(UroToday.com) The 2023 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA between February 16th and 18th was host to a prostate cancer and urothelial carcinoma poster session. Ian McElree presented the results of retrospective analysis evaluating the intravesical combination of gemcitabine and docetaxel versus Bacillus Calmette-Guerin (BCG) as first line-therapy for high-risk non-muscle invasive bladder cancer (NMIBC),
BCG remains the standard of care treatment post-TURBT for patients with NMIBC. Due to BCG shortages, sequential intravesical gemcitabine/docetaxel has been increasingly utilized in the first-line setting. The objective of this study was to compare the oncologic outcomes of patients with high-risk, treatment naïve NMIBC treated with Gem/Doce versus BCG.
The authors retrospectively identified 312 patients from 2011 to 2021, of whom 174 received BCG and 138 Gem/Doce. Patients in the Gem/Doce group received 6 weekly induction instillations of 1 gram Gemcitabine + 37.5 mg Docetaxel, whereas those in the BCG group received 1 vial of BCG (with or without IFNa-2b). Patients received monthly maintenance for two years if there was no evidence of disease recurrence. The primary outcome of the study was recurrence-free survival, with outcome measures analysed using Kaplan Meier curves (univariable) and Cox proportional hazards regression analysis (multivariable).
At a median follow up of 49 months for BCG treated patients and 23 months for Gem/Doce treated patients, multivariable cox regression analysis adjusting for gender and pre-treatment CIS demonstrated that patients receiving Gem/Doce had significantly improved RFS (HR: 0.56, 95% CI: 0.34 – 0.92, p=0.02) and high grade RFS rates(HR: 0.57, 95% CI: 0.33 – 0.97, p=0.04).
There were no significant differences in other oncologic outcomes.
There were increased odds of induction treatment discontinuation among patients receiving BCG (p=0.02).
The authors concluded that in the setting of ongoing BCG production shortages, the combination of intravesical Gem/Doce is an efficacious and well-tolerated alternative first-line therapy for high-risk NMIBC. Prospective randomized evaluation is being planned.
Presented by: Ian M. McElree, Medical Student, The University of Iowa Carver College of Medicine, Iowa City, Iowa City, IAs
Written by: Rashid Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, Thurs, Feb 16 – Sat, Feb 18, 2023.