Artemis: A Randomised Trial Of Bevacizumab With Neoadjuvant Chemotherapy (Nact) For Patients With Her2-Negative Early Breast Cancer-Primary Endpoint, Pathological Complete Response (Pcr).

1014 Background: Bevacizumab (bev) has been used with NACT in breast cancer trials. Geparquinto reported benefit for bev in triple negative (neg) patients (pts) (pCR 36.4% v 27.8% p=0.02), as did CALGB 40603 (pCR 52% v 44%, p=0.057), although the NSABP-B40 study showed benefit in ER-positive (pos) pts (pCR 23.3% v 15.2%, p=0.008). Methods: ARTemis is a randomised phase 3 trial adding bev to NACT (docetaxel (D)-FEC). Pts with HER2-neg invasive breast cancer were eligible. Stratification was by age, ER status (neg: weak pos: strong pos), tumour size (T2:T3/4), clinical involvement of axillary nodes and inflammatory/locally advanced disease. Pts were randomised (1:1) to bev+D-FEC or D-FEC. The primary endpoint was pCR, defined as no residual invasive cancer in the breast or axillary lymph nodes after NACT. 800 pts were required to detect 10% differences in pCR rates, at the 5% (2-sided) level of significance with 85% power. Results: 800 pts were randomised from 66 UK centres (May’09 to Jan’13). 68% were <50 years old, 19% had inflammatory and/or locally advanced disease, 79% of tumours <50mm, 52% clinical node pos and 33% ER-neg. A 2-reader independent review of pathology reports was carried out. Significantly more pts on bev+D-FEC had a pCR (22% (18-27%) vs 17% (13-21%) with D-FEC; p=0.03 [adjusted for stratification factors]). pCR rates differed significantly across ER groups (neg 38%, weak pos 39%, strong pos 7%; p<0.0001). Treatment effect of bev remained significant after adjustment for ER (p=0.03). Conclusions: ARTemis showed a significant improvement in pCR with the addition of bev to D-FEC. ER-neg and ER-weak pos / HER2-neg breast cancer pts appeared to benefit most from bev, whilst pCR rates in ER-strong pos pts were lower and did not appear to show improvement from the addition of bev. Our results are similar to those reported in Geparquinto and CALGB 40603. Clinical trial information: 68502941. Factor D-FEC pCR (95% CI) bev+D-FEC pCR (95% CI) p* ER-neg (Allred 0-2) (n=253) 32% (24-41) 44% (36-54) 0.03 ER-weak pos (Allred 3-5) (n=67) 26% (13-44) 52% (34-69) ER-strong pos (Allred 6-8) (n=461) 7% (4-11) 6% (3-10) * p-value across treatment groups, after adjusting for ER.