Study
| Multicenter, randomized phase II/III trial |
| HER 2–positive, >= clinical tumor 2 or clinical nodal–positive resectable EGA |
| Four pre and postoperative cycles of either FLOT alone (N:41) or combined with trastuzumab and pertuzumab, followed by nine cycles of trastuzumab/pertuzumab (N:40) |
Efficacy
| pCR rate: 12% vs 35%; P:0.02 |
| Pathologic lymph node negativity: 39% vs 68% |
| R0 resection rate: 90% vs 93% |
| mDFS: 26 m vs NR (HR: 0.58; P:0.14) |
| 24 months DFS:54% vs 70%, OS:77% vs 84% |
Safety
| Grade >= 3 diarrhea 5% vs 41% and leukopenia 13% vs 23% |
| Grade 1 or 2 weight loss: 10% vs 38% |
Oncol. 2022 Jun 16;JCO2200380
http://doi.org/10.1200/jco.22.00380
Reviewed by Hasan Cagri Yildirim, MD on Jul 16, 2022
