Arizona Cancer Center patients were among the 676 individuals who participated in a worldwide drug trial that, for the first time, demonstrated increased survival for patients with metastatic melanoma. The study results were presented at the 46th annual meeting of the American Society of Clinical Oncology June 5 in Chicago.
"We are seeing the beginning of a new era of effective therapy for metastatic melanoma," says Lee Cranmer, MD, PhD, director of the AZCC's Melanoma/Sarcoma Program. "I am proud that the patients and staff of the Arizona Cancer Center were able to contribute directly to this seminal research."
In the randomized phase III study, patients with advanced, previously treated melanoma who received the antibody ipilimumab alone or with the “gp100” vaccine lived 34 percent longer than those who received only the vaccine. Median survival time with ipilimumab increased from 6.4 to 10 months, which Dr. Cranmer says is significant in a disease where few, if any, effective treatment options exist.
Dr. Cranmer says the drug works through a patient’s immune system, releasing the immune system’s brakes to attack and kill the cancer cells.
"This was a very important study. It is the first rigorous, randomized study to demonstrate a survival benefit in patients with advanced melanoma," Dr. Cranmer said.
The drug’s developer is expected to seek Food and Drug Administration approval for ipilimumab this year.
"It is nevertheless important to realize this study's limitations," Cranmer cautioned. "This is not a cure for melanoma. It prolongs survival, at the cost of some significant and unusual toxicities. Much work remains to be done to determine where this therapy will fit into the melanoma treatment plan."
Melanoma is a form of cancer that begins in melanocytes (cells that make the pigment melanin). It may begin in a mole, but can also begin in other pigmented tissues, such as in the eye or in the intestines. Advanced (or metastatic) melanoma is the most advanced form of the disease, and occurs when cancer spreads beyond the surface of the skin to other organs, such as the lymph nodes, lungs, brain or other areas of the body.
The National Cancer Institute reports that 8,650 Americans died from melanoma in 2009. In Arizona, about 166 people a year died from the disease between 2002 and 2006, the most recent period for which statistics are available from NCI.