Treatment for high-risk non–muscle-invasive bladder cancer (NMIBC) with hyperthermic intravesical chemotherapy (HIVEC) using high-dose mitomycin-C (MMC) is safe, well tolerated, and appears efficacious after short-term follow-up, according to a report from Duke University urologists, which has been published in Urologic Oncology. In a paper presenting the first North American clinical experience with this modality, the investigators summarized outcomes from a cohort of 14 patients who received MMC HIVEC because of the BCG shortage. The median number of instillations received was 6, and the median follow-up for the series was 11 months.
The MMC HIVEC was well tolerated by 11 (79%) of the patients. Seven patients (50%) developed adverse events (AEs), but all were grade 1 or 2. During the available follow-up, 2 patients (14%) experienced a cancer recurrence, but both had discontinued MMC HIVEC after only 2 treatments.
The 14 patients included in the MMC HIVEC series comprised 4 with intermediate-risk disease and 10 with high-risk NIMBC. Twelve patients had recurrent tumors of which 11 had been previously treated with intravesical BCG (median, 6 treatments). Three patients were BCG-naïve.
The MMC HIVEC was administered at a concentration of 2 mg/mL (120 mg diluted in 60 mL sterile water) using a convective hyperthermia system (Combat BRS) with an induction course of 6 weekly instillations followed by up to 12 additional monthly treatments in the setting of a negative postinduction cystoscopy. Dwell time was 60 minutes heated and 30 to 60 minutes unheated following catheter removal.
The study demonstrates the feasibility of HIVEC MMC and suggests it is a reasonable substitute for BCG during global shortages. Brant A. Inman, MD, Associate Professor of Urologic Oncology at Duke University School of Medicine, is senior author of the told Urology Times®: “Many patients have already been seen at a 12-month visit, and preliminarily the data show that durable oncologic control is possible when patients are able to receive full induction courses of high-dose HIVEC MMC.”
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