James G Gurney1, Johnnie K Bass1, Arzu Onar-Thomas1, Jie Huang1, Murali Chintagumpala1, Eric Bouffet1, Tim Hassall1, Sridharan Gururangan1, John A Heath1, Stewart Kellie1, Richard Cohn1, Michael J Fisher1, Atmaram Pai Panandiker1, Thomas E Merchant1, Ashok Srinivasan1, Cynthia Wetmore1, Ibrahim Qaddoumi1, Clinton F Stewart1, Gregory T Armstrong1, Alberto Broniscer1, Amar Gajjar1. 1. Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis Tenneessee (J.G.G., G.T.A.); Department of Rehabilitation Service, St. Jude Children's Research Hospital, Memphis Tenneessee (J.K.B.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis Tenneessee (A.O.-T., J.H.); Department of Oncology, St. Jude Children's Research Hospital, Memphis Tenneessee (C.W., I.Q., G.T.A., A.B., A.G.); Department of Radiological Sciences, St. Jude Children's Research Hospital, Memphis Tenneessee, (A.P.P., T.E.M.); Department of Bone Marrow Transplantation, St. Jude Children's Research Hospital, Memphis, Tenneessee (A.S.); Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis Tenneessee (C.F.S.); Department of Pediatrics, Texas Children's Cancer Center, Houston, Texas (M.C.); Hospital for Sick Children, Toronto, Ontario, Canada (E.B.); Royal Children's Hospital Brisbane, Herston, Australia (T.H.); The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina (S.G.); The Royal Children's Hospital Melbourne, Victoria, Australia (J.A.H.); Children's Hospital at Westmead, Sydney, Australia (S.K.); Sydney Children's Hospital, Sydney, Australia (R.C.); Children's Hospital of Philadelphia, Philadelphia, Pennsylvania (M.J.F.); School of Public Health, University of Memphis, Memphis, Tenneessee (J.G.G.).
Abstract
BACKGROUND: The purpose of this study was to evaluate amifostine for protection from cisplatin-induced serious hearing loss in patients with average-risk medulloblastoma by extending a previous analysis to a much larger sample size. In addition, this study aimed to assess amifostine with serious hearing loss in patients with high-risk medulloblastoma treated withcisplatin. METHODS:Newly diagnosed medulloblastoma patients (n = 379; ages 3-21 years), enrolled on one of 2 sequential St. Jude clinical protocols that included 4 courses of 75 mg/m(2) cisplatin, were compared for hearing loss by whether or not they received 600 mg/m(2) of amifostine immediately before and 3 hours into each cisplatin infusion. Amifostine administration was not randomized. The last audiological evaluation between 5.5 and 24.5 months following protocol treatment initiation was graded using the Chang Ototoxicity Scale. A grade of ≥ 2b (loss requiring a hearing aid or deafness) was considered a serious event. RESULTS: Among average-risk patients (n = 263), amifostine was associated with protection from serious hearing loss (adjusted OR, 0.30; 95% CI, 0.14-0.64). For high-risk patients (n = 116), however, there was not sufficient evidence to conclude that amifostine prevented serious hearing loss (OR, 0.89; 95% CI, 0.31-2.54). CONCLUSIONS: Although patients in this study were not randomly assigned to amifostine treatment, we found evidence in favor of amifostine administration for protection against cisplatin-induced serious hearing loss in average-risk but not in high-risk, medulloblastoma patients.
RCT Entities:
BACKGROUND: The purpose of this study was to evaluate amifostine for protection from cisplatin-induced serious hearing loss in patients with average-risk medulloblastoma by extending a previous analysis to a much larger sample size. In addition, this study aimed to assess amifostine with serious hearing loss in patients with high-risk medulloblastoma treated with cisplatin. METHODS: Newly diagnosed medulloblastomapatients (n = 379; ages 3-21 years), enrolled on one of 2 sequential St. Jude clinical protocols that included 4 courses of 75 mg/m(2) cisplatin, were compared for hearing loss by whether or not they received 600 mg/m(2) of amifostine immediately before and 3 hours into each cisplatin infusion. Amifostine administration was not randomized. The last audiological evaluation between 5.5 and 24.5 months following protocol treatment initiation was graded using the Chang Ototoxicity Scale. A grade of ≥ 2b (loss requiring a hearing aid or deafness) was considered a serious event. RESULTS: Among average-risk patients (n = 263), amifostine was associated with protection from serious hearing loss (adjusted OR, 0.30; 95% CI, 0.14-0.64). For high-risk patients (n = 116), however, there was not sufficient evidence to conclude that amifostine prevented serious hearing loss (OR, 0.89; 95% CI, 0.31-2.54). CONCLUSIONS: Although patients in this study were not randomly assigned to amifostine treatment, we found evidence in favor of amifostine administration for protection against cisplatin-induced serious hearing loss in average-risk but not in high-risk, medulloblastomapatients.
Authors: Brian W Blakley; James I Cohen; Nancy D Doolittle; Leslie L Muldoon; K C Campbell; D Thomas Dickey; Edward A Neuwelt Journal: Laryngoscope Date: 2002-11 Impact factor: 3.325
Authors: Surya Rednam; Michael E Scheurer; Adekunle Adesina; Ching C Lau; Mehmet Fatih Okcu Journal: Pediatr Blood Cancer Date: 2012-10-12 Impact factor: 3.167
Authors: Heng Xu; Giles W Robinson; Jie Huang; Joshua Yew-Suang Lim; Hui Zhang; Johnnie K Bass; Alberto Broniscer; Murali Chintagumpala; Ute Bartels; Sri Gururangan; Tim Hassall; Michael Fisher; Richard Cohn; Tetsuji Yamashita; Tal Teitz; Jian Zuo; Arzu Onar-Thomas; Amar Gajjar; Clinton F Stewart; Jun J Yang Journal: Nat Genet Date: 2015-02-09 Impact factor: 38.330
Authors: Traci W Olivier; Johnnie K Bass; Jason M Ashford; Rebecca Beaulieu; Sarah M Scott; Jane E Schreiber; Shawna Palmer; Donald J Mabbott; Michelle A Swain; Melanie Bonner; Robyn Boyle; Mary Lynn Chapeiski; Karen D Evankovich; Carol L Armstrong; Sarah J Knight; Shengjie Wu; Arzu Onar-Thomas; Amar Gajjar; Heather M Conklin Journal: J Clin Oncol Date: 2019-05-02 Impact factor: 44.544
Authors: Tara M Brinkman; Johnnie K Bass; Zhenghong Li; Kirsten K Ness; Amar Gajjar; Alberto S Pappo; Gregory T Armstrong; Thomas E Merchant; Deo Kumar Srivastava; Leslie L Robison; Melissa M Hudson; James G Gurney Journal: Cancer Date: 2015-08-19 Impact factor: 6.860
Authors: Johnnie K Bass; Chia-Ho Hua; Jie Huang; Arzu Onar-Thomas; Kirsten K Ness; Skye Jones; Stephanie White; Shaum P Bhagat; Kay W Chang; Thomas E Merchant Journal: J Clin Oncol Date: 2016-01-25 Impact factor: 44.544
Authors: Eva Clemens; Marry M van den Heuvel-Eibrink; Renée L Mulder; Leontien C M Kremer; Melissa M Hudson; Roderick Skinner; Louis S Constine; Johnnie K Bass; Claudia E Kuehni; Thorsten Langer; Elvira C van Dalen; Edith Bardi; Nicolas-Xavier Bonne; Penelope R Brock; Beth Brooks; Bruce Carleton; Eric Caron; Kay W Chang; Karen Johnston; Kristin Knight; Paul C Nathan; Etan Orgel; Pinki K Prasad; Jan Rottenberg; Katrin Scheinemann; Andrica C H de Vries; Thomas Walwyn; Annette Weiss; Antoinette Am Zehnhoff-Dinnesen; Richard J Cohn; Wendy Landier Journal: Lancet Oncol Date: 2019-01 Impact factor: 54.433