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5000 例头颈部癌症根治性手术患者化疗作用的荟萃分析:头颈部癌症化疗荟萃分析的亚组分析。

Role of chemotherapy in 5000 patients with head and neck cancer treated by curative surgery: A subgroup analysis of the meta-analysis of chemotherapy in head and neck cancer.

机构信息

Meta-Analysis Unit, Service de Biostatistique et d'Epidémiologie, Gustave Roussy Cancer Campus, INSERM U1018, CESP, Université Paris-Sud, Université Paris-Saclay, Villejuif, France.

Meta-Analysis Unit, Service de Biostatistique et d'Epidémiologie, Gustave Roussy Cancer Campus, INSERM U1018, CESP, Université Paris-Sud, Université Paris-Saclay, Villejuif, France; Department of Radiation Therapy, Gustave Roussy Cancer Campus, Université Paris-Sud, Université Paris-Saclay, Villejuif, France.

出版信息

Oral Oncol. 2019 Aug;95:106-114. doi: 10.1016/j.oraloncology.2019.06.001. Epub 2019 Jun 15.

Abstract

OBJECTIVE

To evaluate the effect of chemotherapy added to a surgical locoregional treatment (LRT) for patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

MATERIALS AND METHODS

We studied the sub-group of trials with surgical LRT included in the meta-analysis on chemotherapy in head and neck cancer (MACH-NC). Data from published and unpublished randomized trials comparing the addition of chemotherapy to LRT in HNSCC patients were sought using electronic database searching for the period 1965-2000, hand searching and by contacting experts in the field. Trials with less than 60 patients, or preoperative radiotherapy or where the type of LRT could not be individually determined were excluded. All individual patient data were checked for internal consistency, compared with published reports, and validated with trialists. Data were pooled using a fixed-effect model. Heterogeneity was assessed using Cochrane test and I statistic.

RESULTS

Twenty-four trials were eligible (5000 patients). Chemotherapy improved overall survival (HR = 0.92 [95%CI: 0.85-0.99] p = 0.02). There was a significant interaction between treatment effect and timing of chemotherapy (p = 0.08 at pre-specified threshold of 0.10) with a greater effect for concomitant chemotherapy (HR = 0.79, 95%CI: 0.69-0.92). The benefit of chemotherapy was greater in women (HR = 0.63, 95%CI: 0.50-0.80) compared to men (HR = 0.96, 95%CI: 0.89-1.04; p for interaction = 0.001).

CONCLUSIONS

This analysis confirmed the benefit of concomitant chemotherapy added to surgical LRT. The role of induction therapy as yet to be determined as it did not improve OS. Women may benefit more than men from chemotherapy.

摘要

目的

评估在局部晚期头颈部鳞状细胞癌(HNSCC)患者中,化疗联合手术局部区域治疗(LRT)的疗效。

材料和方法

我们研究了头颈部癌化疗荟萃分析(MACH-NC)中包含的手术 LRT 亚组试验。使用电子数据库搜索 1965 年至 2000 年期间的研究,手检和联系该领域的专家,以寻找比较 LRT 中添加化疗与 HNSCC 患者的随机试验的数据。排除了患者少于 60 例的试验、术前放疗或无法单独确定 LRT 类型的试验。使用固定效应模型对所有个体患者数据进行合并。使用 Cochrane 检验和 I 统计评估异质性。

结果

有 24 项试验符合条件(5000 例患者)。化疗改善了总生存(HR=0.92[95%CI:0.85-0.99],p=0.02)。化疗效果与化疗时机之间存在显著交互作用(在预先指定的 0.10 阈值处 p=0.08),同期化疗的效果更大(HR=0.79,95%CI:0.69-0.92)。与男性(HR=0.96,95%CI:0.89-1.04;p 交互=0.001)相比,女性(HR=0.63,95%CI:0.50-0.80)从化疗中获益更大。

结论

这项分析证实了同期化疗联合手术 LRT 的益处。诱导治疗的作用尚未确定,因为它并未改善 OS。女性可能比男性从化疗中获益更多。

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