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一项同期西妥昔单抗-顺铂联合调强放疗治疗局部晚期鼻咽癌的 II 期研究。

A phase II study of concurrent cetuximab-cisplatin and intensity-modulated radiotherapy in locoregionally advanced nasopharyngeal carcinoma.

机构信息

State Key Laboratory in Oncology in South China, Sir YK Pao Centre for Cancer, Department of Clinical Oncology, Hong Kong Cancer Institute. The Chinese University of Hong Kong.

State Key Laboratory in Oncology in South China, Sir YK Pao Centre for Cancer, Department of Clinical Oncology, Hong Kong Cancer Institute. The Chinese University of Hong Kong.

出版信息

Ann Oncol. 2012 May;23(5):1287-1292. doi: 10.1093/annonc/mdr401. Epub 2011 Sep 23.

DOI:10.1093/annonc/mdr401
PMID:21948811
Abstract

BACKGROUND

Based on our previous work on the clinical activity of cetuximab in recurrent nasopharyngeal carcinoma (NPC), we evaluated the feasibility of adding cetuximab to concurrent cisplatin and intensity-modulated radiotherapy (IMRT) in locoregionally advanced NPC.

PATIENTS AND METHODS

Patients with American Joint Committee on Cancer stage III-IVB NPC were given an initial dose of cetuximab (400 mg/m(2)) 7-10 days before receiving concurrent IMRT, weekly cisplatin (30 mg/m(2)/week) and cetuximab (250 mg/m(2)/week).

RESULTS

Thirty patients (median age of 45 years) with stage III (67%), IVA (30%) and IVB (3%) nonkeratinizing NPC were enrolled. Grade 3-4 oropharyngeal mucositis occurred in 26 (87%) patients and 10 (33%) patients required short-term nasogastric feeding. Grade 3 radiotherapy-related dermatitis occurred in six patients (20%) and three patients (10%) had grade 3 cetuximab-related acneiform rash. These grade 3-4 skin and mucosal toxic effects were manageable and reversible. At a median follow-up of 31.8 months [95% confidence interval (CI) 26.2-32.1 months], the 2-year progression-free survival was 86.5% (95% CI 74.3% to 98.8%).

CONCLUSIONS

Concurrent administration of cetuximab, weekly cisplatin and IMRT is a feasible strategy against locoregionally advanced NPC. Preliminary survival data compare favorably with historic data and further follow-up is warranted.

摘要

背景

基于我们之前关于西妥昔单抗在复发性鼻咽癌(NPC)中的临床活性的研究,我们评估了在局部晚期 NPC 中添加西妥昔单抗与顺铂同期和调强放疗(IMRT)的可行性。

患者和方法

III-IVB 期 NPC 患者在接受同期 IMRT 前 7-10 天接受初始剂量的西妥昔单抗(400mg/m2),每周给予顺铂(30mg/m2/周)和西妥昔单抗(250mg/m2/周)。

结果

30 例(中位年龄 45 岁)未分化型 III 期(67%)、IVA 期(30%)和 IVB 期(3%)NPC 患者入组。26 例(87%)患者发生 3-4 级口咽黏膜炎,10 例(33%)患者需要短期鼻饲。6 例(20%)患者发生 3 级放射性皮炎,3 例(10%)患者发生 3 级西妥昔单抗相关痤疮样皮疹。这些 3-4 级皮肤和黏膜毒性反应是可管理和可逆的。中位随访 31.8 个月[95%置信区间(CI)26.2-32.1 个月],2 年无进展生存率为 86.5%(95%CI 74.3%-98.8%)。

结论

西妥昔单抗、每周顺铂和 IMRT 同期治疗是局部晚期 NPC 的一种可行策略。初步生存数据与历史数据相比表现良好,需要进一步随访。

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