The HER2-positive study participants were given Herceptin along with standard chemotherapy drugs used to treat bladder cancer. Patients received on average six cycles of chemotherapy and Herceptin.
Researchers found 70 percent of patients responded to the chemotherapy and Herceptin treatment and saw their tumors shrink. Only 7 percent saw their cancer progress, or worsen. Patients lived an average of 15 months, comparable to overall survival rates for advanced bladder cancer. But, Hussain points out, the patients participating in this study had a more aggressive disease.
"There was a tendency for these patients to have worse disease more sites of involvement with metastasis, and more bone and liver disease, which is one of the very poor features of bladder cancer in general. We were quite encouraged to see in this study good responses to treatment. This lays the foundation for a future phase III trial to compare Herceptin and chemotherapy to standard chemotherapy," Hussain says.
This phase II trial found Herceptin could be used safely for bladder cancer with few serious adverse effects related to Herceptin. The most common problems were low blood counts.
Bladder cancer affects more than 63,000 people each year and causes about 13,000 deaths per year. It strikes men three times as often as women.
In addition to Hussain, U-M study authors were research associate Rodney Dunn and David C. Smith, M.D., associate professor of internal medicine and urology and medical director of the Multidisciplinary Urologic Oncology Clinic. Other study authors were Daniel Petrylak, M.D., Columbia University; Ulka Vaishampayan, M.D., Wayne State University; Primo N. Lara Jr., M.D., University of California-Davis; Gurkamal Chatta, M.D., University of Pittsburgh; David Nanus, M.D., Cornell University; L. Michael Glode, M.D.,
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14-May-2005