MP16-19: Comparison of BCG to Gemcitabine/Docetaxel in The Intermediate Risk Group Composed Mostly of TaHG
Friday, May 3, 2024 1:00 PM to 3:00 PM · 2 hr. (US/Central)
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Abstract
Information
Full Abstract and Figures
Author Block
Reuben Ben-David*, Parissa Alerasool, Kaushik P. Kolanukuduru, Neeraja Tillu, Justin Eisenhauer, Nikhil Waingankar, Kyrollis Attalla, Reza Mehrazin, Peter Wiklund, John P. Sfakianos, New York, NY
Introduction
The combination of sequential intravesical gemcitabine and docetaxel (Gem/Doce) chemotherapy has been considered a feasible alternative for BCG treatment in non-invasive bladder cancer (NIMBC), gaining popularity during BCG shortage period. We seek to compare recurrence free survival (RFS) in patients receiving either BCG or Gem/Doce in the intermediate risk group composed mainly of patients with TaHG disease.
Methods
A retrospective analysis of consecutive patients treated with Gem/Doce or BCG for NIMBC between 2012-2023 was performed. Baseline characteristics, risk group stratification (AUA guidelines), pathological, and oncological outcomes were collected from electronic medical charts. RFS was assessed using the Kaplan-Meier method and log-rank test. R language version 4.3 was used for all statistical analyses.
Results
A total of 118 patients were included. The median age was 70 years (IQR 63-77), and 25 were females (21.2%). The median follow up period was 31 months (IQR 16-59). The intermediate risk group consisted of 66 (56%) patients with TaHG and 52 patients (44%) with TaLG. Seventy-seven patients were included in the BCG arm and 41 in the Gem/Doce arm. More patients had TaHG in the BCG group 64% vs. 42.5% (p=0.031). In the BCG group, 29.9% received maintenance therapy vs. 34% in the Gem/Doce group (p=0.68). For the entire cohort any grade recurrence occurred in 57 patients (48.3%) and high-grade recurrence in 23 patients (19.5%) without statistical difference between the groups. Kaplan-Meier curves demonstrated that patients in the Gem/Doce group had significantly worse RFS than the BCG group (log-rank, p=0.009, Fig 1A), with RFS of 67% vs 70% at 12 months, 52% vs 68% at 18 months, and 35% vs 62% at 24 months, respectively. No difference in RFS was found for high-grade recurrence (log-rank, p=0.36, Fig 1B). Progression to metastatic disease was 2.4% in the Gem/Doce group and 3.9% in the BCG group.
Conclusions
In a cohort of patients with intermediate risk group consisting mainly of TaHG Gem/Doce has worse any grade RFS than BCG. No difference was found for high-grade RFS. Previously reported studies mainly compared patients with primary or recurrent TaLG disease. Our findings should be considered when tailoring the treatment for TaHG patients. Prospective trial with a larger cohort is necessary to validate our results.
Source Of Funding
None
Author Block
Reuben Ben-David*, Parissa Alerasool, Kaushik P. Kolanukuduru, Neeraja Tillu, Justin Eisenhauer, Nikhil Waingankar, Kyrollis Attalla, Reza Mehrazin, Peter Wiklund, John P. Sfakianos, New York, NY
Introduction
The combination of sequential intravesical gemcitabine and docetaxel (Gem/Doce) chemotherapy has been considered a feasible alternative for BCG treatment in non-invasive bladder cancer (NIMBC), gaining popularity during BCG shortage period. We seek to compare recurrence free survival (RFS) in patients receiving either BCG or Gem/Doce in the intermediate risk group composed mainly of patients with TaHG disease.
Methods
A retrospective analysis of consecutive patients treated with Gem/Doce or BCG for NIMBC between 2012-2023 was performed. Baseline characteristics, risk group stratification (AUA guidelines), pathological, and oncological outcomes were collected from electronic medical charts. RFS was assessed using the Kaplan-Meier method and log-rank test. R language version 4.3 was used for all statistical analyses.
Results
A total of 118 patients were included. The median age was 70 years (IQR 63-77), and 25 were females (21.2%). The median follow up period was 31 months (IQR 16-59). The intermediate risk group consisted of 66 (56%) patients with TaHG and 52 patients (44%) with TaLG. Seventy-seven patients were included in the BCG arm and 41 in the Gem/Doce arm. More patients had TaHG in the BCG group 64% vs. 42.5% (p=0.031). In the BCG group, 29.9% received maintenance therapy vs. 34% in the Gem/Doce group (p=0.68). For the entire cohort any grade recurrence occurred in 57 patients (48.3%) and high-grade recurrence in 23 patients (19.5%) without statistical difference between the groups. Kaplan-Meier curves demonstrated that patients in the Gem/Doce group had significantly worse RFS than the BCG group (log-rank, p=0.009, Fig 1A), with RFS of 67% vs 70% at 12 months, 52% vs 68% at 18 months, and 35% vs 62% at 24 months, respectively. No difference in RFS was found for high-grade recurrence (log-rank, p=0.36, Fig 1B). Progression to metastatic disease was 2.4% in the Gem/Doce group and 3.9% in the BCG group.
Conclusions
In a cohort of patients with intermediate risk group consisting mainly of TaHG Gem/Doce has worse any grade RFS than BCG. No difference was found for high-grade RFS. Previously reported studies mainly compared patients with primary or recurrent TaLG disease. Our findings should be considered when tailoring the treatment for TaHG patients. Prospective trial with a larger cohort is necessary to validate our results.
Source Of Funding
None