SNFGE SNFGE
 
Thématique :
- Cancers autres (hors CCR et CHC)
Originalité :
Réexamen
Solidité :
Intermédiaire
Doit faire évoluer notre pratique :
Dans certains cas
 
 
Nom du veilleur :
Docteur Roger FAROUX
Coup de coeur :
 
 
Annals of oncology
  2018/02  
 
  2018 Feb 1;29(2):452-458.  
  doi: 10.1093/annonc/mdx698.  
 
  A randomized phase III study evaluating the efficacy of single-dose NEPA, a fixed antiemetic combination of netupitant and palonosetron, versus an aprepitant regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving h  
 
  Zhang L, Lu S, Feng J, Dechaphunkul A, Chang J, Wang D, Chessari S, Lanzarotti C, Jordan K, Aapro M  
  https://www.ncbi.nlm.nih.gov/pubmed/29092012  
 
 

Abstract

BACKGROUND:

Co-administration of multiple antiemetics that inhibit several molecular pathways involved in emesis is required to optimize chemotherapy-induced nausea and vomiting (CINV) control in patients receiving highly emetogenic chemotherapy (HEC). NEPA, a fixed combination of a highly selective NK1 receptor antagonist, netupitant (300 mg), and the pharmacologically distinct 5-HT3RA, palonosetron (PALO 0.50 mg), has shown superior CINV prevention compared with PALO in cisplatin and anthracycline/cyclophosphamide-based settings. This study is the first head-to-head comparison of NEPA versus an aprepitant (APR)/granisetron (GRAN) regimen.

PATIENTS AND METHODS:

This randomized, double-blind phase III study conducted in Asia was designed with the primary objective to demonstrate non-inferiority of a single oral dose of NEPA compared with a 3-day oral APR/GRAN regimen in chemotherapy-naïve patients receiving cisplatin-based HEC. All patients also received oral dexamethasone (DEX) on days 1-4. The primary efficacy endpoint was complete response (CR: no emesis/no rescue medication) during the overall (0-120 h) phase. Non-inferiority was defined as a lower 95% CI greater than the non-inferiority margin set at - 10%. Secondary efficacy endpoints included no emesis, no rescue medication, and no significant nausea (NSN).

RESULTS:

Treatment groups were comparable for the 828 patients analyzed: predominantly male (71%); mean age 54.5 years; ECOG 0-1 (98%); lung cancer (58%). NEPA demonstrated non-inferiority to APR/GRAN for overall CR [NEPA 73.8% versus APR/GRAN 72.4%, 95% CI (-4.5%, 7.5%)]. No emesis [NEPA 75.0% versus APR/GRAN 74.0%, 95% CI (-4.8%, 6.9%)] and NSN rates [NEPA 75.7% versus APR/GRAN 70.4%, 95% CI (-0.6%, 11.4%)] were similar between groups, but significantly more NEPA patients did not take rescue medication [NEPA 96.6% versus APR/GRAN 93.5%, 95% CI (0.2%, 6.1%)]. NEPA was well tolerated with a similar safety profile to APR/GRAN.

CONCLUSIONS:

In this first study comparing NK1RA regimens and DEX, NEPA administered only on day 1 was non-inferior to a 3-day oral APR/GRAN regimen in preventing CINV associated with HEC.

 

 
Question posée
 
Établir la non-infériorité en termes d’efficacité d’une dose unique orale de l’association fixe nétupitant/palonosétron (300 mg/0,50 mg) par rapport à celle de l’association aprépitant/granisétron, en association à la dexaméthasone (DEX), sur la prévention des nausées et vomissements induits par une chimiothérapie hautement émétisante (CHE) à base de cisplatine.
 
Question posée
 
Non infériorité démontrée.
 
Commentaires

Données sur une population asiatique, à confirmer sur une population occidentale.
Démonstration uniquement pour des chimiothérapies fortement émétisantes à base de cisplatine.

 
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