As many as half of patients with superficial bladder cancer do not respond to the standard first-line chemotherapy placed into the bladder, according to current multi-center outcomes data.
When this happens, typically, their only option is surgical removal of the bladder. Now, researchers at the Herbert Irving Comprehensive Cancer Center of NewYork-Presbyterian Hospital and Columbia University Medical Center are investigating an FDA-approved metastatic breast-cancer drug called Abraxane that may prove a safe and effective alternative to surgery for these patients.
Bladder cancer is the fourth leading cause of cancer in men and the ninth leading cause of cancer in women in the United States. In a given year, more than 60,000 new cases are diagnosed, and 13,000 will die from the disease.
"When the standard treatment does not work, currently the only option is surgical removal of the bladder -- something that, for all patients, is unappealing, and for some sicker patients is not even possible. With this study, we hope to find an effective second line medical option for these patients," says Dr. James McKiernan, director of urologic oncology at the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian Hospital and Columbia University Medical Center, and vice chairman of the Department of Urology and assistant professor of urology at Columbia University College of Physicians and Surgeons.
The Phase I/II study will follow 18 patients for six weeks to assess dosage safety, followed by a second group of 19 patients who will be followed for six weeks to measure the effectiveness of the therapy.
The study is open to patients with recurrent bladder cancer that has not responded to standard therapy -- BCG (bacillus Calmette-Guerin) treatment.
In 2006, Dr. McKiernan, together with departmental chair Dr. Mitchell C Benson, led a phase I study of the drug Taxotere, also used to treat breast cancer, on a similar patient population, finding the drug to be safe with 12 of 18 patients responding (results were published in the July 1, 2006, Journal of Clinical Oncology). Since then, a favorable percentage of patients have survived with intact bladders.
Abraxane, he believes, will show similar or better results. "Abraxane has an analogous structure to Taxotere, but has the advantage of being more soluble due to its solvent-free formulation allowing for administration at higher concentrations," says Dr. McKiernan. "In one study of Abraxane for metastatic breast cancer, the drug successfully shrank tumors and had few side effects."