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37 results on '"H.S. Rugo"'

2. Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase III trial

Author

C.E. Geyer, W.M. Sikov, J. Huober, H.S. Rugo, N. Wolmark, J. O’Shaughnessy, D. Maag, M. Untch, M. Golshan, J. Ponce Lorenzo, O. Metzger, M. Dunbar, W.F. Symmans, P. Rastogi, J.H. Sohn, R. Young, G.S. Wright, C. Harkness, K. McIntyre, D. Yardley, and S. Loibl

Subjects
Oncology, Hematology
Published
2022

3. First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis

Author

L.A. Emens, S. Adams, C.H. Barrios, V. Diéras, H. Iwata, S. Loi, H.S. Rugo, A. Schneeweiss, E.P. Winer, S. Patel, V. Henschel, A. Swat, M. Kaul, L. Molinero, S.Y. Chui, and P. Schmid

Subjects
0301 basic medicine, medicine.medical_specialty, Paclitaxel, Population, Triple Negative Breast Neoplasms, Antibodies, Monoclonal, Humanized, Placebo, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Atezolizumab, Interquartile range, Albumins, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, education, Triple-negative breast cancer, education.field_of_study, business.industry, Hazard ratio, Hematology, medicine.disease, Survival Analysis, Confidence interval, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, business
Abstract

Background Guidelines recommend atezolizumab plus nab-paclitaxel (A + nP) for first-line treatment of unresectable, locally advanced, or metastatic triple-negative breast cancer expressing programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (IC), based on IMpassion130. We report the final overall survival (OS) and safety of that study as per the prespecified analysis plan. Patients and methods Patients were randomized to nP 100 mg/m2 (days 1, 8, and 15 of a 28-day cycle) with atezolizumab 840 mg (A + nP) or placebo (P + nP; days 1 and 15), until progression or unacceptable toxicity. Coprimary endpoints were progression-free survival [intention-to-treat (ITT) and PD-L1 IC-positive populations] and OS (tested hierarchically in the ITT population and, if significant, in the PD-L1 IC-positive population). Results Each arm comprised 451 patients; 666 (73.8%) had died by the final OS analysis cut-off (median follow-up, 18.8 months; interquartile range, 8.9-34.7 months). Median OS in the ITT population was 21.0 months [95% confidence interval (CI), 19.0-23.4 months] with A + nP, and 18.7 months (95% CI, 16.9-20.8 months) with P + nP [stratified hazard ratio (HR), 0.87; 95% CI, 0.75-1.02; P = 0.077]. Exploratory analysis in the PD-L1 IC-positive population showed a median OS of 25.4 months (95% CI, 19.6-30.7 months) with A + nP (n = 185) and 17.9 months (95% CI, 13.6-20.3 months) with P + nP (n = 184; stratified HR, 0.67; 95% CI, 0.53-0.86). Safety outcomes were consistent with previous analyses and the known toxicity profiles of each agent. Immune-mediated adverse events of special interest were reported in 58.7% and 41.6% of patients treated with A + nP and P + nP, respectively. Conclusion Although the OS benefit in the ITT population was not statistically significant, precluding formal testing, clinically meaningful OS benefit was observed with A + nP in PD-L1 IC-positive patients, consistent with prior interim analyses. This combination remained safe and tolerable with longer follow-up.

Published
2021

9. 185O Trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): A detailed safety analysis of the randomized, phase III DESTINY-Breast04 trial

Author

H.S. Rugo, W. Jacot, E. Tokunaga, J. Sohn, F. Cardoso, B. Xu, M.J. Vidal Losada, M.J. Gil, N.T. Ueno, A. Prat, H. Moore, U. Hasler-Strub, D.A.A. Cameron, H. Lindman, K. Mezei, R. Rajagopalan, C.M.A. Orbegoso, F-C. Cheng, A. Puri, and S. Modi

Subjects
Cancer Research, Oncology
Published
2023

14. 217O Patient-reported outcomes (PROs) from DESTINY-Breast04, a randomized phase III study of trastuzumab deruxtecan (T-DXd) vs treatment of physician's choice (TPC) in patients (pts) with HER2-low metastatic breast cancer (MBC)

Author

N.T. Ueno, W. Jacot, T. Yamashita, J. Sohn, E. Tokunaga, A. Prat, J. Tsurutani, Y.H. Park, H.S. Rugo, B. Xu, F. Cardoso, Z. Mitri, R. Mahtani, K. Dunton, Y. Wang, D. Gambhire, F. Cottone, N. Harbeck, D.A. Cameron, and S. Modi

Subjects
Oncology, Hematology
Published
2022

18. 274TiP Datopotamab deruxtecan (Dato-DXd), a TROP2 antibody-drug conjugate, vs investigators’ choice of chemotherapy (ICC) in previously-treated, inoperable or metastatic hormone-receptor (HR) positive, HER2-negative (HR+/HER2–) breast cancer: TROPION-Breast01

Author

A. Bardia, K. Kalinsky, J. Tsurutani, E.P. Hamilton, S. Johnston, J. Sohn, K.H. Park, Y.H. Park, S-A. Im, K.S. Lee, D. Dastur, V. Haddad, S. Khan, B. Xu, B. Pistilli, and H.S. Rugo

Subjects
Oncology, Hematology
Published
2022

22. 164O Health-related quality of life (HRQoL) with pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) + chemo as 1L treatment for advanced triple-negative breast cancer (TNBC): Results from KEYNOTE-355

Author

D.W. Cescon, P. Schmid, H.S. Rugo, S-A. Im, M. Md Yusof, C.E. Gallardo, O. Lipatov, C.H. Barrios, J.M. Perez Garcia, H. Iwata, N. Masuda, M.A. Torregroza Otero, E. Gokmen, S. Loi, A. Haiderali, X. Zhou, Z. Guo, A. Martin Nguyen, and J. Cortés

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

29. Corrigendum to ‘First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis’

Author

L.A. Emens, S. Adams, C.H. Barrios, V. Diéras, H. Iwata, S. Loi, H.S. Rugo, A. Schneeweiss, E.P. Winer, S. Patel, V. Henschel, A. Swat, M. Kaul, L. Molinero, S.Y. Chui, and P. Schmid

Subjects
Oncology, medicine.medical_specialty, business.industry, First line, Locally advanced, Hematology, medicine.disease, Breast cancer, Atezolizumab, Internal medicine, Overall survival, Medicine, business, Triple-negative breast cancer, Nab-paclitaxel
Abstract

The authors regret that in the title and throughout the text the term “unresectable, locally advanced, or metastatic triple-negative breast cancer” should have been given as “unresectable locally advanced or metastatic triple-negative breast cancer”. The correct title is as now given above. Similarly, for “unresectable, locally advanced, or metastatic TNBC” read “unresectable locally advanced or metastatic TNBC”. The authors would like to apologise for any inconvenience caused.

Published
2021

31. PCN491 PATIENT REPORTED OUTCOMES (PRO) OF TALAZOPARIB (TALA) VERSUS PHYSICIAN'S CHOICE OF CHEMOTHERAPY (PCT) IN PATIENTS (PTS) WITH ADVANCED BREAST CANCER (ABC) AND A GERMLINE BRCA (GBRCA) MUTATION: A FOCUS ON EMBRACA PTS WITH/ WITHOUT PRIOR CHEMOTHERAPY (CT) SUBGROUPS

Author

H. Bhattacharyya, R.G.W. Quek, Sara A. Hurvitz, A. Goncalves, H.S. Rugo, and Johannes Ettl

Subjects
Oncology, Chemotherapy, medicine.medical_specialty, business.industry, Health Policy, Advanced breast, medicine.medical_treatment, Public Health, Environmental and Occupational Health, Cancer, medicine.disease, Germline, chemistry.chemical_compound, chemistry, Internal medicine, Mutation (genetic algorithm), Talazoparib, Medicine, In patient, business
Published
2019

33. Iniparib

Author

J. Li, A. Glencer, and H.S. Rugo

Subjects
Pharmacology, Pharmacology (medical)
Published
2012

35. O-102 Results of a phase 2 study of the oral tyrosine kinase inhibitor (TKI): axitinib (AG-013736; AG) in combination with docetaxel (DOC) vs DOC plus placebo (PL) in first-line metastatic breast cancer (MBC)

Author

Sunil Verma, A.A. Joy, D. Soulieres, K. F. Liau, Paul Bycott, H.S. Rugo, Stephen L. Chan, Sinil Kim, A. Stopeck, and Ana Lluch

Subjects
Oncology, Cancer Research, medicine.medical_specialty, business.industry, medicine.drug_class, First line, Phases of clinical research, medicine.disease, Placebo, Metastatic breast cancer, Tyrosine-kinase inhibitor, Axitinib, Docetaxel, Internal medicine, medicine, business, medicine.drug
Published
2007

36. 2103 ORAL A randomized, double-blind phase 2 study of the oral tyrosine kinase inhibitor (TKI) axitinib (AG-013736; AG) in combination with docetaxel (DOC) vs DOC plus placebo (PL) in first-line metastatic breast cancer (MBC)

Author

Stephen L. Chan, D. Soulieres, Sunil Verma, A.A. Joy, H.S. Rugo, A. Stopeck, F.K. Liau, Sinil Kim, Paul Bycott, and A. Lluch

Subjects
Oncology, Cancer Research, medicine.medical_specialty, business.industry, medicine.drug_class, First line, Phases of clinical research, medicine.disease, Placebo, Metastatic breast cancer, Tyrosine-kinase inhibitor, Double blind, Axitinib, Docetaxel, Internal medicine, medicine, business, medicine.drug
Published
2007

37. SU11248 (sunitinib malate) therapy in patients with refractory metastatic breast cancer: preliminary safety and efficacy results from a phase II study

Author

H.S. Rugo, K.D. Miller, Peter D. Eisenberg, Anthony D. Elias, Bonne J. Adams, Antonio C. Wolff, Burstein, Charles M. Baum, M.A. Cobleigh, and M. Collier

Subjects
Oncology, Cancer Research, medicine.medical_specialty, business.industry, Phases of clinical research, Sunitinib malate, medicine.disease, Metastatic breast cancer, Refractory, Internal medicine, medicine, In patient, business
Published
2006

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