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 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."
Dr. Gianni suggested that if current adjuvant trials confirm the
benefit of sequential paclitaxel, "concurrent
doxorubicin/paclitaxel could be compared with the sequential approach."