Linked Life Data

15476595

Source:http://linkedlifedata.com/resource/pubmed/id/15476595

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2
pubmed:dateCreated
2004-10-12
pubmed:abstractText
A phase II trial was designed to evaluate the efficacy and toxicity of gemcitabine in patients with non-small-cell lung cancer (NSCLC) previously treated with platinum-containing regimens and prospectively categorized for platinum response status. Treatment consisted of gemcitabine 1000 mg/m2 given intravenously on days 1 and 8 of a 21-day cycle. The status of p53 in pretreatment tumor tissue was assessed by immunohistochemistry (IHC). Sixty-one patients who progressed or recurred following platinum-based therapy were enrolled, 26 platinum-sensitive and 35 platinum-refractory. A median of 4 treatment courses (range, 2-7 courses) was delivered. Of the 55 patients assessable for response, there was 1 confirmed complete response and 3 with a confirmed partial response for an overall response proportion of 7%. Twenty-one patients had stable disease while 28 progressed and 2 patients had an unconfirmed partial response. Three of the responders (2 confirmed, 1 unconfirmed) were platinum-refractory. Median progression-free survival (PFS) and overall survival for all patients were 4.1 months and 8.6 months, respectively. Median PFS and overall survival for the platinum-sensitive and platinum-refractory cohorts were 5.4 months versus 3.1 months, and 11.9 months versus 7.1 months, respectively. Toxicity was principally hematologic with grade 3/4 neutropenia in 21% and grade 4 platelets in 8%. There were no treatment-related deaths. Twenty-four of 33 patients (73%) had p53-positive tumors. Although no significant association between platinum sensitivity and p53 status was seen, patients with platinum-sensitive disease and negative p53 by IHC had a trend toward longer survival compared to those with platinum-refractory disease and/or p53 positivity (P = 0.06). We concluded that salvage gemcitabine in this dose and schedule is safe and tolerable in previously platinum-treated patients with NSCLC.
pubmed:grant
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Sep
pubmed:issn
1525-7304
pubmed:author
pubmed:issnType
Print
pubmed:volume
6
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
102-7
pubmed:dateRevised
2008-12-12
pubmed:meshHeading
pubmed-meshheading:15476595-Adult, pubmed-meshheading:15476595-Aged, pubmed-meshheading:15476595-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:15476595-Carcinoma, Non-Small-Cell Lung, pubmed-meshheading:15476595-Deoxycytidine, pubmed-meshheading:15476595-Dose-Response Relationship, Drug, pubmed-meshheading:15476595-Drug Administration Schedule, pubmed-meshheading:15476595-Female, pubmed-meshheading:15476595-Follow-Up Studies, pubmed-meshheading:15476595-Humans, pubmed-meshheading:15476595-Infusions, Intravenous, pubmed-meshheading:15476595-Lung Neoplasms, pubmed-meshheading:15476595-Male, pubmed-meshheading:15476595-Middle Aged, pubmed-meshheading:15476595-Neoplasm Staging, pubmed-meshheading:15476595-Prospective Studies, pubmed-meshheading:15476595-Risk Assessment, pubmed-meshheading:15476595-Salvage Therapy, pubmed-meshheading:15476595-Survival Analysis, pubmed-meshheading:15476595-Treatment Outcome
pubmed:year
2004
pubmed:articleTitle
Gemcitabine in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: a phase II California cancer consortium trial.
pubmed:affiliation
University of California Davis Cancer Center, Sacramento, CA 95817, USA. primo.lara@ucdmc.ucdavis.edu.
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study, Research Support, U.S. Gov't, P.H.S., Research Support, Non-U.S. Gov't, Clinical Trial, Phase II