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Large adjuvant trial shows no benefit of adding a taxane

Large adjuvant trial shows no benefit of adding a taxane

SAN ANTONIO—Sequential docetaxel (Taxotere)-based chemotherapy did not lead to better outcomes than standard anthracycline-based chemotherapy among women with resected breast cancer in the Taxotere as Adjuvant Chemotherapy Trial (TACT), the largest primary adjuvant trial of taxanes to date.

Although the CALGB 9344 and NSABP B28 adjuvant trials found better disease-free survival in patients given sequential paclitaxel, compared with AC alone, the duration of treatment was longer with the addition of paclitaxel, lead author Paul A. Ellis, MD, said at the 30th annual San Antonio Breast Cancer Symposium (abstract 78).

Controlled for duration

"In the UK at least, that led to debate: Was the benefit related to the taxane or was it related to increased duration? There was huge enthusiasm for a national adjuvant taxane trial controlling for the variable of duration," Dr. Ellis explained.

The multicenter trial enrolled women with completely resected, node-positive or high-risk node-negative invasive breast cancer, according to Dr. Ellis, an oncologist with the Guy's and St. Thomas' NHS Foundation Trust in London.

The study patients were assigned in balanced fashion to a control arm—either FEC (eight cycles) or E-CMF (four cycles of epirubicin followed by four cycles of CMF) at each center's discretion—or to an experimental arm—FEC-T (four cycles of FEC followed by four cycles of docetaxel)—with the arms having equivalent durations (eight cycles).

The median follow-up among the 4,162 women randomized was 51.8 months. About 80% received all eight cycles of treatment and 76% had a relative dose intensity exceeding 85%, with no difference between arms.

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