HAMBURG—Although BCG is extremely effective in high-risk bladder cancer and carcinoma in situ, many physicians hesitate to use it because of the intense inflammation and systemic side effects it produces. Moreover, no consensus has yet been reached about whether BCG is actually superior to chemotherapy.
To tackle the questions of whether BCG affords any real clinical advantage and whether its toxicity can be suppressed without interfering with its antitumor effect, the European Organization for Research and Treatment of Genitourinary Cancer (EORTC-GU) Group launched a multicenter phase III trial. EORTC-GU investigator Maurizio Brausi, MD, reported preliminary results at the Ninth European Cancer Conference (ECCO 9).
The study randomized nearly 1,000 patients with intermediate- or high-risk pTa-pT1 bladder cancer to receive intravesical epirubicin(Drug information on epirubicin), 50 mg once a week for 6 weeks; intravesical BCG, 5 × 108 cfu once weekly for 3 years; or intravesical BCG plus the tuberculostatic agent isoniazid(Drug information on isoniazid) (INH), 300 mg given one day before, the same day as, and one day after BCG instillation.
“The objective of our study was, first of all, to compare the efficacy of epirubicin with that of BCG and BCG plus INH, with the endpoints being the disease-free interval, the recurrence rate, progression to greater than T1 disease, and the incidence of carcinoma in situ during follow-up,” said Dr. Brausi, professor of urology, B. Ramazzini Hospital, Carpi-Modena, Italy.
Another key goal, he said, was to determine whether prophylactic administration of the tuberculostatic agent would actually protect patients against BCG-related local and systemic side effects.
Preliminary analysis showed that the time to first recurrence was “probably” longer in the two groups that received BCG, Dr. Brausi reported. “I say ‘probably’ because the follow-up is still too short to draw any conclusions,” he noted.
Disappointingly, however, INH prophylaxis failed to reduce the incidence of BCG-linked urinary frequency, chemical cystitis, bacterial cystitis, hematuria, granulomatous prostatitis, orchitis, ureteral obstruction, fever, malaise, chills, or skin eruptions. In addition, INH was responsible for transient disturbances in liver function.
