Ado-trastuzumab emtansine

(Kadcyla®)

Kadcyla®

Drug updated on 5/6/2024

Dosage FormInjection (intravenous; 100 mg, 160 mg)
Drug ClassHER2 inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the treatment of patients who received prior therapy for metastatic disease with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for metastatic disease or developed disease recurrence during or within six months of completing adjuvant therapy.
  • For the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

Latest News

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Summary
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  • Ado-trastuzumab emtansine (Kadcyla) is utilized for the treatment of patients with HER2-positive, metastatic breast cancer who have previously received trastuzumab and a taxane, whether separately or in combination. It is also indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.
  • Eighty-four systematic reviews/meta-analyses were examined to gather information about this drug.
  • The studies indicated that ado-trastuzumab emtansine delivers substantial benefits in metastatic breast cancer patients previously treated with trastuzumab and a taxane. It enhances progression-free survival (PFS) rates and overall survival (OS), demonstrating favorable comparisons against single-agent chemotherapy.
  • Dual anti-HER2 therapy, notably the combination of trastuzumab with pertuzumab plus chemotherapy, has been recognized for providing improved survival outcomes over monochemotherapy or dual therapy without chemotherapy, albeit with an increased likelihood of adverse events.
  • Tyrosine Kinase Inhibitors, such as lapatinib and pyrotinib combined with chemotherapy, offer significant improvements in PFS among patients compared to monochemotherapy or dual-targeted treatments alone. Pyrotinib has emerged as an effective alternative for early-stage or locally advanced HER2-positive breast cancer; however, managing its side effects, such as diarrhea, is critical.
  • Adverse events, including fatigue and gastrointestinal issues, are common across all treatments involving trastuzumab derivatives. Cardiotoxicity remains a significant concern, especially when using anthracyclines, underscoring the necessity for guidelines or treatments to mitigate cardiac risks.
  • Treatments, including TDM1, fare better in early-stage diseases, offering longer disease-free periods, while caution regarding adverse events is advised during their use in metastatic conditions.
  • Patients with HER2-positive status exhibit substantial benefits from anti-HER2 based therapies, highlighting the importance of accurate HER2 testing.
  • Hormone receptor statuses impact the efficacy of trastuzumab combinations. Hormone receptor-negative patients may derive more benefit, especially in neoadjuvant settings.
  • For HER2-positive metastatic breast cancer patients, ado-trastuzumab emtansine presents a more effective strategy with improved survival outcomes over traditional treatments like trastuzumab and a taxane alone. However, careful patient monitoring is necessary due to the increased potential for adverse events such as cardiotoxicity.

Product Monograph / Prescribing Information

Document TitleYearSource
Kadcyla (ado-trastuzumab emtansine) Prescribing Information.2022Genentech, Inc., South San Francisco, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Combination chemotherapy with trastuzumab in early-stage breast cancer: a meta-analysis and Bayesian decision analysis of different treatment regimens.2024European Review for Medical and Pharmacological Sciences
Efficacy and safety of first-line therapy in patients with HER2-positive advanced breast cancer: a network meta-analysis of randomized controlled trials.2024Journal of Cancer Research and Clinical Oncology
Trastuzumab deruxtecan in human epidermal growth factor receptor 2-positive breast cancer brain metastases: a systematic review and meta-analysis.2024ESMO Open
Incidence of antibody-drug conjugate-related fatigue in patients with breast cancer: A systematic review and meta-analysis.2024Critical Reviews in Oncology/Hematology
The cardioprotective potential of sodium-glucose cotransporter 2-inhibitors in breast cancer therapy-related cardiac dysfunction - A systematic review.2024Current Problems in Cardiology
A systematic review of health-related quality of life in women with HER2-positive metastatic breast cancer treated with trastuzumab.2024PharmacoEconomics
A review regarding the article 'The cardioprotective potential of sodium-glucose cotransporter 2-inhibitors in breast cancer therapy-related cardiac dysfunction-A systematic review'.2024Current Problems in Cardiology
Safety and efficacy of pyrotinib for HER‑2‑positive breast cancer in the neoadjuvant setting: A systematic review and meta‑analysis.2024Oncology Letters
Landscape of neoadjuvant therapy in HER2-positive breast cancer: a systematic review and network meta-analysis. 2023European Journal of Cancer
Safety profile of trastuzumab-emtansine (T-DM1) with concurrent radiation therapy: A systematic review and meta-analysis. 2023Radiotherapy and Oncology
Efficacy and safety of antibody-drug conjugates in triple-negative and HER-2 positive breast cancer: A systematic review and meta-analysis of clinical trials. 2023Breast Disease
Identifying the optimal therapeutics for patients with hormone receptor-positive, HER2-positive advanced breast cancer: a systematic review and network meta-analysis. 2023ESMO Open
Efficacy of anti-HER2 drugs in the treatment of patients with HER2-mutated cancers: a systematic review and meta-analysis.2023Clinical and Experimental Medicine
The impact of genomic context on outcomes of solid cancer patients treated with genotype-matched targeted therapies: a comprehensive review.2023Annals of Oncology
Efficacy and safety of trastuzumab deruxtecan in breast cancer: a systematic review and meta-analysis.2023Clinical Breast Cancer
Racial disparities in treatment-related cardiovascular toxicities amongst women with breast cancer: a scoping review.2023Journal of Cancer Survivorship
ACEI/ARB and beta-blocker therapies for preventing cardiotoxicity of antineoplastic agents in breast cancer: a systematic review and meta-analysis.2023Heart Failure Reviews
Clinical benefit, price, and uptake for cancer biosimilars vs reference drugs in China: a systematic review and meta-analysis.2023JAMA Network Open
Evaluation of HER-2 positive breast cancer treated with dual-targeted treatment of trastuzumab plus pertuzumab.2023Immunopharmacology and Immunotoxicology
Risk prediction models for antineoplastic-associated cardiotoxicity in treatment of breast cancer: A systematic review.2023American Journal of Health-System Pharmacy
The value of neoadjuvant anthracycline-based regimens for HER2-positive breast cancer: a systematic review and meta-analysis including 1366 patients.2023Clinical Medicine Insights: Oncology
A meta-analysis to assess the efficacy of HER2-targeted treatment regimens in her2-positive metastatic colorectal cancer (mCRC).2023Current Oncology
Chemotherapy induced right ventricular cardiomyopathy; a systematic review and meta-analysis.2023Frontiers in Cardiovascular Medicine
Incidence of interstitial lung disease and cardiotoxicity with trastuzumab deruxtecan in breast cancer patients: a systematic review and single-arm meta-analysis.2023ESMO Open
The efficacy and safety of trastuzumab deruxtecan (T-DXd) in HER2-expressing solid tumours: a single-arm meta-analysis.2023Japanese Journal of Clinical Oncology
Cardioprotective agents for the primary prevention of trastuzumab-associated cardiotoxicity: a systematic review and meta-analysis.2023Pharmaceuticals
Efficacy and safety of trastuzumab deruxtecan in the treatment of HER2-low/positive advanced breast cancer: a single-arm meta-analysis.2023Frontiers in Pharmacology
Health-related quality of life in Her2-positive early breast cancer woman using trastuzumab: A systematic review and meta-analysis.2023Frontiers in Pharmacology
Epidemiology, clinical outcomes, and unmet needs of patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases: A systematic literature review.2023Cancer Treatment Reviews
Adjuvant treatment with trastuzumab of patients with HER2-positive, T1a-bN0M0 breast tumors: A systematic review and meta-analysis.2023Critical Reviews in Oncology/Hematology
Dual neoadjuvant blockade plus chemotherapy versus monotherapy for the treatment of women with non-metastatic HER2-positive breast cancer: a systematic review and meta-analysis.2023Clinical & Translational Oncology
Neoadjuvant therapy with vs. without anthracyclines for HER2-positive breast cancer: a systematic review and meta-analysis. 2023Annals of Translational Medicine
Prognostic value of left ventricular global longitudinal strain on speckle echocardiography for predicting chemotherapy-induced cardiotoxicity in breast cancer patients: A systematic review and meta-analysis.2023Echocardiography
Treatment options for patients with human epidermal growth factor 2-positive breast cancer brain metastases: A systematic review and meta-analysis.2023Frontiers in Oncology
Treatment-related adverse events associated with HER2-Targeted antibody-drug conjugates in clinical trials: a systematic review and meta-analysis.2023EClinicalMedicine
Axillary downstaging and the impact of clinical axillary status on efficacy of neoadjuvant therapy for HER2-positive breast cancer: a network meta-analysis.2023Technology in Cancer Research & Treatment
Neoadjuvant treatment with HER2-targeted therapies in HER2-positive breast cancer: a systematic review and network meta-analysis.2022Cancers
Effectiveness and cost-effectiveness of trastuzumab emtansine in women with HER2-positive locally advanced or metastatic breast cancer: a systematic review and meta-analysis.2022Journal of Cancer Research and Therapeutics
Systemic Therapy for Patients with HER2-Positive Breast Cancer and Brain Metastases: A Systematic Review and Meta-Analysis. 2022Cancers
Incidence and risk of severe adverse events associated with trastuzumab emtansine (T-DM1) in the treatment of breast cancer: an up-to-date systematic review and meta-analysis of randomized controlled clinical trials. 2022Expert Review of Clinical Pharmacology
T-DM1 efficacy in trastuzumab-pertuzumab pre-treated HER2 positive metastatic breast cancer patients: a meta-analysis. 2022BMC Cancer
Trastuzumab biosimilars vs trastuzumab originator in the treatment of HER2-positive breast cancer: a systematic review and network meta-analysis.2022Immunopharmacology and Immunotoxicology
Multiple Bayesian network meta-analyses to establish therapeutic algorithms for metastatic triple negative breast cancer.2022Cancer Treatment Reviews
The adverse effects of trastuzumab-containing regimes as a therapy in breast cancer: A piggy-back systematic review and meta-analysis.2022PLoS One
Lapatinib and lapatinib plus trastuzumab therapy versus trastuzumab therapy for HER2 positive breast cancer patients: an updated systematic review and meta-analysis.2022Systematic Reviews
Cardiotoxicity in cancer patients treated with chemotherapy: A systematic review.2022International Journal of Health Sciences
Safety of trastuzumab deruxtecan: A meta-analysis and pharmacovigilance study.2022Journal of Clinical Pharmacy and Therapeutics
Efficacy and safety of PI3K/Akt/mTOR inhibitors combined with trastuzumab therapy for HER2-positive breast cancer: a meta-analysis.2022European Review for Medical and Pharmacological Sciences
Pertuzumab combined with trastuzumab compared to trastuzumab in the treatment of HER2-positive breast cancer: A systematic review and meta-analysis of randomized controlled trials.2022Frontiers in Oncology
Trastuzumab combined chemotherapy for the treatment of HER2-positive advanced gastric cancer: A systematic review and meta-analysis of randomized controlled trial.2022Medicine
Insights on the molecular targets of cardiotoxicity induced by anticancer drugs: A systematic review based on proteomic findings.2022Metabolism
A systematic review and meta-analysis of beta-blockers and renin-angiotensin system inhibitors for preventing left ventricular dysfunction due to anthracyclines or trastuzumab in patients with breast cancer.2022European Heart Journal
Determining the optimal (neo)adjuvant regimen for human epidermal growth factor receptor 2-positive breast cancer regarding survival outcome: a network meta-analysis.2022Frontiers in Immunology
Genetic and RNA-related molecular markers of trastuzumab-chemotherapy-associated cardiotoxicity in HER2 positive breast cancer: a systematic review.2022BMC Cancer
Adjuvant and neoadjuvant breast cancer treatments: A systematic review of their effects on mortality.2022Cancer Treatment Reviews
Survival after neoadjuvant therapy with trastuzumab-lapatinib and chemotherapy in patients with HER2-positive early breast cancer: a meta-analysis of randomized trials.2022ESMO Open
Efficacy of second-line treatments for patients with advanced human epidermal growth factor receptor 2 positive breast cancer after trastuzumab-based treatment: a systematic review and Bayesian network analysis.2021Journal of Cancer
Assessment of racial differences in the incidence of thrombocytopenia induced by trastuzumab emtansine: a systematic review and meta-analysis. 2021Annals of Translational Medicine
Efficacy of tucatinib for HER2-positive metastatic breast cancer after HER2-targeted therapy: a network meta-analysis.2021Future Oncology
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-analysis.2021Frontiers in Oncology
Prolonged responses with trastuzumab emtasine treatment of human epidermal growth factor receptor 2-positive metastatic breast cancer refractory to trastuzumab and pertuzumab: systematic review of evidence.2021Clinical Breast Cancer
Docetaxel and bevacizumab with or without trastuzumab as first-line treatment for patients with metastatic breast cancer: a meta-analysis.2021European Review for Medical and Pharmacological Sciences
Treatment outcomes among human epidermal growth factor receptor 2 positive breast cancer patients: A systematic review.2021Journal of Oncology Pharmacy Practice
Efficacy and safety of anti-HER2 agents in combination with chemotherapy for metastatic her2-positive breast cancer patient: a network meta-analysis.2021Frontiers in Oncology
Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials.2021The Lancet Oncology
Use of trastuzumab in treating breast cancer during pregnancy: a systematic review and meta-analysis.2021BMC Women’s Health
6 versus 12 months of adjuvant trastuzumab in HER2+ early breast cancer: A systematic review and meta-analysis.2021Medicine
Methodological quality evaluation of systematic reviews or meta-analysis of trastuzumab-based therapy for breast cancer: A systematic review.2021Medicine
The efficacy and safety of additional anti-HER2-targeting drugs in the treatment of her2-positive advanced breast cancer: a meta-analysis.2021Anticancer Agents in Medicinal Chemistry
Dual HER2 blockade in neoadjuvant treatment of HER2+ breast cancer: a meta-analysis and review.2020Technology in Cancer Research & Treatment
A network meta-analysis on the efficacy of HER2-targeted agents in combination with taxane-containing regimens for treatment of HER2-positive metastatic breast cancer.2020Breast Cancer
Benefits of adjuvant treatment including trastuzumab in HER2-positive pT1a-bN0M0 breast cancer: a systematic review and meta-analysis. 2020Annals of Translational Medicine
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 Trials.2020Journal of Oncology
Evaluating the clinical effectiveness and safety of various HER2-targeted regimens after prior taxane/trastuzumab in patients with previously treated, unresectable, or metastatic HER2-positive breast cancer: a systematic review and network meta-analysis.2020Breast Cancer Research and Treatment
Six months vs. 12 months of adjuvant trastuzumab among women with HER2-positive early-stage breast cancer: a meta-analysis of randomized controlled trials. 2020Frontiers in Oncology
Regimens of neo-adjuvant chemotherapy in the treatment of breast cancer: A systematic review & network meta-analysis with PRISMA-NMA compliance.2020Critical Reviews in Oncology/Hematology
Do all patients with HER2 positive breast cancer require one year of adjuvant trastuzumab? A systematic review and meta-analysis.2020Breast
Targeted neoadjuvant therapy in the HER-2-positive breast cancer patients: a systematic review and meta-analysis.2019OncoTargets and Therapy
One year versus a shorter duration of adjuvant trastuzumab for HER2-positive early breast cancer: a systematic review and meta-analysis.2019Breast Cancer Research and Treatment
Comparative efficacy of adjuvant trastuzumab-containing chemotherapies for patients with early HER2-positive primary breast cancer: a network meta-analysis.2019Breast Cancer Research and Treatment
Optimal duration of adjuvant trastuzumab in treatment of early breast cancer: a meta-analysis of randomized controlled trials.2019Breast Cancer Research and Treatment
Short-duration versus 1-year adjuvant trastuzumab in early HER2 positive breast cancer: A meta-analysis of randomized controlled trials.2019Cancer Treatment Reviews
Disease-free survival as a surrogate for overall survival in patients with HER2-positive, early breast cancer in trials of adjuvant trastuzumab for up to 1 year: a systematic review and meta-analysis.2019The Lancet Oncology
Trastuzumab biosimilar in metastatic breast cancer: Evaluating equivalence with originator using network meta-analysis.2019International Journal of Clinical Pharmacology and Therapeutics
Clinical efficacy of combination of pertuzumab, trastuzumab, and docetaxel for treatment of patients with HER2-positive breast cancer.2019Medicine
Adjuvant trastuzumab regimen for HER2-positive early-stage breast cancer: a systematic review and meta-analysis.2019Expert Review of Clinical Pharmacology
Effectiveness of Added Targeted Therapies to Neoadjuvant Chemotherapy for Breast Cancer: A Systematic Review and Meta-analysis.2019Clinical Breast Cancer

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