Long-term outcome of the REMAGUS 02 trial, a multicenter randomised phase II trial in locally advanced breast cancer patients treated with neoadjuvant chemotherapy with or without celecoxib or trastuzumab according to HER2 status.

摘要: Abstract Background The REMAGUS-02 multicenter randomised phase II trial showed that the addition to neoadjuvant chemotherapy (NAC) of trastuzumab in patients with localised HER2-positive breast cancer (BC) increased pathological complete response (pCR) rate and celecoxib HER2-negative cases did not increase pCR rate. We report here long-term follow-up results for disease-free survival (DFS) overall (OS). Patients methods From 2004 2007, 340 stage II–III BC were randomly assigned receive EC-T (four cycles epirubicin–cyclophosphamide followed by four docetaxel) +/− (n = 220) and ± trastuzumab (n = 120). September 2005, all received adjuvant T (n = 106). Results Median was nearly 8 years (94.4 months, 20–127 m). In subgroup, associated a DFS benefit. Favourable factors smaller tumour size, expression progesterone receptor status (PgR) pCR. population, Axillary only prognostic factor this group [HR = 0.44, 95% CI = 0.2–0.97], p = 0.035]. To note, OS significantly higher than (HR = 0.58 [0.36–0.92], p = 0.021). Conclusion Celecoxib combined NAC provided neither nor benefit BC. Absence PgR is major factor. Neoadjuvant rates without translation into or compared only. could be more relevant surrogate population. A retrospective comparison shows tumours have better outcome showing impact on natural history