根治性放化疗后替吉奥辅助化疗治疗局部晚期头颈部鳞状细胞癌患者：ACTS-HNC 研究的再分析。
Adjuvant chemotherapy with S-1 after curative chemoradiotherapy in patients with locoregionally advanced squamous cell carcinoma of the head and neck: Reanalysis of the ACTS-HNC study.
机构信息
Department Head and Neck Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation, Kobe, Japan.
出版信息
PLoS One. 2018 Jun 8;13(6):e0198391. doi: 10.1371/journal.pone.0198391. eCollection 2018.
BACKGROUND
Chemoradiotherapy (CRT) has improved organ preservation or overall survival (OS) of locoregionally advanced head and neck squamous cell cancer (LAHNSCC), but in clinical trials of conventional CRT, increasing CRT intensity has not been shown to improve OS. In the Adjuvant ChemoTherapy with S-1 after curative treatment in patients with Head and Neck Cancer (ACTS-HNC) phase III study, OS of curative locoregional treatments improved more with adjuvant chemotherapy with S-1 (tegafur gimeracil oteracil potassium) than with tegafur/uracil (UFT). ACTS HNC study showed the significant efficacy of S-1 after curative radiotherapy in sub-analysis. We explored the efficacy of S-1 after curative CRT in a subset of patients from the ACTS-HNC study.
METHODS
Patients with stage III, IVA, or IVB LAHNSCC were enrolled in this study to evaluate the efficacy of S-1 compared with UFT as adjuvant chemotherapy after curative CRT in the ACTS-HNC study. Patients received S-1 at 80-120 mg/day in two divided doses for 2 weeks, followed by a 1-week rest, or UFT 300 or 400 mg/day in two or three divided doses daily, for 1 year. The endpoints were OS, disease-free survival, locoregional relapse-free survival, distant metastasis-free survival (DMFS), and post-locoregional relapse survival.
RESULTS
One hundred eighty patients (S-1, n = 87; UFT, n = 93) were included in this study. Clinical characteristics of the S-1 and UFT arms were similar. S-1 after CRT significantly improved OS (hazard ratio [HR], 0.46; 95% confidence interval [CI], 0.22-0.93) and DMFS (HR, 0.50; 95% CI, 0.26-0.97) compared with UFT.
CONCLUSION
As adjuvant chemotherapy, S-1 demonstrated better efficacy for OS and DMFS than UFT in patients with LAHNSCC after curative CRT and may be considered a treatment option following curative CRT. For this study was not preplanned in the ACTS-HNC study, the results is hypothesis generating but not definitive.
背景
放化疗（CRT）已提高局部晚期头颈部鳞状细胞癌（LAHNSCC）的器官保存或总生存（OS），但在常规 CRT 的临床试验中，增加 CRT 强度并未显示能改善 OS。在头颈部癌症患者根治性治疗后的辅助化疗 S-1（Adjuvant ChemoTherapy with S-1 after curative treatment in patients with Head and Neck Cancer，ACTS-HNC）III 期研究中，辅助化疗 S-1（替加氟吉美嘧啶奥替拉西钾）的 OS 改善程度高于替加氟/尿嘧啶（UFT）。ACTS HNC 研究对头颈部癌症患者根治性放疗后的亚分析显示 S-1 的显著疗效。我们在 ACTS-HNC 研究中探索了 CRT 后局部区域治疗的 S-1 疗效。
方法
本研究纳入 III 期、IVA 期或 IVB 期 LAHNSCC 患者，评估在 ACTS-HNC 研究中，CRT 后 S-1 与 UFT 作为辅助化疗的疗效。患者接受 S-1 80-120mg/天，分两次服用 2 周，然后休息 1 周，或 UFT 300 或 400mg/天，分两次或三次服用，每天服用 1 年。终点为 OS、无病生存、局部区域无复发生存、远处转移无复发生存（DMFS）和局部区域复发后生存。
结果
本研究纳入 180 例患者（S-1 组 87 例，UFT 组 93 例）。S-1 和 UFT 组的临床特征相似。与 UFT 相比，CRT 后 S-1 显著改善 OS（风险比[HR]，0.46；95%置信区间[CI]，0.22-0.93）和 DMFS（HR，0.50；95% CI，0.26-0.97）。
结论
作为辅助化疗，S-1 在 CRT 后 LAHNSCC 患者中的 OS 和 DMFS 方面优于 UFT，可作为 CRT 后治疗选择。由于本研究未在 ACTS-HNC 研究中预先计划，因此结果是产生假说但非确定的。
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