Results of a 7-day aprepitant schedule for the prevention of nausea and vomiting in 5-day cisplatin-based germ cell tumor chemotherapy

Ian Olver, Peter Grimison, Mark Chatfield, Martin Stockler, Guy Toner, Val Gebski, Rosemary Harrup, Craig Underhill, Ganessan Kichenadasse, Nimit Singhal, Ian Davis, Amy Boland, Ann McDonald, Damien Thomson

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Purpose: The purpose of this study was to determine the efficacy of adding a 7-day aprepitant schedule to a 5HT3 receptor antagonist and dexamethasone for patients with germ cell tumors receiving first-line 5-day cisplatin-based chemotherapy.

Methods: In a single-arm, open-label, multi-center, phase 2 trial, chemo-naive patients received aprepitant 125 mg PO (per oral) on day 1 and 80 mg PO on days 2 to 7, a 5HT3 receptor antagonist on days 1 to 5, and dexamethasone 8 mg on days 1 to 8. The primary endpoint was no emesis (vomiting or dry retching) during days 1 to 7 of cycle 1.

Results: Fifty patients were recruited. For cycle 1, proportions reporting no emesis on day 1, no emesis on days 1 to 7, no nausea on day 1, and no nausea on days 1 to 7 were 96, 82, 71, and 27%, respectively. The efficacy was maintained in all cycles with over 80% of patients reporting no emesis on any given day of any given cycle. Emesis was more common on days 4 to 7 (68% episodes) than on days 1 to 3 (32% episodes). Over any 24-h period, 49% of patients with emesis reported no more than two episodes, and 62% of patients with nausea reported intensity as 3 or less on a scale from 0 to 10. There were no unexpected or serious adverse events reported.

Conclusion: Adding 7 days of aprepitant to a 5HT3 receptor antagonist and dexamethasone effectively controlled acute and delayed emesis with 5-day cisplatin regimens. Days of nausea were more common than days of vomiting.
Original languageEnglish
Pages (from-to)1561-1568
Number of pages8
JournalSupportive Care in Cancer
Volume21
Issue number6
DOIs
Publication statusPublished - Jun 2013

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aprepitant
Germ Cell and Embryonal Neoplasms
Nausea
Cisplatin
Vomiting
Appointments and Schedules
Drug Therapy

Cite this

Olver, Ian ; Grimison, Peter ; Chatfield, Mark ; Stockler, Martin ; Toner, Guy ; Gebski, Val ; Harrup, Rosemary ; Underhill, Craig ; Kichenadasse, Ganessan ; Singhal, Nimit ; Davis, Ian ; Boland, Amy ; McDonald, Ann ; Thomson, Damien. / Results of a 7-day aprepitant schedule for the prevention of nausea and vomiting in 5-day cisplatin-based germ cell tumor chemotherapy. In: Supportive Care in Cancer. 2013 ; Vol. 21, No. 6. pp. 1561-1568.
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title = "Results of a 7-day aprepitant schedule for the prevention of nausea and vomiting in 5-day cisplatin-based germ cell tumor chemotherapy",
abstract = "Purpose: The purpose of this study was to determine the efficacy of adding a 7-day aprepitant schedule to a 5HT3 receptor antagonist and dexamethasone for patients with germ cell tumors receiving first-line 5-day cisplatin-based chemotherapy.Methods: In a single-arm, open-label, multi-center, phase 2 trial, chemo-naive patients received aprepitant 125 mg PO (per oral) on day 1 and 80 mg PO on days 2 to 7, a 5HT3 receptor antagonist on days 1 to 5, and dexamethasone 8 mg on days 1 to 8. The primary endpoint was no emesis (vomiting or dry retching) during days 1 to 7 of cycle 1.Results: Fifty patients were recruited. For cycle 1, proportions reporting no emesis on day 1, no emesis on days 1 to 7, no nausea on day 1, and no nausea on days 1 to 7 were 96, 82, 71, and 27{\%}, respectively. The efficacy was maintained in all cycles with over 80{\%} of patients reporting no emesis on any given day of any given cycle. Emesis was more common on days 4 to 7 (68{\%} episodes) than on days 1 to 3 (32{\%} episodes). Over any 24-h period, 49{\%} of patients with emesis reported no more than two episodes, and 62{\%} of patients with nausea reported intensity as 3 or less on a scale from 0 to 10. There were no unexpected or serious adverse events reported.Conclusion: Adding 7 days of aprepitant to a 5HT3 receptor antagonist and dexamethasone effectively controlled acute and delayed emesis with 5-day cisplatin regimens. Days of nausea were more common than days of vomiting.",
author = "Ian Olver and Peter Grimison and Mark Chatfield and Martin Stockler and Guy Toner and Val Gebski and Rosemary Harrup and Craig Underhill and Ganessan Kichenadasse and Nimit Singhal and Ian Davis and Amy Boland and Ann McDonald and Damien Thomson",
year = "2013",
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language = "English",
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Olver, I, Grimison, P, Chatfield, M, Stockler, M, Toner, G, Gebski, V, Harrup, R, Underhill, C, Kichenadasse, G, Singhal, N, Davis, I, Boland, A, McDonald, A & Thomson, D 2013, 'Results of a 7-day aprepitant schedule for the prevention of nausea and vomiting in 5-day cisplatin-based germ cell tumor chemotherapy', Supportive Care in Cancer, vol. 21, no. 6, pp. 1561-1568. https://doi.org/10.1007/s00520-012-1696-0

Results of a 7-day aprepitant schedule for the prevention of nausea and vomiting in 5-day cisplatin-based germ cell tumor chemotherapy. / Olver, Ian; Grimison, Peter; Chatfield, Mark; Stockler, Martin; Toner, Guy; Gebski, Val; Harrup, Rosemary; Underhill, Craig; Kichenadasse, Ganessan; Singhal, Nimit; Davis, Ian; Boland, Amy; McDonald, Ann; Thomson, Damien.

In: Supportive Care in Cancer, Vol. 21, No. 6, 06.2013, p. 1561-1568.

Research output: Contribution to journalArticleResearchpeer-review

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T1 - Results of a 7-day aprepitant schedule for the prevention of nausea and vomiting in 5-day cisplatin-based germ cell tumor chemotherapy

AU - Olver, Ian

AU - Grimison, Peter

AU - Chatfield, Mark

AU - Stockler, Martin

AU - Toner, Guy

AU - Gebski, Val

AU - Harrup, Rosemary

AU - Underhill, Craig

AU - Kichenadasse, Ganessan

AU - Singhal, Nimit

AU - Davis, Ian

AU - Boland, Amy

AU - McDonald, Ann

AU - Thomson, Damien

PY - 2013/6

Y1 - 2013/6

N2 - Purpose: The purpose of this study was to determine the efficacy of adding a 7-day aprepitant schedule to a 5HT3 receptor antagonist and dexamethasone for patients with germ cell tumors receiving first-line 5-day cisplatin-based chemotherapy.Methods: In a single-arm, open-label, multi-center, phase 2 trial, chemo-naive patients received aprepitant 125 mg PO (per oral) on day 1 and 80 mg PO on days 2 to 7, a 5HT3 receptor antagonist on days 1 to 5, and dexamethasone 8 mg on days 1 to 8. The primary endpoint was no emesis (vomiting or dry retching) during days 1 to 7 of cycle 1.Results: Fifty patients were recruited. For cycle 1, proportions reporting no emesis on day 1, no emesis on days 1 to 7, no nausea on day 1, and no nausea on days 1 to 7 were 96, 82, 71, and 27%, respectively. The efficacy was maintained in all cycles with over 80% of patients reporting no emesis on any given day of any given cycle. Emesis was more common on days 4 to 7 (68% episodes) than on days 1 to 3 (32% episodes). Over any 24-h period, 49% of patients with emesis reported no more than two episodes, and 62% of patients with nausea reported intensity as 3 or less on a scale from 0 to 10. There were no unexpected or serious adverse events reported.Conclusion: Adding 7 days of aprepitant to a 5HT3 receptor antagonist and dexamethasone effectively controlled acute and delayed emesis with 5-day cisplatin regimens. Days of nausea were more common than days of vomiting.

AB - Purpose: The purpose of this study was to determine the efficacy of adding a 7-day aprepitant schedule to a 5HT3 receptor antagonist and dexamethasone for patients with germ cell tumors receiving first-line 5-day cisplatin-based chemotherapy.Methods: In a single-arm, open-label, multi-center, phase 2 trial, chemo-naive patients received aprepitant 125 mg PO (per oral) on day 1 and 80 mg PO on days 2 to 7, a 5HT3 receptor antagonist on days 1 to 5, and dexamethasone 8 mg on days 1 to 8. The primary endpoint was no emesis (vomiting or dry retching) during days 1 to 7 of cycle 1.Results: Fifty patients were recruited. For cycle 1, proportions reporting no emesis on day 1, no emesis on days 1 to 7, no nausea on day 1, and no nausea on days 1 to 7 were 96, 82, 71, and 27%, respectively. The efficacy was maintained in all cycles with over 80% of patients reporting no emesis on any given day of any given cycle. Emesis was more common on days 4 to 7 (68% episodes) than on days 1 to 3 (32% episodes). Over any 24-h period, 49% of patients with emesis reported no more than two episodes, and 62% of patients with nausea reported intensity as 3 or less on a scale from 0 to 10. There were no unexpected or serious adverse events reported.Conclusion: Adding 7 days of aprepitant to a 5HT3 receptor antagonist and dexamethasone effectively controlled acute and delayed emesis with 5-day cisplatin regimens. Days of nausea were more common than days of vomiting.

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