Randomized phase II BGOG/ENGOT-cx1 study of paclitaxel-carboplatin with or without nintedanib in first-line recurrent or advanced cervical cancer

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • I. Vergote - , KU Leuven (Author)
  • E. Van Nieuwenhuysen - , KU Leuven (Author)
  • A. Casado - , Complutense University (Author)
  • A. Laenen - , KU Leuven (Author)
  • D. Lorusso - , Catholic University of the Sacred Heart (Author)
  • E. I. Braicu - , Charité – Universitätsmedizin Berlin (Author)
  • E. Guerra-Alia - , Hospital Ramon y Cajal (Author)
  • P. Zola - , University of Turin (Author)
  • P. Wimberger - , Department of Gynecology and Obstetrics (Author)
  • P. R. Debruyne - , AZ Groeninge (Author)
  • E. Falcó - , GEICO and Policlinica Miramar (Author)
  • A. Ferrero - , University of Turin (Author)
  • M. Z. Muallem - , Charité – Universitätsmedizin Berlin (Author)
  • J. Kerger - , Université libre de Bruxelles (ULB) (Author)
  • E. García-Martinez - , Hospital Morales Meseguer (Author)
  • S. Pignata - , IRCCS Istituto nazionale tumori Fondazione Giovanni Pascale - Napoli (Author)
  • J. Sehouli - , Charité – Universitätsmedizin Berlin (Author)
  • T. Van Gorp - , KU Leuven (Author)
  • C. Gennigens - , University of Liege (Author)
  • M. J. Rubio - , Hospital Universitario Reina Sofía (Author)

Abstract

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.

Details

Original languageEnglish
Pages (from-to)80-88
Number of pages9
JournalGynecologic oncology
Volume174
Publication statusPublished - Jul 2023
Peer-reviewedYes

External IDs

PubMed 37167896

Keywords

Sustainable Development Goals

ASJC Scopus subject areas

Keywords

  • Angiogenesis, Cervical cancer, Chemotherapy, Nintedanib, Recurrent, Vascular Endothelial Growth Factor A, Double-Blind Method, Humans, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Neoplasm Recurrence, Local/pathology, Uterine Cervical Neoplasms/drug therapy, Lung Neoplasms/drug therapy, Paclitaxel, Carboplatin, Female