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Stage IV Bladder Cancer

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    Several less nephrotoxic regimens have been studied in clinical trials, but most of these trials have not focused on patients with renal impairment or poor performance status. Published regimens that have been studied in trials limited to patients with a medical contraindication to cisplatin include gemcitabine plus carboplatin, single-agent docetaxel, and single-agent paclitaxel.[15,16,17,18,19,20] In general, outcomes of studies in patients unfit for cisplatin have been inferior to those of cisplatin-based regimens with reported median survival times of less than 1 year. A randomized, phase II/III trial comparing gemcitabine plus carboplatin (GCa) to methotrexate, carboplatin and vinblastine (M-CAVI) reported that in the phase II portion of the trial, the response rate was 42% with GCa compared to 30% with M-CAVI.[16] However, patients with a performance status of 2 and a creatinine clearance less than 60 mL/min had a response rate of only 26% and 20%, respectively and a severe acute toxicity rate of 26% and 25%, respectively. These regimens were judged to be nonbeneficial for patients meeting both those criteria.

    Many other doublet and singlet noncisplatin chemotherapy regimens, such as gemcitabine plus paclitaxel, have been studied in healthier subjects with advanced-stage urothelial carcinoma.[21,22,23,24] Studies of these regimens have reported longer survival in unselected subjects than in subjects selected on the basis of impaired renal function and/or poor performance status. In the absence of any published randomized controlled trials showing improved outcomes with a noncisplatin regimen, it is impossible to know whether any of those regimens benefit patients.

    For patients with T4b, N0, M0 and Any T, N1–N3, M0 disease:

    Treatment options:

    1. Radical cystectomy with pelvic lymph node dissection.[2,25,26]
    2. External-beam radiation therapy (EBRT).[27,28]
    3. Urinary diversion or cystectomy for palliation.
    4. Chemotherapy as an adjunct to local treatment as seen in the RTOG-8512 trial, for example.[29,30,31,32,33]

    For patients with Any T, Any N, M1 disease:

    Standard treatment options:

    1. Chemotherapy alone or as an adjunct to local treatment.[3,4,9]
    2. EBRT for palliation.
    3. Urinary diversion or cystectomy for palliation.
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