Urinary bother, urinalysis, and two-year efficacy follow-up results of phase I trial of intravesical bacillus Calmette-Guérin combined with intravenous pembrolizumab in recurrent or persistent high-grade non-muscle-invasive bladder cancer after previous bacillus Calmette-Guérin treatment

Authors

Jazzmyne Montgomery, Southern Illinois University School of Medicine, Southern Illinois School of Medicine, Springfield, IL.
Daniel Lybbert, Southern Illinois University School of Medicine, Southern Illinois School of Medicine, Springfield, IL.
Sherjeel Sana, Advocate Health - MidwestFollow
Ahmed El-Zawahry, Department of Urology, The University of Toledo Medical Center, Toledo, OH.
James Peabody, Henry Ford Health System, Detroit, MI.
Tiffany Pearce, Henry Ford Health System, Detroit, MI.
Nicole Adams, Henry Ford Health System, Detroit, MI.
Mustafa Deebajah, Henry Ford Health System, Detroit, MI.
Danuta Dynda, Southern Illinois University School of Medicine, Southern Illinois School of Medicine, Springfield, IL.
Kara Babaian, Southern Illinois University School of Medicine, Southern Illinois School of Medicine, Springfield, IL.
Jane Crabtree, Southern Illinois University School of Medicine, Southern Illinois School of Medicine, Springfield, IL.
Kristin Delfino, Southern Illinois University School of Medicine, Southern Illinois School of Medicine, Springfield, IL.
Kevin McVary, Loyola University Medical Center, Department of Urology, Maywood, IL.
Kathy Robinson, Southern Illinois University School of Medicine, Southern Illinois School of Medicine, Springfield, IL.
Krishna Rao, Southern Illinois University School of Medicine, Southern Illinois School of Medicine, Springfield, IL.
Shaheen Alanee, Detroit Medical Center, Detroit, MI. Electronic address: salanee@dmc.org.

Abstract

Objective: To report urinary bother, urinalysis changes, disease-free survival (DFS), and overall survival (OS) over 2 years for subjects enrolled in a phase I dose-escalation trial (NCT02324582) of intravesical Bacillus Calmette-Guérin (BCG) in combination with systemic pembrolizumab for recurrent or persistent high-grade non-muscle invasive bladder cancer (HGNMIBC).

Methods: Eighteen patients consented to the study. Five were screen failures. Clinical activity was determined using cystoscopy and cytology with a biopsy of suspicious lesions. Urinalysis and International Prostate symptom score were assessed at pre-treatment, Week 10 (during combined BCG and pembrolizumab treatment), and 3 and 6 months from treatment completion. IPSS was analyzed using a mixed-model repeated measures analysis. A Chi-square test was used to compare urinalysis results at each interval.

Results: The pathologic disease stage after restaging transurethral resection and before treatment was pTa in 6 (46.2%), CIS in 6 (46.2%), and pT1 in 1 (7.7%). There was no increase in reported urinary bother throughout treatment. Quality of life measurements demonstrated no change in subjective burden. On urinalysis, we did not observe significant differences at 3 months compared to baseline evaluation. At 12 months, the DFS and OS were 69.23% and 92.31%, respectively. At 24 months, the DFS and OS were 38.46% and 92.31%, respectively.

Conclusions: Treatment with BCG combined with intravenous pembrolizumab is not showing increased urinary bother or adverse urinalysis changes. Two-year response data is promising and await confirmation in the phase III study (Keynote 676).

Type

Article

PubMed ID

38554570


 

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