Anti-HER2 therapy and breast cancer

  The tremendous progress of targeted therapy in breast cancer treatment has not only brought benefits to patients, but also advanced the development and clinical research of targeted drugs, and this year’s SABCS, targeted therapy has taken an important place without exception.  Targeted therapy for HER2-positive breast cancer 1. Trastuzumab and adjuvant therapy: The most important advancement for HER2-positive breast cancer is the further results reported from two large clinical trials with long-term follow-up, N9831 and BCIRG006. In both studies, trastuzumab (Trastuzumab, Herceptin, H) was shown to reduce the risk of recurrence in postoperative adjuvant therapy, with at least 80% of all patients treated with H for 1 year remaining disease-free at five-year follow-up, and concluded that H offers a great chance of cure for HER2-positive breast cancer, and further confirmed that 1 year of H treatment is an essential N9831 was the only trial to affect the combination modality of H and chemotherapy, and very clearly demonstrated a long-term benefit of 1 year of H treatment, as well as a greater benefit when applied concurrently with chemotherapy during the chemotherapy phase. BCIRG006 evaluated the results of H in anthracycline and non-anthracycline combinations, and both showed prolonged survival with both modalities, including DFS and OS, but the non-anthracycline regimen showed a better cardiac safety profile.Abstract #701, N9831, is a phase III, randomized, multicenter, open one-year adjuvant H treatment completed by NCCTG in the United States for HER2-positive early-stage breast cancer, with H applied concurrently with chemotherapy, or after the end of chemotherapy, with chemotherapy regimens AC→T,AC→TH,TCH, respectively. The primary observed endpoint was H+ chemotherapy compared with chemotherapy alone, which showed that H+ chemotherapy had a significantly longer DFS than chemotherapy alone, patients with H had a 30% reduced risk of recurrence, and 80% of patients remained disease-free at 5-year follow-up.  BCIRG006 is an independent phase III randomized clinical study. It compares the efficacy of Tysodi + Carboplatin + H, sequential anthracyclines and cyclophosphamide in early-stage HER2-positive breast cancer, looking primarily at DFS, OS toxicity and the predictive role of molecular markers. This study showed that the use of H + anthracycline-containing agents reduced the risk of recurrence by 36% and the risk of death by 37% compared to the no-H group, and that the combination with non-anthracyclines reduced the risk of recurrence by 25% and the risk of death by 23%. Both were statistically significant, showing that anthracycline-containing analogs were more effective, but non-anthracycline analogs showed better cardiac safety profiles. And at 5 years of follow-up, 80% of all patients treated with H survived disease-free.  2. Trastuzumab and neoadjuvant therapy: NOAH is a phase III clinical trial studying 228 patients, HER2-positive, T3N1 or any T plus N2 or N3. All patients receive a standard neoadjuvant chemotherapy, 3 cycles of PTX + EPI, sequential 4 cycles of PTX, and finally 4 CMF, and these patients are randomized to receive chemotherapy + H or chemotherapy alone, for 8 months. neoadjuvant chemotherapy, all patients had surgery, followed by radiotherapy and adjuvant TAM, and continued with H for a total of 52 weeks. This trial included 99 patients with HER(-) receiving chemotherapy, radiotherapy and TAM only. the primary observed endpoint was event-free survival (defined as progression on treatment, recurrence after surgery, death from any cause) at 3 years in the group treated with H compared to the non-H group, risk ratio 0.55, p=0.006; pathological complete remission rate was 43% in the group treated with H compared to 23% in the non-H group, p=0.002; where The overall response rate was 89% with H versus 77% without, P=0.02. Three-year overall survival was better with H but did not reach statistical significance, HR 0.65, P=0.18. There was no significant cardiotoxicity, said Dr. GiamiIn: NOAH trial becomes neoadjuvant H+ chemotherapy for HER2-positive breast cancer become a standard treatment option.