Efficacy and tolerability of biweekly gemcitabine plus cisplatin (GEMCIS) or gemcitabine plus paclitaxel (GEMPAC) as neoadjuvant chemotherapy in patients with muscle invasive urothelial carcinoma of the bladder.

Abstract

e15006 Background: Cisplatin, gemcitabine and paclitaxel are active chemotherapeutic agents for invasive urothelial carcinoma of the bladder (UCB). Biweekly administration of gemcitabine in combination with cisplatin (GEMCIS) or paclitaxel (GEMPAC) has been reported to have better tolerability than other schedules. Methods: Between 2009- 2011, we have treated 34 patients (median age 69 years, range 56-85) with muscle invasive UCB using gemcitabine (1500 mg/m2) in combination with cisplatin (50 mg/m2) or paclitaxel (150 mg/m2) given on days 1 and 15, every 4 weeks, for 3 cycles prior to radical cystectomy (RC) with bilateral pelvic lymph node dissection and urinary diversion. Patients deemed unsuitable for GEMCIS due to old age, frailty, multiple comorbidities or poor renal function received GEMPAC (n=9); all others received GEMCIS (n=25). Results: Clinical staging revealed T2, T3 and T4 disease in 20 (58.8 %), 8 (23.5 %) and 6 (17.6 %) patients, respectively. Patients were re-evaluated after 2 cycles with MRI or CT scans, which showed improvement in 21 (61.8 %) patients, no change in 12 (35.3 %) and progression in 1 patient (2.9%). Pathologic examination of the surgical specimens revealed T0, Tis, T2, T3 and T4 disease in 8 (23.5 %), 6 (17.6 %), 10 (29.4 %), 6 (17.6 %) and 4 (11.8 %) patients, respectively. Overall, pathologic downstaging was observed in 41.1% of patients. In the GEMCIS group, 12 patients (48%) had pT0 or pTis; in the GEMPAC group, 2 pts (22.2%) had pT0 disease. The most commonly observed toxicities are tabulated below. Conclusions: Biweekly GEMCIS or GEMPAC regimens were active and exceptionally well tolerated in the neoadjuvant setting in patients with muscle invasive UCB, producing favorable pathologic outcomes in an initial cohort of patients. To our knowledge, these data represent the first report detailing clinical results with these regimens in this setting. [Table: see text]