A phase II randomized trial comparing neoadjuvant chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in advanced squamous cell carcinoma of the pharynx or larynx.

A phase II randomized trial comparing neoadjuvant chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in advanced squamous cell carcinoma of the pharynx or larynx.
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DOI:
10.1016/j.bj.2018.04.003
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发表时间:
2018-04
期刊:
影响因子:
5.5
通讯作者:
Wang HM
Wang HM
中科院分区:
医学2区
文献类型:
--
作者:
Huang PW;Lin CY;Hsieh CH;Hsu CL;Fan KH;Huang SF;Liao CT;Ng SK;Yen TC;Chang JT;Wang HM

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旨在阐明诱导化疗(ICT)对同步放化疗(CCRT)治疗的晚期咽喉鳞状细胞癌(PLSCC)患者的效果。初治非转移性晚期 PLSCC 患者根据疾病分期(III 或 IV)和可切除性进行分层,然后随机分配到 ICT/CCRT 组或 CCRT 组。在 ICT 和 CCRT 期间采用顺铂/替加氟-尿嘧啶/亚叶酸治疗方案。主要终点是总生存期(OS)。我们在2006年12月至2011年2月期间招募了151名患者。存活患者的中位随访时间为54.5个月。 ICT/CCRT 组包括更多下咽癌患者(57.1% vs 40.5%,p = 0.09)和 N2 或 N3 疾病患者(85.7% vs 74.4%,p = 0.02)。在 ICT/CCRT 和 CCRT 组中,5 年 OS 分别为 48.1% 和 53.2% (p = 0.45);无进展生存期 (PFS) 分别为 31.8% 和 55.6% (p = 0.015);和局部区域控制 (LRC) 分别为 37.7% 和 56.2% (p = 0.026)。不良事件和放疗依从性相似。然而,在 ICT/CCRT 组中,CCRT 期间接受顺铂总剂量 <150 mg/m2 的患者比例较高(46.8% vs 16.2%;p = 0.000),并且在多变量分析中独立预测 PFS 和 LRC 较差。 ICT/CCRT 组和 CCRT 组之间的操作系统没有差异。然而,在 ICT/CCRT 组中观察到 CCRT 依从性较差,LRC 和 PFS 较差。优化 ICT 和 CCRT 中的治疗比例对于为晚期 PLSCC 患者制定序贯策略是必要的。
To clarify the effect of induction chemotherapy (ICT) in patients with advanced pharyngeal and laryngeal squamous cell carcinoma (PLSCC) treated with concurrent chemoradiotherapy (CCRT). Patients with treatment-naïve nonmetastatic advanced PLSCC were stratified according to disease stage (III or IV) and resectability before being randomized to either a ICT/CCRT or CCRT arm. A cisplatin/tegafur-uracil/leucovorin regimen was administered during ICT and CCRT. The primary end point was overall survival (OS). We enrolled 151 patients during December 2006 to February 2011. The median follow-up of surviving patients was 54.5 months. The ICT/CCRT arm included more patients with hypopharynx cancer (57.1% vs 40.5%, p = 0.09) and N2 or N3 diseases (85.7% vs 74.4%, p = 0.02). In the ICT/CCRT and CCRT arms, the 5-year OS was 48.1% and 53.2% (p = 0.45); progression-free survival (PFS) was 31.8% and 55.6% (p = 0.015); and locoregional control (LRC) was 37.7% and 56.2% (p = 0.026), respectively. The adverse events and compliance to radiotherapy were similar. However, the proportion of patients receiving a total dose of cisplatin during CCRT <150 mg/m2 was higher in the ICT/CCRT arm (46.8% vs 16.2%; p = 0.000) and independently predicted poorer PFS and LRC in multivariate analysis. OS did not vary between the ICT/CCRT and CCRT arms. However, poorer compliance to CCRT and inferior LRC and PFS were observed in the ICT/CCRT arm. Optimizing the therapeutic ratio in both ICT and CCRT settings are necessary for developing a sequential strategy for patients with advanced-stage PLSCC.
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