TY - JOUR
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
N1 - Funding Information:
Acknowledgments This research was sponsored by Helsinn Healthcare, S.A., Pambio-Noranco (Lugano), Switzerland and supported by MGI PHARMA, INC., Bloomington, MN, USA. Bruce Roth, MD, from Vanderbilt Medical Center, Nashville, TN, USA contributed to this research as a principal investigator. Medical writing and editorial assistance in the preparation of this manuscript were provided by Thomson Scientific Connexions through support from MGI PHARMA, INC. Portions of this research have been presented in poster form at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2–6, 2006, Atlanta, GA, USA; at the 2006 MASCC/ISOO18th International Symposium, June 22–24, 2006, Toronto, Canada; and at the 2nd Annual Chicago Supportive Oncology Conference, September 28–30, 2006, Chicago, IL, USA.
PY - 2007/11
Y1 - 2007/11
N2 - 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.
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.
KW - Chemotherapy-induced nausea and vomiting
KW - Cisplatin
KW - Multiple-day
KW - Palonosetron
KW - Testicular cancer
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U2 - 10.1007/s00520-007-0255-6
DO - 10.1007/s00520-007-0255-6
M3 - Article
C2 - 17436025
AN - SCOPUS:35348818158
SN - 0941-4355
VL - 15
SP - 1293
EP - 1300
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
IS - 11
ER -