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Docetaxel Outperforms Paclitaxel in First Head-to-Head Study: Presented at ECCO

By Michael Smith

COPENHAGEN, DENMARK -- September 23, 2003 -- In the first head-to-head comparison between the 2 major taxanes, docetaxel outperformed paclitaxel in women with advanced breast cancer, a researcher said here September 23^rd at ECCO 12: The European Cancer Conference.

"Given as a single agent, docetaxel is more effective than paclitaxel and more important, the patients live longer," Dr. Peter Ravdin, MD, University of Texas Health Science Center, San Antonio, Texas, United States.

"Every patient and every physician choosing [treatment] needs this information to make a balanced, informed decision," Dr. Ravdin told reporters in advance of his formal presentation.

But he said physicians must take care when prescribing docetaxel because it has significant toxicity compared to paclitaxel. "It is a toxic therapy," Dr. Ravdin said.

The study included 449 women with metastatic or locally advanced but inoperable breast cancer, who were randomised starting in 1994 to get either docetaxel or paclitaxel at standard doses and schedules. They were followed until their disease progressed.

One major end point of the study was objective response, defined as a 50% or greater shrinkage of the tumour. The rate was 32% in the docetaxel arm and 25% in the paclitaxel arm -- a result that Dr. Ravdin called "a trend in favour of docetaxel."

On the other hand, he said, results were statistically stronger for other measures. The median overall survival was 15.4 months for docetaxel and 12.7 for paclitaxel, and the median times to progression were 5.7 months and 3.6, respectively.

"This just shows how serious the disease state was for these patients, but they were living longer if they got docetaxel," he said.

The major side effects of docetaxel were neutropaenia (93.3% versus 54.5%), asthenia (23.9% versus 6.8%), infection (14.0% versus 5.0%), and edema (11.3% versus 4.5%). Fifteen percent of the docetaxel patients developed febrile neutropaenia, compared with 2% in the paclitaxel arm. As well, there were 3 deaths owing to infection among the docetaxel patients, but none in the paclitaxel group.

Dr. Ravdin said the study strengthens the case for using docetaxel in early breast cancer, "where we're talking not about palliation, but about increasing the cure rate," because a benefit in advanced disease often translates into cures in early cancer.


[Study title: Phase III Comparison of Docetaxel (D) and Paclitaxel (P) in Patients with Metastatic Breast Cancer (MBC). Abstract 670]

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