Evaluation of amifostine for protection against cisplatin-induced serious hearing loss in children treated for average-risk or high-risk medulloblastoma

James G. Gurney, Johnnie K. Bass, Arzu Onar-Thomas, Jie Huang, Murali Chintagumpala, Eric Bouffet, Tim Hassall, Sridharan Gururangan, John A. Heath, Stewart Kellie, Richard Cohn, Michael J. Fisher, Atmaram Pai Panandiker, Thomas E. Merchant, Ashok Srinivasan, Cynthia Wetmore, Ibrahim Qaddoumi, Clinton F. Stewart, Gregory Armstrong, Alberto Broniscer & 1 others Amar Gajjar

Research output: Contribution to journalArticle

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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 with cisplatin. 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/m2 cisplatin, were compared for hearing loss by whether or not they received 600 mg/m2 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.

Original languageEnglish (US)
Pages (from-to)848-855
Number of pages8
JournalNeuro-oncology
Volume16
Issue number6
DOIs
StatePublished - Jan 1 2014

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Amifostine
Medulloblastoma
Hearing Loss
Cisplatin
Clinical Protocols
Hearing Aids
Deafness
Sample Size

All Science Journal Classification (ASJC) codes

  • Oncology
  • Clinical Neurology
  • Cancer Research

Cite this

Evaluation of amifostine for protection against cisplatin-induced serious hearing loss in children treated for average-risk or high-risk medulloblastoma. / Gurney, James G.; Bass, Johnnie K.; Onar-Thomas, Arzu; Huang, Jie; Chintagumpala, Murali; Bouffet, Eric; Hassall, Tim; Gururangan, Sridharan; Heath, John A.; Kellie, Stewart; Cohn, Richard; Fisher, Michael J.; Panandiker, Atmaram Pai; Merchant, Thomas E.; Srinivasan, Ashok; Wetmore, Cynthia; Qaddoumi, Ibrahim; Stewart, Clinton F.; Armstrong, Gregory; Broniscer, Alberto; Gajjar, Amar.

In: Neuro-oncology, Vol. 16, No. 6, 01.01.2014, p. 848-855.

Research output: Contribution to journalArticle

Gurney, JG, Bass, JK, Onar-Thomas, A, Huang, J, Chintagumpala, M, Bouffet, E, Hassall, T, Gururangan, S, Heath, JA, Kellie, S, Cohn, R, Fisher, MJ, Panandiker, AP, Merchant, TE, Srinivasan, A, Wetmore, C, Qaddoumi, I, Stewart, CF, Armstrong, G, Broniscer, A & Gajjar, A 2014, 'Evaluation of amifostine for protection against cisplatin-induced serious hearing loss in children treated for average-risk or high-risk medulloblastoma', Neuro-oncology, vol. 16, no. 6, pp. 848-855. https://doi.org/10.1093/neuonc/not241
Gurney, James G. ; Bass, Johnnie K. ; Onar-Thomas, Arzu ; Huang, Jie ; Chintagumpala, Murali ; Bouffet, Eric ; Hassall, Tim ; Gururangan, Sridharan ; Heath, John A. ; Kellie, Stewart ; Cohn, Richard ; Fisher, Michael J. ; Panandiker, Atmaram Pai ; Merchant, Thomas E. ; Srinivasan, Ashok ; Wetmore, Cynthia ; Qaddoumi, Ibrahim ; Stewart, Clinton F. ; Armstrong, Gregory ; Broniscer, Alberto ; Gajjar, Amar. / Evaluation of amifostine for protection against cisplatin-induced serious hearing loss in children treated for average-risk or high-risk medulloblastoma. In: Neuro-oncology. 2014 ; Vol. 16, No. 6. pp. 848-855.
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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 with cisplatin. 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/m2 cisplatin, were compared for hearing loss by whether or not they received 600 mg/m2 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.",
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T1 - Evaluation of amifostine for protection against cisplatin-induced serious hearing loss in children treated for average-risk or high-risk medulloblastoma

AU - Gurney, James G.

AU - Bass, Johnnie K.

AU - Onar-Thomas, Arzu

AU - Huang, Jie

AU - Chintagumpala, Murali

AU - Bouffet, Eric

AU - Hassall, Tim

AU - Gururangan, Sridharan

AU - Heath, John A.

AU - Kellie, Stewart

AU - Cohn, Richard

AU - Fisher, Michael J.

AU - Panandiker, Atmaram Pai

AU - Merchant, Thomas E.

AU - Srinivasan, Ashok

AU - Wetmore, Cynthia

AU - Qaddoumi, Ibrahim

AU - Stewart, Clinton F.

AU - Armstrong, Gregory

AU - Broniscer, Alberto

AU - Gajjar, Amar

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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 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/m2 cisplatin, were compared for hearing loss by whether or not they received 600 mg/m2 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.

AB - 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 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/m2 cisplatin, were compared for hearing loss by whether or not they received 600 mg/m2 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.

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DO - 10.1093/neuonc/not241

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