Amifostine does not prevent platinum-induced hearing loss associated with the treatment of children with hepatoblastoma: A report of the intergroup hepatoblastoma study p9645 as a part of the Children's Oncology Group

Howard M. Katzenstein, Kay W. Chang, Mark Krailo, Zhengjia Chen, Milton J. Finegold, Jon Rowland, Marleta Reynolds, Alberto Pappo, Wendy B. London, Marcio Malogolowkin

Research output: Contribution to journalArticle

57 Citations (Scopus)

Abstract

BACKGROUND: The current study was conducted to determine whether amifostine is effective in reducing the toxicities associated with the administration of platinum-containing regimens in children with hepatoblastoma (HB). METHODS: Patients were enrolled on P9645 beginning in March of 1999. Patients who had stage I/II disease received treatment with 4 cycles of combined cisplatin, 5-fluorouracil, and vincristine (C5V) with or without amifostine. Patients who had stage III/IV disease were randomized to receive treatment with 6 cycles of either C5V with or without amifostine or carboplatin alternating with cisplatin (CC) with or without amifostine. Patients who were randomized to receive amifostine were given a dose of 740 mg/m2 intravenously over 15 minutes before each administration of a platinum agent. RESULTS: Eighty-two patients were considered in a special interim analysis of the incidence of toxicity. The disease outcome for patients who received amifostine was similar to the outcome for patients who did not receive amifostine (P=.22). The incidence of significant hearing loss (>40 dB) was similar for patients who did or did not receive amifostine (38% [14 of 37 patients] vs 38% [17 of 45 patients], respectively; P=.68). There were no differences in the incidence of renal or bone marrow toxicities evaluated. Patients who received amifostine had a higher incidence of hypocalcemia (5% vs 0.5%; P=.00006). CONCLUSIONS: Amifostine in the doses and schedule used in this study failed to significantly reduce the incidence of platinum-induced toxicities in patients with HB.

Original languageEnglish (US)
Pages (from-to)5828-5835
Number of pages8
JournalCancer
Volume115
Issue number24
DOIs
StatePublished - Dec 15 2009
Externally publishedYes

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Amifostine
Hepatoblastoma
Platinum
Hearing Loss
Therapeutics
Incidence
Cisplatin
Vincristine
Fluorouracil
Hypocalcemia
Carboplatin

Keywords

  • Amifostine
  • Hearing
  • Hepatoblastoma
  • Ototoxicity

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Amifostine does not prevent platinum-induced hearing loss associated with the treatment of children with hepatoblastoma : A report of the intergroup hepatoblastoma study p9645 as a part of the Children's Oncology Group. / Katzenstein, Howard M.; Chang, Kay W.; Krailo, Mark; Chen, Zhengjia; Finegold, Milton J.; Rowland, Jon; Reynolds, Marleta; Pappo, Alberto; London, Wendy B.; Malogolowkin, Marcio.

In: Cancer, Vol. 115, No. 24, 15.12.2009, p. 5828-5835.

Research output: Contribution to journalArticle

Katzenstein, Howard M. ; Chang, Kay W. ; Krailo, Mark ; Chen, Zhengjia ; Finegold, Milton J. ; Rowland, Jon ; Reynolds, Marleta ; Pappo, Alberto ; London, Wendy B. ; Malogolowkin, Marcio. / Amifostine does not prevent platinum-induced hearing loss associated with the treatment of children with hepatoblastoma : A report of the intergroup hepatoblastoma study p9645 as a part of the Children's Oncology Group. In: Cancer. 2009 ; Vol. 115, No. 24. pp. 5828-5835.
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abstract = "BACKGROUND: The current study was conducted to determine whether amifostine is effective in reducing the toxicities associated with the administration of platinum-containing regimens in children with hepatoblastoma (HB). METHODS: Patients were enrolled on P9645 beginning in March of 1999. Patients who had stage I/II disease received treatment with 4 cycles of combined cisplatin, 5-fluorouracil, and vincristine (C5V) with or without amifostine. Patients who had stage III/IV disease were randomized to receive treatment with 6 cycles of either C5V with or without amifostine or carboplatin alternating with cisplatin (CC) with or without amifostine. Patients who were randomized to receive amifostine were given a dose of 740 mg/m2 intravenously over 15 minutes before each administration of a platinum agent. RESULTS: Eighty-two patients were considered in a special interim analysis of the incidence of toxicity. The disease outcome for patients who received amifostine was similar to the outcome for patients who did not receive amifostine (P=.22). The incidence of significant hearing loss (>40 dB) was similar for patients who did or did not receive amifostine (38{\%} [14 of 37 patients] vs 38{\%} [17 of 45 patients], respectively; P=.68). There were no differences in the incidence of renal or bone marrow toxicities evaluated. Patients who received amifostine had a higher incidence of hypocalcemia (5{\%} vs 0.5{\%}; P=.00006). CONCLUSIONS: Amifostine in the doses and schedule used in this study failed to significantly reduce the incidence of platinum-induced toxicities in patients with HB.",
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T1 - Amifostine does not prevent platinum-induced hearing loss associated with the treatment of children with hepatoblastoma

T2 - A report of the intergroup hepatoblastoma study p9645 as a part of the Children's Oncology Group

AU - Katzenstein, Howard M.

AU - Chang, Kay W.

AU - Krailo, Mark

AU - Chen, Zhengjia

AU - Finegold, Milton J.

AU - Rowland, Jon

AU - Reynolds, Marleta

AU - Pappo, Alberto

AU - London, Wendy B.

AU - Malogolowkin, Marcio

PY - 2009/12/15

Y1 - 2009/12/15

N2 - BACKGROUND: The current study was conducted to determine whether amifostine is effective in reducing the toxicities associated with the administration of platinum-containing regimens in children with hepatoblastoma (HB). METHODS: Patients were enrolled on P9645 beginning in March of 1999. Patients who had stage I/II disease received treatment with 4 cycles of combined cisplatin, 5-fluorouracil, and vincristine (C5V) with or without amifostine. Patients who had stage III/IV disease were randomized to receive treatment with 6 cycles of either C5V with or without amifostine or carboplatin alternating with cisplatin (CC) with or without amifostine. Patients who were randomized to receive amifostine were given a dose of 740 mg/m2 intravenously over 15 minutes before each administration of a platinum agent. RESULTS: Eighty-two patients were considered in a special interim analysis of the incidence of toxicity. The disease outcome for patients who received amifostine was similar to the outcome for patients who did not receive amifostine (P=.22). The incidence of significant hearing loss (>40 dB) was similar for patients who did or did not receive amifostine (38% [14 of 37 patients] vs 38% [17 of 45 patients], respectively; P=.68). There were no differences in the incidence of renal or bone marrow toxicities evaluated. Patients who received amifostine had a higher incidence of hypocalcemia (5% vs 0.5%; P=.00006). CONCLUSIONS: Amifostine in the doses and schedule used in this study failed to significantly reduce the incidence of platinum-induced toxicities in patients with HB.

AB - BACKGROUND: The current study was conducted to determine whether amifostine is effective in reducing the toxicities associated with the administration of platinum-containing regimens in children with hepatoblastoma (HB). METHODS: Patients were enrolled on P9645 beginning in March of 1999. Patients who had stage I/II disease received treatment with 4 cycles of combined cisplatin, 5-fluorouracil, and vincristine (C5V) with or without amifostine. Patients who had stage III/IV disease were randomized to receive treatment with 6 cycles of either C5V with or without amifostine or carboplatin alternating with cisplatin (CC) with or without amifostine. Patients who were randomized to receive amifostine were given a dose of 740 mg/m2 intravenously over 15 minutes before each administration of a platinum agent. RESULTS: Eighty-two patients were considered in a special interim analysis of the incidence of toxicity. The disease outcome for patients who received amifostine was similar to the outcome for patients who did not receive amifostine (P=.22). The incidence of significant hearing loss (>40 dB) was similar for patients who did or did not receive amifostine (38% [14 of 37 patients] vs 38% [17 of 45 patients], respectively; P=.68). There were no differences in the incidence of renal or bone marrow toxicities evaluated. Patients who received amifostine had a higher incidence of hypocalcemia (5% vs 0.5%; P=.00006). CONCLUSIONS: Amifostine in the doses and schedule used in this study failed to significantly reduce the incidence of platinum-induced toxicities in patients with HB.

KW - Amifostine

KW - Hearing

KW - Hepatoblastoma

KW - Ototoxicity

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