532-1827pii
6602553journal_volume
92pub_type
临床试验,杂志文章abstract:BACKGROUND:Human polypyrimidine tract binding protein 3 (PTBP3) was first discovered in 1999 and has been well characterised as a differentiation regulator. However, its role in human cancer has rarely been reported. Our previous study revealed increased PTBP3 protein level in gastric cancer tissues. Downregulation of ...
journal_title:British journal of cancer
pub_type: 杂志文章
doi:10.1038/bjc.2017.32
更新日期:2017-03-28 00:00:00
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journal_title:British journal of cancer
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pub_type: 杂志文章
doi:10.1038/sj.bjc.6603546
更新日期:2007-01-29 00:00:00
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doi:10.1038/sj.bjc.6601022
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pub_type: 杂志文章
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pub_type: 杂志文章,meta分析
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pub_type: 杂志文章
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pub_type: 杂志文章
doi:10.1038/sj.bjc.6690416
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journal_title:British journal of cancer
pub_type: 杂志文章
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journal_title:British journal of cancer
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:British journal of cancer
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journal_title:British journal of cancer
pub_type: 杂志文章
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journal_title:British journal of cancer
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journal_title:British journal of cancer
pub_type: 临床试验,杂志文章
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更新日期:1993-05-01 00:00:00
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journal_title:British journal of cancer
pub_type: 杂志文章,多中心研究
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journal_title:British journal of cancer
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