title: A phase 2 study of bortezomib in combination with ifosfamide/vinorelbine in paediatric patients and young adults with refractory/recurrent Hodgkin lymphoma: a Children's Oncology Group study.
abstract: A Children's Oncology Group clinical trial aimed to determine if bortezomib (B) increased the efficacy of ifosfamide and vinorelbine (IV) in paediatric Hodgkin lymphoma (HL). This study enrolled 26 relapsed HL patients (<30 years) treated with two to four cycles of IVB. The primary endpoint was anatomic complete response (CR) after two cycles. Secondary endpoints included overall response (OR: CR + partial response) at study completion compared to historical controls [72%; 95% confidence interval (CI): 59-83%]. Although few patients achieved the primary objective, OR with IVB improved to 83% (95% CI: 61-95%; p = 0.32). Although not statistically different, results suggest IVB may be a promising combination.
authors.affiliation: Department of Pediatrics, Division of Pediatric Haematology-Oncology, Texas Children's Cancer Center and Baylor College of Medicine, Houston, TX, USA.
authors.forename: Terzah M
authors.initials: TM
authors.lastname: Horton
authors.affiliation: UMDNJ-Robert Wood Johnson Medical School, Brunswick, NJ, USA.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Drachtman
authors.affiliation: Children's Oncology Group, Statistics and Data Center, Monrovia, CA, USA.
authors.forename: Lu
authors.initials: L
authors.lastname: Chen
authors.affiliation: Department of Pediatrics, The Children's Hospital at Montefiore, Albert Einstein College of Medicine, Bronx, NY, USA.
authors.forename: Peter D
authors.initials: PD
authors.lastname: Cole
authors.affiliation: Quality Assurance Response Centre (QARC), Brown University, Providence, RI, USA.
authors.forename: Kathleen
authors.initials: K
authors.lastname: McCarten
authors.affiliation: Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Stephan
authors.initials: S
authors.lastname: Voss
authors.affiliation: Department of Pediatric Radiology, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Guillerman
authors.affiliation: Children's Oncology Group, Statistics and Data Center, Monrovia, CA, USA.
authors.forename: Allen
authors.initials: A
authors.lastname: Buxton
authors.affiliation: Department of Oncology, St. Jude's Children's Research Hospital, Memphis, TN, USA.
authors.forename: Scott C
authors.initials: SC
authors.lastname: Howard
authors.affiliation: Department of Pharmacy, University of Mississippi, Jackson, MS, USA.
authors.forename: Shirley M
authors.initials: SM
authors.lastname: Hogan
authors.affiliation: Department of Pathology, Texas Children's Hospital and Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Andrea M
authors.initials: AM
authors.lastname: Sheehan
authors.affiliation: Department of Pathology, Texas Children's Hospital and Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Dolores
authors.initials: D
authors.lastname: López-Terrada
authors.affiliation: Department of Pediatrics, Division of Pediatric Haematology-Oncology, Texas Children's Cancer Center and Baylor College of Medicine, Houston, TX, USA.
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Mrazek
authors.affiliation: Department of Pediatrics, Division of Pediatric Haematology-Oncology, Texas Children's Cancer Center and Baylor College of Medicine, Houston, TX, USA.
authors.forename: Neeraj
authors.initials: N
authors.lastname: Agrawal
authors.affiliation: Division of Biostatistics, Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Meng-Fen
authors.initials: MF
authors.lastname: Wu
authors.affiliation: Division of Biostatistics, Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Hao
authors.initials: H
authors.lastname: Liu
authors.affiliation: St. Jude Midwest Affiliate, Peoria, IL, USA.
authors.forename: Pedro A
authors.initials: PA
authors.lastname: De Alarcon
authors.affiliation: Memorial Sloan-Kettering Cancer Centre, New York, NY, USA.
authors.forename: Tanya M
authors.initials: TM
authors.lastname: Trippet
authors.affiliation: Department of Pediatrics, MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Cindy L
authors.initials: CL
authors.lastname: Schwartz
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage; D000069286:Bortezomib; D002648:Child; D002675:Child, Preschool; D018572:Disease-Free Survival; D006689:Hodgkin Disease / Q000188:drug therapy*; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D011719:Pyrazines / Q000008:administration & dosage; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D055815:Young Adult
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; D014747:Vinblastine; D000069286:Bortezomib; D000077235:Vinorelbine; D007069:Ifosfamide
keywords: NF-κB; childhood haematological malignancies; clinical trials; paediatric oncology
references.citation: J Clin Oncol. 2005 Sep 1;23(25):6181-9
references.pmid: 16135485
references.citation: Radiol Clin North Am. 2008 Mar;46(2):213-23, vii
references.pmid: 18619377
references.citation: Blood. 2009 Sep 3;114(10):2051-9
references.pmid: 19584400
references.citation: Curr Pharm Des. 2011;17(15):1483-99
references.pmid: 21504411
references.citation: Pediatr Blood Cancer. 2013 Jun;60(6):972-8
references.pmid: 23255501
references.citation: Pediatr Blood Cancer. 2015 Jan;62(1):60-4
references.pmid: 25308760