Feasibility Study of EndoTAG-1, a Tumor Endothelial Targeting Agent, in Combination with Paclitaxel followed by FEC as Induction Therapy in HER2-Negative Breast Cancer
| Autor: | Andrea Gombos, Stefan Michiels, Fabienne Lebrun, Dimitrios Zardavas, Christos Sotiriou, Ahmad Awada, Lieveke Ameye, Jean-Marie Nogaret, Michail Ignatiadis, Evandro de Azambuja, Marion Maetens, Denis Larsimont, Celine Wilke, Marianne Paesmans, Véronique D'Hondt, Martine Piccart, Lissandra Dal Lago, Fanny Bustin, Marie-Catherine Vanderbeeken, Marc Lemort, Isabelle Veys |
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| Přispěvatelé: | Herrada, Anthony, Clinique d'Oncologie Médicale [Brussels, Belgium], Université libre de Bruxelles (ULB)-Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB)-Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB), Laboratoire de recherche translationnelle sur le cancer du sein [Brussels, Belgium], Breast International Group [Brussels, Belgium] (BIG aisbl), Département de Radiologie [Brussels, Belgium] (ULB), Medigene AG [Planegg, Germany], Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Méthodologie et épidémiologie clinique en oncologie moléculaire (U1018 (Équipe 2)), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Gustave Roussy (IGR), IJB was the sponsor of this study and Medigene AG provided the EndoTAG-1 and an educational grant. Medigene AG provided support in the form of salaries for author CW., Institut Jules Bordet [Bruxelles], Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB) |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_treatment
Psychologie appliquée Diagnostic Radiology 0302 clinical medicine Animal Cells Antineoplastic Combined Chemotherapy Protocols Medicine lcsh:Science MESH: Treatment Outcome MESH: Middle Aged Induction Chemotherapy Sciences bio-médicales et agricoles MESH: Induction Chemotherapy 3. Good health MESH: Antineoplastic Combined Chemotherapy Protocols Oncology Paclitaxel Fluorouracil 030220 oncology & carcinogenesis MESH: Biomarkers Tumor Cellular Types Biologie Clinical Oncology medicine.medical_specialty Imaging Techniques Immune Cells Immunology Urology Surgical and Invasive Medical Procedures MESH: Epirubicin 03 medical and health sciences Breast cancer Drug Therapy [SDV.CAN] Life Sciences [q-bio]/Cancer Humans Cyclophosphamide Blood Cells MESH: Humans lcsh:R Biology and Life Sciences MESH: Cyclophosphamide MESH: Adult medicine.disease 030104 developmental biology chemistry lcsh:Q Neoplasm Grading Clinical Medicine MESH: Female MESH: Fluorouracil 0301 basic medicine MESH: Combined Modality Therapy Receptor ErbB-2 Cancer Treatment lcsh:Medicine MESH: Neoplasm Grading MESH: Magnetic Resonance Imaging White Blood Cells chemistry.chemical_compound Breast Tumors Medicine and Health Sciences Multidisciplinary [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology Pharmaceutics Radiology and Imaging MESH: Neoplasm Staging Middle Aged Combined Modality Therapy Magnetic Resonance Imaging MESH: Receptor ErbB-2 Treatment Outcome Surgical Oncology Female Research Article medicine.drug Epirubicin Adult Neutropenia Breast Neoplasms [SDV.CAN]Life Sciences [q-bio]/Cancer Research and Analysis Methods Diagnostic Medicine Breast Cancer Biomarkers Tumor Hypersensitivity Chemotherapy MESH: Paclitaxel Neoplasm Staging business.industry Cancers and Neoplasms Induction chemotherapy Cell Biology Surgery Clinical Immunology business MESH: Breast Neoplasms [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| Zdroj: | PLoS ONE PLoS ONE, 2016, 11 (7), pp.e0154009. ⟨10.1371/journal.pone.0154009⟩ PloS one, 11 (7 PLoS ONE, Vol 11, Iss 7, p e0154009 (2016) PLoS ONE, Public Library of Science, 2016, 11 (7), pp.e0154009. ⟨10.1371/journal.pone.0154009⟩ |
| ISSN: | 1932-6203 |
| DOI: | 10.1371/journal.pone.0154009⟩ |
| Popis: | Background: EndoTAG-1, a tumor endothelial targeting agent has shown activity in metastatic triple-negative breast cancer (BC) in combination with paclitaxel. Methods: HER2-negative BC patients candidates for neoadjuvant chemotherapy were scheduled to receive 12 cycles of weekly EndoTAG-1 22mg/m2 plus paclitaxel 70mg/m2 followed by 3 cycles of FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2) every 3 weeks followed by surgery. Primary endpoint was percent (%) reduction in Magnetic Resonance Imaging (MRI) estimated Gadolinium (Gd) enhancing tumor volume at the end of EndoTAG-1 plus paclitaxel administration as compared to baseline. Safety, pathological complete response (pCR) defined as no residual tumor in breast and axillary nodes at surgery and correlation between % reduction in MRI estimated tumor volume and pCR were also evaluated. Results: Fifteen out of 20 scheduled patients were included: Six patients with estrogen receptor (ER)-negative/HER2-negative and 9 with ER-positive/HER2-negative BC. Nine patients completed treatment as per protocol. Despite premedication and slow infusion rates, grade 3 hypersensitivity reactions to EndoTAG-1 were observed during the 1st, 2nd, 3rd and 6th weekly infusion in 4 patients, respectively, and required permanent discontinuation of the EndoTAG-1. Moreover, two additional patients stopped EndoTAG-1 plus paclitaxel after 8 and 9 weeks due to clinical disease progression. Two patients had grade 3 increases in transaminases and 1 patient grade 4 neutropenia. pCR was achieved in 5 of the 6 ER-/HER2- and in none of the 9 ER+/HER2- BC patients. The mean % reduction in MRI estimated tumor volume at the end of EndoTAG-1 plus paclitaxel treatment was 81% (95% CI, 66% to 96%, p SCOPUS: ar.j info:eu-repo/semantics/published |
| Databáze: | OpenAIRE |
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