Palonosetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy for germ cell cancer

Lawrence H. Einhorn, Mary J. Brames, Robert Dreicer, Craig R. Nichols, Michael T. Cullen, Joseph Bubalo

    Research output: Contribution to journalArticle

    73 Citations (Scopus)

    Abstract

    Goals of work: The aims of this study were to assess the safety and antiemetic efficacy of multiple-day dosing of palonosetron plus dexamethasone in patients receiving highly emetogenic multiple-day cisplatin-based chemotherapy for germ cell tumors. Materials and methods: Forty-one men undergoing 5-day cisplatin-based chemotherapy for testicular cancer received palonosetron 0.25 mg IV once daily 30 min before chemotherapy on days 1, 3, and 5 plus IV dexamethasone 20 mg before chemotherapy on days 1 and 2, and 8 mg PO bid on days 6 and 7 and 4 mg bid on day 8. Safety and efficacy were assessed in 24-h intervals for 9 days. Efficacy endpoints included emesis, intensity of nausea and its interference with patient functioning, and rescue antiemetic use. A subset of patients (n=11) was studied for electrocardiograph effects and pharmacokinetic evaluation. Main results: This multiple-day antiemetic regimen was safe, with headache and constipation the most common treatment-related adverse events, mostly mild. Neither adverse events nor electrocardiographic changes appeared to increase in frequency, duration, or intensity over time despite a 1.42-fold systemic accumulation of palonosetron with repeated doses. The majority of patients had no emesis at any time throughout days 1-5 (51%) or days 6-9 (83%), had no moderate-to-severe nausea, and did not require rescue medication. Most patients reported that nausea had no significant effect on daily functioning on days 1-4 (72%) and days 5-9 (85%). Conclusions: Palonosetron on days 1, 3, and 5, along with a regimen of dexamethasone, was safe and well tolerated and effectively controlled both nausea and emesis in patients undergoing 5-day cisplatin-based chemotherapy for testicular cancer.

    Original languageEnglish (US)
    Pages (from-to)1293-1300
    Number of pages8
    JournalSupportive Care in Cancer
    Volume15
    Issue number11
    DOIs
    StatePublished - Nov 2007

    Fingerprint

    Germ Cell and Embryonal Neoplasms
    Nausea
    Dexamethasone
    Cisplatin
    Vomiting
    Drug Therapy
    Antiemetics
    Testicular Neoplasms
    Safety
    Constipation
    Headache
    palonosetron
    Electrocardiography
    Pharmacokinetics

    Keywords

    • Chemotherapy-induced nausea and vomiting
    • Cisplatin
    • Multiple-day
    • Palonosetron
    • Testicular cancer

    ASJC Scopus subject areas

    • Oncology
    • Nursing(all)

    Cite this

    Palonosetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy for germ cell cancer. / Einhorn, Lawrence H.; Brames, Mary J.; Dreicer, Robert; Nichols, Craig R.; Cullen, Michael T.; Bubalo, Joseph.

    In: Supportive Care in Cancer, Vol. 15, No. 11, 11.2007, p. 1293-1300.

    Research output: Contribution to journalArticle

    Einhorn, Lawrence H. ; Brames, Mary J. ; Dreicer, Robert ; Nichols, Craig R. ; Cullen, Michael T. ; Bubalo, Joseph. / Palonosetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy for germ cell cancer. In: Supportive Care in Cancer. 2007 ; Vol. 15, No. 11. pp. 1293-1300.
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    abstract = "Goals of work: The aims of this study were to assess the safety and antiemetic efficacy of multiple-day dosing of palonosetron plus dexamethasone in patients receiving highly emetogenic multiple-day cisplatin-based chemotherapy for germ cell tumors. Materials and methods: Forty-one men undergoing 5-day cisplatin-based chemotherapy for testicular cancer received palonosetron 0.25 mg IV once daily 30 min before chemotherapy on days 1, 3, and 5 plus IV dexamethasone 20 mg before chemotherapy on days 1 and 2, and 8 mg PO bid on days 6 and 7 and 4 mg bid on day 8. Safety and efficacy were assessed in 24-h intervals for 9 days. Efficacy endpoints included emesis, intensity of nausea and its interference with patient functioning, and rescue antiemetic use. A subset of patients (n=11) was studied for electrocardiograph effects and pharmacokinetic evaluation. Main results: This multiple-day antiemetic regimen was safe, with headache and constipation the most common treatment-related adverse events, mostly mild. Neither adverse events nor electrocardiographic changes appeared to increase in frequency, duration, or intensity over time despite a 1.42-fold systemic accumulation of palonosetron with repeated doses. The majority of patients had no emesis at any time throughout days 1-5 (51{\%}) or days 6-9 (83{\%}), had no moderate-to-severe nausea, and did not require rescue medication. Most patients reported that nausea had no significant effect on daily functioning on days 1-4 (72{\%}) and days 5-9 (85{\%}). Conclusions: Palonosetron on days 1, 3, and 5, along with a regimen of dexamethasone, was safe and well tolerated and effectively controlled both nausea and emesis in patients undergoing 5-day cisplatin-based chemotherapy for testicular cancer.",
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    T1 - Palonosetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy for germ cell cancer

    AU - Einhorn, Lawrence H.

    AU - Brames, Mary J.

    AU - Dreicer, Robert

    AU - Nichols, Craig R.

    AU - Cullen, Michael T.

    AU - Bubalo, Joseph

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    AB - Goals of work: The aims of this study were to assess the safety and antiemetic efficacy of multiple-day dosing of palonosetron plus dexamethasone in patients receiving highly emetogenic multiple-day cisplatin-based chemotherapy for germ cell tumors. Materials and methods: Forty-one men undergoing 5-day cisplatin-based chemotherapy for testicular cancer received palonosetron 0.25 mg IV once daily 30 min before chemotherapy on days 1, 3, and 5 plus IV dexamethasone 20 mg before chemotherapy on days 1 and 2, and 8 mg PO bid on days 6 and 7 and 4 mg bid on day 8. Safety and efficacy were assessed in 24-h intervals for 9 days. Efficacy endpoints included emesis, intensity of nausea and its interference with patient functioning, and rescue antiemetic use. A subset of patients (n=11) was studied for electrocardiograph effects and pharmacokinetic evaluation. Main results: This multiple-day antiemetic regimen was safe, with headache and constipation the most common treatment-related adverse events, mostly mild. Neither adverse events nor electrocardiographic changes appeared to increase in frequency, duration, or intensity over time despite a 1.42-fold systemic accumulation of palonosetron with repeated doses. The majority of patients had no emesis at any time throughout days 1-5 (51%) or days 6-9 (83%), had no moderate-to-severe nausea, and did not require rescue medication. Most patients reported that nausea had no significant effect on daily functioning on days 1-4 (72%) and days 5-9 (85%). Conclusions: Palonosetron on days 1, 3, and 5, along with a regimen of dexamethasone, was safe and well tolerated and effectively controlled both nausea and emesis in patients undergoing 5-day cisplatin-based chemotherapy for testicular cancer.

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    KW - Cisplatin

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    KW - Palonosetron

    KW - Testicular cancer

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