Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer

Triantafyllidi, Eleni; Triantafillidis, John K.

doi:10.3390/biomedicines10082045

Cited by 25 publications

(13 citation statements)

References 73 publications

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“…Real-world findings concur: in a retrospective analysis of 44 patients with HER2-positive early breast cancer, neoadjuvant CT-P6-based treatment was associated with cost savings of €1,474 per patient versus reference trastuzumab, with no difference in efficacy [25]. Lower cost, evidence of long-term clinical equivalence to reference products, and improved education and training are all factors that should influence the future adoption of anti-HER2 biosimilars [26,27].…”

Section: Discussionmentioning

confidence: 92%

Six-Year Survival Outcomes for Patients with HER2-Positive Early Breast Cancer Treated with CT-P6 or Reference Trastuzumab: Observational Follow-Up Study of a Phase 3 Randomised Controlled Trial

et al. 2023

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Background The Phase 3 CT-P6 3.2 study demonstrated equivalent efficacy and comparable safety between CT-P6 and reference trastuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive early breast cancer after up to 3 years' follow-up. Objective To investigate long-term survival with CT-P6 and reference trastuzumab. Methods In the CT-P6 3.2 study, patients with HER2-positive early breast cancer were randomised to neoadjuvant chemotherapy with CT-P6 or reference trastuzumab, surgery, and adjuvant CT-P6 or reference trastuzumab before a 3-year posttreatment follow-up. Patients who completed the study could enter a 3-year extension (CT-P6 4.2 study). Data were collected every 6 months to assess overall survival (OS), disease-free survival (DFS), and progression-free survival (PFS). Results Of 549 patients enrolled in the CT-P6 3.2 study, 216 (39.3%) patients continued in the CT-P6 4.2 study (CT-P6, 107; reference trastuzumab, 109) (intention-to-treat extension set). Median follow-up was 76.4 months for both groups. Medians were not reached for time-to-event parameters; estimated hazard ratios (95% confidence intervals) for CT-P6 versus reference trastuzumab were 0.59 (0.17-2.02) for OS, 1.07 (0.50-2.32) for DFS, and 1.08 (0.50-2.34) for PFS. Corresponding 6-year survival rates in the CT-P6 and reference trastuzumab groups, respectively, were 0.

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Section: Discussionmentioning

confidence: 92%

Six-Year Survival Outcomes for Patients with HER2-Positive Early Breast Cancer Treated with CT-P6 or Reference Trastuzumab: Observational Follow-Up Study of a Phase 3 Randomised Controlled Trial

et al. 2023

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“…In addition, disruption of antibody-drug conjugates (ADCs) and other agents targeting HER2 has resulted in numerous clinical trials with promising results[ 42 ]. Trastuzumab can be combined either with fluoropyrimidine and a platinum agent or in combination with capecitabine + oxaliplatin (XELOX)/PF[ 43 ]. In HER2-negative patients, treatment regimens include nivolumab, cindilimab, and tislelizumab in combination with first-line chemotherapy.…”

Section: Treatment Modalitiesmentioning

confidence: 99%

Immunotherapy of gastric cancer: Present status and future perspectives

Triantafillidis,

Konstadoulakis,

Papalois

2024

World J Gastroenterol

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In this editorial, we comment on the article entitled “Advances and key focus areas in gastric cancer immunotherapy: A comprehensive scientometric and clinical trial review (1999-2023),” which was published in the recent issue of the World Journal of Gastroenterology . We focused on the results of the authors’ bibliometric analysis concerning gastric cancer immunotherapy, which they analyzed in depth by compiling the relevant publications of the last 20 years. Before that, we briefly describe the most recent data concerning the epidemiological parameters of gastric cancer (GC) in different countries, attempting to give an interpretation based on the etiological factors involved in the etiopathogenesis of the neoplasm. We then briefly discuss the conservative treatment (chemotherapy) of the various forms of this malignant neoplasm. We describe the treatment of resectable tumors, locally advanced neoplasms, and unresectable (advanced) cases. Special attention is given to modern therapeutic approaches with emphasis on immunotherapy, which seems to be the future of GC treatment, especially in combination with chemotherapy. There is also a thorough analysis of the results of the study under review in terms of the number of scientific publications, the countries in which the studies were conducted, the authors, and the scientific centers of origin, as well as the clinical studies in progress. Finally, an attempt is made to draw some con-clusions and to point out possible future directions.

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“…Several trastuzumab (±pertuzumab) biosimilars have been approved for use in HER2+ BC. 31 Benefits include the option of subcutaneous administration in some cases, which is quicker and convenient, as well as reduced costs for patients and oncology infusion centers. 32 However, widespread adoption has been slow, due to concerns regarding efficacy and insurance issues.…”

Section: Her2-targeted Therapiesmentioning

confidence: 99%

Standard-of-Care Treatment for HER2+ Metastatic Breast Cancer and Emerging Therapeutic Options

Premji,

O’Sullivan

2024

Breast Cancer�(Auckl)

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Prior to the advent of the HER2-targeted monoclonal antibody trastuzumab, HER2+ breast cancer (BC) was considered an aggressive disease with a poor prognosis. Over the past 25 years, innovations in molecular biology, pathology, and early therapeutics have transformed the treatment landscape. With the advent of multiple HER2-directed therapies, there have been immense improvements in oncological outcomes in both adjuvant and metastatic settings. Currently, 8 HER2-targeted therapies are approved by the Food and Drug Administration (FDA) for the treatment of early-stage and/or advanced/metastatic disease. Nonetheless, approximately 25% of patients develop recurrent disease or metastasis after HER2-targeted therapy and most patients with HER2+ metastatic breast cancer (MBC) die from their disease. Given the many mechanisms of resistance to HER2-directed therapy, there is a pressing need to further personalize care for patients with HER2+ MBC, by the identification of reliable predictive biomarkers, and the development of novel therapies and combination regimens to overcome therapeutic resistance. Of particular interest are established and novel antibody-drug conjugates, as well as other novel therapeutics and multifaceted approaches to harness the immune system (checkpoint inhibitors, bispecific antibodies, and vaccine therapy). Herein, we discuss standard-of-care treatment of HER2+ MBC, including the management of breast cancer brain metastases (BCBM). Furthermore, we highlight novel treatment approaches for HER2+ MBC, including endeavors to personalize therapy, and discuss ongoing controversies and challenges.

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Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer

Cited by 25 publications

References 73 publications

Six-Year Survival Outcomes for Patients with HER2-Positive Early Breast Cancer Treated with CT-P6 or Reference Trastuzumab: Observational Follow-Up Study of a Phase 3 Randomised Controlled Trial

Six-Year Survival Outcomes for Patients with HER2-Positive Early Breast Cancer Treated with CT-P6 or Reference Trastuzumab: Observational Follow-Up Study of a Phase 3 Randomised Controlled Trial

Immunotherapy of gastric cancer: Present status and future perspectives

Standard-of-Care Treatment for HER2+ Metastatic Breast Cancer and Emerging Therapeutic Options

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