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序贯治疗:新辅助生物化疗(西妥昔单抗、紫杉醇和顺铂)联合西妥昔单抗基于同期放化疗治疗高危局部晚期口腔鳞状细胞癌:一项 2 期临床试验的最终分析。

Sequential therapy of neoadjuvant biochemotherapy with cetuximab, paclitaxel, and cisplatin followed by cetuximab-based concurrent bioradiotherapy in high-risk locally advanced oral squamous cell carcinoma: Final analysis of a phase 2 clinical trial.

机构信息

Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.

Institute of Population Health Sciences, National Health Research Institutes, Miaoli, Taiwan.

出版信息

Head Neck. 2019 Jun;41(6):1703-1712. doi: 10.1002/hed.25640. Epub 2019 Jan 12.

DOI:10.1002/hed.25640
PMID:30636183
Abstract

BACKGROUND

The prognosis of advanced oral squamous cell carcinoma is poor. We investigated the effect of cetuximab-based sequential therapy as a primary treatment.

METHODS

Forty-seven treatment-naive patients with advanced tumors originating from the oral cavity or oropharynx were enrolled. Neoadjuvant cetuximab, paclitaxel, and cisplatin were administered, followed by cetuximab-based radiotherapy. Immunohistochemical staining was applied to study the tissues.

RESULTS

The best overall response rate was 70.2%, including 4 patients with a complete response and 29 with a partial response. The median progression-free and overall survival rates were 10.3 and 15.2 months, respectively. Patients with more than 50% tumor reduction with neoadjuvant therapy had better survival outcomes. Twenty-two patients had severe adverse events with mostly dermatological complications. Of the 16 patients who received operations, 9 had increased PD-L1 staining compared to pretreatment biopsy in the post hoc study.

CONCLUSION

The regimen was effective in selected patients. Increased PD-L1 suggested altered tumor features.

摘要

背景

晚期口腔鳞状细胞癌的预后较差。我们研究了西妥昔单抗为基础的序贯治疗作为初始治疗的效果。

方法

47 例初治的口腔或口咽来源的晚期肿瘤患者入组。患者接受新辅助西妥昔单抗、紫杉醇和顺铂治疗,然后进行西妥昔单抗为基础的放疗。应用免疫组化染色研究组织。

结果

最佳总缓解率为 70.2%,包括 4 例完全缓解和 29 例部分缓解。中位无进展生存期和总生存期分别为 10.3 和 15.2 个月。新辅助治疗中肿瘤缩小超过 50%的患者有更好的生存结果。22 例患者发生严重不良事件,主要为皮肤并发症。16 例接受手术的患者中,9 例在术后研究中与预处理活检相比 PD-L1 染色增加。

结论

该方案在选定的患者中有效。PD-L1 增加提示肿瘤特征改变。

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