Prof. dr. Xavier Pivot, MD, Ph.D., Professor of Oncology, General Director of Paul Strauss anti-Cancer Center, Chairman of the Regional Cancer Institute at Institute De Cancerologie Stansbourg (iCANS). In this video, he speaks about the Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting.
Â
Overview:
Â
Importance HD201 is a biosimilar candidate to trastuzumab in the treatment of breast cancer.
Â
The goal of this study was to evaluate the efficacy of HD201 to that of the comparator trastuzumab.
Â
Design, environment, and participants:
Â
This randomized clinical trial (TROIKA) recruited 502 women with ERBB2-positive early breast cancer who were treated with HD201 or trastuzumab as a control. It was carried out in 70 centers throughout 12 nations, spanning Western and Eastern Europe, as well as Asia. The randomization was stratified by tumor hormone receptor status, clinical stage, and recruitment region. This study was carried out on February 12, 2021, after the adjuvant phase was completed after a median of 31 months (IQR, 28-33 months) of follow-up.
Â
Patients with ERBB2-positive early breast cancer were randomly randomized to receive HD201 or a control trastuzumab in the neoadjuvant setting for 8 cycles, contemporaneous with 4 cycles of docetaxel, followed by 4 cycles of epirubicin and cyclophosphamide. Following surgery, patients were treated with 10 cycles of adjuvant HD201 or comparable trastuzumab.
Â
The major end point was the total pathological complete response (tpCR) measured following neoadjuvant treatment. If the 95 percent CI of the absolute difference in tpCR between arms in the per-protocol set was within the margin of more or less than 15%, equivalence was concluded. Other goals included achieving a complete pathological response in the breast, an overall response, event-free and overall survival, safety, pharmacokinetics, and immunogenicity.
Â
Results:Â
Â
Results:Â The baseline characteristics of the two arms were well balanced; 195 tumors (38.8%) were hormone receptor-negative, and 213 patients (42.4%) had clinical stage III illness. The tpCR rates with HD201 and referent trastuzumab were 45 and 48.7 percent, respectively. The difference between the two groups was not statistically significant, falling within the predetermined equivalence limits at 3.8 percent (95 percent CI, 12.8 percent to 5.4 percent). The tpCR rate ratio between the two arms was 0.92. (95 percent CI, 0.76 to 1.12). During the entire treatment period, 433 patients (86.1 percent) experienced 2232 treatment-emergent adverse events of special relevance for trastuzumab, with 220 (88.0 percent) and 213 (84.5 percent) patients in the HD201 and referent trastuzumab groups, respectively.
Â
Conclusions and Implications: According to the findings of this randomized clinical trial, HD201 demonstrated equivalence to the reference trastuzumab in terms of efficacy for the end point of tpCR, with a similar safety profile.