Red-Hot Research in Bladder Cancer

Post-operative instillation of the bladder with gemcitabine reduces the chances that a resected tumor will return. Canadian and European clinical trials had already proven this true, and now Messing and his S0337 team have done the same here in the U.S. The impact of this simple, post-surgical step is significant: The S0337 team saw a 34 percent reduction in risk of recurrence in patients receiving gemcitabine. This is a “big deal,” Messing notes in a press release because the low-grade, non-muscle invasive form of bladder cancer they were treating recurs frequently – causing anxiety and pain and costing time and money for thousands of people a year.

S0337 is classic SWOG. The study isn’t testing a potentially lucrative new drug, but putting to the test a change in medical practice that could benefit significant numbers of patients. It is the type of publicly-funded research the cooperative groups were created to perform. S0337 is an exemplar of something else – SWOG’s red-hot bladder cancer portfolio.

We have several important bladder trials underway:

• S1011, a Phase III surgical trial led by Dr. Seth Lerner, is comparing the effects of performing a standard lymph node removal against a more extensive removal during surgery for muscle invasive bladder cancer. Experts in bladder cancer are uncertain if a more extensive operation, which may carry a high risk of complications, will reduce disease recurrence and progression. Regardless of the study’s result, it will establish a new standard of care.
   
• S1605, a Phase II immunotherapy registration trial led by Drs. Peter Black and Parminder Singh, is testing the new FDA-approved atezolizumab in patients who don’t respond to BCG treatment, to see if the drug affects tumors within the bladder, reduces recurrence, and potentially allows the patient to avoid cystectomy. S1605 is the first NCI-funded immune checkpoint inhibitor trial for non-muscle invasive bladder cancer – and it was just featured in the ASCO Post.
   
• S1314, a Phase II chemotherapy trial led by Dr. Thomas Flaig, is studying whether a patient with bladder cancer’s gene expression can predict response to two standard chemotherapy regimens. Results could help physicians decide which patients benefit most from chemotherapy, and which kind, before moving on to surgery or radiation. This would help some patients receive the best treatment and avoid expensive, toxic chemo that may not work well for their specific disease state.
   
• S1602, a Phase III randomized immunotherapy trial led by Dr. Robert Svatek, is comparing the effects of two different strains of BCG – Tokyo and TICE – on cancer recurrence. Another study objective is to determine whether “priming” patients with an SQ injection of the Tokyo strain prior to intravesical treatment improves outcomes. Because there are occasional shortages of the TICE strain of BCG, results could open up another source of this mainstay drug.

Bladder cancer is the sixth most commonly diagnosed cancer in the U.S., and the third most common among men. It’s finally seeing a surge in drug development and research, and it’s gratifying that SWOG is playing a key role in that discovery boom.

Dr. Ian Thompson and advocate Rick Bangs deserve major credit for the great crop of bladder trials we’ve got going. Indeed, the genitourinary committee as a whole is seeing continued success. For example, GU’s other advocate, Tony Crispino, is third author on the new AUA clinically-localized prostate cancer guideline. Hats off to Ian and to all GU advocates and investigators. They are helping SWOG make a big difference.

The San Antonio Breast Cancer Symposium (SABCS) abstract submission deadline is coming up. Please submit your abstracts to SWOG publications manager Pat Arlauskas by June 5 at arlauskp@ohsu.edu for processing.