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.).
Neuro Oncol. 2014 Jun;16(6):848-55. doi: 10.1093/neuonc/not241. Epub 2014 Jan 10.
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.
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.
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).
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.
本研究旨在通过扩大先前的分析范围，评估氨磷汀对接受顺铂治疗的平均风险髓母细胞瘤患者保护作用，以防止顺铂引起的严重听力损失。此外，本研究旨在评估氨磷汀对接受顺铂治疗的高危髓母细胞瘤患者严重听力损失的作用。
本研究纳入了 379 例新诊断的髓母细胞瘤患者（年龄 3-21 岁），他们参加了两项连续的圣裘德临床研究方案中的一项，方案中包括 4 个周期的 75mg/m²顺铂治疗，比较了他们是否在每次顺铂输注前 3 小时内接受 600mg/m²氨磷汀。氨磷汀的给药不是随机的。在方案治疗开始后 5.5 至 24.5 个月之间进行最后一次听力评估，使用 Chang 耳毒性量表进行分级。≥2b 级（需要助听器或耳聋的损失）被认为是严重事件。
在平均风险患者（n=263）中，氨磷汀与严重听力损失的保护作用相关（调整后的 OR，0.30；95%CI，0.14-0.64）。然而，对于高危患者（n=116），没有足够的证据表明氨磷汀可以预防严重听力损失（OR，0.89；95%CI，0.31-2.54）。
尽管本研究中的患者未随机分配接受氨磷汀治疗，但我们发现证据支持氨磷汀用于保护平均风险但不是高危髓母细胞瘤患者免受顺铂引起的严重听力损失。
