title: 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.
abstract: 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.
  
  
  
  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 %.
  
  
  
  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 %).
  
  
  
  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.
authors.affiliation: Division of Hematology/Oncology, Melvin & Bren Simon Cancer Center, Indiana University School of Medicine, 535 Barnhill Drive, RT 400, Indianapolis, IN, 46202, USA. nadra@iu.edu.
authors.forename: Nabil
authors.initials: N
authors.lastname: Adra
authors.affiliation: Division of Hematology/Oncology, Melvin & Bren Simon Cancer Center, Indiana University School of Medicine, 535 Barnhill Drive, RT 400, Indianapolis, IN, 46202, USA.
authors.forename: Costantine
authors.initials: C
authors.lastname: Albany
authors.affiliation: Division of Hematology/Oncology, Melvin & Bren Simon Cancer Center, Indiana University School of Medicine, 535 Barnhill Drive, RT 400, Indianapolis, IN, 46202, USA.
authors.forename: Mary J
authors.initials: MJ
authors.lastname: Brames
authors.affiliation: Division of Hematology/Oncology, Melvin & Bren Simon Cancer Center, Indiana University School of Medicine, 535 Barnhill Drive, RT 400, Indianapolis, IN, 46202, USA.
authors.forename: Somer
authors.initials: S
authors.lastname: Case-Eads
authors.affiliation: Department of Biostatistics, Indiana University, Indianapolis, IN, USA.
authors.forename: Cynthia S
authors.initials: CS
authors.lastname: Johnson
authors.affiliation: Department of Biostatistics, Indiana University, Indianapolis, IN, USA.
authors.forename: Ziyue
authors.initials: Z
authors.lastname: Liu
authors.affiliation: Division of Hematology/Oncology, Melvin & Bren Simon Cancer Center, Indiana University School of Medicine, 535 Barnhill Drive, RT 400, Indianapolis, IN, 46202, USA.
authors.forename: Christopher A
authors.initials: CA
authors.lastname: Fausel
authors.affiliation: Hoosier Cancer Research Network, Indianapolis, IN, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Breen
authors.affiliation: Division of Hematology/Oncology, Melvin & Bren Simon Cancer Center, Indiana University School of Medicine, 535 Barnhill Drive, RT 400, Indianapolis, IN, 46202, USA.
authors.forename: Nasser H
authors.initials: NH
authors.lastname: Hanna
authors.affiliation: Methodist Hospital/Nebraska Cancer Specialists, Omaha, NE, USA.
authors.forename: Ralph J
authors.initials: RJ
authors.lastname: Hauke
authors.affiliation: Division of Hematology/Oncology, Washington University School of Medicine, St. Louis, MO, USA.
authors.forename: Joel
authors.initials: J
authors.lastname: Picus
authors.affiliation: Division of Hematology/Oncology, Melvin & Bren Simon Cancer Center, Indiana University School of Medicine, 535 Barnhill Drive, RT 400, Indianapolis, IN, 46202, USA.
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Einhorn
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002945:Cisplatin / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy* / Q000473:pathology; D058831:Serotonin 5-HT3 Receptor Antagonists / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D009025:Morpholines; D058831:Serotonin 5-HT3 Receptor Antagonists; C579707:fosaprepitant; D003907:Dexamethasone; D002945:Cisplatin
keywords: Chemotherapy-induced nausea and vomiting; Fosaprepitant; Germ cell tumor; Testicular cancer
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