Randomized phase III trial of a neoadjuvant regimen of four cycles of adriamycin plus cyclophosphamide followed by four cycles of docetaxel (AC4-D4) versus a shorter treatment of three cycles of FEC followed by three cycles of docetaxel (FEC3-D3) in node-positive breast cancer (Neo-Shorter; NCT02001506)

Abstract

Abstract Purpose To determine whether six cycles of FEC3-D3 has a comparable efficacy to eight of AC4-D4. Methods The enrolled patients (pts) were clinically diagnosed with stage II or III breast cancer. The primary endpoint was a pathologic complete response (pCR), and the secondary endpoints were 3-year disease-free survival (3Y DFS), toxicities, and health-related quality of life (HRQoL). Results Among the 248 pts enrolled, one case was ineligible for screening; 10 discontinued treatment due to progressive disease (7 and 3 in the AC4-D4 and FEC3-D3 arms), 16 dropped out due to a withdrawal of consent, and 3 were unable to complete the study (2 and 1 in the AC4-D4 and FEC3-D3 arms). The 218 pts who completed the surgery were included in the current analysis. The baseline characteristics of these subjects were well balanced between the two arms. By ITT analysis, pCR was achieved in 15/121 (12.4%) pts in the FEC3-D3 arm and 18/126 (14.3%) in the AC4-D4 arm (P = 0.40). With a median follow up of 64.1 months, the 3-year DFS was comparable between the two arms (77.0% in FEC3-D3 vs. 74.9% in AC4-D4; P = 0.82). The most common adverse event (AE) was Grade 3/4 neutropenia, which arose in 27/126 (21.4%) AC4-D4 arm pts vs 23/121 (19.0%) FEC3-D3 arm cases. The primary HRQoL domains were similar between the two groups (FACT-B scores at baseline, P = 0.35; at the midpoint of NACT, P = 0.20; at the completion of NACT, P = 0.44). Conclusion Both NACT AC4-D4 and FEC3-D3 show comparable outcomes in terms of pCR, three-year DFS, toxicities, and QoL Shorter neo-adjuvant FEC3-D3 could be an alternative to AC4-D4 for stage II or III operable breast cancer. Trial registration ClinicalTrials.gov NCT02001506. Registered December 5,2013 https://clinicaltrials.gov/ct2/show/NCT02001506