A phase I trial for the use of intravesical cabazitaxel, gemcitabine, and cisplatin (CGC) in the treatment of BCG-refractory nonmuscle invasive urothelial carcinoma of the bladder.

Authors

null

Guarionex Joel DeCastro

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

Organizations

Department of Urology, Columbia University Medical Center, New York, NY, Department of Urology, Columbia University, New York, NY, Columbia University Medical Center Irving Cancer Research Center, New York, NY, Columbia University Medical Center, New York Presbyterian Hospital, New York, NY, University of Wisconsin-Madison, Madison, WI, Columbia University Medical Center, New York, NY

Research Funding

Pharmaceutical/Biotech Company

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

PatientCabaxitaxel
dose (mg)
Cisplatin
dose (mg)
Pretrial stageResponseNo. Grade 1
local toxicity
No. Grade 2
local toxicity
12.5-HG Ta + TisCR21
22.5-HG Ta + TisCR01
35.0-HG TaCR30
45.0-HG TaNR00
55.066HG T1 + TisCR10
65.066HG TaCR00
75.080HG Ta + TisCR20
85.080TisCR02
95.0100Tis31

Completed induction but post-treatment clinical stage not available

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Abstract Details

Meeting

2017 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Prostate Cancer and Urothelial Carcinoma

Track

Prostate Cancer,Urothelial Carcinoma,Prostate Cancer

Sub Track

Urothelial Carcinoma

Clinical Trial Registration Number

NCT02202772

Citation

J Clin Oncol 35, 2017 (suppl 6S; abstract 313)

DOI

10.1200/JCO.2017.35.6_suppl.313

Abstract #

313

Poster Bd #

F2

Abstract Disclosures