Study: Gemcitabine Helps Prevent Recurrence of Low-Grade Bladder Cancer

Friday, December 14, 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, MD, 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,” says Edward M. Messing, MD, 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 types of cancer.

For patients with low-grade non–muscle-invasive urothelial cancer, 34 of 102 patients (four-year estimate, 34 percent) in the gemcitabine group and 59 of 113 patients (four-year estimate, 54 percent) in the saline group had cancer recurrence.

“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 says. “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.”

According to the American Cancer Society, nearly 80,000 men and women are expected to be diagnosed with bladder cancer in 2018. 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 says. 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 says.

“The importance of this study is that we now have a readily available drug that’s fairly inexpensive, well-tolerated and effective,” says Dr. Messing, Professor of oncology and pathology at the University of Rochester School of Medicine and Dentistry.

The study was conducted through SWOG, a National Cancer Institute-supported cancer clinical trials group, and involved supporting faculty from UT Health San Antonio, including Joseph Basler, MD, 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.

The trial was supported by the National Cancer Institute, as well as Eli Lilly and Company.

Based on these outstanding results, Dr. Svatek is implementing this therapeutic approach in his patients at the UT Health San Antonio MD Anderson Cancer Center.

New Technology: Robert Svatek, MD, attending urologic oncologist at UT Health San Antonio, explains the simplicity of treating bladder cancer with gemcitabine.

“Gemcitabine sits in the bladder for an hour and then it’s removed and the patient goes home. While Gemcitabine has been traditionally used against other cancers, this procedure is unique because the chemotherapy agent is applied directly to the bladder instead of the bloodstream. This drug reduces the risk of tumors coming back by up to 47 percent, which is a large effect on the relapse rate.”

According to Dr. Svatek, carcinogens in the blood are filtered out by the kidneys and then stored in the bladder as a reservoir, exposing the organ to continuous amounts of toxins. He says that’s why the bladder is particularly susceptible to developing cancer from these environmental toxins. Dr. Svatek points out bladder cancer generally affects people in their 60s and 70s as that is the exposure time needed for the cancer to develop.