Study Finds Gemcitabine-Docetaxel Combo Outperforms BCG in Treating High-Risk Bladder Cancer

Gemcitabine and docetaxel therapy may be a viable alternative to bacillus Calmette-Guérin (BCG) for patients with high-risk non-muscle invasive bladder cancer (NMIBC), according to study results published in JAMA Network Open.

“Randomized clinical trials often take many years to complete and, during the current period of BCG shortage, the lack of a well-studied alternative treatment has come at the cost of patient outcomes,” explained Ian McElree, MS, Carver College of Medicine, University of Iowa in Iowa City, and coauthors. “Therefore, to fill this gap, we aimed to compare oncological outcomes between patients treated with BCG vs gemcitabine and docetaxel for high-risk treatment-naïve NMIBC at our institution between 2011 and 2021,” they added.

The retrospective study analyzed data from 312 patients with high-risk NMIBC treated between 2011 and 2021. Of these, 174 received BCG therapy, while 138 received gemcitabine and docetaxel. The primary outcome was high-grade recurrence-free survival (RFS).

Gemcitabine and docetaxel therapy was associated with better RFS and high-grade RFS than BCG therapy. At 2 years, the high-grade RFS was 81% for the gemcitabine and docetaxel group vs 69% for the BCG group. Additionally, patients receiving gemcitabine and docetaxel had a lower risk of recurrence and high-grade recurrence, with hazard ratios of 0.56 and 0.57, respectively, compared to those treated with BCG.

Importantly, gemcitabine and docetaxel therapy appeared to be better tolerated than BCG. Patients receiving gemcitabine and docetaxel were less likely to discontinue induction therapy due to adverse events (2.9% vs 9.2%). While both treatments had similar overall rates of adverse events, severe adverse events were less common in the gemcitabine and docetaxel group.s

“While awaiting results from an ongoing randomized clinical trial and in the setting of the current BCG shortage, the findings of this study support the use of gemcitabine and docetaxel for the treatment of high-risk NMIBC, suggesting that this regimen can be considered for recommendation in updated practice guidelines,” concluded the study authors.

Reference

McElree IM, Steinberg RL, Mott SL, O'Donnell MA, Packiam VT. Comparison of sequential intravesical gemcitabine and docetaxel vs bacillus calmette-guérin for the treatment of patients with high-risk non-muscle-invasive bladder cancer. JAMA Netw Open. 2023;6(2):e230849. doi:10.1001/jamanetworkopen.2023.0849