Neoadjuvant cisplatin/gemcitabine chemotherapy for muscle invasive bladder carcinoma: A single institution experience.

Abstract

e15016 Background: Neoadjuvant chemotherapy (NAC) with MVAC has been shown to improve overall survival in patients with muscle invasive transitional cell carcinoma of the bladder (MIBC), with pathological complete response (pCR) correlating with a survival benefit. Despite the lack of randomized data for cisplatin/gemcitabine (GC) in the neoadjuvant setting, it is commonly used in clinical practice, given its favorable toxicity profile and comparable efficacy to MVAC in the context of metastatic disease. Methods: Data was retrospectively obtained on 93 patients with T2-T4, N0-2 M0 MIBC treated with curative intent in our institution between 2005-2011. Characteristics of patients treated with GC NAC, along with treatment tolerance and outcomes, were collected. Results: Of 93 patients, 27% (n=25) were treated with GC NAC. Median age was 66 (range 49-81). 88% (n=22) of patients were clinical stage T3/4 and/or N1/2. 68% of patients received 28-day cycles of GC, with 32% receiving 21-day cycles of GC. One patient had split cisplatin dosing. 91% and 82% of planned cisplatin and gemcitabine were delivered, respectively. There were no treatment-related deaths. On completion of NAC, 52% (n=13) of patients underwent radical cystectomy, of whom 38% (n=5) achieved a pCR, and 62% (n=8) were downstaged to non-muscle invasive bladder cancer (nMIBC). Definitive chemoradiotherapy was used in 20% (n=5) of patients, whilst 12% (n=3) had no radical treatment due to progressive disease (n=2), or to a decline in ECOG performance status (n=1). Amongst patients without radical cystectomy, 12% (n=3) of patients achieved a biopsy-proven clinical complete response (cCR). In the intent-to-treat population, median disease-free survival was 32 months, and median overall survival 38.8 months. All patients with a pCR, cCR, or downstaging to nMIBC (n=12), were alive at a median follow-up of 16 months (3.9 – 49.1 months), although 1 patient had relapsed. Conclusions: GC is a well-tolerated regimen in the neoadjuvant treatment of MIBC, with a pCR rate comparable to that reported with MVAC. Our findings support the use of GC in the neoadjuvant treatment of MIBC.