Currently, only a small fraction of patients with stage IV bladder cancer can be cured and for many patients, the emphasis is on palliation of symptoms. The potential for cure is restricted to patients with stage IV disease with involvement of pelvic organs by direct extension or metastases to regional lymph nodes.
Major drug companies continually research and develop new medications and treatments for bladder cancer that must be shown to be safe and effective before doctors can prescribe them to patients. Through clinical trials, researchers test the effects of new drugs on a group of volunteers with bladder cancer. Following a strict protocol and using carefully controlled conditions, researchers evaluate the investigational drugs under development and measure the ability of the new drug to treat bladder...
Cisplatin-based combination chemotherapy regimens are the standard of care for stage IV bladder cancer.[2,3,4,5,6] The only chemotherapy regimens that have been shown to result in longer survival in randomized controlled trials are methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC); high-dose MVAC; and cisplatin, methotrexate, and vinblastine (CMV). Gemcitabine plus cisplatin (GC) was compared with MVAC in a randomized controlled trial and no difference in response rate or survival was reported. Of note, patients with good performance status and lymph node-only disease have a low but significant rate of achieving a durable complete remission with MVAC or GC. In the large randomized controlled trial that compared MVAC with GC, for example, 5-year overall survival (OS) in patients with lymph node-only disease was 20.9%.
Single-agent cisplatin and multiagent regimens that do not include cisplatin have never been shown to improve survival in a randomized controlled trial. Thus, there is no regimen that has been shown to prolong survival in patients who are not candidates for cisplatin-based multiagent chemotherapy regimens. Many regimens have been shown to be active, however, with regard to producing radiologically measurable responses:
These include carboplatin plus paclitaxel, carboplatin plus gemcitabine,[9,10,11] paclitaxel plus gemcitabine,[12,13,14] single-agent gemcitabine,[15,16] and single-agent paclitaxel.[17,18,19] Regimens of carboplatin, methotrexate, and vinblastine; carboplatin, epirubicin, methotrexate, and vinblastine; and paclitaxel, gemcitabine, and carboplatin have been studied but are not widely used.[20,21,22,23]