The effect of isoniazid on BCG-induced toxicity in patients with superficial bladder cancer.

Abstract

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.

• Authors: M Al Khalifa, P Elfving, W Månsson, S Colleen, S Hellsten, M Duchek, G Nyberg, P Callaghan, C Rademark, R Eriksson, R Olsson, G Hagberg, C E Nelson
• Journal: European urology (Eur Urol) Vol. 37 Suppl 1 Pg. 26-30 ( 2000) ISSN: 0302-2838 [Print] Switzerland
• PMID: 10575269 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2000 S. Karger AG, Basel

Chemical References

• Antitubercular Agents
• BCG Vaccine
• Isoniazid

Topics

• Administration, Intravesical
• Aged
• Antitubercular Agents (therapeutic use)
• BCG Vaccine (administration & dosage, adverse effects)
• Carcinoma in Situ (therapy)
• Carcinoma, Transitional Cell (therapy)
• Double-Blind Method
• Exanthema (chemically induced, prevention & control)
• Female
• Fever (chemically induced, prevention & control)
• Humans
• Isoniazid (therapeutic use)
• Male
• Nausea (chemically induced, prevention & control)
• Proportional Hazards Models
• Prospective Studies
• Statistics, Nonparametric
• Urinary Bladder Diseases (etiology, prevention & control)
• Urinary Bladder Neoplasms (therapy)