Supervisors info:
Χαρά Κανή, Διδάκτωρ, Ιατρική Σχολή, ΕΚΠΑ
Ηλίας Κοττέας, Αναπληρωτής Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Κωνσταντίνος Ν. Συρίγος, Καθηγητής, Ιατρική Σχολή ΕΚΠΑ
Summary:
Background: About 15%-20% of breast cancer cases are HER-2 positive. Targeted therapies, such as trastuzumab, are available for treating HER-2 positive breast cancer.
Aim: The aim of this study was to evaluate the efficacy and safety of drugs used as adjuvant therapy for HER-2 positive breast cancer. Specifically, it compared trastuzumab plus chemotherapy versus chemotherapy alone or in combination with pertuzumab.
Methods: Randomized clinical trials were searched in these databases: PubMed, The Cochrane Library και Clinical Trials. Data were extracted in order to conduct the meta-analysis, risk of bias was assessed and the outcomes were evaluated based on the GRADE system. The outcomes studied were disease-free survival (DFS), overall survival (OS) and cardiovascular adverse events (CAEs).
Results: A total of 10 studies were included in this study, of which 6 referred to adjuvant therapy and 4 to neo-adjuvant therapy. In the meta-analysis for the adjuvant therapy, the hazard ratio (HR) value for DFS was 0.70 [95% CI, 0.63, 0.77] and the HR value for OS was 0.69 [95% CI, 0.64, 0.76], whereas for the neo-adjuvant therapy the HR value for DFS was 1.13 [95% CI, 0.34, 3.73]. Overall, for both adjuvant and neo-adjuvant therapies, the HR value for DFS was 0.71 [95% CI), 0.63, 0.80] and the HR value for OS was 0.69 [95% CI, 0.64, 0.75]. Regarding safety (CAEs), the odds ratio (OR) value for the adjuvant therapy was 2.45 [95% CI, 1.43, 4.22] , for the neo-adjuvant therapy was 0.95 [95% CI, 0.35, 2.58] and overall was 1.92 [95% CI, 1.20, 3.09].
Conclusion: The combination of trastuzumab with chemotherapy appears to be more effective than chemotherapy alone. However, further investigation is needed regarding safety due to an increased incidence of cardiovascular adverse events.
Keywords:
Trastuzumab, Safety, Efficacy, HER-2 positive breast cancer
