Version 1
: Received: 28 April 2024 / Approved: 29 April 2024 / Online: 30 April 2024 (10:29:47 CEST)
How to cite:
Bakula, M.; Hudolin, T.; Knezevic, N.; Zimak, Z.; Andelic, J.; Juric, I.; Gamulin, M.; Gnjidic, M.; Kastelan, Z. Intravesical Gemcitabine and Docetaxel Therapy for BCG-Naïve Patients: a Promising Approach in Non-Muscle Invasive Bladder Cancer. Preprints2024, 2024041917. https://doi.org/10.20944/preprints202404.1917.v1
Bakula, M.; Hudolin, T.; Knezevic, N.; Zimak, Z.; Andelic, J.; Juric, I.; Gamulin, M.; Gnjidic, M.; Kastelan, Z. Intravesical Gemcitabine and Docetaxel Therapy for BCG-Naïve Patients: a Promising Approach in Non-Muscle Invasive Bladder Cancer. Preprints 2024, 2024041917. https://doi.org/10.20944/preprints202404.1917.v1
Bakula, M.; Hudolin, T.; Knezevic, N.; Zimak, Z.; Andelic, J.; Juric, I.; Gamulin, M.; Gnjidic, M.; Kastelan, Z. Intravesical Gemcitabine and Docetaxel Therapy for BCG-Naïve Patients: a Promising Approach in Non-Muscle Invasive Bladder Cancer. Preprints2024, 2024041917. https://doi.org/10.20944/preprints202404.1917.v1
APA Style
Bakula, M., Hudolin, T., Knezevic, N., Zimak, Z., Andelic, J., Juric, I., Gamulin, M., Gnjidic, M., & Kastelan, Z. (2024). Intravesical Gemcitabine and Docetaxel Therapy for BCG-Naïve Patients: a Promising Approach in Non-Muscle Invasive Bladder Cancer. Preprints. https://doi.org/10.20944/preprints202404.1917.v1
Chicago/Turabian Style
Bakula, M., Milena Gnjidic and Zeljko Kastelan. 2024 "Intravesical Gemcitabine and Docetaxel Therapy for BCG-Naïve Patients: a Promising Approach in Non-Muscle Invasive Bladder Cancer" Preprints. https://doi.org/10.20944/preprints202404.1917.v1
Abstract
Bacillus Calmette-Guérin (BCG) therapy for patients with non-muscle invasive bladder cancer (NMIBC) faces limitations in efficacy and significant side effects, aggravated by a recent global shortage. In this prospective clinical study, we report outcomes of sequential intravesical adminis-tration of gemcitabine and docetaxel (Gem/Doce) as the first-line treatment in BCG-naïve patients with high-risk NMIBC (HR NMIBC). From October 2019 until April 2022, we enrolled 52 patients and followed treatment protocol set by the University of Iowa. Follow-up assessments were con-ducted every 3 months. In this cohort, 25 (48.1%) patients were diagnosed with T1HG bladder cancer, 10 (19.2%) patients had carcinoma in situ (CIS), and 17 (32.7%) patients had a combination of CIS+T1HG. Median time to first recurrence in T1HG, CIS and T1HG+CIS groups was 11, 10.5 and 8.8 months, respectively. The recurrence-free survival was 98.1%, 94.2% and 80.8% at 6, 9 and 12 months, respectively. The rate of progression-free survival was 100%, 98.1% and 92.3% at 6, 9 and 12 months, respectively. We demonstrated the safety and efficacy of Gem/Doce therapy in BCG-naïve patients with HR NMIBC during a one-year follow-up. Further research with extended follow-up, as well as direct comparison of Gem/Doce and other anticancer agents, are essential.
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.