Phase II study of fosaprepitant + 5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: a Hoosier Cancer Research Network study

Nabil Adra, Costantine Albany, Mary J. Brames, Somer Case-Eads, Cynthia S. Johnson, Ziyue Liu, Christopher A. Fausel, Timothy Breen, Nasser Hanna, Ralph J. Hauke, Joel Picus, Lawrence Einhorn

Research output: Contribution to journalArticle

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Abstract

Purpose: A phase III study adding aprepitant to a 5HT3 receptor antagonist (5HT3-RA) plus dexamethasone in germ cell tumor (GCT) patients treated with 5-day cisplatin combination chemotherapy demonstrated a significant improvement in complete response (CR) (J Clin Onc 30:3998-4003, 2012). Fosaprepitant has demonstrated non-inferiority compared to aprepitant in single-day cisplatin chemotherapy and is approved as a single-dose alternative. This single-arm phase II study is the first clinical trial evaluating fosaprepitant in patients receiving multi-day cisplatin regimen. Methods: GCT patients receiving a 5-day cisplatin combination chemotherapy were enrolled. Fosaprepitant 150 mg was given IV on days 3 and 5. A 5HT3-RA days 1–5 (days 1, 3, and 5, if palonosetron) plus dexamethasone 20 mg days 1 and 2 and 4 mg po bid days 6, 7, and 8 was administered. Rescue antiemetics were allowed. The primary objective was to determine the CR rate—no emetic episodes or use of rescue medications. Accrual of 64 patients was planned with expected CR > 27 %. Results: Sixty-five patients were enrolled of whom 54 were eligible for analysis. Median age was 33. Fifty-one patients received bleomycin, etoposide, and cisplatin (BEP) chemotherapy. CR was observed in 13 (24.1 %) patients (95 % Agresti-Coull binomial C.I. 14.5 %, 37.1 %). Conclusion: The data in this phase II study, in contrast to our prior phase III study, appears to indicate a lower CR rate with the substitution of fosaprepitant for aprepitant. It is unknown whether the substitution of fosaprepitant for aprepitant provides the same benefit in multi-day cisplatin that was achieved with single-day cisplatin. Trial registration Clinical trial information NCT01736917

Original languageEnglish (US)
Pages (from-to)2837-2842
Number of pages6
JournalSupportive Care in Cancer
Volume24
Issue number7
DOIs
StatePublished - Jul 1 2016

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fosaprepitant
aprepitant
Germ Cell and Embryonal Neoplasms
Cisplatin
Drug Therapy
Research
Neoplasms
Combination Drug Therapy
Dexamethasone
Clinical Trials
Emetics
Antiemetics
Bleomycin
Etoposide
dexamethasone receptor

Keywords

  • Chemotherapy-induced nausea and vomiting
  • Fosaprepitant
  • Germ cell tumor
  • Testicular cancer

ASJC Scopus subject areas

  • Oncology

Cite this

Phase II study of fosaprepitant + 5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy : a Hoosier Cancer Research Network study. / Adra, Nabil; Albany, Costantine; Brames, Mary J.; Case-Eads, Somer; Johnson, Cynthia S.; Liu, Ziyue; Fausel, Christopher A.; Breen, Timothy; Hanna, Nasser; Hauke, Ralph J.; Picus, Joel; Einhorn, Lawrence.

In: Supportive Care in Cancer, Vol. 24, No. 7, 01.07.2016, p. 2837-2842.

Research output: Contribution to journalArticle

Adra, Nabil ; Albany, Costantine ; Brames, Mary J. ; Case-Eads, Somer ; Johnson, Cynthia S. ; Liu, Ziyue ; Fausel, Christopher A. ; Breen, Timothy ; Hanna, Nasser ; Hauke, Ralph J. ; Picus, Joel ; Einhorn, Lawrence. / Phase II study of fosaprepitant + 5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy : a Hoosier Cancer Research Network study. In: Supportive Care in Cancer. 2016 ; Vol. 24, No. 7. pp. 2837-2842.
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abstract = "Purpose: A phase III study adding aprepitant to a 5HT3 receptor antagonist (5HT3-RA) plus dexamethasone in germ cell tumor (GCT) patients treated with 5-day cisplatin combination chemotherapy demonstrated a significant improvement in complete response (CR) (J Clin Onc 30:3998-4003, 2012). Fosaprepitant has demonstrated non-inferiority compared to aprepitant in single-day cisplatin chemotherapy and is approved as a single-dose alternative. This single-arm phase II study is the first clinical trial evaluating fosaprepitant in patients receiving multi-day cisplatin regimen. Methods: GCT patients receiving a 5-day cisplatin combination chemotherapy were enrolled. Fosaprepitant 150 mg was given IV on days 3 and 5. A 5HT3-RA days 1–5 (days 1, 3, and 5, if palonosetron) plus dexamethasone 20 mg days 1 and 2 and 4 mg po bid days 6, 7, and 8 was administered. Rescue antiemetics were allowed. The primary objective was to determine the CR rate—no emetic episodes or use of rescue medications. Accrual of 64 patients was planned with expected CR > 27 {\%}. Results: Sixty-five patients were enrolled of whom 54 were eligible for analysis. Median age was 33. Fifty-one patients received bleomycin, etoposide, and cisplatin (BEP) chemotherapy. CR was observed in 13 (24.1 {\%}) patients (95 {\%} Agresti-Coull binomial C.I. 14.5 {\%}, 37.1 {\%}). Conclusion: The data in this phase II study, in contrast to our prior phase III study, appears to indicate a lower CR rate with the substitution of fosaprepitant for aprepitant. It is unknown whether the substitution of fosaprepitant for aprepitant provides the same benefit in multi-day cisplatin that was achieved with single-day cisplatin. Trial registration Clinical trial information NCT01736917",
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author = "Nabil Adra and Costantine Albany and Brames, {Mary J.} and Somer Case-Eads and Johnson, {Cynthia S.} and Ziyue Liu and Fausel, {Christopher A.} and Timothy Breen and Nasser Hanna and Hauke, {Ralph J.} and Joel Picus and Lawrence Einhorn",
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AU - Brames, Mary J.

AU - Case-Eads, Somer

AU - Johnson, Cynthia S.

AU - Liu, Ziyue

AU - Fausel, Christopher A.

AU - Breen, Timothy

AU - Hanna, Nasser

AU - Hauke, Ralph J.

AU - Picus, Joel

AU - Einhorn, Lawrence

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N2 - Purpose: A phase III study adding aprepitant to a 5HT3 receptor antagonist (5HT3-RA) plus dexamethasone in germ cell tumor (GCT) patients treated with 5-day cisplatin combination chemotherapy demonstrated a significant improvement in complete response (CR) (J Clin Onc 30:3998-4003, 2012). Fosaprepitant has demonstrated non-inferiority compared to aprepitant in single-day cisplatin chemotherapy and is approved as a single-dose alternative. This single-arm phase II study is the first clinical trial evaluating fosaprepitant in patients receiving multi-day cisplatin regimen. Methods: GCT patients receiving a 5-day cisplatin combination chemotherapy were enrolled. Fosaprepitant 150 mg was given IV on days 3 and 5. A 5HT3-RA days 1–5 (days 1, 3, and 5, if palonosetron) plus dexamethasone 20 mg days 1 and 2 and 4 mg po bid days 6, 7, and 8 was administered. Rescue antiemetics were allowed. The primary objective was to determine the CR rate—no emetic episodes or use of rescue medications. Accrual of 64 patients was planned with expected CR > 27 %. Results: Sixty-five patients were enrolled of whom 54 were eligible for analysis. Median age was 33. Fifty-one patients received bleomycin, etoposide, and cisplatin (BEP) chemotherapy. CR was observed in 13 (24.1 %) patients (95 % Agresti-Coull binomial C.I. 14.5 %, 37.1 %). Conclusion: The data in this phase II study, in contrast to our prior phase III study, appears to indicate a lower CR rate with the substitution of fosaprepitant for aprepitant. It is unknown whether the substitution of fosaprepitant for aprepitant provides the same benefit in multi-day cisplatin that was achieved with single-day cisplatin. Trial registration Clinical trial information NCT01736917

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KW - Testicular cancer

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