Grade 3/4 nonhematologic toxicities (>1% in either arm) were irregular menses (10.50% vs 15.96%; P=0.00042), fatigue (3.4% vs 7.93%; P<0.00001), sensory neuropathy (0 vs 5.39%; P<0.00001), vomiting (4.12% vs 4.23%), nausea (2.57% vs 2.64%), stomatitis/pharyngitis (1.65% vs 1.8%; P=0.80167), myalgia (0.21% vs 1.48%; P=0.00151), SGPT/ALT (1.03% vs 2.33%; P=0.02684), and thrombosis/embolism (0.10% vs 1.06%; P=0.00468, which included one toxic death in cycle 7 in the FAC followed by weekly paclitaxel arm). FAC was associated with more late cardiac toxicity: 3 deaths from cardiac ischemia/infections and 2 from arrhythmia, Dr. Martin said.
Factors that predict paclitaxel efficacy in this population are needed, he concluded.
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