Randomized phase II BGOG/ENGOT-cx1 study of paclitaxel-carboplatin with or without nintedanib in first-line recurrent or advanced cervical cancer. - 2023
[en] [en] OBJECTIVE: Nintedanib is an oral tyrosine kinase inhibitor targeting, among others, vascular endothelial growth factor receptor. The aim was to establish the role of nintedanib in addition to paclitaxel and carboplatin in first-line recurrent/metastatic cervical cancer.
METHODS: Double-blind phase II randomized study in patients with first-line recurrent or primary advanced (FIGO stage IVB) cervical cancer. Patients received carboplatin-paclitaxel with oral nintedanib 200 mg BID/placebo. The primary endpoint was progression-free survival (PFS) at 1.5 years and α = 0.15, β = 80%, one sided.
RESULTS: 120 patients (62 N, 58C) were randomized. Median follow-up was 35 months. Baseline characteristics were similar in both groups (total population: squamous cell carcinoma 62%, prior radiotherapy 64%, primary advanced 25%, recurrent 75%). The primary endpoint was met with a PFS at 1.5 years of 15.1% versus 12.8% in favor of the nintedanib arm (p = 0.057). Median overall survival (OS) was 21.7 and 16.4 months for N and C, respectively. Confirmed RECIST response rate was 48% for N and 39% for C. No new adverse events were noted for N. However, N was associated with numerically more serious adverse events for anemia and febrile neutropenia. Global health status during and at the end of the study was similar in both arms.
CONCLUSION: The study met its primary endpoint with a prolonged PFS in the N arm. No new safety signals were observed.
Disciplines :
Oncologie
Auteur, co-auteur :
Vergote, I; Belgium and Luxembourg Gynaecological Oncology Group (BGOG) and University Hospitals Leuven, Division of Gynaecological Oncology, Leuven, European Union, Belgium. Electronic address: Ignace.vergote@uzleuven.be
Van Nieuwenhuysen, E; Belgium and Luxembourg Gynaecological Oncology Group (BGOG) and University Hospitals Leuven, Division of Gynaecological Oncology, Leuven, European Union, Belgium
Casado, A; Hospital Clínico San Carlos, Spain and Grupo Español de Cáncer de Ovario (GEICO), Madrid, Spain
Laenen, A; Leuven Biostatistics and Statistical Bioinformatics Centre, KU Leuven, Leuven, Belgium
Lorusso, D; Multicentre Italian Trials in Ovarian Cancer and Gynecologic malignancies (MITO) and Fondazione Policlinico Universitario Gemelli IRCCS and Catholic University of Sacred Heart, Roma, Italy
Braicu, E I; Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie e.V (NOGGO) and Department of Gynecology with Center for Oncological Surgery, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Virchow Campus Clinic, Charité Medical University, Berlin, Germany, Stanford University, Department of Obstetrics and Gynecology, CA, USA
Guerra-Alia, E; Hospital Universitario Ramón y Cajal, and GEICO, Madrid, Spain
Zola, P; Mario Negri Gynecologic Oncology Group (MaNGO) and Department of Surgical Sciences Università degli Studi di Torino, Italy
Wimberger, P; NOGGO and Technische Universität Dresden and NCT Dresden, Dresden, Germany
Debruyne, P R; BGOG and Kortrijk Cancer Centre, AZ Groeninge, Kortrijk, Belgium, School of Life Sciences, Anglia Ruskin University, Cambridge, UK, School of Nursing & Midwifery, University of Plymouth, Plymouth, UK
Falcó, E; GEICO and Policlinica Miramar, Palma de Mallorca, Spain
Ferrero, A; MaNGO and Mauriziano Hospital and University of Torino, Torino, Italy
Muallem, M Z; Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie e.V (NOGGO) and Department of Gynecology with Center for Oncological Surgery, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Virchow Campus Clinic, Charité Medical University, Berlin, Germany
Kerger, J; BGOG and Instituut Jules Bordet, Brussels, Belgium
García-Martinez, E; Hospital General Universitario Morales Meseguer, Murcia, Spain and GEICO
Pignata, S; MITO and Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Napoli, Italy
Sehouli, J; Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie e.V (NOGGO) and Department of Gynecology with Center for Oncological Surgery, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Virchow Campus Clinic, Charité Medical University, Berlin, Germany
Van Gorp, T; Belgium and Luxembourg Gynaecological Oncology Group (BGOG) and University Hospitals Leuven, Division of Gynaecological Oncology, Leuven, European Union, Belgium
Gennigens, Christine ; Centre Hospitalier Universitaire de Liège - CHU > > Service d'oncologie médicale
Rubio, M J; Hospital Reina Sofía, Córdoba, Spain and GEICO
The study was supported by an education grant of Boehringer-Ingelheim. The funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report. All authors had full access to all the raw data. The authors thank the data managers of the Belgian and Luxemburg Gynaecological oncology Group (BGOG) Joke De Roover, Leen Hombrouck and Marijke Vanspauwen for their support and Nancy Trolin for her support in manuscript preparation. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
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