PURPOSE: Response rates to current second line intravesical therapies for recurrent nonmuscle invasive bladder cancer range between 10% and 30%. Nanoparticle albumin bound (nab-)paclitaxel has increased solubility and lower toxicity compared to other taxanes. Results of the phase I intravesical trial of this compound demonstrated minimal toxicity during dose escalation. We now report the results of a phase II trial to assess efficacy. MATERIALS AND METHODS: This study was an investigator initiated, single center, single arm, phase II trial investigating the use of nab-paclitaxel in patients with recurrent Tis, T1 and Ta urothelial carcinoma in whom at least 1 prior regimen of intravesical bacillus Calmette-Guérin failed. Patients received 500 mg/100 ml nab-paclitaxel administered in 6 weekly intravesical instillations. Efficacy was evaluated with cystoscopy, biopsy, cytology and imaging. If complete response was achieved, patients were treated with full dose monthly maintenance treatments for 6 months. RESULTS: A total of 28 patients were enrolled in the study. Of these patients 10 (35.7%) exhibited a complete response after initial treatment. At 1 year all of these responses remained durable after maintenance therapy. At a mean followup of 21 months (range 5 to 47) 19 of 28 (67.8%) patients retained their bladders without progression or distant metastases. A single patient had progression to muscle invasive disease at radical cystectomy. Treatment related adverse events were noted in 9 of 28 (32.1%) patients and were limited to grade 1 or 2. CONCLUSIONS: Intravesical nab-paclitaxel has minimal toxicity and a 35.7% response rate in patients with nonmuscle invasive bladder cancer and previous bacillus Calmette-Guérin failure. Complete response remained durable at 1 year followup in this heavily pretreated patient population.
PURPOSE: Response rates to current second line intravesical therapies for recurrent nonmuscle invasive bladder cancer range between 10% and 30%. Nanoparticle albumin bound (nab-)paclitaxel has increased solubility and lower toxicity compared to other taxanes. Results of the phase I intravesical trial of this compound demonstrated minimal toxicity during dose escalation. We now report the results of a phase II trial to assess efficacy. MATERIALS AND METHODS: This study was an investigator initiated, single center, single arm, phase II trial investigating the use of nab-paclitaxel in patients with recurrent Tis, T1 and Ta urothelial carcinoma in whom at least 1 prior regimen of intravesical bacillus Calmette-Guérin failed. Patients received 500 mg/100 ml nab-paclitaxel administered in 6 weekly intravesical instillations. Efficacy was evaluated with cystoscopy, biopsy, cytology and imaging. If complete response was achieved, patients were treated with full dose monthly maintenance treatments for 6 months. RESULTS: A total of 28 patients were enrolled in the study. Of these patients 10 (35.7%) exhibited a complete response after initial treatment. At 1 year all of these responses remained durable after maintenance therapy. At a mean followup of 21 months (range 5 to 47) 19 of 28 (67.8%) patients retained their bladders without progression or distant metastases. A single patient had progression to muscle invasive disease at radical cystectomy. Treatment related adverse events were noted in 9 of 28 (32.1%) patients and were limited to grade 1 or 2. CONCLUSIONS: Intravesical nab-paclitaxel has minimal toxicity and a 35.7% response rate in patients with nonmuscle invasive bladder cancer and previous bacillus Calmette-Guérin failure. Complete response remained durable at 1 year followup in this heavily pretreated patient population.
Authors: Bimal Bhindi; Ronald Kool; Girish S Kulkarni; D Robert Siemens; Armen G Aprikian; Rodney H Breau; Fadi Brimo; Adrian Fairey; Christopher French; Nawar Hanna; Jonathan I Izawa; Louis Lacombe; Victor McPherson; Ricardo A Rendon; Bobby Shayegan; Alan I So; Alexandre R Zlotta; Peter C Black; Wassim Kassouf Journal: Can Urol Assoc J Date: 2021-08 Impact factor: 1.862
Authors: Roger Li; Debasish Sundi; Jingsong Zhang; Youngchul Kim; Richard J Sylvester; Philippe E Spiess; Michael A Poch; Wade J Sexton; Peter C Black; James M McKiernan; Gary D Steinberg; Ashish M Kamat; Scott M Gilbert Journal: Eur Urol Date: 2020-03-04 Impact factor: 20.096
Authors: Stephen A Boorjian; Mehrdad Alemozaffar; Badrinath R Konety; Neal D Shore; Leonard G Gomella; Ashish M Kamat; Trinity J Bivalacqua; Jeffrey S Montgomery; Seth P Lerner; Joseph E Busby; Michael Poch; Paul L Crispen; Gary D Steinberg; Anne K Schuckman; Tracy M Downs; Robert S Svatek; Joseph Mashni; Brian R Lane; Thomas J Guzzo; Gennady Bratslavsky; Lawrence I Karsh; Michael E Woods; Gordon Brown; Daniel Canter; Adam Luchey; Yair Lotan; Tracey Krupski; Brant A Inman; Michael B Williams; Michael S Cookson; Kirk A Keegan; Gerald L Andriole; Alexander I Sankin; Alan Boyd; Michael A O'Donnell; David Sawutz; Richard Philipson; Ruth Coll; Vikram M Narayan; F Peter Treasure; Seppo Yla-Herttuala; Nigel R Parker; Colin P N Dinney Journal: Lancet Oncol Date: 2020-11-27 Impact factor: 41.316