Long-term Survival Outcomes With Intravesical Nanoparticle Albumin-bound Paclitaxel for Recurrent Non-muscle-invasive Bladder Cancer After Previous Bacillus Calmette-Guérin Therapy.
OBJECTIVE
To report long-term follow-up results of a phase II trial of salvage intravesical nanoparticle albumin-bound (nab)-paclitaxel for patients with recurrent non-muscle-invasive bladder cancer after previous intravesical bacillus Calmette-Guérin (BCG) therapy.


METHODS
This was a phase II trial investigating the use of intravesical nab-paclitaxel in patients with recurrent Tis, Ta, and T1 urothelial carcinoma who failed at least 1 prior induction course of intravesical BCG. Patients received 500 mg/100 mL of nab-paclitaxel in 6 weekly intravesical instillations. Complete responders were offered full-dose maintenance for 6 months. Overall survival, recurrence-free survival, cystectomy-free survival, and cancer-specific survival were assessed via Kaplan-Meier analysis.


RESULTS
A total of 28 patients were enrolled with a median follow-up of 41 months (range 5-76). There were 22 men and 6 women with a median age of 79 (range 36-93), and the median number of prior intravesical therapies was 2. Twenty-one of the 28 patients (75%) were BCG refractory. Ten of the 28 patients (36%) achieved complete response. Six of the 28 patients remain cancer free, with a recurrence-free survival rate of 18%. Five-year overall and cancer-specific survival rates were 56% and 91%, respectively. Radical cystectomy occurred in 11 of the 28 patients (39%), of whom 2 out of 11 (18%) had pT2 or greater disease.


CONCLUSIONS
With a median follow-up of 41 months, 18% of this cohort treated with nab-paclitaxel was disease free. Cystectomy-free survival was 61% and bladder cancer-specific mortality was 9%. Nab-paclitaxel is a reasonable treatment option in this high-risk population.
Department of Urology, Columbia University Irving Medical Center, New York, NY. Electronic address: djr2168@cumc.columbia.edu.
Dennis J
DJ
Robins
Department of Urology, Columbia University Irving Medical Center, New York, NY.
Wilson
W
Sui
Department of Urology, Columbia University Irving Medical Center, New York, NY.
Justin T
JT
Matulay
Division of Urology, Department of Surgery, American University of Beirut Medical Center, Beirut, Lebanon.
Rashed
R
Ghandour
Department of Urology, Columbia University Irving Medical Center, New York, NY.
Christopher B
CB
Anderson
Department of Urology, Columbia University Irving Medical Center, New York, NY.
G Joel
GJ
DeCastro
Department of Urology, Columbia University Irving Medical Center, New York, NY.
James M
JM
McKiernan
D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D000283:Administration, Intravesical; D000368:Aged; D000418:Albumins / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage; D001500:BCG Vaccine / Q000008:administration & dosage / Q000009:adverse effects; D002295:Carcinoma, Transitional Cell / Q000473:pathology / Q000628:therapy; D015653:Cystectomy / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D053758:Nanoparticles / Q000008:administration & dosage; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage*; D015996:Survival Rate; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000473:pathology / Q000628:therapy
C520255:130-nm albumin-bound paclitaxel; D000276:Adjuvants, Immunologic; D000418:Albumins; D000970:Antineoplastic Agents; D001500:BCG Vaccine; D017239:Paclitaxel