P281 Randomized phase II trial of adjuvant vinorelbine and epirubicin versus adriamycin and cyclophosphamide in node negative breast cancer [AViEN trial]

LVEF 56% and performance status 0 or 1 were required for each eligible patient. 4 cycles of FEC (F: 500mg/m2, E: 100mg/m2, C: 500mg/m2) iv followed by 4 cycles of D (75mg/m2) and H were administered. H was given at 6mg/kg iv over 90 minutes every 3 weeks after a loading dose of 8mg/kg given at 1st cycle. After 4 cycles of DH, H was continued every 3 weeks for 1 year. The primary endpoint was a completion rate of the protocol treatment and others were safety profiles and tolerability of the regimen. Results: Forty-five patients were enrolled. Median age was 55 (range, 30−70 years). Performance status was 0 in 43 patients. ER and PgR were positive in 23 and 16 and negative in 22 and 29 patients, respectively. Lymph-node metastasis was negative in 19 and positive in 26 patients, respectively. Completion rate of FEC and DH were 100% and 91.1%, respectively. Four patients were taken off the study due to a decline of LVEF to 40%, fatigue, peripheral edema with pain and febrile neutropenia in one of each patient. Grade 3−4 toxicity during FEC and DH included neutropenia in 29 and 19 patients, and febrile neutropenia in 9 and 8, respectively. Of 348 cycles, 25 cycles (7.2%) were delayed from the scheduled day and dose reduction was needed in 9 cycles (3.6%) due to adverse events. The average dose intensity for E and D was 30.9mg/m2/week and 23.8mg/m2/week, respectively. Conclusion: Adjuvant chemotherapy with FEC (100) followed by concomitant use of D (75) plus H given at a 3-week interval was well tolerated with an acceptable toxicity in HER2/neu-positive breast cancer, although longer follow up is needed especially in cardiac toxicity. Disclosure of Interest: None Declared