Supportive Care in Cancer

, Volume 19, Issue 8, pp 1159–1164

Palonosetron plus 3-day aprepitant and dexamethasone to prevent nausea and vomiting in patients receiving highly emetogenic chemotherapy

  • Flavia Longo
  • Giovanni Mansueto
  • Vittoria Lapadula
  • Rita De Sanctis
  • Silvia Quadrini
  • Roberta Grande
  • Bruno Gori
  • Amelia Altavilla
  • I. D’Antoni
  • Ester Del Signore
  • Luciano Stumbo
  • Cristina De Luca
  • Barbara Cimadon
  • Enrico Cortesi
  • Teresa Gamucci
  • Marisa Di Seri
Original Article

Abstract

Background

The combination of a neurokinin-1 receptor antagonist, dexamethasone, and a 5-HT3 receptor antagonist is currently the standard antiemetic treatment in patients receiving cisplatin-based high emetogenic chemotherapy (HEC). The aim of this study was to evaluate the efficacy of a combination of palonosetron, a unique second-generation 5-HT3 receptor antagonist, aprepitant, the only approved neurokinin-1 receptor antagonist, and dexamethasone as antiemetic prophylaxis in patients receiving HEC (cisplatin ≥50 mg/mq).

Methods

Chemotherapy-naïve adult patients, receiving cisplatin-based HEC, were treated with palonosetron 0.25 mg/i.v., dexamethasone 20 mg/i.v., and aprepitant 125 mg/p.o., 1-h before chemotherapy. Aprepitant 80 mg/p.o. and dexamethasone 4 mg p.o. were administered on days 2–3. Primary end point was complete response (CR; no vomiting and no use of rescue medication), during the overall study period (0–120 h). Secondary end points were complete control (CR and no more than mild nausea), emesis-free rate, and nausea-free rate during the acute (0–24 h), delayed (24–120 h), and overall (0-120 h) periods. Safety was also evaluated.

Results

A total of 222 patients were included in the study. Median age was 62 years, 76.6% were male and 23.4% female, and most common tumors were lung (66.7%) and head and neck (15.8%); 70.3% of patients achieved CR during the overall study period. Complete control, emesis-free rate, and nausea-free rate were 70.3%, 92.8%, and 59.9%, respectively, during the overall phase. The most commonly reported side effects were constipation (39% of patients) and headache (5%).

Conclusions

This study shows that palonosetron in combination with aprepitant and dexamethasone is effective to prevent chemotherapy-induced nausea and vomiting in patients treated with cisplatin-based HEC.

Keywords

Aprepitant CINV Dexamethasone HEC Palonosetron 5-HT3 receptor antagonist 

Copyright information

© Springer-Verlag 2010

Authors and Affiliations

  • Flavia Longo
    • 1
  • Giovanni Mansueto
    • 2
  • Vittoria Lapadula
    • 1
  • Rita De Sanctis
    • 1
  • Silvia Quadrini
    • 1
  • Roberta Grande
    • 2
  • Bruno Gori
    • 1
  • Amelia Altavilla
    • 3
  • I. D’Antoni
    • 1
  • Ester Del Signore
    • 1
  • Luciano Stumbo
    • 1
  • Cristina De Luca
    • 1
  • Barbara Cimadon
    • 3
  • Enrico Cortesi
    • 3
  • Teresa Gamucci
    • 2
  • Marisa Di Seri
    • 1
  1. 1.Department of Clinical Oncology A“Sapienza” University of Rome, Policlinico Umberto PrimoRomeItaly
  2. 2.U.O.C. Clinical OncologyOspedale Umberto PrimoFrosinoneItaly
  3. 3.Department of Clinical Oncology B“Sapienza” University of Rome, Policlinico Umberto PrimoRomeItaly

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