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, Richard J. Gralla, A. D. Carides, A. Taylor, J. K. Evans, K. J. Horgan

Research output: Contribution to journalArticle

72 Citations (Scopus)

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/m 2) 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.

Original languageEnglish (US)
Pages (from-to)354-360
Number of pages7
JournalSupportive Care in Cancer
Volume14
Issue number4
DOIs
StatePublished - Apr 2006
Externally publishedYes

Fingerprint

aprepitant
Nausea
Vomiting
Adrenal Cortex Hormones
Drug Therapy
Therapeutics
Ondansetron
Control Groups
Antiemetics
Dexamethasone
Cisplatin
Logistic Models

Keywords

  • Aprepitant
  • Cancer
  • Nausea and vomiting
  • NK antagonist
  • Supportive care

ASJC Scopus subject areas

  • Oncology
  • Nursing(all)

Cite this

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. / Hesketh, P. J.; Grunberg, S. M.; Herrstedt, J.; De Wit, R.; Gralla, Richard J.; Carides, A. D.; Taylor, A.; Evans, J. K.; Horgan, K. J.

In: Supportive Care in Cancer, Vol. 14, No. 4, 04.2006, p. 354-360.

Research output: Contribution to journalArticle

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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/m 2) 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.",
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AU - Grunberg, S. M.

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