G-DISCO: Phase 1 Study of Combined Chemotherapy for Bladder Cancer Treatment

What is it about?

This study investigates the safety, feasibility, and tolerability of synchronous intravesical co-administration of gemcitabine and docetaxel in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who are ineligible for or unresponsive to BCG therapy. The G-DISCO trial is a phase I study that recruits 15 patients to receive a single instillation of gemcitabine and docetaxel diluted in saline via urinary catheter, with a minimum dwell time of 60 minutes. The study aims to reduce procedural burden and healthcare costs while maintaining efficacy compared to the standard sequential administration. Key endpoints include feasibility, defined as 66% of participants completing at least four of six instillations, safety assessed by adverse event severity, and tolerability measured through patient-reported outcome measures. Secondary outcomes focus on recurrence rates at 3 months, while tertiary outcomes include pharmacokinetics and tumor molecular sub-typing. The study also considers a maintenance extension for eligible patients, reflecting an effort to advance treatment options for BCG-unresponsive or ineligible patients unfit for cystectomy.

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Why is it important?

This study investigates a novel approach to treating high-risk non-muscle-invasive bladder cancer (NMIBC) in patients unresponsive or ineligible for BCG therapy. The significance of this research lies in its potential to offer a more convenient and efficient bladder-sparing treatment option for patients who are unsuitable for radical cystectomy. By exploring the synchronous intravesical co-administration of gemcitabine and docetaxel, this study addresses a critical need for alternative therapies that reduce procedural time while maintaining efficacy. Key Takeaways: 1. The research demonstrates that the synchronous intravesical co-administration of gemcitabine and docetaxel is designed to be more time-efficient than the standard sequential regimen, potentially reducing the procedural burden on patients and healthcare services. 2. The study aims to establish the safety, feasibility, and tolerability of this new administration method, with co-primary endpoints focusing on at least 66% of participants completing the majority of their treatment and assessing adverse events and patient-reported outcomes. 3. Secondary and tertiary outcomes include evaluating the recurrence rate at 3 months and analyzing the pharmacokinetics and molecular sub-typing of tumors, which could inform future treatment strategies and patient management.