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儿童肿瘤研究组关于接受顺铂化疗儿童耳毒性评估的全组前瞻性研究(ACCL05C1):一份报告

Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy (ACCL05C1): A Report From the Children's Oncology Group.

作者信息

Knight Kristin R, Chen Lu, Freyer David, Aplenc Richard, Bancroft Mary, Bliss Bonnie, Dang Ha, Gillmeister Biljana, Hendershot Eleanor, Kraemer Dale F, Lindenfeld Lanie, Meza Jane, Neuwelt Edward A, Pollock Brad H, Sung Lillian

机构信息

Kristin R. Knight and Edward A. Neuwelt, Oregon Health and Science University, Portland, OR; Lu Chen and Ha Dang, Children's Oncology Group, Monrovia; David Freyer, Children's Hospital Los Angeles; Ha Dang, University of Southern California, Los Angeles; Lanie Lindenfeld, City of Hope, Duarte; Brad H. Pollock, University of California, Davis, Davis, CA; Richard Aplenc, Children's Hospital of Philadelphia, Philadelphia, PA; Mary Bancroft, University of Florida, Gainesville; Dale F. Kraemer, University of Florida, Jacksonville, FL; Bonnie Bliss, Biljana Gillmeister, Jane Meza, and Lillian Sung, The Hospital for Sick Children, Toronto; and Eleanor Hendershot, McMaster Children's Hospital, Hamilton, Ontario, Canada.

出版信息

J Clin Oncol. 2017 Feb;35(4):440-445. doi: 10.1200/JCO.2016.69.2319. Epub 2016 Dec 12.

Abstract

Purpose Optimal assessment methods and criteria for reporting hearing outcomes in children who receive treatment with cisplatin are uncertain. The objectives of our study were to compare different ototoxicity classification systems, to evaluate the feasibility of including otoacoustic emissions and extended high frequency audiometry, and to evaluate a central review mechanism for audiologic results for cisplatin-treated children in the cooperative group setting. Patients and Methods Eligible participants were 1 to 30 years, with planned cisplatin-containing treatment. Hearing evaluations were conducted at baseline, before each cisplatin cycle, and at the end of therapy. Audiologic results were assessed and graded by the testing audiologist and by two central review audiologists using the American Speech-Language-Hearing Association Ototoxicity Criteria (ASHA), Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE), and Brock Ototoxicity Grades (Brock). One central reviewer also used the International Society of Pediatric Oncology Ototoxicity Scale (SIOP). Results At the end of treatment, the prevalence of any degree of ototoxicity ranged from 40% to 56%, and severe ototoxicity ranged from 7% to 22%. Compared with CTCAE, SIOP detected significantly more ototoxicity ( P = .004), whereas Brock criteria detected significantly fewer patients with any or severe ototoxicity ( P < .001 for both). SIOP detected ototoxicity earlier than did the other scales. Agreement between the central reviewers and the institutional audiologist was almost perfect for ASHA and Brock, whereas the poorest agreement occurred with CTCAE. Conclusion The SIOP scale may be superior to ASHA, Brock, and CTCAE scales for classifying ototoxicity in pediatric patients who were treated with cisplatin. Future studies should evaluate inter-rater reliability of the SIOP scale.

摘要

目的 对于接受顺铂治疗的儿童,目前尚无确定的最佳听力结果评估方法和报告标准。我们研究的目的是比较不同的耳毒性分类系统,评估纳入耳声发射和扩展高频听力测定的可行性,并评估在合作组环境下对顺铂治疗儿童的听力结果进行集中审查的机制。

患者和方法 符合条件的参与者年龄在1至30岁之间,计划接受含顺铂的治疗。在基线、每个顺铂疗程前以及治疗结束时进行听力评估。听力结果由测试听力学家以及两名集中审查听力学家使用美国言语-语言-听力协会耳毒性标准(ASHA)、不良事件通用术语标准第3.0版(CTCAE)和布罗克耳毒性分级(Brock)进行评估和分级。一名集中审查员还使用了国际小儿肿瘤学会耳毒性量表(SIOP)。

结果 在治疗结束时,任何程度耳毒性的患病率在40%至56%之间,严重耳毒性的患病率在7%至22%之间。与CTCAE相比,SIOP检测到的耳毒性明显更多(P = .004),而布罗克标准检测到的任何程度或严重耳毒性的患者明显更少(两者P均 < .001)。SIOP比其他量表更早检测到耳毒性。集中审查员与机构听力学家之间对于ASHA和布罗克标准的一致性几乎完美,而与CTCAE的一致性最差。

结论 在对接受顺铂治疗的儿科患者进行耳毒性分类时,SIOP量表可能优于ASHA、布罗克和CTCAE量表。未来的研究应评估SIOP量表的评分者间信度。

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