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27 results on '"S.M. Tolaney"'

5. 7P Independent validation of HER2DX ERBB2 mRNA score to predict HER2-positive (HER2+), HER2-low and HER2-0 status in breast cancer

Author

E. Sanfeliu Torres, G. Villacampa, T. Pascual, M. Oliveira, M.J. Vidal Losada, M. Bellet-Ezquerra, B. Gonzalez-Farre, J.A. Puig-Butille, P. Jares, S. Pernas Simon, C. Bueno Muiño, M. Martin Jimenez, P. Tarantino, A.G. Waks, E.A. Mittendorf, S.M. Tolaney, J. Cortés, A. Llombart Cussac, A. Prat, and F. Brasó-Maristany

Subjects
Cancer Research, Oncology
Published
2023

8. 126MO HER2DX and pathological complete response in HER2-positive breast cancer: A combined analysis of 4 neoadjuvant studies

Author

A.G. Waks, G. Villacampa, L. Pare Brunet, N.M. Tung, C. Bueno Muiño, I. Echavarria Diaz-Guardamino, S. Lopez-Tarruella Cobo, M. Marín-Aguilera, F. Brasó-Maristany, T. Pascual, O. Martinez Saez, A.C. Wolff, A. Demichele, C.M. Perou, A. Fernandez-Martinez, L.A. Carey, E.A. Mittendorf, M. Martin Jimenez, A. Prat, and S.M. Tolaney

Subjects
Cancer Research, Oncology
Published
2023

20. 272TiP HARMONIA SOLTI-2101 / AFT-58: A head-to-head phase III study comparing ribociclib (RIB) and palbociclib (PAL) in patients (pts) with hormone receptor-positive/HER2-negative/HER2-enriched (HR+/HER2-/HER2-E) advanced breast cancer (ABC)

Author

T. Pascual, D.G. Stover, A. Thuerigen, C.M. Perou, E.M. Ciruelos, A. Casas Fernandez Tejerina, P. Spears, E. Roux, H. Hu, Y-S. Lu, S.M. Tolaney, A. Partridge, G. Villacampa Javierre, J.M. Ferrero Cafiero, L. Carey, and A. Prat

Subjects
Oncology, Hematology
Published
2022

24. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study

Author

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, 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, and Vall d'Hebron Barcelona Hospital Campus

Subjects
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
Abstract

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).

Published
2021

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