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贝伐单抗联合多西他赛及放疗用于局部晚期头颈部鳞状细胞癌的II期研究

Phase II study of bevacizumab in combination with docetaxel and radiation in locally advanced squamous cell carcinoma of the head and neck.

作者信息

Yao Min, Galanopoulos Nicholas, Lavertu Pierre, Fu Pingfu, Gibson Michael, Argiris Athanassios, Rezaee Rod, Zender Chad, Wasman Jay, Machtay Mitchell, Savvides Panos

机构信息

Department of Radiation Oncology, University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.

Department of Otolaryngology - Head and Neck Surgery, University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.

出版信息

Head Neck. 2015 Nov;37(11):1665-71. doi: 10.1002/hed.23813. Epub 2014 Oct 29.

Abstract

BACKGROUND

The purpose of this study was to establish the efficacy and toxicities of concurrent bevacizumab and docetaxel with radiation for locally advanced head and neck squamous cell carcinoma (HNSCC).

METHODS

Patients with previously untreated HNSCC received standard daily radiotherapy (RT) with concurrent weekly docetaxel (20 mg/m(2) ) and biweekly bevacizumab (5 mg/kg). Biweekly bevacizumab was then continued for up to 1 year after RT. The primary objective was progression-free survival (PFS). Secondary objectives included overall survival (OS), patterns of failure, and toxicities of treatment.

RESULTS

Thirty patients were recruited. With median follow-up of 38 months, the 3-year PFS, OS, locoregional recurrence-free survival, and distant metastasis-free survival was 61.7%, 68.2%, 84.5%, and 80.5%, respectively. The most common local toxicities were mucositis and dermatitis. Two patients developed hemorrhage. There was no grade 5 toxicity.

CONCLUSION

The combination of bevacizumab, docetaxel, and RT is tolerable and effective in HNSCC. This regimen is worthy of further study in appropriate subset of patients receiving chemoradiation therapy.

摘要

背景

本研究的目的是确定贝伐单抗和多西他赛同步放疗治疗局部晚期头颈部鳞状细胞癌(HNSCC)的疗效和毒性。

方法

既往未接受过治疗的HNSCC患者接受标准每日放疗(RT),同时每周使用多西他赛(20 mg/m²),每两周使用贝伐单抗(5 mg/kg)。放疗后每两周继续使用贝伐单抗,持续长达1年。主要目标是无进展生存期(PFS)。次要目标包括总生存期(OS)、失败模式和治疗毒性。

结果

招募了30例患者。中位随访38个月,3年PFS、OS、局部区域无复发生存期和远处转移无复发生存率分别为61.7%、68.2%、84.5%和80.5%。最常见的局部毒性是粘膜炎和皮炎。2例患者发生出血。无5级毒性。

结论

贝伐单抗、多西他赛和放疗联合方案在HNSCC中耐受性良好且有效。该方案值得在接受放化疗的合适患者亚组中进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e59/4272911/9fd2cd34bf91/nihms607513f1.jpg

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