Linked Life Data

2195135

Source:http://linkedlifedata.com/resource/pubmed/id/2195135

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
1990-8-15
pubmed:abstractText
5-Fluorouracil (5-FU) has been the treatment of choice for colorectal carcinoma with an overall response rate of about 20%. Recent studies have shown that folate (LV) can increase 5-FU therapeutic efficacy, achieving about a 40% response rate without a clear impact on survival. Cisplatinum (CDDP) is usually inactive in colorectal carcinoma, but the association with 5-FU results in a synergistic antineoplastic effect. A phase I-II study was done to assess the maximally tolerated dose (MTD) of CDDP in association with 5-FU + LV. The MTD for CDDP was 20 mg/m2/wk in association with 5-FU 400-500 mg/m2/wk and LV 500 mg/m2/wk. WHO criteria were used for evaluation of both toxicity and response. In the phase I part we found that the main side-effect in 27 evaluable patients (pts) was gastrointestinal toxicity, mainly in the form of nausea/vomiting (92%) and diarrhea (70%) which caused one therapy-related death. Renal (26%) and marrow (59%) toxicity were acceptable. In the phase II part of the study 1 out of 19 evaluable pts (5%) had a complete response of 309 days, 3 pts achieved a partial response (16%) with a median duration od 410 days, 2 pts had a minimal response (10%) with a median duration of 261 days, and 8 pts experienced no change (42%) with a mean duration of 196 + days. In our opinion the 21% response rate obtained in this series is not satisfactory. Nevertheless the very high number of minimal response + no change patients together with the interesting impact on survival in responders may suggest further phase II-III studies.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Feb
pubmed:issn
1120-009X
pubmed:author
pubmed:issnType
Print
pubmed:volume
2 Suppl 1
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
28-32
pubmed:dateRevised
2009-8-4
pubmed:meshHeading
pubmed:year
1990
pubmed:articleTitle
A phase I-II study on the toxicity and therapeutic efficacy of 5-fluorouracil in combination with leucovorin and cisplatinum in patients with advanced colorectal carcinoma.
pubmed:affiliation
Istituto di Farmacologia, Università di Palermo, Italy.
pubmed:publicationType
Journal Article, Clinical Trial