Compared with bacillus Calmette-Guérin (BCG) therapy, sequential gemcitabine and docetaxel is associated with a lower likelihood of recurrence of high-risk nonmuscle invasive bladder cancer (NMIBC), a new study finds.
Among 312 patients at the University of Iowa with high-risk NMIBC during 2011-2021, 138 were treated with sequential intravesical gemcitabine (1 g) and docetaxel (37.5 mg) and 174 with BCG as first-line therapy after transurethral resection of bladder tumor. At 6, 12, and 24 months, high-grade recurrence-free survival rates were 92%, 85%, and 81% in the gemcitabine-docetaxel group compared with 76%, 71%, and 69% in the BCG group, respectively.
In multivariable Cox regression analyses adjusted for carcinoma in situ, age, sex, and treatment year, gemcitabine and docetaxel was significantly associated with a 43% and 44% reduced risk of high-grade and overall recurrence, respectively, compared with BCG, Vignesh T. Packiam, MD, of the University of Iowa Hospitals and Clinics in Iowa City, and colleagues reported in JAMA Network Open.
Grade 3 to 5 adverse events, such as complicated urinary tract infection, occurred in 2 patients (1.4%) in the gemcitabine and docetaxel group and 7 patients (4.0%) in the BCG group. Induction therapy for gemcitabine and docetaxel was associated with a significantly lower treatment discontinuation rate than BCG induction therapy (2.9% vs 9.2%).
“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,” Dr Packiam’s team wrote. They encourage further prospective studies and trials.
Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
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. doi:10.1001/jamanetworkopen.2023.0849