Combined data from two phase III trials of the NK1 antagonist aprepitant plus a 5HT3 antagonist and a corticosteroid for prevention of chemotherapy-induced nausea and vomiting: effect of gender on treatment response

  • P. J. Hesketh
  • S. M. Grunberg
  • J. Herrstedt
  • R. de Wit
  • R. J. Gralla
  • A. D. Carides
  • A. Taylor
  • J. K. Evans
  • K. J. Horgan
Original Article

Abstract

Goals of work

Prevention of chemotherapy-induced nausea and vomiting (CINV) with standard antiemetics has been more difficult to achieve in female patients. Data from two phase III trials of the NK1 antagonist aprepitant were assessed for potential effect of gender on treatment response.

Patients and methods

1,044 patients receiving cisplatin (≥70 mg/m2) were randomly assigned to control regimen [ondansetron (O) 32 mg i.v. and dexamethasone (D) 20 mg p.o. on day 1; D 8 mg twice daily on days 2–4] or aprepitant (A) regimen (A 125 mg p.o. plus O 32 mg and D 12 mg on day 1; A 80 mg and D 8 mg once daily on days 2–3; and D 8 mg on day 4). The primary endpoint was overall complete response (no emesis and no rescue therapy over days 1–5). Data were analyzed by a modified intent-to-treat approach. Between-treatment comparisons for each gender were made using logistic regression.

Main results

Women comprised 42 and 43% of the aprepitant and control groups, respectively. In the control group, 41% of women had overall complete response compared with 53% of men. In the aprepitant group, 66% of women had overall complete response compared with 69% of men.

Conclusion

The addition of aprepitant may negate the adverse prognostic effect of female gender on the prevention of CINV in patients receiving highly emetogenic chemotherapy.

Keywords

Nausea and vomiting Aprepitant NK1 antagonist Cancer Supportive care 

Notes

Acknowledgement

This study was funded by Merck and Co., Inc., manufacturer of aprepitant.

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Copyright information

© Springer-Verlag 2006

Authors and Affiliations

  • P. J. Hesketh
    • 1
  • S. M. Grunberg
    • 2
  • J. Herrstedt
    • 3
  • R. de Wit
    • 4
  • R. J. Gralla
    • 5
  • A. D. Carides
    • 6
  • A. Taylor
    • 6
  • J. K. Evans
    • 6
  • K. J. Horgan
    • 6
  1. 1.Caritas St. Elizabeth’s Medical CenterBrightonUSA
  2. 2.University of VermontBurlingtonUSA
  3. 3.Copenhagen University Hospital HerlevHerlevDenmark
  4. 4.Rotterdam Cancer Institute & University HospitalEA RotterdamThe Netherlands
  5. 5.New York Lung Cancer AllianceNew YorkUSA
  6. 6.Merck Research LaboratoriesBlue BellUSA

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