Two-drug combination therapy shows promise against melanoma

June 19, 2000

Melanoma researchers at University of California, San Diego (UCSD) have developed a new drug-combination therapy that has proven in Phase II clinical trials to be significantly better at extending patients' lives than any other drug therapy.

The two drugs, tamoxifen and cisplatin, are commonly used chemotherapeutic agents. Interestingly, neither drug, when used alone, has proven effective against melanoma.

"For reasons that aren't yet clear, this combination creates a synergism that is highly toxic to melanoma cells," said Edward F. McClay, M.D., principal investigator of the study and director of the Melanoma Care Unit at UCSD Cancer Center.

Results of the clinical trial are being published in the July 2000 issue of the British Journal of Cancer. The clinical trial was based upon earlier laboratory work in which McClay and colleagues first identified this synergistic interaction.

"If diagnosed and treated early, melanoma is highly curable," said McClay, professor of medicine at UCSD School of Medicine and a respected national authority on melanoma. "Unfortunately, melanoma is often diagnosed when it's more advanced and the chances of recurrence are quite high. If it recurs, it often does so with a much more aggressive and lethal personality."

In this study, the researchers treated 153 patients who were at high risk for recurrence or who had already had a recurrence. Participants received tamoxifen for seven days with the addition of a single dose of cisplatin on the second day; they underwent the weeklong therapy each month for four months. The principal side effect was nausea. With a median follow-up period in this study of 36 months, the researchers can predict with confidence that 79 percent of participants will be alive five years after treatment. Of equal importance, 62 percent of the patients will not have had a tumor recurrence during the five years.

"These statistics, while preliminary, are very encouraging because we have had precious little to offer patients with metastatic melanoma," said McClay. "With the best currently available treatment, the five-year survival rate in similar patients is only about 35 to 45 percent."

Because this study was a non-randomized Phase II trial, the researchers stress the importance of next conducting a national multi-site randomized study.

Malignant melanoma is one of the most virulent and deadly types of cancer. This year, at least 48,000 new cases of melanoma will be diagnosed in the United States and 7,700 people will die of the disease. In San Diego there will be approximately 250 new cases.
This work was supported in part by a grant from the National Cancer Institute and by the Bruce Brunner Gorder Memorial Melanoma Fund. Co-authors are Mary Eileen T. McClay of UCSD Cancer Center; and Linda Monroe, Paul L. Baron, David J. Cole, Paul H. O'Brien, John S. Metcalf and John C. Maize, all of the Hollings Cancer Center of the Medical University of South Carolina, in Charleston, S.C.

The Melanoma Care Unit is a patient-care and research program of UCSD Cancer Center, the only cancer center in San Diego and Imperial counties designated for both research and clinical care by the National Cancer Institute.

For information about melanoma clinical trials at UCSD, call 858-657-8705; for trials at institutions throughout the U.S., call the National Cancer Institute's Cancer Information Service at 800-4-CANCER.

University of California - San Diego

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