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西妥昔单抗联合放疗用于不可切除的局部晚期头颈部鳞状细胞癌患者——一项开放标签单臂II期研究。

Cetuximab plus radiotherapy in patients with unresectable locally advanced squamous cell carcinoma of head and neck region--a open labelled single arm phase II study.

作者信息

Dattatreya S, Goswami C

机构信息

Department of Medical Oncology, Omega Hospital, Banjara Hills, Hyderabad, Andhra Pradesh, India.

出版信息

Indian J Cancer. 2011 Apr-Jun;48(2):154-7. doi: 10.4103/0019-509X.82873.

DOI:10.4103/0019-509X.82873
PMID:21768658
Abstract

PURPOSE

To evaluate feasibility, safety and outcome of cetuximab concurrent with radiotherapy in locally advanced head-neck cancer.

MATERIALS AND METHODS

Between March 2007 and January 2008 eligible cases of locally advanced unresectable (Stage IV) squamous cell carcinoma of head and neck were enrolled in this single arm, open labeled phase II Study. They were treated with cetuximab for a duration of 8 weeks and concomitant RT for 7 weeks (starting one week after initiating Cetuximab).

RESULTS

A total of 19 eligible patients were enrolled. The median age of patients was 53 years, all patients happening to be male. The performance status of the patients was 0/1. The location of the primary tumor was oropharynx in 12 cases, oral cavity in 4, larynx in 2, and hypopharynx in one case. The overall response rate (ORR) was 68.42% and the overall survival at 2 year was 84 %. All 13 patients who completed two years follow-up after completion of study treatment continued to be alive with no evidence of disease progression. One patient also remained alive with progressive disease.

CONCLUSIONS

Cetuximab concurrent with radiotherapy is a safe and effective option in advanced head-neck cancer patients.

摘要

目的

评估西妥昔单抗与放疗联合用于局部晚期头颈癌的可行性、安全性及疗效。

材料与方法

2007年3月至2008年1月期间,符合条件的局部晚期不可切除(IV期)头颈鳞状细胞癌患者纳入本单臂、开放标签的II期研究。患者接受西妥昔单抗治疗8周,并同时接受放疗7周(在开始使用西妥昔单抗一周后开始)。

结果

共纳入19例符合条件的患者。患者的中位年龄为53岁,所有患者均为男性。患者的体能状态为0/1。原发肿瘤部位为口咽12例、口腔4例、喉2例、下咽1例。总缓解率(ORR)为68.42%,2年总生存率为84%。完成研究治疗后完成两年随访的13例患者均存活,无疾病进展证据。1例患者虽疾病进展但仍存活。

结论

西妥昔单抗与放疗联合用于晚期头颈癌患者是一种安全有效的选择。

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