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. Issue 2 (February 2018)

• Record Type: Journal Article
• Authors: Walter, Thomas; Malka, David; Hentic, Olivia; Lombard-Bohas, Catherine; Le Malicot, Karine; Smith, Denis; Ferru, Aurélie; Assenat, Eric; Cadiot, Guillaume; Lievre, Astrid; Kurtz, Jean-Emmanuel; Dahan, Laetitia; Dubreuil, Olivier; Hautefeuille, Vincent; Lepere, Céline; Gangloff, Alice; Elhajbi, Farid; Coriat, Romain; Roquin, Guillaume; Bouarioua, Nadia; Granger, Victoire; Scoazec, Jean-Yves; Lepage, Côme
• Is Part Of: Digestive and liver disease. Volume 50:Issue 2(2018)
• Page Start: 195
• Page End: 198
• Publication Date: 2018-02
• Subjects: Bevacizumab -- Clinical trial -- FOLFIRI -- Gastroenteropancreatic -- Neuroendocrine carcinoma; Digestive organs -- Diseases -- Periodicals; Liver -- Diseases -- Periodicals; 616.33005
• DOI: 10.1016/j.dld.2017.11.020
• Languages: English
• ISSNs: 1590-8658

Abstract

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.