Lawrence H Einhorn1,2, Mary J Brames3, Robert Dreicer4, Craig R Nichols5, Michael T Cullen6, Joseph Bubalo5. 1. Division of Hematology-Oncology, Indiana University School of Medicine, Indiana University Cancer Center, 535 Barnhill Drive, Room 473, Indianapolis, IN, 46202-5289, USA. leinhorn@iupui.edu. 2. Lance Armstrong Foundation, P.O. Box 161150, Austin, TX, 78716-1150, USA. leinhorn@iupui.edu. 3. Division of Hematology-Oncology, Indiana University School of Medicine, Indiana University Cancer Center, 535 Barnhill Drive, Room 473, Indianapolis, IN, 46202-5289, USA. 4. Department of Solid Tumor Oncology, Taussig Cancer Center, The Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195, USA. 5. Oregon Health and Science University, OHSU Cancer Institute, 3181 SW Sam Jackson Park Road, Portland, OR, 97239, USA. 6. MGI PHARMA, INC., 5775 W. Old Shakopee Road, Bloomington, MN, 55437, USA.
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.
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.
Authors: R J Gralla; D Osoba; M G Kris; P Kirkbride; P J Hesketh; L W Chinnery; R Clark-Snow; D P Gill; S Groshen; S Grunberg; J M Koeller; G R Morrow; E A Perez; J H Silber; D G Pfister Journal: J Clin Oncol Date: 1999-09 Impact factor: 44.544
Authors: Lawrence H Einhorn; Bernardo Rapoport; Jim Koeller; Steven M Grunberg; Petra Feyer; Cynthia Rittenberg; Matti Aapro Journal: Support Care Cancer Date: 2004-10-09 Impact factor: 3.603
Authors: R Gralla; M Lichinitser; S Van Der Vegt; H Sleeboom; J Mezger; C Peschel; G Tonini; R Labianca; A Macciocchi; M Aapro Journal: Ann Oncol Date: 2003-10 Impact factor: 32.976
Authors: P J Hesketh; W H Harvey; W G Harker; T M Beck; T Ryan; L J Bricker; J A Kish; W K Murphy; J D Hainsworth; B Haley Journal: J Clin Oncol Date: 1994-03 Impact factor: 44.544
Authors: F Roila; M Tonato; F Cognetti; E Cortesi; G Favalli; M Marangolo; D Amadori; M A Bella; V Gramazio; D Donati Journal: J Clin Oncol Date: 1991-04 Impact factor: 44.544
Authors: J García Gómez; M E Pérez López; M Alonso Bermejo; Y Escobar Álvarez; J García Mata Journal: Clin Transl Oncol Date: 2013-09-10 Impact factor: 3.405
Authors: Bruce Feinberg; James Gilmore; Sally Haislip; James Jackson; Gagan Jain; Sanjeev Balu; Deborah Buchner Journal: Support Care Cancer Date: 2011-03-29 Impact factor: 3.603
Authors: I N Olver; P Grimison; M Chatfield; M R Stockler; G C Toner; V Gebski; R Harrup; C Underhill; G Kichenadasse; N Singhal; I D Davis; A Boland; A McDonald; D Thomson Journal: Support Care Cancer Date: 2012-12-30 Impact factor: 3.603