Trastuzumab-strf

(Hercessi®)

Hercessi®

Drug updated on 12/11/2024

Dosage FormInjection (Intravenous; 150 mg)
Drug ClassHER2/neu receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of HER2-overexpressing breast cancer
  • Indicated for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Latest News

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Summary
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  • This summary is based on the review of 43 systematic review(s)/meta-analysis(es). [1-41]
  • Trastuzumab-Based Regimens: Trastuzumab combined with epirubicin significantly increased the pathological complete response (pCR) rate compared to non-anthracycline regimens (odds ratio (OR) = 1.48, 95% confidence interval (CI), 1.04 to 2.12). Additionally, the addition of pertuzumab to trastuzumab further enhanced pCR rates (OR = 2.10, 95% CI, 1.56 to 2.83).
  • Pyrotinib combined with trastuzumab and chemotherapy achieved a pooled pCR rate of 57% (95% CI: 47-68%). There was no significant difference in pCR between anthracycline-free and anthracycline-containing regimens (OR = 0.95; 95% CI: 0.61-1.48).
  • In terms of survival outcomes, 12 months of trastuzumab significantly improved disease-free survival (DFS) and overall survival (OS) compared to shorter durations, and dual anti-HER2 therapy (trastuzumab + pertuzumab) significantly improved OS (hazard ratio (HR) = 0.77, 95% CI: 0.59-0.99) and progression-free survival (PFS) (HR = 0.74, 95% CI: 0.63-0.86).
  • For advanced/metastatic disease, trastuzumab combined with tyrosine kinase inhibitors (TKIs) showed better progression-free survival (PFS) and overall response rate (objective response rate (ORR) (>/= 3 adverse events (AEs))) compared to dual-targeted therapy. Monochemotherapy with dual-target therapy remained optimal for advanced breast cancer patients.
  • The combination of trastuzumab and epirubicin did not significantly increase cardiotoxicity compared to nonconcurrent regimens (RR = 1.18, 95% CI = 0.68-2.05), while dual anti-HER2 therapy (trastuzumab + pertuzumab) was associated with an increased risk of clinical heart failure (RR = 1.97, 95% CI: 1.05-3.70).
  • Pyrotinib combined with trastuzumab and chemotherapy resulted in high rates of treatment-related adverse events (TRAEs), with diarrhea occurring in 98% of patients, anemia in 71%, vomiting in 69%, and leucopenia in 66%.
  • Anthracycline-containing regimens showed a higher incidence of left ventricular ejection fraction decreases compared to anthracycline-free regimens (OR = 0.50; 95% CI: 0.35-0.71), highlighting specific cardiotoxic risks with these treatments.
  • In hormone receptor (HR)-negative patients, trastuzumab and pertuzumab therapy demonstrated higher efficacy, while concurrent trastuzumab and epirubicin regimens in HR-positive patients increased cardiotoxicity and showed less significant pCR rates. Dual-target therapy was highly recommended for node-positive patients, while lapatinib with trastuzumab was preferred for node-negative patients.

Product Monograph / Prescribing Information

Document TitleYearSource
Hercessi (trastuzumab-strf) Prescribing Information.2024Accord BioPharma Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Concurrent epirubicin and trastuzumab use increases complete pathological response rate without additional cardiotoxicity in patients with human epidermal growth factor receptor 2-positive early breast cancer: A meta-regression analysis2024Cancer Medicine
Safety and efficacy of pyrotinib for HER‑2‑positive breast cancer in the neoadjuvant setting: A systematic review and meta‑analysis2024Oncology Letters
A Systematic Review of Health-Related Quality of Life in Women with HER2-Positive Metastatic Breast Cancer Treated with Trastuzumab2024 PharmacoEconomics - Open
Efficacy and safety of first-line therapy in patients with HER2-positive advanced breast cancer: a network meta-analysis of randomized controlled trials2024Journal of Cancer Research and Clinical Oncology
Combination chemotherapy with trastuzumab in early-stage breast cancer: a meta-analysis and Bayesian decision analysis of different treatment regimens2024European Review for Medical and Pharmacological Sciences
Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China: A Systematic Review and Meta-Analysis2023JAMA Network Open
Pathologic Complete Response Achieved in Early-Stage HER2-Positive Breast Cancer After Neoadjuvant Therapy With Trastuzumab and Chemotherapy vs. Trastuzumab, Chemotherapy, and Pertuzumab: A Systematic Review and Meta-Analysis of Clinical Trials2023Cureus
Landscape of neoadjuvant therapy in HER2-positive breast cancer: a systematic review and network meta-analysis2023European Journal of Cancer
Health-related quality of life in Her2-positive early breast cancer woman using trastuzumab: A systematic review and meta-analysis2023Frontiers in Pharmacology
Neoadjuvant therapy with vs. without anthracyclines for HER2-positive breast cancer: a systematic review and meta-analysis2023Annals of Translational Medicine
Axillary Downstaging and the Impact of Clinical Axillary Status on Efficacy of Neoadjuvant Therapy for HER2-Positive Breast Cancer: A Network Meta-Analysis2023Technology in Cancer Research & Treatment
Comparative efficacy and tolerability of targeted and immunotherapy combined with chemotherapy as first-line treatment for advanced gastric cancer: a Bayesian network meta-analysis2022Scientific Reports
Lapatinib and lapatinib plus trastuzumab therapy versus trastuzumab therapy for HER2 positive breast cancer patients: an updated systematic review and meta-analysis2022Systematic Reviews
The adverse effects of trastuzumab-containing regimes as a therapy in breast cancer: A piggy-back systematic review and meta-analysis2022PloS One
Systemic Therapy for Patients with HER2-Positive Breast Cancer and Brain Metastases: A Systematic Review and Meta-Analysis2022Cancers
Pertuzumab combined with trastuzumab compared to trastuzumab in the treatment of HER2-positive breast cancer: A systematic review and meta-analysis of randomized controlled trials2022Frontiers in Oncology
Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer2022Biomedicines
Determining the Optimal (Neo)Adjuvant Regimen for Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer Regarding Survival Outcome: A Network Meta-Analysis2022Frontiers in Immunology
Genetic and RNA-related molecular markers of trastuzumab-chemotherapy-associated cardiotoxicity in HER2 positive breast cancer: a systematic review2022BMC Cancer
Adjuvant and neoadjuvant breast cancer treatments: A systematic review of their effects on mortality2022 Cancer Treatment Reviews
Efficacy of targeted therapy in patients with HER2-positive non-small cell lung cancer: A systematic review and meta-analysis2022British Journal of Clinical Pharmacology
Pertuzumab Cardiotoxicity in Patients With HER2-Positive Cancer: A Systematic Review and Meta-analysis2021CJC Open
Heart Failure Therapies for the Prevention of HER2-Monoclonal Antibody-Mediated Cardiotoxicity: A Systematic Review and Meta-Analysis of Randomized Trials2021Cancers
Docetaxel and bevacizumab with or without trastuzumab as first-line treatment for patients with metastatic breast cancer: a meta-analysis2021European Review for Medical and Pharmacological Sciences
Efficacy and Safety of Anti-HER2 Agents in Combination With Chemotherapy for Metastatic HER2-Positive Breast Cancer Patient: A Network Meta-Analysis2021Frontiers in Oncology
Efficacy of tucatinib for HER2-positive metastatic breast cancer after HER2-targeted therapy: a network meta-analysis2021Future Oncology
Incidence of central nervous system metastases in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer treated with trastuzumab: A meta-analysis2021Clinics
Meta-Analysis of HER2-Enriched Subtype Predicting the Pathological Complete Response Within HER2-Positive Breast Cancer in Patients Who Received Neoadjuvant Treatment2021Frontiers in Oncology
Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials2021The Lancet
Toward a Treatment Sequencing Strategy: A Systematic Review of Treatment Regimens in Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma2021The Oncologist
A systematic review of HER2 blockade for the curative treatment of gastroesophageal adenocarcinoma: Successes achieved and opportunities ahead2021Cancer Treatment Reviews
Efficacy and Safety of Pyrotinib Versus T-DM1 in HER2+ Metastatic Breast Cancer Patients Pre-Treated With Trastuzumab and a Taxane: A Bayesian Network Meta-Analysis2021Frontiers in Oncology
Trastuzumab administration during pregnancy: an update2021BMC Cancer
6 versus 12 months of adjuvant trastuzumab in HER2+ early breast cancer: A systematic review and meta-analysis2021Medicine
Do all patients with HER2 positive breast cancer require one year of adjuvant trastuzumab? A systematic review and meta-analysis2020Breast
Evaluation of 1-Year vs Shorter Durations of Adjuvant Trastuzumab Among Patients With Early Breast Cancer: An Individual Participant Data and Trial-Level Meta-analysis2020JAMA Network Open
Six Months vs. 12 Months of Adjuvant Trastuzumab Among Women With HER2-Positive Early-Stage Breast Cancer: A Meta-Analysis of Randomized Controlled Trials2020Frontiers in Oncology
Dual HER2 Blockade versus a Single Agent in Trastuzumab-Containing Regimens for HER2-Positive Early Breast Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials2020Journal of Oncology
Cardiotoxicity of trastuzumab given for 12 months compared to shorter treatment periods: a systematic review and meta-analysis of six clinical trials2020ESMO Open
Quality of Life During Palliative Systemic Therapy for Esophagogastric Cancer: Systematic Review and Meta-Analysis2020Journal of the National Cancer Institute
Efficacy and safety of HER2 inhibitors in combination with or without pertuzumab for HER2-positive breast cancer: a systematic review and meta-analysis2019BMC Cancer

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