Flushing the bladder with gemcitabine—a common chemotherapy drug—immediately after surgery significantly reduces the chances of bladder cancer returning, according to a major study led by Edward M. Messing, MD, and an international clinical trials network (SWOG) funded by the National Cancer Institute (NCI).
Published in the Journal of the American Medical Association (JAMA), the study notes this may be the first phase 3 trial in the U.S. in two decades to show a benefit from this treatment strategy. European and Canadian urologists have been using it for years, with their own clinical trial data to support the procedure.
“The real importance of this study is that we now have a readily available drug that’s fairly inexpensive, well tolerated, and effective,” said Dr. Messing, a SWOG investigator and professor of Urology, Oncology, and Pathology at the University of Rochester Medical Center and its Wilmot Cancer Institute. “One of the biggest issues with low-grade bladder cancer is that it frequently returns. I know some patients who have to undergo four surgeries a year, and if we can cut down on these recurrences, we will save a lot of people a lot of pain, money, and time lost to recovery.”
The clinical trials network, known as SWOG, conducted the randomized, double-blind trial involving 406 eligible patients at 23 cancer centers. JAMA also published an editorial about the trial, which noted that it focused on a problem that’s meaningful to patients, and concluded that it has “practice-changing implications.”
Surgeons removed all cancerous tissue from study participants with a procedure known as transurethral resection of bladder tumor. Then, 201 or roughly half of the patients received gemcitabine mixed with saline and administered via catheter to the bladder area within three hours after surgery. Gemcitabine works by blocking new DNA and killing any dividing cells. It’s used to treat several other cancers, including advanced bladder cancer, but had not been studied in this setting among low-grade cancer patients. The second group of 205 patients received saline alone.
Researchers followed all patients for four years—the time period when most bladder cancers return—seeking to discover which treatment strategy worked better. The results were clear: a 34% reduction in the risk of recurrence for patients receiving the gemcitabine infusion. Sixty-seven patients in the gemcitabine group (35%) experienced a recurrence, compared with 91 patients in the saline group (47%).
However, further research is needed to compare various chemotherapy agents for their effectiveness. About 80,000 Americans a year are diagnosed with bladder cancer, and the low-grade nonmuscle invasive form makes up more than half of the new cases annually.
The trial was supported by the NCI of the National Institutes of Health under Award Numbers CA180888 and CA180819. Eli Lilly and Company also supported the work.
Source: University of Rochester Medical Center; May 8, 2018.