Amifostine does not prevent platinum‐induced hearing loss associated with the treatment of children with hepatoblastoma

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/m 2 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. Cancer 2009. © 2009 American Cancer Society.