Evaluating bevacizumab in combination with FOLFIRI after the failure of platinum-etoposide regimen in patients with advanced poorly differentiated neuroendocrine carcinoma: The PRODIGE 41–BEVANEC randomized phase II study

Thomas Walter 1 David Malka 2 Olivia Hentic 3 Catherine Lombard-Bohas 1 Karine Le Malicot 4 Denis Smith 5 Aurélie Ferru 6 Eric Assénat 7, 8, 9 Guillaume Cadiot 10 Astrid Lièvre 11 Jean-Emmanuel Kurtz 12 Laetitia Dahan 13 Olivier Dubreuil 14 Vincent Hautefeuille 15 Céline Lepere 16 Alice Gangloff 17 Farid Elhajbi 18 Romain Coriat 19 Guillaume Roquin 20 Nadia Bouarioua Victoire Granger 21 Jean-Yves Scoazec 22, 23 Come Lepage 24
Abstract : Introduction : Patients with gastroenteropancreatic (GEP), metastatic or locally advanced, non-resectable, grade 3 poorly-differentiated neuroendocrine carcinoma (NEC) are treated with cisplatin (or carboplatin)-etoposide in first-line palliative chemotherapy (CT1). However, nearly all patients will develop resistance and there is no standard second-line treatment. Aim : PRODIGE 41–BEVANEC is an academic randomized, phase II study designed to evaluate the efficacy of bevacizumab in combination with FOLFIRI after failure of CT1 in unknown primary NEC and GEP-NEC. Materials and methods : The main eligibility criteria are age ≥18 years, metastatic (synchronous or metachronous) or locally advanced, non-resectable, grade 3 GEP-NEC, and documented progressive disease during or after CT1 therapy. Results : A total of 124 patients will be randomly assigned (1:1) to receive either 5 mg/kg bevacizumab with FOLFIRI, or FOLFIRI alone, every 14 days until disease progression or unacceptable toxicity. The hypothesis is to demonstrate a 6-month overall survival for at least 50% of the patients in bevacizumab arm versus 35% in the control arm (FOLFIRI alone). Secondary endpoints are objective response, response duration, progression-free survival, toxicity, and biochemical response. Conclusion : The study is currently opened in France (NCT02820857). The first patient was randomized on September 6, 2017.
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https://hal.archives-ouvertes.fr/hal-01699411
Contributor : Lnc - Université de Bourgogne <>
Submitted on : Friday, February 2, 2018 - 12:12:51 PM
Last modification on : Wednesday, October 2, 2019 - 1:24:08 AM

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Thomas Walter, David Malka, Olivia Hentic, Catherine Lombard-Bohas, Karine Le Malicot, et al.. Evaluating bevacizumab in combination with FOLFIRI after the failure of platinum-etoposide regimen in patients with advanced poorly differentiated neuroendocrine carcinoma: The PRODIGE 41–BEVANEC randomized phase II study. Digestive and Liver Disease, WB Saunders, 2018, 50 (2), pp.195-198. ⟨10.1016/j.dld.2017.11.020⟩. ⟨hal-01699411⟩

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