At EAU26: 41st Annual EAU Congress, held 13–16th March 2026 in London, Dr Kevin Keane (Department of Urology, Fiona Stanley Hospital, University of Western Australia, Perth, WA, Australia) presented early results from a first-in-human study exploring a streamlined intravesical approach for patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC). The G-DISCO trial evaluates synchronous administration of gemcitabine and docetaxel – an innovation that could reduce treatment burden while preserving efficacy in a population with limited bladder-sparing options.
The major unmet need is for effective, bladder-preserving therapies. While radical cystectomy remains the gold standard, many patients are either unfit for surgery or wish to avoid it. Although newer bladder-preserving options – such as systemic immunotherapies and gene therapies – have emerged, access remains inconsistent globally, durability is still debated and both financial and medical toxicities are significant.
Gemcitabine–docetaxel, by contrast, is inexpensive, widely available and increasingly used sequentially in this setting. The rationale behind synchronous administration was to build on that established efficacy while simplifying delivery. By combining both agents into a single instillation, we aimed to reduce procedural burden without compromising the biological synergy of two drugs with complementary mechanisms of action.
G-DISCO is a phase I, single-arm, investigator-initiated trial conducted at Fiona Stanley Hospital in Western Australia. We enrolled 15 patients with high-risk, fully resected NMIBC who were either BCG-unresponsive or ineligible, and who were unwilling or unable to undergo cystectomy. Patients received a combination of 1 g gemcitabine and 37.5 mg docetaxel in a single intravesical instillation weekly for six weeks. The treatment aimed for a minimum dwell time of 60 minutes, ideally 90.
The primary endpoints were safety, feasibility and tolerability. Feasibility was defined as at least two-thirds of patients completing four or more instillations with adequate dwell time. Tolerability was assessed using validated symptom indices. The secondary endpoint was recurrence at three months, assessed via cystoscopy and biopsy.
We found that synchronous administration was safe, feasible and well tolerated. There were no serious adverse events attributable to the treatment, and the side-effect profile was comparable to other intravesical therapies. Feasibility was achieved in 93% of patients, with 13 out of 15 completing all six instillations. Importantly, symptom scores remained stable throughout treatment.
At three months, all patients underwent biopsy, and we observed a complete response rate of 67%, with high-grade recurrence-free survival of 80%. While these are encouraging early signals, clinicians should interpret them cautiously given the small sample size and short follow-up. That said, they are certainly comparable to what we might expect from sequential therapy.
The key advantages are practical. This approach shortens treatment time for patients, reduces nursing workload and improves efficiency within busy urology units. There are also cost benefits and reduced exposure for healthcare staff handling cytotoxic agents. Importantly, gemcitabine and docetaxel are already widely available and inexpensive – significantly cheaper than some newer therapies – which makes this approach highly scalable across different healthcare systems.
The phase II G-DISCOTEQ (Gemcitabine Docetaxel Intravesical Synchronous COadministration Therapeutic Efficacy Quantification) trial has now opened and will expand recruitment across multiple centres in Australia. Its primary goal is to better define efficacy and enable meaningful comparisons with sequential gemcitabine–docetaxel.
Key unanswered questions include long-term durability of response, optimal patient selection and whether synchronous delivery can truly match – or even outperform – sequential regimens. These are critical considerations if this approach is to become part of standard care.
Cite: Inside the G-DISCO trial in BCG-unresponsive NMIBC. touchONCOLOGY. March 25th, 2026
Disclosure: Kevin Keane has no financial or non-financial conflicts of interest to declare in relation to this article. This short article was prepared by touchONCOLOGY in collaboration with Dr Kevin Keane. Views expressed are the author’s own and do not necessarily reflect the views of Touch Medical Media.
Editor: Sophie Nickelson (Editorial Director).
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