[2075] Adjuvant trastuzumab: long-term results of E2198.

Sledge GW, O'Neill A, Thor A, Kahanic SP, Zander PJ, Davidson N.. for the Eastern Cooperative Oncology Group

E2198 was a pilot adjuvant trial examining the cardiac effects of paclitaxel plus trastuzumab (TH) administered prior to doxorubicin plus cyclophosphamide (AC) in 234 HER2-positive (IHC 2+ or 3+) stage II breast cancer patients (pts). Pts. were randomized either to T 175 mg/m2 q3w X 4 + H (4 mg/kg loading dose followed by 2 mg/kg X 9w) followed by AC q3w X 4 (Arm A), or to the same regimen followed by H for 52 weeks (Arm B). Results: Median follow-up is 64 months. Congestive heart failure (CHF) was reported in 7 patients, occurring at 2, 4, 9, 10, 14, 20 and 36 months following initiation of therapy (3 Arm A, 4 Arm B). Disease-free survival at 5 years is equivalent for Arms A and B (76%% vs. 73%, p = 0.55 log rank test). Overall survival at 5 years is equivalent in the two arms (88% vs. 83%, p = 0.29 log rank test). Conclusions: Although not designed or powered to test the question of trastuzumab duration, E2198 does not show a significant advantage for prolonged trastuzumab administration. Most CHF events occur at an early point in time (4/7 within the first year, and none after 3 years), and overall incidence is similar to N9831 and NSABP B-31.

Friday, December 15, 2006 7:00 AM

Poster Session II: Treatment: Adjuvant Therapy (7:00 AM-9:00 AM)