title: Improving the safety of BCG immunotherapy by dose reduction. Cooperative Group CUETO.
abstract: The preliminary results of a randomized, multicentre, prospective trial conducted by the Spanish Oncology Group (CUETO) are presented. The primary aim of the trial was to determine whether or not lowering the dose of bacillus Calmette-Guérin (BCG) could reduce toxicity without compromising efficacy. From February 1991 to June 1992, 500 patients with superficial bladder cancer (TaG2-3, T1G1-3) entered the trial. Of these patients, 252 were included in group A (BCG, 81 mg) and 248 in group B (BCG, 27 mg). There were no significant differences in clinical and pathological characteristics between the two groups. Following treatment, significant differences arose between groups A and B in local severe toxicity (22.6 vs. 4.2%, respectively; p < 0.01). Systemic toxicity was more common in group A than in group B (p < 0.01): pulmonary effects (2.3 vs. 0.4%), fever (26.9 vs. 12.9%) and malaise (16.2 vs. 8.4%), all p < 0.01. Regarding efficacy, 204 patients in group A and 210 in group B were evaluated after a mean follow-up of 18.6 months. No significant differences in recurrence rate (18.1 vs. 19.5%) or progression rate (2.4 vs. 4.8%) were found. However, in patients with superficial bladder cancer with high risk of recurrence and progression (carcinoma in situ and G3), caution must be exercised in selecting the dose.
authors.affiliation: Cooperative Group CUETO, Spain.
authors.forename: J A
authors.initials: JA
authors.lastname: Martínez-Piñeiro
authors.forename: E
authors.initials: E
authors.lastname: Solsona
authors.forename: N
authors.initials: N
authors.lastname: Flores
authors.forename: S
authors.initials: S
authors.lastname: Isorna
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000008:administration & dosage* / Q000009:adverse effects; D002278:Carcinoma in Situ / Q000401:mortality / Q000473:pathology / Q000628:therapy; D016009:Chi-Square Distribution; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D011446:Prospective Studies; D013030:Spain; D001749:Urinary Bladder Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000628:therapy*
chemical_list: D001500:BCG Vaccine