术前放疗后局部晚期头颈部鳞状细胞癌患者病理完全缓解的预后影响：一项 3 期临床研究的再分析。

Prognostic impact of pathological complete remission after preoperative irradiation in patients with locally advanced head and neck squamous cell carcinoma: re-analysis of a phase 3 clinical study.

机构信息

Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Department of Radiation Oncology, Peking University Cancer Hospital and Institute, Beijing, China.

出版信息

Radiat Oncol. 2019 Dec 12;14(1):225. doi: 10.1186/s13014-019-1428-4.

DOI:10.1186/s13014-019-1428-4

PMID:31831042

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6909460/

Abstract

PURPOSE

The purpose of this study was to determine the associations between pathological complete remission (pCR) and clinical outcomes in patients with locally advanced head and neck squamous cell carcinoma (HNSCC) who received preoperative radiotherapy or chemoradiotherapy in a phase 3 clinical study.

METHODS

A total of 222 newly diagnostic stage III/IVM0 HNSCC patients were randomly assigned to a preoperative concurrent chemoradiotherapy group (n = 104) or preoperative radiotherapy alone group (n = 118). Over a mean follow-up of 59 months, 72 patients were defined as non-responders to preoperative therapy and subsequently underwent resection of the primary lesion with or without neck dissection. The relationship between the pathological tumor response of the primary lesion and treatment prognosis was analyzed. Kaplan-Meier and Cox regression multivariate analyses were performed to evaluate the impact of pCR on local control (LC), overall survival (OS), progression-free survival (PFS), and distant metastasis-free survival (DMFS).

RESULTS

Among the 72 non-responders, 25 patients, 10 in the chemotherapy group and 15 in the radiotherapy group, achieved pCR. The 5-year LC, OS, PFS, and DMFS of pCR patients and non-pCR patients were 93.2% vs. 67.7% (p = 0.007), 83.3% vs. 39.7% (p = 0.0006), 76.1% vs. 44.0% (p = 0.009), and 90.4% vs. 56.3% (p = 0.005), respectively. In multivariate analysis, pCR is also an independent prognostic factor in prognosis, with statistically significant differences.

CONCLUSION

pCR after preoperative radiotherapy or concurrent chemoradiotherapy is a good prognostic factor in locally advanced HNSCC.

TRIAL REGISTRATION

Number:ChiCTR-TRC-114004322 Date:05 Mar, 2014.

摘要

目的

本研究旨在确定在一项 3 期临床试验中，接受术前放疗或放化疗的局部晚期头颈部鳞状细胞癌（HNSCC）患者中，病理完全缓解（pCR）与临床结局之间的关系。

方法

共 222 例新诊断的 III/IVM0 HNSCC 患者随机分为术前同期放化疗组（n=104）或术前单纯放疗组（n=118）。在平均随访 59 个月后，72 例患者被定义为术前治疗无反应者，随后行原发灶切除术加或不加颈清扫术。分析原发肿瘤病理肿瘤反应与治疗预后的关系。采用 Kaplan-Meier 和 Cox 回归多因素分析评估 pCR 对局部控制（LC）、总生存（OS）、无进展生存（PFS）和无远处转移生存（DMFS）的影响。

结果

在 72 例无反应者中，化疗组和放疗组各有 10 例和 15 例患者达到 pCR。pCR 患者和非 pCR 患者的 5 年 LC、OS、PFS 和 DMFS 分别为 93.2% vs. 67.7%（p=0.007）、83.3% vs. 39.7%（p=0.0006）、76.1% vs. 44.0%（p=0.009）和 90.4% vs. 56.3%（p=0.005）。多因素分析显示，pCR 也是预后的独立预后因素，差异有统计学意义。