Effectiveness and Safety of Zercepac and Reference Trastuzumab in the Neoadjuvant Setting for Early-Stage Breast Cancer: A Retrospective Cohort Study

Abstract

Aim. Since the high cost of reference trastuzumab limits its clinical application, this study aimed to compare the effectiveness and safety of the Zercepac and reference product trastuzumab in neoadjuvant therapy for HER2-positive breast cancer. Methods. This study retrospectively collected clinical data of patients with early-stageHER2-positive breast cancer, who received trastuzumab, pertuzumab, docetaxel, and platinum as neoadjuvant therapy from November 2020 to July 2021. Patients were divided into the Zercepac and reference trastuzumab groups. Reduction in tumor size, clinical response based on RECIST1.1 criteria, pathological complete response (pCR), and adverse events (AEs) were evaluated. Multivariate logistic regression analyses were used to adjust confounders. Results. A total of 105 patients were included in the study, among them, 65 were in the Zercepac group and 40 were in the reference trastuzumab group. The percentage of tumor shrinkage from baseline was comparable between the Zercepac and reference trastuzumab group (47.6 ± 18.6% vs. 43.0 ± 19.9%, p = 0.235). Clinical partial response rate was similar between the two groups (81.5% vs. 70.0%, p = 0.172). There were 28 cases of pCR (70.0%) in the reference trastuzumab group and 46 cases of pCR (70.8%) in the Zercepac group ( p = 0.933). The choice of Zercepac or reference trastuzumab was not significantly associated with pCR (OR = 0.96, 95%CI: 0.41-2.28, p = 0.933). Adverse events (AEs) were observed in all patients, and the incidence of ≥3 grade AEs was comparable between the two groups (81.5% vs. 70.0%, p = 0.172). Conclusion. Zercepac has similar effectiveness and safety profile compared with reference trastuzumab in neoadjuvant therapy, which provides treatment options for patients with HER2-positive breast cancer.

Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China

“…eFigure 2 in Supplement 1 shows the process of study screening. Of the 1195 records sourced from the database and manually searched, 49 studies met the inclusion criteria, including 39 RCTs and 10 cohort studies …”

“…Table 1 and eTable 7 in Supplement 1 summarize the characteristics of the 10 cohort studies with a total of 1998 patients . Of the 10 cohort studies, 1 (10.0%) was of a bevacizumab biosimilar, 3 (30.0%) were of rituximab biosimilars, and 6 (60.0%) were of trastuzumab biosimilars . All cohort study designs were retrospective.…”

“…Of the RCTs, 32 (82.1%) were low risk, 5 (12.8%) were uncertain risk, and 2 (5.1%) were high risk . Of the cohort studies, 4 (40.0%) were high risk and 6 (60.0%) were low risk …”

“…Of the 1195 records sourced from the database and manually searched, 49 studies met the inclusion criteria, including 39 RCTs 32-70 and 10 cohort studies. [71][72][73][74][75][76][77][78][79][80]…”

“…[32][33][34][35][36][37][38][39][40][41][42][43][47][48][49][50][51][52][53][54][55]58,[62][63][64][65][66][67] Table 1 and eTable 7 in Supplement 1 summarize the characteristics of the 10 cohort studies with a total of 1998 patients. [71][72][73][74][75][76][77][78][79][80] Of the 10 cohort studies, 1 (10.0%) was of a bevacizumab biosimilar, 71 3 (30.0%) were of rituximab biosimilars, [72][73][74] and 6 (60.0%) were of trastuzumab biosimilars. [75][76][77][78][79][80] All cohort study designs were retrospective.…”