SWOG Now Searches for BCG Replacement
Back in 1991, a SWOG team led by Donald Lamm, MD, published results of S8216 in the New England Journal of Medicine. This bladder cancer trial turned out to be historic. The aim was to compare the effectiveness of intravesical chemotherapy against one of the first cancer immunotherapies – bacilli Calmette-Guerin, or BCG, a vaccine made from live tuberculosis bacteria.
Dr. Lamm and his team enrolled 262 eligible patient volunteers, randomizing them to treatment with either intravesicular doxorubicin or BCG, the latter also given percutaneously, and followed those volunteers for a median of 65 months. Complete responses were far more common with BCG, and disease-free survival was prolonged.
That single NEJM article changed the standard of care and has been cited 349 times. BCG remains the best treatment option for people diagnosed with early-stage, non-muscle invasive bladder cancer.
But there have been chronic, national shortages of BCG in recent years leading some clinics and hospitals to run out, and some to ration supplies. Merck, the sole producer of the TICE strain of BCG, has ramped up production, but the shortage persists. The Bladder Cancer Advocacy Network has weighed in on the crisis, and this month convened a group of physicians and experts to offer guidance to urologists and patients about managing during the shortage. Meanwhile, STAT, the health and medicine news site, expertly explained the crisis and its implications in a Feb. 20 article.
SWOG research may help us fill the void. The same clinical trials group that helped establish the effectiveness of BCG may also help establish the effectiveness of a replacement.
S1602 is a phase III randomized trial that is comparing the effectiveness of three treatment regimens for non-muscle invasive bladder cancer – one uses the current TICE strain of BCG, another a Tokyo-172 strain of BCG, and a third uses a “priming” dose of the Tokyo strain delivered percutaneously, then continuing doses of the Tokyo strain injected intravesicularly. If the Tokyo strain proves as or more effective, the trial results could open up a new mainstay source of the drug.
Robert Svatek, MD, of the University of Texas Health Science Center is leading S1602, which generated a lot of buzz at the ASCO Genitourinary Cancers Symposium held a couple of weeks ago in San Francisco. After the meeting, a few urologists took up the cause on Twitter, urging colleagues to enroll patients to the trial as a long-term means of dealing with the current crisis.
Not surprisingly, I concur! I encourage all SWOG members to read up on S1602, and to open the trial at your sites. Two years after activation, the trial has met 25 percent of its accrual goal, so there’s plenty of room.
It’s incredibly satisfying to be part of an organization that continues to do research with the potential to change standard of care. Potentially doing so, while solving a major problem for patients, is even better.