Do most patients recover from Herceptin-induced LVEF dysfunction?
• A: Adjuvant Among 32 patients in studies B-31 and N9831 receiving adjuvant Herceptin treatment with clinical cardiac events as determined by an external safety committee, one patient died of cardiomyopathy and all other patients were receiving cardiac medication at last follow-up. • Approximately half of the surviving patients had recovery to normal LVEF (defined as ≥50%) on continuing medical management. Metastatic (Seidman et al, 2002; Slamon et al, 2001) In the pivotal trial, 63 patients receiving AC (anthracycline and cyclophosphamide) or paclitaxel chemotherapy with or without Herceptin experienced symptomatic cardiac dysfunction (39 patients had received AC + Herceptin; 11 AC only; 12 paclitaxel + Herceptin; 1 paclitaxel alone). An independent cardiac review and evaluation committee reviewed the data from these patients. • Of the 63 patients with cardiac dysfunction, 44 received standard medical treatment. • The condition improved in 33 of these 44 patients, did not change in 5
