Linked Life Data

16816536

Source:http://linkedlifedata.com/resource/pubmed/id/16816536

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2006-7-31
pubmed:abstractText
LV5FU2 with high-dose leucovorin (LV), weekly infusional 5-fluorouracil (5FU) (AIO schedule) and raltitrexed have been demonstrated to be active agents in first-line treatment of colorectal cancer. We performed a 4-arm randomised trial to compare (1) a low-dose intravenous bolus of LV (20 mg/m2), followed by an intravenous bolus of 5FU (400 mg/m2), followed by a 22-hour continuous infusion of 5FU (600 mg/m2) on day 1 and day 2/2 weeks (ldLV5FU2 arm), (2) a weekly continuous infusion of high-dose 5FU (2.6 g/m2/week) for 6 weeks followed by a rest week (HD-FU arm) and (3) raltitrexed (Tomudex arm; 3 mg/m2/3 weeks) to standard LV5FU2. From 1997 to 2001, 294 patients were included. The 4 arms were well balanced for sex ratio, age, WHO performance status, the primary tumour site and prior adjuvant chemotherapy. Treatment was stopped due to low accrual. Two toxicity-related deaths were observed in the Tomudex arm. The treatments gave rise to different rates of grade 3-4 neutropenia (3, 4, 11 and 14% of the patients in the LV5FU2, ldLV5FU2, HD-FU and Tomudex arms, respectively, p = 0.028), leucopenia and vomiting. At least one episode of grade 3-4 toxicity was observed in 27, 25, 38 and 47% of the patients in the LV5FU2, ldLV5FU2, HD-FU and Tomudex arms, respectively (p = 0.016). An objective response was observed in 28, 21, 22 and 10% of the patients in the LV5FU2, ldLV5FU2, HD-FU and Tomudex arms, respectively (p = 0.04). Progression-free survival (PFS) of the patients in the Tomudex arm was statistically lower compared to that of patients treated with LV5FU2 or ldLV5FU2 (combined group; p = 0.013, log rank test). In conclusion, Tomudex is more toxic and yields shorter PFS than infusional 5FU. Despite the early closure of the study and the lack of power of the comparison, it seems that ldLV5FU2 could be considered as an active, easier and less expensive option for the treatment of metastatic colorectal cancer compared to classic LV5FU2 or weekly HD-FU.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0030-2414
pubmed:author
pubmed:copyrightInfo
Copyright 2006 S. Karger AG, Basel.
pubmed:issnType
Print
pubmed:volume
70
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
222-30
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:16816536-Aged, pubmed-meshheading:16816536-Antimetabolites, Antineoplastic, pubmed-meshheading:16816536-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:16816536-Chemotherapy, Adjuvant, pubmed-meshheading:16816536-Colorectal Neoplasms, pubmed-meshheading:16816536-Disease-Free Survival, pubmed-meshheading:16816536-Drug Administration Schedule, pubmed-meshheading:16816536-Female, pubmed-meshheading:16816536-Fluorouracil, pubmed-meshheading:16816536-France, pubmed-meshheading:16816536-Humans, pubmed-meshheading:16816536-Infusions, Intravenous, pubmed-meshheading:16816536-Male, pubmed-meshheading:16816536-Middle Aged, pubmed-meshheading:16816536-Neoplasm Staging, pubmed-meshheading:16816536-Quality of Life, pubmed-meshheading:16816536-Quinazolines, pubmed-meshheading:16816536-Thiophenes, pubmed-meshheading:16816536-Treatment Outcome
pubmed:year
2006
pubmed:articleTitle
Randomised trial comparing three different schedules of infusional 5FU and raltitrexed alone as first-line therapy in metastatic colorectal cancer. Final results of the Fédération Francophone de Cancérologie Digestive (FFCD) 9601 trial.
pubmed:affiliation
Institut Gustave-Roussy, Villejuif, France. ducreux@igr.fr
pubmed:publicationType
Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study