Department of Oncology, Division of Medical Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Department of Internal Medicine, Division of Hematology-Oncology, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan.
BMC Cancer. 2024 Oct 5;24(1):1227. doi: 10.1186/s12885-024-12425-0.
In recent years, the addition of cetuximab to chemotherapy has improved treatment outcomes for patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). In this study, we present the real-world survival data of R/M HNSCC patients who received cetuximab-containing regimens from thirteen medical centers in Taiwan, as well as a three-level risk stratification model for this patient population.
This study enrolled R/M HNSCC patients from thirteen medical centers in Taiwan who received cetuximab-containing regimens from January 1, 2017 to June 6, 2022. The cases were divided into a training cohort and a validation cohort based on the start of treatment. Overall survival (OS) was evaluated in both cohorts and exploratory analysis was performed to identify associated adverse clinical and laboratory factors. The results of the exploratory analysis were used to construct a three-level risk stratification prediction model for OS.
A total of 1434 patients with R/M HNSCC were enrolled in this study and received cetuximab-containing regimens. The overall population had a median OS of 8.57 months (95% CI: 8.07 - 9.08). Multivariate analysis of the training cohort identified poor ECOG performance status, heavy alcohol consumption, and prior adjuvant CCRT or lack of prior RT as adverse prognostic factors. Comparison of laboratory data between patients with OS≦6 and OS > 6 also revealed unfavorable factors, including increased white blood cell count, decreased hemoglobin level, increased platelet count, increased absolute neutrophil count, decreased absolute lymphocyte count, and increased neutrophil-to-lymphocyte ratio. Using forward prediction, a three-level risk stratification prediction model was constructed using the variables of ECOG performance status, alcohol consumption, skin metastasis, modality of radiation therapy, hemoglobin level, and neutrophil-to-lymphocyte ratio. The median OS in the low-risk, intermediate-risk, and high-risk groups were 12.02 months (95% CI 10.44-13.61), 7.5 months (95% CI 7.33-8.17), and 4.01 months (95% CI 3.94-4.08), respectively, with a log-rank test p-value < 0.001.
This study presents a three-level risk stratification model with strong prediction ability for OS in R/M HNSCC patients who received cetuximab-containing regimens. The results are based on real-world data and may provide valuable information for clinicians in treatment planning and future drug development.
近年来,西妥昔单抗联合化疗方案改善了复发/转移性头颈部鳞状细胞癌(R/M HNSCC)患者的治疗效果。本研究旨在报道台湾 13 家医疗中心接受西妥昔单抗方案治疗的 R/M HNSCC 患者的真实生存数据,并构建针对该人群的三级风险分层模型。
本研究纳入了自 2017 年 1 月 1 日至 2022 年 6 月 6 日期间,在台湾 13 家医疗中心接受西妥昔单抗方案治疗的 R/M HNSCC 患者。根据治疗开始时间,将患者分为训练队列和验证队列。分别对两个队列的患者进行总生存(OS)评估,并进行探索性分析,以确定与不良临床和实验室因素相关的因素。探索性分析的结果用于构建 OS 的三级风险分层预测模型。
本研究共纳入 1434 例 R/M HNSCC 患者,接受西妥昔单抗方案治疗。总体人群的中位 OS 为 8.57 个月(95%CI:8.07-9.08)。训练队列的多变量分析显示,ECOG 表现状态差、大量饮酒以及辅助 CCRT 或缺乏放疗史为不良预后因素。比较 OS≦6 个月和 OS>6 个月患者的实验室数据也揭示了一些不利因素,包括白细胞计数增加、血红蛋白水平降低、血小板计数增加、绝对中性粒细胞计数增加、绝对淋巴细胞计数降低和中性粒细胞与淋巴细胞比值增加。通过正向预测,使用 ECOG 表现状态、饮酒、皮肤转移、放疗方式、血红蛋白水平和中性粒细胞与淋巴细胞比值等变量构建了三级风险分层预测模型。低危、中危和高危组的中位 OS 分别为 12.02 个月(95%CI 10.44-13.61)、7.5 个月(95%CI 7.33-8.17)和 4.01 个月(95%CI 3.94-4.08),对数秩检验 p 值<0.001。
本研究提出了一种针对接受西妥昔单抗方案治疗的 R/M HNSCC 患者的 OS 具有较强预测能力的三级风险分层模型。该研究结果基于真实世界数据,可为临床医生的治疗计划和未来药物开发提供有价值的信息。