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PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
2000-4-11
pubmed:abstractText
The use of bacillus Calmette-Guérin in the treatment of transitional cell cancer of the bladder has caused concern because of its associated adverse effects. We conducted a randomized prospective, double-blind, multicentre study to determine whether isoniazid prophylaxis could reduce BCG-induced toxicity without compromising its immunotherapeutic effects. Patients (n = 160) with histologically documented urothelial cancer (pTa-T1, pTis, G1-3) were treated with 6 weekly instillations of BCG Connaught strain, 81 mg, administered concomitantly with a 3-day course of isoniazid (300 mg o.d.) or placebo. Side-effects were recorded with each treatment and at follow-up. Of the patients treated with isoniazid, 19% remained free from side-effects, compared with 16% of the placebo group. Local side-effects confined to the bladder were significantly lower among those receiving isoniazid (35% vs. 48%, p < 0.01). Local side-effects together with systemic adverse effects such as fever, nausea or skin rash were experienced by 30% of patients in each arm. There were no differences in tumour recurrence between the two patient groups. Concomitant isoniazid reduces the local, but not the systemic side-effects of topically applied BCG without compromising the antitumour effect on superficial, transitional cell cancer of the bladder during a follow-up period that now exceeds 2 years.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0302-2838
pubmed:author
pubmed:copyrightInfo
Copyright 2000 S. Karger AG, Basel
pubmed:issnType
Print
pubmed:volume
37 Suppl 1
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
26-30
pubmed:dateRevised
2009-12-30
pubmed:meshHeading
pubmed-meshheading:10575269-Administration, Intravesical, pubmed-meshheading:10575269-Aged, pubmed-meshheading:10575269-Antitubercular Agents, pubmed-meshheading:10575269-BCG Vaccine, pubmed-meshheading:10575269-Carcinoma, Transitional Cell, pubmed-meshheading:10575269-Carcinoma in Situ, pubmed-meshheading:10575269-Double-Blind Method, pubmed-meshheading:10575269-Exanthema, pubmed-meshheading:10575269-Female, pubmed-meshheading:10575269-Fever, pubmed-meshheading:10575269-Humans, pubmed-meshheading:10575269-Isoniazid, pubmed-meshheading:10575269-Male, pubmed-meshheading:10575269-Nausea, pubmed-meshheading:10575269-Proportional Hazards Models, pubmed-meshheading:10575269-Prospective Studies, pubmed-meshheading:10575269-Statistics, Nonparametric, pubmed-meshheading:10575269-Urinary Bladder Diseases, pubmed-meshheading:10575269-Urinary Bladder Neoplasms
pubmed:year
2000
pubmed:articleTitle
The effect of isoniazid on BCG-induced toxicity in patients with superficial bladder cancer.
pubmed:affiliation
Department and Sections of Urology, University Hospitals of Lund, Sweden.
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study