Background: Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. WSG-AGO epiribicine and cyclophosphamide (EC)-Doc is a large trial evaluating modern taxane-based chemotherapy in patients with 1-3 positive lymph nodes (LNs) only.
Patients And Methods: A total of 2011 BC patients (18-65 years, pN1) were entered into a randomized phase III trial comparing 4 × E90C600 q3w followed by 4 × docetaxel 100 q3w (n = 1008) with the current standard: 6 × F500E100C500 q3w (n = 828) or C600M40F600 d1, 8× q4w (n = 175). Primary end point was event-free survival (EFS); secondary end points were overall survival (OS), toxicity, translational research, and quality of life. Central tumor bank samples were evaluable in a representative collective (n = 772; 40%). Ki-67 was assessed centrally in hormone receptor-positive disease as a surrogate marker for the distinction of luminal A/B-like tumors.
Results: Baseline characteristics were well balanced between study arms in both main study and central tumor bank subset. At 59-month median follow-up, superior efficacy of EC-Doc [versus FEC (a combination of 5-fluorouracil, epirubicin, and cyclophosphamide)] was seen in EFS and OS: 5-year EFS: 89.8% versus 87.3% (P = 0.038); 5-year OS: 94.5% versus 92.8% (P = 0.034); both tests one-tailed. EC-Doc caused more toxicity. In hormone receptor-positive (HR)+ disease, only high-Ki-67 tumors (≥ 20%) derived significant benefit from taxane-based therapy: hazard ratio = 0.39 (95% CI 0.18-0.82) for EC-Doc versus FEC (test for interaction; P = 0.01).
Conclusion: EC-Doc significantly improved EFS and OS versus FEC in intermediate-risk BC (1-3 LNs) within all subgroups as defined by local pathology. In HR+ disease, patients with luminal A-like tumors may be potentially over-treated by taxane-based chemotherapy.
Clinical Trial Number: ClinicalTrials.gov, NCT02115204.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1093/annonc/mdu186 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Effect of single-pill versus free equivalent combinations on persistence and major adverse cardiovascular events in hypertension: a real-world analysis.
J Hypertens
December 2024
Metabolic Centre, South-Buda Centrum Hospital - St. Imre University Teaching Hospital, Budapest, Hungary.
Objectives: Hypertension guidelines recommend the use of single-pill combinations (SPCs) of antihypertensive drugs to improve treatment persistence and blood pressure control. This study aimed to investigate the long-term effects of ramipril/amlodipine (R/A) SPC versus free equivalent dose combinations (FEC) on cardiovascular outcomes and treatment persistence.
Methods: This retrospective, observational study analysed the database of the Hungarian National Health Insurance Fund.
Inappropriate Therapy and Shock Rates Between the Subcutaneous and Transvenous Implantable Cardiac Defibrillator: A Secondary Analysis of the PRAETORIAN Trial.
Circ Arrhythm Electrophysiol
December 2024
Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.).
Article Synopsis
- Inappropriate therapy (IAT) is a significant issue associated with implantable cardiac defibrillator (ICD) therapy, particularly highlighted in early subcutaneous ICD (S-ICD) studies which showed high rates of inappropriate shocks (IAS).
- The PRAETORIAN trial, an international study with 849 patients, found no major differences in IAT and IAS rates between S-ICD and transvenous ICD (TV-ICD) groups, as both groups had similar cumulative incidences.
- Key predictors for IAT varied between the two groups, with TV-ICD patients experiencing IAT mainly from supraventricular tachycardias, while S-ICD patients faced issues from cardiac oversensing
Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial.
Circ Cardiovasc Qual Outcomes
November 2024
Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).
Article Synopsis
- The S-ICD was created to eliminate lead-related issues found in the TV-ICD, as it is an external device that sits under the skin rather than using leads inside the body.
- This analysis comes from the PRAETORIAN trial, where patients were randomly assigned to either S-ICD or TV-ICD and assessed for quality of life through various questionnaires at different stages.
- Results showed no significant differences in physical and mental well-being between the groups, but patients who experienced a shock recently reported lower social functioning and emotional health compared to those who did not.
Cost-effectiveness analysis of levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg versus other long-acting reversible contraceptives for contraception in Spain.
Eur J Contracept Reprod Health Care
October 2024
Departamento de Market Access, Bayer Hispania S.L, Sant Joan Despí, Barcelona, Spain.
Introduction: Condoms and combined oral contraceptive pills are widely used in Spain with high failure rates. Long-Acting Reversible Contraceptive (LARC) methods offer better efficacy and adherence and reduce unintended pregnancies (UP) compared with short-acting reversible contraceptive (SARC) methods.
Objective: To assess the cost-effectiveness of LNG-IUS 52 mg (Mirena) versus other LARC for contraception in Spain.
Cost-effectiveness analysis comparing single-pill combination of perindopril/amlodipine/indapamide to the free equivalent combination in patients with hypertension from an Italian national health system perspective.
Expert Rev Pharmacoecon Outcomes Res
October 2024
Zebgene LLC, Malvern, PA, USA.
Objective: To evaluate the cost-effectiveness of a single-pill combination (SPC) of perindopril/amlodipine/indapamide versus its free equivalent combination (FEC) in adults with hypertension in Italy.
Methods: A Markov model was developed to perform a cost-utility analysis with a lifetime horizon and an Italian healthcare payer's perspective. In the model, the additional effect of the SPC on blood pressure level compared with the FEC was translated into a decreased risk of cardiovascular events and CKD, which was modeled via Framingham risk algorithms.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!