Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer

Autor: Alexey Manikhas, Hans Friedrich Koch, Charuwan Akewanlop, Kakhaber Baramidze, Sirshendu Roy, Gopichand Mamillapalli, Ashwani Marwah, Virote Sriuranpong, Eduardo Yanez Ruiz, Miguel Hernandez-Bronchud, Unmesh Gopalakrishnan, Maria Luisa T. Abesamis-Tiambeng, Guzel Mukhametshina, Abhijit Barve, Joseph D. Parra, Adolfo Fuentes-Alburo, Ihor Vynnychenko, Sarika Deodhar, Gia Nemsadze, Igor Bondarenko, Eduardo J. Pennella, Cornelius F. Waller, Hope S. Rugo, Jay Herson, Subramanian Loganathan
Rok vydání: 2021
Předmět:
0301 basic medicine
Oncology
Cancer Research
Receptor
ErbB-2
ErbB-2
0302 clinical medicine
Trastuzumab
Monoclonal
Antineoplastic Combined Chemotherapy Protocols
Overall survival
skin and connective tissue diseases
Humanized
Cancer
education.field_of_study
Biosimilar
Metastatic breast cancer
Clinical Trial
Treatment Outcome
6.1 Pharmaceuticals
030220 oncology & carcinogenesis
Female
Receptor
medicine.drug
medicine.medical_specialty
Randomization
Clinical Trials and Supportive Activities
Clinical Sciences
Oncology and Carcinogenesis
Population
Breast Neoplasms
Antibodies
Monoclonal
Humanized
Antibodies
03 medical and health sciences
Breast cancer
Clinical Research
Internal medicine
Breast Cancer
medicine
Humans
Oncology & Carcinogenesis
education
Until Disease Progression
neoplasms
Taxane
business.industry
Evaluation of treatments and therapeutic interventions
medicine.disease
Survival Analysis
030104 developmental biology
business
Zdroj: Breast Cancer Research and Treatment
Breast cancer research and treatment, vol 188, iss 2
ISSN: 1573-7217
0167-6806
DOI: 10.1007/s10549-021-06197-5
Popis: Purpose The phase 3 HERITAGE trial demonstrated that the biosimilar trastuzumab-dkst is well tolerated with similar efficacy (measured by overall response rate [ORR] and progression-free survival [PFS]) compared with originator trastuzumab combined with taxane followed by monotherapy in patients with HER2-positive metastatic breast cancer (MBC). Herein, we present final overall survival (OS) from HERITAGE. Methods HERITAGE is a multicenter, double-blind, randomized, parallel-group study. Patients were randomized 1:1 to receive trastuzumab-dkst or trastuzumab plus taxane followed by continued monotherapy until disease progression. Overall survival was to be assessed at 36 months or after 240 deaths, whichever occurred first, as observed from time of randomization of last patient. Results At the final analysis (36 months), 242 patients in the intention-to-treat population had died during the study: 116 and 124 in the trastuzumab-dkst and trastuzumab groups, respectively, and 1 untreated patient from each treatment group. Median OS by Kaplan–Meier analysis was 35.0 months with trastuzumab-dkst and 30.2 months with trastuzumab. Evaluation of PFS showed a median of 11.1 months in both treatment groups. No new safety concerns were reported from week 48 until the end of the survival follow-up. Conclusion This is the first phase 3 trial of a trastuzumab biosimilar to report long-term survival data similar to originator trastuzumab in patients with MBC. The comparable long-term OS between the trastuzumab-dkst and originator trastuzumab groups further supports the similarity of trastuzumab-dkst with originator trastuzumab and establishes trastuzumab-dkst as a safe and effective treatment option for patients with HER2-positive MBC. ClinicalTrials.gov NCT02472964; 6/16/2015
Databáze: OpenAIRE
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