Researchers have found that a safe, inexpensive chemotherapy combination may be better tolerated and more effective at preventing high-grade recurrence in patients with non–muscle-invasive bladder cancer than the standard-of-care bacillus Calmette-Guérin (BCG), according to a novel study published by McElree et al in JAMA Network Open. As a result of an ongoing, worldwide shortage, many patients with non–muscle-invasive bladder cancer have had limited access to BCG.
Background
Non–muscle-invasive bladder cancer accounts for about 75% of cases of bladder cancer—the sixth most common tumor type in the United States. Patients with high-risk non–muscle-invasive bladder cancer experience a significant risk of both disease recurrence and progression. Typical treatment involves surgical resection of the tumor followed by treatment with BCG.
The new approach aims to replace BCG with a combination of two inexpensive, readily available chemotherapy drugs—gemcitabine and docetaxel. A recent study published by McElree et al in The Journal of Urology demonstrated a 2-year recurrence-free survival rate of 82% in patients with high-risk non–muscle-invasive bladder cancer who were treated with the combination chemotherapy instead of BCG. Already, other major cancer centers have increasingly adopted this regimen.
“With that earlier study, we showed that patients with untreated non–muscle-invasive bladder cancer who received gemcitabine and docetaxel had excellent safety and efficacy outcomes that were on par with historical outcomes of BCG,” commented senior study author Vignesh Packiam, MD, Clinical Assistant Professor of Urology at the University of Iowa Health Care. “This was novel and impactful as it provides the first highly effective and accessible alternative to BCG, for which none previously existed. However, one limitation in that study was there was no direct comparison to the standard-of-care treatment—BCG.”
Study Methods and Results
In the novel study, Dr. Packiam and colleagues retrospectively compared outcomes in 312 patients who received either the combination of gemcitabine and docetaxel or the standard-of-care BCG over a 10-year period. They found that the combination chemotherapy resulted in better recurrence-free survival in patients with high-risk non–muscle-invasive bladder cancer compared with BCG. Additionally, fewer patients who received the combination chemotherapy discontinued their treatment compared with patients who received BCG.
Conclusions
“The results were very promising,” underscored Dr. Packiam. “We believe this new study will have an immediate impact as it shows stronger evidence for using gemcitabine and docetaxel for [newly diagnosed] patients with non–muscle-invasive bladder cancer—for whom there is no alternative option due to the BCG shortage,” he added.
The findings also provided valuable support for the prospective, multi-institutional, randomized, controlled phase III BRIDGE trial (ClinicalTrials.gov identifier NCT05538663)—which was recently launched and is anticipated to be the definitive trial comparing gemcitabine and docetaxel to BCG in patients with non–muscle-invasive bladder cancer.
Disclosure: The study was funded in part by grants from the National Cancer Institute and the John and Carol Walter Family Foundation. For full disclosures of the study authors, visit jamanetwork.com.
