Salvage intravesical treatment with a novel triple-drug combination may improve outcomes in patients with nonmuscle-invasive bladder cancer (NMIBC) refractory to bacillus Calmette-Guérin (BCG), according to the findings of small study presented at the 20th annual meeting of the Society of Urologic Oncology in Washington, DC.
The treatment consists of docetaxel, gemcitabine, and cisplatin (DGC). In a retrospective study that included 10 men who received DGC as salvage therapy for high-grade BCG-refractory NMIBC, a team at Columbia University Medical Center in New York led by James M. McKiernan, MD, found that all patients experienced initial downgrading, downstaging, or both, and all remained on maintenance treatment. No patient had disease progression or underwent radical cystectomy (RC).
“In this period of recent BCG shortages, this regimen may prove to be a reasonable treatment for BCG-naïve and refractory patients,” Dr McKiernan and his colleagues concluded in their study abstract.
The 10 men had a median age of 70 years (range 57-85 years). Nine previously received at least 2 BCG induction courses with or without interferon, and 3 previously received intravesical chemotherapy. All of the men had high-grade disease prior to DGC treatment.
The treatment protocol included a 6-week induction of separate-day weekly docetaxel (80 mg), weekly gemcitabine (1000 or 2000 mg), and biweekly cisplatin (100 mg) to decrease the risk of platinum-induced hypersensitivity. For patients with a treatment response, a maintenance regimen of separate-day monthly docetaxel (80 mg) and monthly gemcitabine (1000 mg) was initiated.
All patients underwent cystoscopy and urine cytology studies every 3 months. All had normal findings on computed tomography or magnetic resonance imaging of the upper urinary tract within 3 months of starting the DGC regimen. The primary outcome was recurrence, defined as biopsy-proven cancer of any grade or stage. The investigators defined progression as development of T2 or higher disease or metastases as detected by biopsy, RC pathologic findings, or imaging.
Of the 7 patients who have at least undergone the first surveillance cystoscopy (median follow-up 41 weeks, range 23-74 weeks), 2 experienced disease recurrence. At last follow-up, all 7 patients were still on maintenance treatment.
Pak J, Vila Reyes H, DeCastro J, et al. Short-term outcomes of novel combination regimen of intravesical docetaxel, gemcitabine, and cisplatin in patients with BCG-refractory non-muscle invasive urothelial carcinoma of the bladder. Presented at the 20th annual meeting of the Society of Urologic Oncology held December 4 to 6 in Washington, DC. Poster 24.