Phase II trial of neoadjuvant gemcitabine and cisplatin in patients with resectable bladder carcinoma

Daniel Herchenhorn,Denise M Moreira,Isabele A Small,Franz S De Campos,Valdelice O Santos,Hedilene Cardoso,Fabio A Peixoto,Rodrigo Dienstmann,Carlos G Ferreira

doi:10.1590/s1677-55382007000500004

Daniel Herchenhorn, Denise M Moreira + Show 7 more

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Journal: International braz j urol	Publication Date: Oct 1, 2007
Citations: 33	License type: cc-by

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Gemcitabine and cisplatin (GC) is an active combination in the treatment of metastatic bladder cancer. We have prospectively analyzed the efficacy and tolerability of GC as neoadjuvant treatment of invasive bladder cancer. In this single-institution phase II trial, patients with muscle-invasive transitional cell carcinoma received three cycles of gemcitabine 1200 mg/m2 on days 1 and 8 with cisplatin 75 mg/m2 on day 1 prior to surgery. Radiologic response was evaluated by computed tomography and magnetic resonance imaging. All patients were referred to surgery after chemotherapy completion. Between June 2002 and March 2005, 22 patients (19 males) were enrolled. Median age was 63 years. Initial stage was II (T2) in 11 and III (T3-4) in 11 patients. Median follow-up is 26 months (4-43). Partial or complete radiologic response rate was documented in 13 out of 20 assessable patients (70%). One patient was excluded due to sarcomatoid carcinoma at definitive pathologic examination. Cystectomy was performed in 15 patients and pelvic radiotherapy in four patients. Nine out of 21 patients (43%) relapsed and four (19%) died due to disease progression. Complete pathologic response was observed in four patients (26.7% of 15). Median progression-free survival was 27 months (CI 95% not reached) with median overall survival of 36 months (CI 95%: 28.7 - 43.3). Grade III/IV toxicity was infrequent, with no deaths due to chemotherapy. The combination of GC is effective and well-tolerated when used as neoadjuvant therapy in muscle-invasive bladder cancer. Longer follow-up is necessary to evaluate its impact on the overall survival of these patients.

Highlights

Bladder carcinoma is the second most prevalent genitourinary tract neoplasm in Brazil, with estimated 2000 deaths each year, which represents 1.7% of all cancer deaths [1]
There is a need for additional therapeutic modalities as an adjunct to local treatment in order to improve the outcome of patients with invasive bladder carcinoma
Systemic chemotherapy is active in advanced bladder cancer, with objective response rates in more than 50% of patients treated with MVAC [3]

Summary

Introduction

Bladder carcinoma is the second most prevalent genitourinary tract neoplasm in Brazil, with estimated 2000 deaths each year, which represents 1.7% of all cancer deaths [1]. Systemic chemotherapy is active in advanced bladder cancer, with objective response rates in more than 50% of patients treated with MVAC (combination of methotrexate, vinblastine, adriamycin and cisplatin) [3]. The administration of preoperative chemotherapy has the advantage of immediate treatment of microscopic disease and better tolerability when compared with postsurgical treatment Another major benefit of the neoadjuvant approach is the ability to assess the response of the primary lesion, which is of prognostic significance. This was illustrated in a report of 125 patients enrolled in multiple trials of cisplatin-based neoadjuvant therapy followed by definitive surgery [6]. Neoadjuvant cisplatin-based combination chemotherapy resulted in a significant 14% reduction in the risk of death, which translated into a 5% absolute improvement in five-year overall survival (from 45% to 50%)

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