MILAN, Italy--Concern about the cardiotoxicity reported in early studies of AT--doxorubicin (Adriamycin)/paclitaxel (Taxol)--in advanced breast cancer was somewhat eased by a retrospective analysis of all previous AT studies.
The review showed that AT can be given safely as adjuvant therapy for at least 6 cycles in these patients. Luca Gianni, MD, of the Istituto Nazionale Tumori, Milan, reported the findings at a poster session of the ASCO annual meeting.
Dr. Giannis analysis included data from 10 clinical trials: eight single-arm studies of AT, one of AT vs FAC, and one of AT vs doxorubicin(Drug information on doxorubicin) alone. The four earliest studies included 8 or more cycles of AT. Subsequent studies included 4 or 6 cycles.
This analysis included 922 patients: 389 in single-arm AT studies and 533 in randomized studies.
Dr. Gianni said that in patients who received 4 to 6 cycles of AT, "the overall incidence of CHF (4%) and the well-maintained LVEF compare favorably with historical data and with the two control arms of the randomized AT trials."
He added that the effect on cardiac function "must be viewed in the light of pharmacokinetic data suggesting a 30% increase in doxorubicin exposure when given prior to paclitaxel(Drug information on paclitaxel)."
Dr. Gianni suggested that if current adjuvant trials confirm the benefit of sequential paclitaxel, "concurrent doxorubicin/paclitaxel could be compared with the sequential approach."