"At a median follow-up of 66 months, Taxotere/cyclophosphamide compared to Adriamycin/cyclophosphamide was associated with superior disease-free survival -- a 33% decreased risk," said Stephen Jones, MD, medical director, US Oncology Research, Houston, Texas. The difference in disease-free survival reached statistical significance at the P = .015 level.

"We also saw a strong trend toward overall survival," Dr. Jones said on December 11^th in the final general session. "There was a 24% reduction in the risk of death, which did not reach statistical significance [P = .13]. However, we think that the difference in disease-free survival will eventually translate to a significant overall survival benefit."

Dr. Jones noted that for more than a generation the combination of Adriamycin and cyclophosphamide had been the standard treatment for women with early-stage breast cancer, but recent studies have indicated that taxanes might offer a better survival benefit for these patients.

The researchers in 1997 began enrolling 1,016 women and offered 506 of them adjuvant chemotherapy with four cycles of the Taxotere-based therapy consisting of 75-mg/m² Taxotere and 600-mg/m² cyclophosphamide every 21 days and offered 510 patients four cycles of the Adriamycin-based chemotherapy with 60-mg/m² Adriamycin and 600-mg/m² cyclophosphamide every 21 days.

All the patients underwent radiation therapy after finishing chemotherapy. After radiation, patients were given tamoxifen if they were found to have hormone-responsive cancer.

One problem with the Adriamycin combination -- cardiac toxicity -- is not a concern with Taxotere, Dr. Jones said. In his study, he reported, there was no cardiac toxicity in either arm.

In the trial, breast cancer recurred in 59 patients on the Taxotere regimen (12%); 80 patients on Adriamycin experienced a recurrence (16%).

"Taxotere/cyclophosphamide (TC) should now be considered as a standard nonanthracycline adjuvant regimen for operable breast cancer," Dr. Jones said.


[Presentation title: Final analysis: TC (Docetaxel/Cyclophosphamide, 4 Cycles) has a Superior Disease-Free Survival Compared to Standard AC (Doxorubicin/Cyclophosphamide) in 1016 Women With Early Stage Breast Cancer. Abstract 40]

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