Metastatic bladder cancer – pro

Lay Summary: Chemotherapy agents that have shown activity in metastatic bladder cancer include paclitaxel, docetaxel, ifosfamide, gallium nitrate, and gemcitabine.

A prospective, randomized trial of methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) compared with cisplatin, cyclophosphamide, and doxorubicin demonstrated improved response and median survival rates (48 weeks vs. 36 weeks, P = .0003) with the former regimen. Results from a randomized trial that compared M-VAC with single-agent cisplatin in advanced bladder cancer also showed a significant advantage with M-VAC in both response rate and median survival (12.5 months vs. 8.2 months, P = .0002). The (outpatient) regimen of paclitaxel and carboplatin achieved response rates in the range of 50% in single-institution phase II trials. [Level of evidence: 3iiiDiii] However, when this regimen was evaluated in a multicenter phase II study conducted by the Southwest Oncology Group, the response rate was only 21%. Gemcitabine has shown activity in phase II trials of patients with metastatic bladder cancer. In a multicenter, randomized, phase III trial comparing the combination of gemcitabine/cisplatin (GC) with the M-VAC regimen in 405 patients with advanced or metastatic bladder cancer, GC yielded similar response rates, time-to-progression, and overall survival (hazard ratio [HR] = 1.04; 95% confidence interval [CI], 0.82-1.32; P = .75) compared with M-VAC, but GC had a better safety profile and was better tolerated than M-VAC. Although this study was not designed to show the equivalence of the 2 regimens, the similar efficacy and reduced toxic effects of GC make it a reasonable alternative in patients who may not tolerate the M-VAC regimen. Another regimen that compares in effectiveness is cispatin/methotrexate/vinblastine.

The regimen of cisplatin/gemcitabine/paclitaxel is in an active phase II trial. As such it is considered by the plan to be investigtional/experimental. It is not standard of care.

Oosterlinck W, Lobel B, Jakse G, Malmstrom PU, Stockle M, Sternberg C Guidelines on bladder cancer.Eur Urol. 2002 Feb;41(2):105-12.

Genitourinary Disease Site Group. Use of chemotherapy in advanced unresectable or metastatic transitional cell carcinoma of the bladder or urothelium [full report]. Toronto (ON): Cancer Care Ontario (CCO); 2002 Jun 19. 20 p. (Practice guideline; no. 3-12). [19 references]

http://www.nccn.org/professionals/physician_gls/PDF/bladder.pdf#search=%22bladder%20cancer%2C%20chemotherapy%20guidelines%22

http://www.uroweb.org/fileadmin/user_upload/Guidelines/2001_Bladder%20_Cancer.PDFGE. Perabo and S. Muller
New agents for treatment of advanced transitional cell carcinoma
Ann. Onc., May 1, 2007; 18(5): 835 – 843.

Cora N. Sternberga, S. Machele Donatb, Joaquim Bellmuntc, Randall E. Millikand, Walter Stadlere, Pieter De Mulderf, Amir Sherifg, Hans von der Maaseh, Taiji Tsukamotoi, Mark S. Solowayj
Chemotherapy for Bladder Cancer: Treatment Guidelines for Neoadjuvant Chemotherapy, Bladder Preservation, Adjuvant Chemotherapy, and Metastatic Cancer Urology Volume 69, Issue 1, Pages 62-79 (January 2007)

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