NEW YORK (Reuters Health) - The long-term findings of a large, multicenter study show that breast cancer survival is significantly improved and side effects are significantly less severe with Taxotere (also called docetaxel) than with Adriamycin (also called doxorubicin).
The findings "have the potential to be practice-changing," principal investigator Dr. Stephen Jones of the US Oncology Medical Center in Houston, Texas told Reuters Health.
Jones presented his group's findings today, the opening day of the San Antonio Breast Cancer Symposium.
The trial involved 1,016 women with breast cancer who had complete surgical excision of the primary tumor. In approximately half of the women, the cancer had not spread to the lymph nodes.
Between June 1997 and December 1999, women were randomly assigned to four cycles of Taxotere plus cyclophosphamide or four cycles of standard therapy with Adriamycin plus cyclophosphamide, administered by infusion every 3 weeks as adjuvant or "add-on" chemotherapy.
Radiation therapy and tamoxifen were given after completion of chemotherapy for patients with so-called hormone receptor-positive disease.
There was a significant survival advantage with Taxotere, Jones announced. "Stated another way, these women had a 31 percent lower risk of dying during follow-up" than those receiving the gold standard, he said.
Taxotere has the "added advantage of fewer and less severe adverse effects," Jones said. Adriamycin has a significant risk of cardiac toxicity, especially in older women. It is also associated with some types of leukemia, he explained.
Taxotere does have some side effects, however. It can still cause nausea and vomiting and hair loss, "but this is not as severe as with (Adriamycin)," the Houston investigator said. "We have shown that a lot of women with early breast cancers don't have to receive Adriamycin-based regimens."
Taxotere plus cyclophosphamide "would appear to be the new standard of care for node-negative women and for those with involvement of up to three local nodes...We don't have a lot of information on women with more than four positive nodes," Jones acknowledged.
"Now that we can see this survival advantage, we can incorporate this regimen into other treatment regimens with other agents," Jones added.