Results Of Taxol-Adriamycin National Study Released At ACOG

INDIANAPOLIS--Results of a large three-year nationwide clinical trial evaluating Taxol and Adriamycin to treat advanced breast cancer indicate the two drugs are equivalent in effectiveness when used as single therapy agents. The results were presented Monday, May 19, during the 33rd annual meeting of the American Society of Clinical Oncology (ASCO) in Denver.

In a plenary address at the meeting, George Sledge, M.D., Ballve'-Lantero Professor of Oncology at Indiana University School of Medicine and principal investigator for the Phase III multi-center randomized clinical trial, said the study looked at three ways of treating advanced or metastatic breast cancer. Patients were either (1) treated initially with Adriamycin, a chemotherapy agent which has been used in breast cancer treatment for more than 20 years and previously considered the most active single agent in metastatic breast cancer, (2) initially given Taxol, a new chemotherapeutic agent which was approved for the treatment of breast cancer in 1994, or (3) administered a combination of the two drugs.

The findings indicate that while Taxol (paclitaxel) and Adriamycin (doxorubicin) are equally active single agents in metastatic breat cancer combining the two agents significantly increased the overall response rate and time to treatment failure, Dr. Sledge said. Also, when a patient received both Taxol and Adriamycin as single agents consecutively over the course of treatments, survival was as good as occurred using the two drugs in combination therapy. It did not matter which of the two drugs was administered first.

"When we looked at overall survival, all three were the same," he said. "The more intensive therapy, in this case the drug combination, did not improve quality or length of life." Median survival rates for metastatic breast cancer patients enrolled in the study was about 22 months.

The trial looked at response rates and time-to-treatment failure for the three different therapies. The time-to-treatment failure or the length of time until disease progression occurred was 6.0 months for patients on Adriamycin, 5.9 months for those on Taxol and 8.0 months for those receiving the combination therapy.

The trial involved 739 women with stage 4 metastatic breast cancer and was the first large randomized study to evaluate these drugs in the United States.

Additionally, the study showed that the side effects for Taxol or Adriamycin as single agents were basically the same, although Adriamycin was slightly more toxic in terms of mortality.

"This study is important because it places a new drug (Taxol) in context," said Dr. Sledge. "It tells us that this drug is fully the equivalent of the best current drug for treating breast cancer."

Adriamycin is a chemotherapy agent which affects the DNA of the cancer cell. Taxol targets the infrastructure of the cell. Adriamycin is a slightly less costly drug than Taxol.

The nationwide trial, the first to compare Taxol and Adriamycin, was funded by the National Cancer Institute, and carried out by physicians in the Eastern Cooperative Oncology Group (ECOG), Southwest Oncology Group (SWOG) and the North Central Cancer Treatment Group (NCCTG).

(Please Note: Accompanying this release is one on a subsequent study to be presented Tuesday, May 20, by Michael Stender, M.D., during the metastatic breast cancer session.)

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