Thématique :
- Cancers autres (hors CCR et CHC)
Originalité :
Très original
Solidité :
A confirmer
Doit faire évoluer notre pratique :
Pas encore
Nom du veilleur :
Professeur Sylvain MANFREDI
Coup de coeur :
Digestive and Liver Disease
  2018 Feb;50(2):195-198.  
  doi: 10.1016/j.dld.2017.11.020.  
  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  
  Walter T, Malka D, Hentic O, Lombard-Bohas C, Le Malicot K, Smith D, Ferru A, Assenat E, Cadiot G, Lievre A, Kurtz JE, Dahan L, Dubreuil O, Hautefeuille V, Lepere C, Gangloff A, Elhajbi F, Coriat R, Roquin G, Bouarioua N, Granger V, Scoazec JY, Lepage C  



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.


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.


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.


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.


The study is currently opened in France (NCT02820857). The first patient was randomized on September 6, 2017.


Question posée
Design paper de l’essai BEVANEC de la FFCD et du groupe PRODIGE. Essai de 2ème ligne des TNE de grade 3 digestives.
Question posée
Essai à ouvrir dans le maximum de centres.

Cancer rare pour lequel une collaboration nationale voire internationale est nécessaire pour l’avancement des connaissances.