Neoadjuvant chemotherapy and HER2 dual blockade including biosimilar trastuzumab (SB3) for HER2-positive early breast cancer: Population based real world data from the Danish Breast Cancer Group (DBCG)

Abstract

Background Dual blockade with trastuzumab and pertuzumab combined with neoadjuvant chemotherapy (NACT) has been increasingly used for HER2-positive tumours >2 cm and/or with positive axillary lymph nodes in order to evaluate pathologic response and obtain better surgical management. SB3 is a registered biosimilar trastuzumab approved following a phase III trial demonstrating similar efficacy in the neoadjuvant setting as trastuzumab. However, the study was done without pertuzumab. Method The database of the Danish Breast Cancer Group was used to extract data on all patients who started NACT with SB3 and pertuzumab between September 1, 2018 and August 31, 2019. The primary endpoint was pathological complete response (pCR) rate. Results In total 215 patients received NACT and dual blockade. The median age was 55 (24–81). NACT used was cyclophosphamide and epirubicin followed by weekly paclitaxel (62% on six cycles, 35% on eight cycles) or other chemotherapy followed by weekly paclitaxel (3%). Overall, 56% of patients achieved pCR. 60 of 88 node-positive patients pre-NACT achieved ypN0(i-) after neoadjuvant treatment. pCR rate was significantly associated with estrogen receptor status and malignancy grade. An association with CEP17/HER2-ratio was assessed. Conclusion Real world data on dual blockade with SB3 and pertuzumab in combination with NACT in a nationwide population-based study show a pCR rate comparable to that seen in previous clinical studies.

Neoadjuvant Pertuzumab Plus Trastuzumab in Combination with Docetaxel and Carboplatin in Patients with HER2-Positive Breast Cancer: Real-World Data from the National Institute of Oncology in Poland

“…Anthracyclines may be used sequentially, followed by taxanes in combination with anti-HER2 drugs, or an anthracycline-free regimen containing taxanes and carboplatin with targeted therapy is recommended [ 1 , 2 , 3 ]. The results of previous studies confirm the similar efficacy of both treatment modalities, with a lower risk of cardiotoxicity in the case of anthracycline-free regimens [ 8 , 9 , 10 , 11 ].…”

“…Grade 3 and 4 toxicity was more common in patients over 60 years of age, and the achieved pCR rate was only 11.1% in patients with the HER2-positive subtype of unclear breast cancer. In most of the publications available, the TCbH-P program is not used in patients over 65 years of age, and often in patients over 60 years of age [ 9 , 10 , 11 , 32 , 33 ]. Our observations confirm that in the group of elderly patients, the use of an aggressive treatment regimen is not associated with the expected response.…”

Biyobenzer İlaçlar

“…31,40,41 Trastuzumab ve pertuzumab ile ikili blokaj afinitesinden faydalanarak HER2+ meme kanseri hastalarının tedavisinde kullanılmak için onaylanmıştır. [42][43][44] Yapılan simülasyonlarla, pertuzumab ve trastuzumab klinik sinerjizminin, kısmen HER2 üzerinde birlikte lokalize olduklarında iki antikor arasındaki işbirlikçi etkileşimlerden kaynaklanan bir afinitede etkisi ile blokaj yaptığı ileri sürülmüştür. 24,45 Şekil 3. de bu afinite simülasyonunu verilmiştir.…”

Neoadjuvant Pertuzumab plus Trastuzumab in Combination with Docetaxel and Carboplatin in Patients with HER2 Positive Breast Cancer: Real-World Data from a National Institute of Oncology in Poland.

“…Anthracyclines may be used sequentially, followed by taxanes in combination with anti-HER2 drugs or an anthracycline-free regimen containing taxanes and carboplatin with targeted therapy is recommended [1][2][3]. The results of studies confirm similar efficacy of both treatment modalities, with a lower risk of cardiotoxicity in the case of anthracycline-free regimens [8][9][10][11].…”