Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer

Summary

Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy. In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing. Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib). This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin \& paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).

Timeline

Start

2012-06

Primary completion

2015-05

Completion

2016-03

Publications

• Marchetti C, Ferron G, Colomban O, Giannarelli D, Blanc-Durand F, Scambia G, Just PA, Lorusso D, Pujade-Lauraine E, Ergasti R, Lortholary A, Sassu CM, Ray-Coquard I, Capomacchia FM, Combe P, Apostol AI, Zannoni GF, Carrot A, Malapelle U, Leary A, Fagotti A, You B. Predictors of Successful Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Management of Ovarian Cancer. JCO Oncol Pract. 2025 Nov 24:OP2500469. doi: 10.1200/OP-25-00469. Online ahead of print.
• Azais H, Brochard C, Taly V, Benoit L, Ferron G, Ray-Coquard I, You B, Abadie-Lacourtoisie S, Lebreton C, Venat L, Louvet C, Favier L, Blonz C, Dohollou N, Malaurie E, Dubot C, Kurtz JE, Pujade-Lauraine E, Rouleau E, Leary A, Bats AS, Blons H, Laurent-Puig P. Prognostic value of circulating tumor DNA at diagnosis and its early decrease after one cycle of neoadjuvant chemotherapy for patients with advanced epithelial ovarian cancer. An ancillary analysis of the CHIVA phase II GINECO trial. Gynecol Oncol. 2025 Jan;192:145-154. doi: 10.1016/j.ygyno.2024.12.004. Epub 2024 Dec 12.
• Yaniz-Galende E, Zeng Q, Bejar-Grau JF, Klein C, Blanc-Durand F, Le Formal A, Pujade-Lauraine E, Chardin L, Edmond E, Marty V, Ray-Coquard I, Joly F, Ferron G, Pautier P, Berton-Rigaud D, Lortholary A, Dohollou N, Desauw C, Fabbro M, Malaurie E, Bonichon-Lamaichhane N, Bello Roufai D, Gantzer J, Rouleau E, Genestie C, Leary A. Spatial Profiling of Ovarian Carcinoma and Tumor Microenvironment Evolution under Neoadjuvant Chemotherapy. Clin Cancer Res. 2024 Jul 1;30(13):2790-2800. doi: 10.1158/1078-0432.CCR-23-3836.
• Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
• Ferron G, De Rauglaudre G, Becourt S, Delanoy N, Joly F, Lortholary A, You B, Bouchaert P, Malaurie E, Gouy S, Kaminsky MC, Meunier J, Alexandre J, Berton D, Dohollou N, Dubot C, Floquet A, Favier L, Venat-Bouvet L, Fabbro M, Louvet C, Lotz JP, Abadie-Lacourtoisie S, Desauw C, Del Piano F, Leheurteur M, Bonichon-Lamichhane N, Rastkhah M, Follana P, Gantzer J, Ray-Coquard I, Pujade-Lauraine E. Neoadjuvant chemotherapy with or without nintedanib for advanced epithelial ovarian cancer: Lessons from the GINECO double-blind randomized phase II CHIVA trial. Gynecol Oncol. 2023 Mar;170:186-194. doi: 10.1016/j.ygyno.2023.01.008. Epub 2023 Jan 25.
• Aide N, Fauchille P, Coquan E, Ferron G, Combe P, Meunier J, Alexandre J, Berton D, Leary A, De Rauglaudre G, Bonichon N, Pujade Lauraine E, Joly F. Predicting tumor response and outcome of second-look surgery with 18F-FDG PET/CT: insights from the GINECO CHIVA phase II trial of neoadjuvant chemotherapy plus nintedanib in stage IIIc-IV FIGO ovarian cancer. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1998-2008. doi: 10.1007/s00259-020-05092-3. Epub 2020 Nov 21.
• Robelin P, Tod M, Colomban O, Lachuer J, Ray-Coquard I, Rauglaudre G, Joly F, Chevalier-Place A, Combe P, Lortholary A, Hamizi S, Raban N, Ferron G, Meunier J, Berton-Rigaud D, Alexandre J, Kaminsky MC, Dubot C, Leary A, Malaurie E, You B. Comparative analysis of predictive values of the kinetics of 11 circulating miRNAs and of CA125 in ovarian cancer during first line treatment (a GINECO study). Gynecol Oncol. 2020 Oct;159(1):256-263. doi: 10.1016/j.ygyno.2020.07.021. Epub 2020 Jul 22.

Drugs

Indications