Study: Gemcitabine helps prevent recurrence of low-grade bladder cancer

Diagnostic form with diagnosis bladder cancer and pills.

SAN ANTONIO (May 8, 2018) ― A multi-institution clinical trial involving researchers from UT Health San Antonio shows significantly lower recurrence of bladder cancer in patients who received the chemotherapy drug gemcitabine.

The results of the trial were published May 8, 2018, in the Journal of the American Medical Association. Robert Svatek, M.D., a UT Health San Antonio genitourinary oncologist, was the university’s study leader.

“Dr. Svatek was not only involved with conducting this study, but he and his site (UT Health San Antonio), along with our site (the University of Rochester), were the two leading recruiting sites for patients,” said Edward M. Messing, M.D., the national leader of the study.

In addition to his oncology practice, Dr. Svatek is an associate professor in the Department of Urology and chief of the Division of Urologic Oncology at UT Health San Antonio.

In the trial, 406 patients with newly diagnosed bladder cancer or low-grade bladder cancer that had not invaded the muscle wall were randomly assigned to one of two groups. One group received one treatment of gemcitabine and a saline solution and the other group received one treatment of only saline solution, both directly instilled into the bladder through a catheter within three hours following surgery. Gemcitabine is already approved by the U.S. Food and Drug Administration to treat several other types of cancer.

For patients receiving the gemcitabine-saline treatment, there was an estimated recurrence rate of 36 percent within four years, compared to a 48 percent recurrence  rate within four years in patients receiving the saline solution-only treatment. “The gemcitabine treatment reduced the risk of recurrence by 34 percent compared to saline for the entire population, and by 47 percent for those with low-grade bladder cancer, the target population for the study,” Dr. Svatek said.

“This is a huge difference in recurrence rate and demonstrated that gemcitabine is a safe and well-tolerated drug. We expect this study to change the standard of care,” Dr. Svatek said, adding that the results support the recommendations of the American Urological Association and European Association of Urology.

According to the American Cancer Society, nearly 80,000 men and women are expected to be diagnosed with bladder cancer in 2017. Urothelial cancer ― cancer that affects the different parts of the urinary system ― is the most expensive type of cancer to treat because it requires frequent invasive follow-up over a patient’s lifetime, Dr. Svatek said. There were no significant side effects for patients in the study, and gemcitabine is less expensive than many other therapies used in the U.S., he said.

“The 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 professor of oncology and pathology at the University of Rochester School of Medicine and Dentistry. “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 study, S0337, was conducted through SWOG, a National Cancer Institute-supported cancer clinical trials group, and involved supporting faculty from UT Health San Antonio including Dr. Joseph Basler, who through his faculty position serves as chief of urology at the Southwest Texas Veterans Healthcare System’s Audie L. Murphy Memorial VA Hospital, where many patients were enrolled.

In addition, the following additional researchers were involved in the study: Cathy Tangen, Dr.P.H., of Fred Hutchinson Cancer Research Center; Deepak Sahasrabudhe, M.D., of University of Rochester; Theresa Koppie of Oregon Health & Science University; David Wood Jr., M.D., of Beaumont Health; Philip Mack, Ph.D., of UC Davis Cancer Center; Christopher Evans, M.D., UC Davis Cancer Center; Khaled Hafez, MD, of University of Michigan; Daniel Culkin, MD, of University of Oklahoma; Timothy Brand, M.D., of Madigan Army Medical Center; Lawrence Karsh, M.D., of The Urology Center of Colorado; Jeffrey Holzbeierlein, M.D., of University of Kansas Cancer Center; Shandra Wilson, M.D., of University of Colorado; Guanming Wu, Ph.D., of Oregon Health & Science University; Melissa Plets, M.S., Fred Hutchinson Cancer Research Center; Seth Lerner, M.D., Baylor College of Medicine; Nicholas Vogelzang, M.D., Comprehensive Cancer Centers of Nevada; and Ian Thompson, Jr., M.D., of CHRISTUS Santa Rosa Medical Center.

The trial was supported by the National Cancer Institute under award numbers CA 180888 and CA 180819, as well as Eli Lilly and Company.

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