Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2010-5-4
pubmed:abstractText
The purpose of this phase I/II study is to evaluate a new combination chemotherapy consisting of docetaxel and S-1 as front-line therapy for patients with untreated advanced non-small cell lung cancer (NSCLC). The treatment included docetaxel on day 1 and oral S-1 at a fixed dose of 40mg/m(2) administered twice daily on days 1-14 and repeated every 3 weeks. In phase I, docetaxel at escalating doses of 40 (level 0), 50 (level 1) and 60mg/m(2) (level 2) was administered starting from level 1. Because only one patient among the 6-patient cohort at level 1 and no patient among the 3-patient cohort at level 2 experienced defined dose-limiting toxicity (DLT), level 2 was determined as the recommended dose. In phase II, 60 patients were treated at the recommended dose for median 3 cycles, and the overall response rate was 30% (95% confidence interval [CI], 18.9-43.2%), and the median overall and progression-free survival times were 15.2 (95% CI: 10.5-17.7) and 4.9 (95% CI: 3.5-5.6) months, respectively. The most frequent toxicities experienced were neutropenia, febrile neutropenia and appetite loss; all toxicities were however well manageable. The present regimen showed a potent activity with mild toxicity in untreated NSCLC.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jun
pubmed:issn
1872-8332
pubmed:author
pubmed:copyrightInfo
Copyright 2009 Elsevier Ireland Ltd. All rights reserved.
pubmed:issnType
Electronic
pubmed:volume
68
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
409-14
pubmed:meshHeading
pubmed-meshheading:19740565-Administration, Oral, pubmed-meshheading:19740565-Adult, pubmed-meshheading:19740565-Aged, pubmed-meshheading:19740565-Carcinoma, Non-Small-Cell Lung, pubmed-meshheading:19740565-Disease Progression, pubmed-meshheading:19740565-Drug Combinations, pubmed-meshheading:19740565-Drug Dosage Calculations, pubmed-meshheading:19740565-Drug Therapy, Combination, pubmed-meshheading:19740565-Female, pubmed-meshheading:19740565-Humans, pubmed-meshheading:19740565-Lung Neoplasms, pubmed-meshheading:19740565-Male, pubmed-meshheading:19740565-Middle Aged, pubmed-meshheading:19740565-Neoplasm Staging, pubmed-meshheading:19740565-Neutropenia, pubmed-meshheading:19740565-Oxonic Acid, pubmed-meshheading:19740565-Survival Analysis, pubmed-meshheading:19740565-Taxoids, pubmed-meshheading:19740565-Tegafur
pubmed:year
2010
pubmed:articleTitle
Phase I/II study of docetaxel and S-1, an oral fluorinated pyrimidine, for untreated advanced non-small cell lung cancer.
pubmed:affiliation
Department of Respirology (B2), Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. takiguchi@faculty.chiba-u.jp
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't, Clinical Trial, Phase II, Clinical Trial, Phase I