Adjuvant dose-dense doxorubicin-cyclophosphamide x 4 with or without bevacizumab is safe: no evidence of short-term changes in left ventricular ejection fraction.

Abstract #4102 Background
 Dose-Dense (dd) doxorubicin-cyclophosphamide (AC)-paclitaxel (P) is superior to q3w AC-P. Both are associated with a 55%) and ddAC → PT-lapatinib (LVEF > 50%). Patients with HER2-normal breast cancer were treated with B-ddAC → B-nanoparticle albumin-bound-P (LVEF > 50%). In all 3 trials LVEF was measured by MUGA scan at enrolment and at month 2 following completion of ddAC x 4. Prospective cardiac safety assessments before and after q 2 week AC x 4 were aggregated to determine the acute risks of cardiac dysfunction.
 Results
 From Jan 905 to May 908 236 pts were enrolled in 3 trials. Median age was 47yrs (range 27-75). Median LVEF pre-ddAC was 68% (range 52-82%). LVEF post-ddAC is available in 233 pts (99%) (1 pt withdrew consent, 1 progressive disease, 1 died from viral pneumonia). Median LVEF was unchanged at 68% (range 47-81%). No pt developed symptomatic CHF. Two pts had asymptomatic LVEF decline >15%: 1 pt (post B-ddAC) had decline from 71 to 53%, which improved to 64% in 4 wks and 1 pt (post ddAC) had decline 68% to 47%, which improved to 64% in 4 wks. No other pt had asymptomatic LVEF decline below 50%. Five of six pts with LVEF declines of 10-15% had improvement in LVEFs and continued treatment while 1 withdrew consent. Post-ddAC LVEF was similar whether or not pts received B.
 Conclusions
 Previously reported high rates of asymptomatic LVEF post q3w AC leading to pt dropout were not seen in these studies of ddAC or B-ddAC. Post-ddAC LVEFs were similar with or without concurrent bevacizumab. Dose-dense AC is safe and not associated with frequent acute changes in LVEF regardless of the concurrent use of B. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4102.