Intravesical treatment with gemcitabine followed by docetaxel may offer an alternative first-line option to bacillus Calmette-Guérin (BCG) for treating patients with high-risk nonmuscle invasive bladder cancer (NMIBC), according to study data presented at the ASCO Genitourinary Cancers Symposium 2022.
“Our study provides evidence that using sequential intravesical gemcitabine and docetaxel is a safe and effective alternative to BCG during the now-chronic BCG shortage,” said lead investigator Vignesh T. Packiam, MD, clinical assistant professor of urology at the University of Iowa in Iowa City. “This will provide a valuable option for patients with nonmuscle-invasive bladder cancer who do not have access to BCG. These results will need prospective evaluation, which is underway with our group and others.”
Dr Packiam and colleagues retrospectively studied 107 patients with BCG-naïve high-risk NMIBC treated with sequential intravesical gemcitabine and docetaxel. The median follow-up was 15 months. Recurrence-free survival (RFS), the primary endpoint, was 85% and 82% at 12 and 24 months, respectively. No difference in RFS was observed in patients with and without carcinoma in situ disease.
For comparison, the investigators cited a contemporary study by Justin T. Matulay, MD, and colleagues showing a 12-month RFS rate of 79% with intravesical BCG used to treat high-risk NMIBC.
Of the 107 patients, 4 (3.7%) were intolerant to the gemcitabine-docetaxel treatment. No patient progressed to metastatic disease.
Disclosure: Some study authors 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, Martin AC, et al. Gemcitabine and docetaxel for the treatment of BCG-naïve high-risk NMIBC. Presented at ASCO GU 2022; February 17-19. Abstract 497.
Matulay JT, Li R, Hensley PJ, et al. Contemporary outcomes of patients with nonmuscle-invasive bladder cancer treated with bacillus Calmette-Guérin: Implications for clinical trial design. J Urol. 205:1612-1621. doi:10.1997/JU.0000000000001633