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199 Randomised Phase II BGOG/ENGOT-cx1 study of paclitaxel-carboplatin with or without nintedanib in first-line recurrent or advanced cervical cancer
  1. IB Vergote1,
  2. E Van Nieuwenhuysen2,
  3. A Casado3,
  4. A Laenen4,
  5. D Lorusso5,
  6. I Braicu6,
  7. E Guerra-Alia7,
  8. P Zola8,
  9. P Wimberger9,
  10. P Debruyne10,
  11. E Falcó11,
  12. A Ferrero12,
  13. MZ Muallem13,
  14. J Kerger14,
  15. E Garcia Martinez15,
  16. S Pignata16,
  17. J Sehouli17,
  18. T Van Gorp2,
  19. C Gennigens18 and
  20. MJ Rubio Pérez19
  1. 1University Hospitals Leuven, Belgium and BGOG, Belgium
  2. 2University Hospitals Leuven, Belgium and BGOG
  3. 3Hospital Clínico San Carlos, Madrid Spain and GEICO
  4. 4Catholic University Leuven, Belgium
  5. 5Policlinico Universitario Agostino Gemelli, Italy and ENGOT
  6. 6Charité Universitätsmedizin Berlin and ENGOT
  7. 7Hospital Ramón y Cajal, Madrid Spain and GEICO
  8. 8Univeristy of Turin, Italy and ENGOT
  9. 9Universitätsklinikum Carl Gustav Carus, Dresden, Germany and ENGOT
  10. 10AZ Groeninge, Kortrijk, Belgium
  11. 11Hospital Son Llatzer, Palma de Mallorca, Spain and GEICO
  12. 12Mauriziano Hospital, Torino, Italy and ENGOT
  13. 13Charité Universitätsmedizin Berlin, Berlin, Germany
  14. 14Institut Jules Bordet, Brussels, Belgium and BGOG
  15. 15Hospital Universitario Morales Meseguer, Murcia Spain and GEICO
  16. 16Instituto Nazionale Tumor, Napoli, Italy and ENGOT
  17. 17Charité Universitätsmedizin Berlin, Berlin, Germany and ENGOT
  18. 18University Hospital (CHU) of Liege, Belgium and BGOG
  19. 19Hospital Universitario Reina Sofía, Córdoba, Spain and GEICO


Introduction/Background*Platinum in combination with paclitaxel (P) and bevacizumab is the standard of care in first-line recurrent/advanced cervical cancer (Tewari, NEJM 2020). Nintedanib is an oral tyrosine kinase inhibitor targeting, among others, vascular endothelial growth factor receptor.

Methodology Double-blind phase II randomised study in patients with first-line recurrent or primary advanced (FIGO stage IVB) cervical cancer. Patients received carboplatin AUC 5-6 and paclitaxel 175mg/m2 q 3 weeks with oral nintedanib 200 mg BID/placebo. Stratification factor was primary advanced versus recurrent disease. The primary endpoint was progression-free survival (PFS) at 1,5 years with at least 87 events and α=0.15, β=80%, one sided, in favor of the nintedanib (N) versus control (C) arm. The study (NCT02009579) was performed according to the ENGOT model A.

Result(s)*120 patients (62 N, 58 C) were randomised between March 2014 and October 2018. 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 favour of the nintedanib arm (p = 0.057). Median overall survival (OS) was 21.7 and 16.4 months for N and C, respectively. Subgroup analysis did not demonstrate a difference in PFS in the primary advanced setting, but in the recurrent setting the 1 year PFS was 22.8% and 14.9% 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. Discontinuation of chemotherapy was similar in both groups. N was discontinued in 3% versus placebo in 1.6% of the patients. Dose reduction of N was necessary in 53% of the patients.

Conclusion*The study met its primary endpoint with a prolonged PFS in the N arm. No new safety signals were observed.

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