Found 2 Presentations For Request "Abs: 176P"
176P - Germline mutation status and therapy response in patients with homologous recombination deficient, HER2-negative early breast cancer: Results of the GeparOLA study (NCT02789332)
- Jan Hauke (Köln, Germany)
Abstract
Background
The phase II GeparOla study randomized patients (pts) with homologous recombination deficient (HRD), HER2-negative early breast cancer (BC) to receive neoadjuvant treatment with paclitaxel 80 mg/m2 iv weekly plus olaparib tablets 100 mg (PO) twice daily for 12 weeks or paclitaxel plus carboplatin AUC 2 iv (PCb) weekly for 12 weeks (PCb) prior to epirubicin/cyclophosphamide (EC). We determined pathological complete response (pCR, ypT0/is ypN0) according to treatment arm and germline mutation status.
Methods
HRD was determined centrally for all pts using the myChoice®
Results
68 pts received PO and 37 PCb. The pCR rates were 53.3% overall (56/105), 55.9% in the PO arm (38/68) and 48.6% in the PCb arm (18/37). We identified pathogenic
Conclusions
Even in pts with HRD tumours, germline
Clinical trial identification
NCT02789332.
Legal entity responsible for the study
GBG Forschungs GmbH.
Funding
AstraZeneca; Köln Fortune Program, Faculty of Medicine, University of Cologne, Germany.
Disclosure
P.A. Fasching: Honoraria (self), Lectures: Amgen; Honoraria (self), Advisory/Consultancy, Advisory Board: Roche; Research grant/Funding (self), Research grant/Funding (institution), Research Support: BionTech; Honoraria (self), Advisory/Consultancy, Advisory Board: Pfizer; Honoraria (self), Advisory/Consultancy, Advisory Board: Celgene; Honoraria (self), Lectures: Daiichi-Sankyo; Honoraria (self), Advisory/Consultancy, Advisory Board, Lectures: Merck Sharp&Dohme; Honoraria (self), Advisory/Consultancy, Advisory Board: Macrogenics; Honoraria (self), Advisory/Consultancy, Advisory Board: Eisai; Research grant/Funding (institution), Research Support: Cepheid; Honoraria (institution), Advisory/Consultancy, Advisory Board, Lectures: Lilly; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Research Support, Advisory Board: Novartis; Honoraria (self), Advisory/Consultancy, Advisory Board: AstraZeneca. C. Jackisch: Honoraria (self): AstraZeneca; Honoraria (self): Roche. K.E. Rhiem: Honoraria (self): AstraZeneca; Honoraria (self): Tesaro; Honoraria (self): Pfizer. J. Huober: Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Travel/Accommodation/Expenses: Roche; Honoraria (self): Lilly; Honoraria (self): Celgene; Honoraria (self), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self): MSD; Honoraria (self): AbbVie; Honoraria (self): Eisai; Research grant/Funding (institution): Hexal; Research grant/Funding (institution): Celgene; Honoraria (self), Research grant/Funding (institution): Novartis; Travel/Accommodation/Expenses: Daiichi. S. Seiler: Research grant/Funding (institution), GeparOla study was supported by AstraZeneca: AstraZeneca; Honoraria (self), Advisory/Consultancy, Advisory Boards: Amgen; Honoraria (self), Advisory/Consultancy, Advisory Boards: Hexal; Honoraria (self), Presentations: Roche; Honoraria (self), Advisory/Consultancy, Advisory Boards: Mundipharma; Travel/Accommodation/Expenses: Novartis. A. Schneeweiss: Research grant/Funding (institution): Celgene; Speaker Bureau/Expert testimony, Research grant/Funding (institution): Roche; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Molecular Partner; Honoraria (self), Speaker Bureau/Expert testimony, Medical writing grant: Roche; Honoraria (self), Speaker Bureau/Expert testimony: AstraZeneca; Honoraria (self), Travel/Accommodation/Expenses: Celgene; Honoraria (self), Travel/Accommodation/Expenses: Roche; Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self): Novartis; Honoraria (self): MSD; Honoraria (self): Tesaro; Honoraria (self): Lilly. C. Denkert: Honoraria (self): Novartis; Honoraria (self): Roche; Honoraria (self): MSD Oncology; Honoraria (self): Daiichi Sankyo; Research grant/Funding (self): Myriad Genetics; Shareholder/Stockholder/Stock options, Cofounder and shareholder: Sividon Diagnostics/Myriad. M. Untch: Honoraria (institution): AbbVie; Honoraria (institution): Amgen; Honoraria (institution): AstraZeneca; Honoraria (institution): BMS; Honoraria (institution): Celgene GmbH; Honoraria (institution): Daiji Sankyo; Honoraria (institution): Eisai GmbH; Honoraria (institution): Lilly Deutschland; Honoraria (institution): Lilly int.; Honoraria (institution): MSD Merck; Honoraria (institution): Mundipharma; Honoraria (institution): Myriad Genetics; Honoraria (self): Odonte; Honoraria (institution): Pfizer GmbH; Honoraria (self): PUMA Biotechnology; Honoraria (institution): Roche Pharma AG; Honoraria (institution): Sanofi Aventis Deutschland GmbH; Honoraria (institution): TEVA Pharmaceuticals Ind Ltd; Honoraria (institution): Novartis; Honoraria (institution): Pierre Fabre; Honoraria (institution): Clovis Oncology. J-U. Blohmer: Honoraria (self): Amgen; Honoraria (self): AstraZeneca; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Roche; Honoraria (self): SonoScape. R.K. Schmutzler: Research grant/Funding (institution): Cologne Fortune Program. S. Loibl: Honoraria (institution), Research grant/Funding (institution): AbbVie; Honoraria (institution), Research grant/Funding (institution): Amgen; Honoraria (institution), Research grant/Funding (institution): AstraZeneca; Honoraria (institution), Research grant/Funding (institution): Celgene; Honoraria (institution), Research grant/Funding (institution): Novartis; Honoraria (institution), Research grant/Funding (institution): Pfizer; Honoraria (institution), Research grant/Funding (institution): Roche; Honoraria (institution): Seattle Genetics; Honoraria (self): Chugai; Research grant/Funding (self): Teva; Research grant/Funding (self): Vifor; Honoraria (institution): PriME/Medscape; Honoraria (institution), Research grant/Funding (institution): Daiichi Sankyo; Honoraria (institution): Lilly; Honoraria (institution): Samsung; Advisory/Consultancy, paid to institution: Eirgenix; Honoraria (institution): BMS; Honoraria (institution): Puma; Honoraria (institution): MSD; Research grant/Funding (institution): Immunomedics. All other authors have declared no conflicts of interest.
1165P - Subgroup analysis by Ki-67 and primary tumour origins of the randomized, placebo-controlled phase III study of surufatinib in advanced well-differentiated extrapancreatic neuroendocrine tumours (SANET-ep)
- Zhiwei Zhou (Guangzhou, China)
Abstract
Background
Surufatinib, a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptors (1,2,3), fibroblast growth factor receptor 1 and colony stimulating factor 1 receptor, has demonstrated superior efficacy in extrapancreatic neuroendocrine tumors (NETs) in a phase III study (SANET-ep, ESMO 2019 Abs. LBA76). The proliferation marker Ki-67 and primary tumor origins are the major prognostic factors in NETs.
Methods
The post-hoc efficacy analysis of surufatinib versus placebo was conducted by Ki-67 subcategory (<3%, 3-10%, >10%) and primary tumor origins (foregut, midgut, hindgut, others or unknown) in patients (pts) with advanced well-differentiated (grade 1 or 2) extrapancreatic NETs. The primary endpoint (progression-free survival [PFS]) and secondary endpoint (objective response rate [ORR]) both by investigator assessment (RECIST1.1) were analyzed.
Results
Median PFS was significantly prolonged with surufatinib compared to placebo in subgroups of Ki-67 3-10% (7.6 vs 4.6 months [mo], hazard ratio [HR] 0.47,
Conclusions
Surufatinib demonstrated clinically significant benefits for pts with advanced well-differentiated extrapancreatic NETs compared to placebo. Results of this exploratory analysis were consistent with those reported for the SANET-ep primary analysis, and improved outcomes were observed across major subgroups.
Clinical trial identification
NCT02588170.
Legal entity responsible for the study
Hutchison MediPharma Limited.
Funding
Hutchison MediPharma Limited.
Disclosure
J. Li, J. He: Full/Part-time employment: Hutchison MediPharma Limited. W. Su: Shareholder/Stockholder/Stock options, Full/Part-time employment: Hutchison MediPharma Limited. All other authors have declared no conflicts of interest.