(UroToday.com) In this study by Linehan and colleagues, the authors focus on the outcomes of female patients from the OLYMPUS trial [NCT02793128], in which patients with low grade upper tract urothelial carcinoma (LG-UTUC) were treated with a novel reverse thermal gel containing mitomycin.
As the authors note, urothelial carcinoma is predominantly in male patients – but women do develop urothelial carcinoma (and may be associated with poorer outcomes). When looking at LG UTUC, the literature on gender-based differences is limited, particularly regarding treatment outcomes.
In the OLYMPUS trial [NCT02793128], patients with LG-UTUC were treated with a novel reverse thermal gel containing mitomycin (UGN-101 – JELMYTO® (mitomycin) for pyelocalyceal solution). Final overall study results were previously presented and summarized at Urotoday. The study demonstrated 58% of patients achieving complete response (CR), and the probability of maintaining CR at the 12-month visit was 81.8%.
In this subset analysis, the authors report the outcomes of female patients from the OLYMPUS trial. The trial included 23 female patients (32% of the entire cohort) - 22 Caucasian, 1 Hispanic patient. Of these, 20 were from the US and 3 from Israel. Further demographics include: mean age 70.0±10.3 years, mean BMI 29.0±7.9 kg/m2, 19 (82.6%) former or current smokers, 10 (43.5%) previous UTUC, 2 (8.7%) with single kidneys.
Looking at outcomes, 15/23 (65.2%) patients achieved CR, 1 withdrew consent prior to continuing on follow-up, 8/14 patients received ≥1 maintenance treatment, and 10/14 (71.4%) patients maintained durable CR at 12 months.
Comparison to the overall cohort and the male population is seen below:
In terms of tolerability, 22/23 (95.7%) reported adverse events (AEs), 14 (60.9%) were serious, with 6 (26.1%) AEs led to study treatment discontinuation. Most common AEs included urinary tract infection (52.2%), hematuria (34.8%), ureteric stenosis (34.8%), flank pain (30.4%), vomiting (30.4%), hydronephrosis (26.1%), dysuria (21.7%), and nausea (21.7%). Serious AEs occurring in >1 patient included dyspnea, flank pain, hydronephrosis, and ureteric stenosis (each 8.7%).
Based on the above, the authors conclude that female patients in the OLYMPUS trial demonstrated CR, durability of CR, and patient-reported AE’s similar to male patients and the overall study population. This analysis is limited by its post-hoc nature and small sample size. Naturally, additional research is warranted to more clearly define gender-related outcomes for female patients with LG-UTUC and all urothelial malignancies.
Presented by: Jennifer Linehan, MD, Associate Professor Urologic Oncology, Providence Saint John's Cancer Institute, Santa Monica, CA
Written by: Thenappan (Thenu) Chandrasekar, MD – Urologic Oncologist, Assistant Professor of Urology, Sidney Kimmel Cancer Center, Thomas Jefferson University, @tchandra_uromd on Twitter during the 2021 American Urological Association, (AUA) Annual Meeting, Fri, Sep 10, 2021 – Mon, Sep 13, 2021.References:
1. Kleinmann N, Matin SF, Pierorazio PM, et al. Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (Olympus): an open-label, single-arm, phase 3 trial. The Lancet Oncology. 2020;21(6):776-785.