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Title: Little Difference Between Docetaxel and Paclitaxel in Treating High-Risk Women With Nonmetastatic Breast Cancer: Presented at SABCS

"Little Difference Between Docetaxel and Paclitaxel in Treating High-Risk Women With Nonmetastatic Breast Cancer: Presented at SABCS"

By Cameron Johnston SAN ANTONIO, TX -- December 14, 2005 -- Never-before-released data show that there is virtually no difference in disease-free survival when a regimen comprising doxorubicin and cyclophosphamide is followed by either docetaxel or paclitaxel. The study also found that there is only a slight trend toward improvement when either of the taxanes is administered every 3 weeks or in a reduced dose every week. Joseph Sparano, MD, medical oncologist, Albert Einstein Comprehensive Cancer Center/Montefiore Medical Center, The Bronx, New York, presented the study results here on December 8[^th at the 28^th San Antonio Breast Cancer Symposium (SABCS).

In the study, known as E1199, 4988 women with node-positive or high-risk node-negative cancer were treated with 1 of 4 regimens: 1) doxorubicin plus cyclophosphamide followed by paclitaxel 175 mg/m² every 3 weeks or paclitaxel 80 mg/m² weekly for 4 cycles; 2) doxorubicin plus cyclophosphamide followed by docetaxel 100 mg/m² every 3 weeks or docetaxel 35 mg/m² weekly for 4 cycles.

The women in the study -- mean age 51 years -- all had undergone lumpectomy or mastectomy plus axillary node dissection with a minimum of 6 nodes removed.

The primary comparisons for the study were between the docetaxel and paclitaxel, as well as to determine whether weekly therapy was superior to 3-week cycles.

The findings were so surprising that the trial's data safety monitoring committee decided in October to release the data early. Further analyses are ongoing.

There was little difference in disease-free survival (DFS) between groups, with rates of 80.6% for the paclitaxel every-3-weeks arm, 83.5% for the paclitaxel weekly arm, 83.1% for the docetaxel every-3-weeks arm, and 80.5% for the docetaxel weekly arm.

Four-year overall survival rates were comparable: 88.8% for the paclitaxel every-3-weeks arm, 91.7% for the paclitaxel weekly arm, 88.3% for the docetaxel every-3-weeks arm, and 88.9% for the docetaxel weekly arm.

There were 15% fewer relapses in the weekly paclitaxel arm and 3 weekly docetaxel arms, but this was not a primary endpoint, Dr. Sparano said.

Overall disease-related adverse events were fewer than anticipated and can be put down to the longer overall survival among women with early-stage breast cancer, a fact that can be attributed to more women being screened mammographically, Dr. Sparano said. This is the case even when there are positive nodes.

Patients in the docetaxel every-3-weeks arm had the worst rate of adverse effects, with 71% experiencing a grade 3 or 4 toxicity compared with 28% of patients in the paclitaxel every week arm; 46% of patients in the docetaxel every-3-weeks arm experienced neutropenia and 16% developed febrile neutropenia.

"In conclusion, the primary comparisons revealed that docetaxel did not improve disease-free survival compared with paclitaxel," Dr. Sparano said. "In addition, weekly taxane therapy did not improve DFS compared with 3-weekly therapy. Finally, there was a trend toward improved DFS in the weekly paclitaxel arm compared with the standard 3 weekly arm."

[Presentation title: Phase III Study of Doxorubicin-Cyclophosphamide followed by Paclitaxel or Docetaxel Given Every 3 Weeks or Weekly in Patients With Axillary Node-Positive or High-Risk Node-Negative Breast Cancer: Results of North American Breast Cancer Intergroup Trial E1199. Abstract 48]

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