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Intravesical Gemcitabine and Docetaxel Therapy for BCG-Naïve Patients: A Promising Approach to Non-Muscle Invasive
Mirko Bakula1,2, Tvrtko Hudolin1,2, Nikola Knezevic1,2
1Department of Urology, University Hospital Centre Zagreb, Kispaticeva 12, 10000 Zagreb, Croatia.
Gemcitabine and docetaxel (Gem/Doce) offers a safe and effective first-line treatment for high-risk non-muscle invasive bladder cancer (NMIBC). This therapy shows promising recurrence-free and progression-free survival rates in patients ineligible for Bacillus Calmette-Guérin (BCG) treatment.
Area of Science:
- Urology
- Oncology
- Clinical Trials
Background:
- Bacillus Calmette-Guérin (BCG) therapy for non-muscle invasive bladder cancer (NMIBC) has limitations in efficacy and tolerability, compounded by global shortages.
- High-risk NMIBC (HR NMIBC) requires effective alternative treatments, especially for patients who are BCG-naïve.
Purpose of the Study:
- To evaluate the safety and efficacy of sequential intravesical gemcitabine and docetaxel (Gem/Doce) as a first-line treatment for BCG-naïve patients with HR NMIBC.
Main Methods:
- A prospective clinical study enrolled 52 BCG-naïve HR NMIBC patients.
- Patients received sequential intravesical Gem/Doce therapy.
- Follow-up assessments were conducted every 3 months for up to one year.
Main Results:
- The study included patients with high-grade T1 (T1HG) bladder cancer, carcinoma in situ (CIS), or a combination.
- Median time to first recurrence varied by diagnosis (T1HG: 11 months, CIS: 10.5 months, T1HG+CIS: 8.8 months).
- Recurrence-free survival at 12 months was 80.8%, and progression-free survival at 12 months was 92.3%.
Conclusions:
- Gem/Doce therapy demonstrates safety and efficacy in BCG-naïve HR NMIBC patients.
- The treatment shows favorable recurrence-free and progression-free survival rates within a one-year follow-up.
- Further research with longer follow-up and comparative studies is warranted.
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