Department of Urology, Columbia University Medical Center, New York, NY
Guarionex Joel DeCastro , Wilson Sui , Jamie S. Pak , Corinne T. Abate-Shen , Shing Mirn Lee , Christopher B. Anderson , Dara Holder , James M. McKiernan
Background: Salvage intravesical chemotherapy has shown benefit in patients with high-risk non-muscle invasive bladder cancer who fail first line therapy. Our preclinical murine intravesical trial showed a combination therapy was superior to single-agents. Our objective was to investigate the safety of intravesical triple agent salvage chemotherapy consisting of cabazitaxel, gemcitabine and cisplatin (CGC). Methods: Patients with BCG refractory or recurrent high-risk non-muscle invasive bladder cancer who refused radical cystectomy were enrolled. All patients underwent a pre-treatment transurethral resection of bladder tumor and then received a 6-week regimen. All patients received the same dose of gemcitabine (2000mg) while the dose of cisplatin and cabazitaxel were escalated as shown in table 1. Toxicity was categorized according to CTC for Adverse Events v4 and included hematuria, dysuria, bladder spasm, urinary retention or frequency. A complete response (CR) was defined as a negative random bladder biopsy and negative cytology six weeks after treatment. Results: Median age of the 9 patients was 74 years (table 1) and the median number of prior intravesical therapies was 4 (range 2-5). All patients completed 6 weeks of induction CGC. Any local toxicity was found in 7 patients with 5 experiencing at least 1 grade 1 toxicity and 4 experiencing at least 1 grade 2 toxicity. Seven of eight patients were complete responders and initiated maintenance therapy. Conclusions: CGC appears to be a well-tolerated intravesical salvage chemotherapy regimen for the treatment of BCG-refractory NMIBC. Clinical trial information: NCT02202772
Patient | Cabaxitaxel dose (mg) | Cisplatin dose (mg) | Pretrial stage | Response | No. Grade 1 local toxicity | No. Grade 2 local toxicity |
---|---|---|---|---|---|---|
1 | 2.5 | - | HG Ta + Tis | CR | 2 | 1 |
2 | 2.5 | - | HG Ta + Tis | CR | 0 | 1 |
3 | 5.0 | - | HG Ta | CR | 3 | 0 |
4 | 5.0 | - | HG Ta | NR | 0 | 0 |
5 | 5.0 | 66 | HG T1 + Tis | CR | 1 | 0 |
6 | 5.0 | 66 | HG Ta | CR | 0 | 0 |
7 | 5.0 | 80 | HG Ta + Tis | CR | 2 | 0 |
8 | 5.0 | 80 | Tis | CR | 0 | 2 |
9 | 5.0 | 100 | Tis | ‡ | 3 | 1 |
‡Completed induction but post-treatment clinical stage not available
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Abstract Disclosures
2023 ASCO Annual Meeting
First Author: Guarionex Joel DeCastro
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First Author: Matt D. Galsky
2023 ASCO Genitourinary Cancers Symposium
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