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Preoperative Chemotherapy May Reduce Risk of NMIBC Recurrence

Web Exclusives
SAN FRANCISCO—Italian researchers have found that delivering a single dose of intravesical chemotherapy preoperatively may be a better approach than postoperative chemotherapy for improving a patient’s risk of recurrence of non–muscle invasive bladder cancer (NMIBC).
Data presented at the 2010 annual meeting of the American Urological Association suggest that a single preoperative intravesical electromotive drug administration (EMDA) instillation of mitomycin C (MMC) may improve a patient’s risk of NMIBC recurrence more than a single postoperative intravesical passive diffusion (PD) instillation. This preventive measure may also enhance a patient’s disease-free interval, according to the researchers.
The investigators studied 352 patients with NMIBC to compare the effects of two delivery systems for a chemotherapy agent with transurethral resection (TUR) alone of the bladder. Patients were randomized into three groups: one received one immediate pre-TUR EMDA/MMC instillation; one received early post-TUR intravesical PD/MMC instillation; and one received TUR without adjuvant therapy. Patients with intermediate- and high-risk NMIBC underwent adjuvant standard intravesical therapy.
Over a follow-up period of 7 years, cancer recurrence was significantly less common in the pre-TUR EMDA/MMC group. This trend was also evident in the overall median disease-free intervals, which were 12.9 months for the TUR-alone group, 16.4 months for the post-TUR PD/MMC group, and 56.9 months for the pre-TUR EMDA/MMC group.
The researchers concluded that in patients with multifocal intermediate- and high-risk NMIBC, one immediate pre-TUR intravesical EMDA/MMC instillation would decrease the risk of recurrence and enhance disease-free intervals compared with one early post-TUR intravesical PD/MMC instillation or TUR alone.
Methodolgy explained
“Electromotive drug administration or EMDA describes the accelerated drug transport under the influence of an electric field. Mitomycin C is nonionized within the tolerable physiological range, and its electromotive mode of delivery is by electroosmosis,” explained lead study investigator Savino Di Stasi, MD, PhD, an associate professor of urology at the University of Rome, Italy.
He said intravesical EMDA is dispensed by a battery-powered generator that delivers a controlled electric current. The current goes between two electrodes, and the active intravesical electrode is integrated into a specifically designed transurethral catheter. Next, the dispersive ground electrodes are placed on the skin of the lower abdomen. Active electrode polarity and current intensity are set on the current generator by the nurses who are the operators.
“The nurses do the catheterizations of the patients, and they do the drug administration,” said Di Stasi in an interview with The Oncology Nurse. “This approach is not in the United States, but they are doing it in Spain, England, France, Austria, Germany, and Denmark, and of course Italy.”
Di Stasisaid in both laboratory and clinical studies, intravesical EMDA has been shown to increase MMC bladder uptake, resulting in improved clinical efficacy in high-risk NMIBC without significant side effects. He cautioned, however, that an early single intravesical post-TUR EMDA/MMC instillation is strongly not recommended, because the catheterization may cause additional mechanical trauma and further injury to the urothelium.

“The nurses really play a key role in this,” Cino Rossi, vice president of Physion, S.R.L., which is developing this technology, said in an interview with The Oncology Nurse. “The presence of the doctor is actually not necessary during the treatment. So the nurse can handle it all.”

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