PORTLAND, OR - Flushing the bladder with a common chemotherapy drug immediately after surgery significantly reduces the chances of bladder cancer returning, according to a major study by SWOG, an international clinical trials network funded by the National Cancer Institute.
The research was led by Edward M. Messing, M.D., a SWOG investigator and professor of urology, and a professor of oncology and pathology, at the University of Rochester School of Medicine and Dentistry and a physician at the Wilmot Cancer Institute.
Published in the May 8 edition of the Journal of the American Medical Association (JAMA), the study notes this may be the first phase III trial in the U.S. to show a benefit from this treatment strategy in two decades. 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," Messing said. "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 JAMA study says the findings "support using this therapy," but adds that 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 non-muscle invasive form makes up about half of the new cases annually.
The SWOG team conducted the randomized, double-blind clinical trial involving 406 eligible patients at 23 cancer centers.
Surgeons removed all cancerous tissue with a procedure known as TURBT, or transurethral resection of bladder tumor. Then, 201 patients received the chemotherapy drug, gemcitabine, mixed with saline, 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 percent reduction in the risk of recurrence for patients receiving the gemcitabine infusion. Sixty\-seven patients in the gemcitabine group, or 35 percent, experienced a recurrence, compared with 91 patients in the saline group, or 47 percent.
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Messing is a former president of the Society of Urologic Oncology, and later this month will receive the American Urological Association (AUA) Ramon Guiteras Award, honoring 35 years of accomplishments that have improved care for patients with urologic cancers. He presented this data in 2017 at the AUA annual meeting.
The trial, S0337, 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. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or Eli Lilly and Company.
Messing's SWOG study team includes: Cathy Tangen, DrPH, of Fred Hutchinson Cancer Research Center; Deepak Sahasrabudhe, MD, of University of Rochester; Theresa Koppie of Oregon Health & Science University; David Wood Jr., MD, of Beaumont Health; Philip Mack, PhD, of UC Davis Cancer Center; Robert Svatek, MD, of UT Health San Antonio; Christopher Evans, MD, UC Davis Cancer Center; Khaled Hafez, MD, of University of Michigan; Daniel Culkin, MD, of University of Oklahoma; Timothy Brand, MD, of Madigan Army Medical Center; Lawrence Karsh, MD, of The Urology Center of Colorado; Jeffrey Holzbeierlein, MD, of University of Kansas Cancer Center; Shandra Wilson, MD, of University of Colorado; Guanming Wu, PhD, of Oregon Health & Science University; Melissa Plets, MS, Fred Hutchinson Cancer Research Center; Seth Lerner, MD, Baylor College of Medicine; Nicholas Vogelzang, MD, Comprehensive Cancer Centers of Nevada; and Ian Thompson, Jr., MD, of CHRISTUS Santa Rosa Medical Center.
SWOG has nearly 12,000 members in 47 states and six foreign countries who design and conduct cancer clinical trials. Founded in 1956, SWOG's 1,300 treatment and prevention trials have led to the approval of 14 cancer drugs, changed the standard of cancer care more than 100 times, and saved more than 2 million years of human life. SWOG is funded by the National Cancer Institute and is a proud member of the NCI's National Clinical Trials Network and the NCI Community Oncology Research Program. Learn more at swog.org.
The University of Rochester Medical Center is home to approximately 3,000 individuals who conduct research on everything from cancer and heart disease to Parkinson's, pandemic influenza, and autism. Spread across many centers, institutes, and labs, our scientists have developed therapies that have improved human health locally, in the region, and across the globe. To learn more, visit urmc.rochester.edu/research.
Journal
JAMA