Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study
| Autor: | N. Harbeck, P. Rastogi, M. Martin, S.M. Tolaney, Z.M. Shao, P.A. Fasching, C.S. Huang, G.G. Jaliffe, A. Tryakin, M.P. Goetz, H.S. Rugo, E. Senkus, L. Testa, M. Andersson, K. Tamura, L. Del Mastro, G.G. Steger, H. Kreipe, R. Hegg, J. Sohn, V. Guarneri, J. Cortés, E. Hamilton, V. André, R. Wei, S. Barriga, S. Sherwood, T. Forrester, M. Munoz, A. Shahir, B. San Antonio, S.C. Nabinger, M. Toi, S.R.D. Johnston, J. O’Shaughnessy, M.M. Jimenez, S. Johnston, F. Boyle, P. Neven, Z. Jiang, M. Campone, J. Huober, C. Shimizu, I. Cicin, A. Wardley, G.G. Abuin, J. Zarba, E. Lim, P. Sant, N. Liao, B. Christiansen, N. Eigeliene, J. Martin-Babau, J. Ettl, D. Mavroudis, J. Chiu, K. Boer, R. Nagarkar, S. Paluch-Shimon, L. Moscetti, Y. Sagara, S.-B. Kim, M.M. Maciel, V. Tjan-Heijnen, R. Broom, A. Lacko, M. Schenker, N. Volkov, Y. Sim Yap, M. Coccia-Portugal, J. Ángel García Sáenz, A. Andersson, T.-Y. Chao, E. Gokmen, H. Harputluoglu, O. Berzoy, D. Patt, H. McArthur, H. Chew, P. Chalasani, P. Kaufman, K. Tedesco, S.L. Graff |
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| Přispěvatelé: | Institut Català de la Salut, [Harbeck N] Breast Center, Department of OB & GYN and CCC Munich, LMU University Hospital, Munich, Germany. [Rastogi P] University of Pittsburgh/UPMC, NSABP Foundation, Pittsburgh, USA. [Martin M] Hospital General Universitario Gregorio Marañon, Universidad Complutense, CIBERONC, GEICAM, Madrid, Spain. [Tolaney SM] Dana-Farber Cancer Institute, Boston, USA. [Shao ZM] Fudan University Shanghai Cancer Center, Shanghai, China. [Fasching PA] University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany. [Cortés J] International Breast Cancer Center (IBCC), Madrid & Barcelona. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine, Madrid, Spain, Vall d'Hebron Barcelona Hospital Campus |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Oncology
Receptor ErbB-2 abemaciclib adjuvant CDK4/6 early breast cancer Ki-67 Aminopyridines Antineoplastic Combined Chemotherapy Protocols Benzimidazoles Chemotherapy Adjuvant Disease-Free Survival Female Humans Ki-67 Antigen Neoplasm Recurrence Local Breast Neoplasms medicine.medical_treatment Neoplasms::Neoplasms by Site::Breast Neoplasms [DISEASES] Other subheadings::Other subheadings::/drug therapy [Other subheadings] chemistry.chemical_compound Tratamiento médico ErbB-2 Clinical endpoint Other subheadings::/therapeutic use [Other subheadings] Abemaciclib education.field_of_study neoplasias::neoplasias por localización::neoplasias de la mama [ENFERMEDADES] biology terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] Hematology Cáncer medicine.anatomical_structure Local Cohort Neoplasias de la mama Adjuvant Receptor medicine.medical_specialty Axillary lymph nodes Mujer Population Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] Quimioteràpia combinada Internal medicine Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] medicine Chemotherapy education business.industry Otros calificadores::/uso terapéutico [Otros calificadores] Interim analysis Neoplasm Recurrence chemistry Mama - Càncer - Tractament biology.protein business |
| Zdroj: | Scientia ABACUS. Repositorio de Producción Científica Universidad Europea (UEM) |
| Popis: | Abemaciclib; Adjuvant; Early breast cancer Abemaciclib; Adjuvant; Càncer de mama precoç Abemaciclib; Adyuvante; Cáncer de mama precoz Background Adjuvant abemaciclib combined with endocrine therapy (ET) previously demonstrated clinically meaningful improvement in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) in hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer at the second interim analysis, however follow-up was limited. Here, we present results of the prespecified primary outcome analysis and an additional follow-up analysis. Patients and methods This global, phase III, open-label trial randomized (1 : 1) 5637 patients to adjuvant ET for ≥5 years ± abemaciclib for 2 years. Cohort 1 enrolled patients with ≥4 positive axillary lymph nodes (ALNs), or 1-3 positive ALNs and either grade 3 disease or tumor ≥5 cm. Cohort 2 enrolled patients with 1-3 positive ALNs and centrally determined high Ki-67 index (≥20%). The primary endpoint was IDFS in the intent-to-treat population (cohorts 1 and 2). Secondary endpoints were IDFS in patients with high Ki-67, DRFS, overall survival, and safety. Results At the primary outcome analysis, with 19 months median follow-up time, abemaciclib + ET resulted in a 29% reduction in the risk of developing an IDFS event [hazard ratio (HR) = 0.71, 95% confidence interval (CI) 0.58-0.87; nominal P = 0.0009]. At the additional follow-up analysis, with 27 months median follow-up and 90% of patients off treatment, IDFS (HR = 0.70, 95% CI 0.59-0.82; nominal P < 0.0001) and DRFS (HR = 0.69, 95% CI 0.57-0.83; nominal P < 0.0001) benefit was maintained. The absolute improvements in 3-year IDFS and DRFS rates were 5.4% and 4.2%, respectively. Whereas Ki-67 index was prognostic, abemaciclib benefit was consistent regardless of Ki-67 index. Safety data were consistent with the known abemaciclib risk profile. Conclusion Abemaciclib + ET significantly improved IDFS in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer, with an acceptable safety profile. Ki-67 index was prognostic, but abemaciclib benefit was observed regardless of Ki-67 index. Overall, the robust treatment benefit of abemaciclib extended beyond the 2-year treatment period. This work was supported by the sponsor (Eli Lilly and Company) and designed together with the study Executive Committee (no grant number). |
| Databáze: | OpenAIRE |
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