Abstract:
:Response rates reported in early phase II clinical trials are often not reproduced in subsequent larger or phase III studies. Independent review of claimed partial or complete responders to gemcitabine was undertaken in four pivotal, open-label phase II studies of advanced, non-small cell lung cancer (NSCLC) to provide accurate, consistent, reproducible response rates. Patients were chemonaive and had stage III or IV NSCLC. In three trials, gemcitabine (800 and 1250 mg/m2) was administered once-weekly for 3 weeks followed by a rest week. In the fourth, gemcitabine (90 mg/m2) was given twice-weekly for 3 weeks in every 4 weeks. The primary endpoint was response rate. Of the 374 evaluable patients, 114 (30%) were claimed as responders. Independent review reduced this to 79 (21%). The response range was reduced from 25-35 to 20-23% after validation; 95% confidence intervals did not overlap. Consistent application of response criteria by an independent panel significantly reduced response rates but produced greater consistency and reproducibility. These results confirm that gemcitabine is active against NSCLC. Subsequent larger-scale studies have produced comparable response rates, vindicating the use of independent review. Independent review is recommended for all trials using response rate as a primary endpoint.
journal_name
Anticancer Drugsjournal_title
Anti-cancer drugsauthors
Gwyther SJ,Aapro MS,Hatty SR,Postmus PE,Smith IEdoi
10.1097/00001813-199909000-00001subject
Has Abstractpub_date
1999-09-01 00:00:00pages
693-8issue
8eissn
0959-4973issn
1473-5741journal_volume
10pub_type
临床试验,杂志文章abstract::Large (>6 microm) rigid microparticles (MPs) become passively entrapped within the lungs after intravenous (i.v.) injection making them an attractive and highly efficient alternative to inhalation for pulmonary delivery. In this study, PEGylated 6 microm polystyrene MPs with multiple copies of the norvaline (Nva) alph...
journal_title:Anti-cancer drugs
pub_type: 杂志文章
doi:10.1097/CAD.0b013e328332a322
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abstract::Small molecule tyrosine kinase inhibitors are rapidly being integrated into the management of cancer. This is the first report of sorafenib and sunitinib, both small molecule tyrosine kinase inhibitors of vascular endothelial growth factor and platelet-derived growth factor receptors, triggering radiation recall derma...
journal_title:Anti-cancer drugs
pub_type: 杂志文章
doi:10.1097/CAD.0b013e328333d679
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journal_title:Anti-cancer drugs
pub_type: 杂志文章,多中心研究
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
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doi:10.1097/00001813-199202000-00003
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journal_title:Anti-cancer drugs
pub_type: 临床试验,杂志文章
doi:10.1097/00001813-199608000-00002
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
pub_type: 杂志文章
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journal_title:Anti-cancer drugs
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1097/00001813-199504000-00004
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
pub_type: 杂志文章
doi:10.1097/00001813-199404000-00007
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journal_title:Anti-cancer drugs
pub_type: 杂志文章
doi:10.1097/00001813-199506000-00009
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journal_title:Anti-cancer drugs
pub_type: 杂志文章
doi:10.1097/CAD.0b013e328323a7ca
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journal_title:Anti-cancer drugs
pub_type: 杂志文章
doi:10.1097/00001813-199208000-00018
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
pub_type: 临床试验,杂志文章,多中心研究
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journal_title:Anti-cancer drugs
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journal_title:Anti-cancer drugs
pub_type: 杂志文章
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journal_title:Anti-cancer drugs
pub_type: 杂志文章
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journal_title:Anti-cancer drugs
pub_type: 临床试验,杂志文章
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journal_title:Anti-cancer drugs
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