Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Intravesical Gemcitabine and Docetaxel Therapy for BCG-Naïve Patients: a Promising Approach in Non-Muscle Invasive Bladder Cancer

Mirko Bakula
ORCID logo ,
Tvrtko Hudolin
* ORCID logo ,
Nikola Knezevic
,
Zoran Zimak
,
Jerko Andelic
,
Ilija Juric
ORCID logo ,
Marija Gamulin
,
Milena Gnjidic
,
Zeljko Kastelan
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. 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. Preprints 2024, 2024041917. 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.

Keywords

BCG shortage; Non-muscle invasive bladder cancer; BCG-Naïve; Docetaxel; Gemcitabine

Subject

Medicine and Pharmacology, Urology and Nephrology

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.

Download PDF

Comments (0)

We encourage comments and feedback from a broad range of readers. See criteria for comments and our Diversity statement.

Leave a public comment
Send a private comment to the author(s)
* All users must log in before leaving a comment
Views 0
Downloads 0
Comments 0
Metrics 0
Get PDF Cite Share 0
Bookmark BibSonomy Mendeley Reddit Delicious
×
Alerts
Notify me about updates to this article or when a peer-reviewed version is published.
We use cookies on our website to ensure you get the best experience.
Read more about our cookies here.