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一项针对局部晚期不可切除食管癌进行化疗选择联合 DCF 治疗及后续转化手术的 2 期研究的 3 年总生存更新结果。

A 3-Year Overall Survival Update From a Phase 2 Study of Chemoselection With DCF and Subsequent Conversion Surgery for Locally Advanced Unresectable Esophageal Cancer.

机构信息

Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.

Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo, Japan.

出版信息

Ann Surg Oncol. 2020 Feb;27(2):460-467. doi: 10.1245/s10434-019-07654-8. Epub 2019 Aug 2.

Abstract

BACKGROUND

A multicenter phase 2 trial analysed chemoselection with docetaxel plus 5-fluorouracil and cisplatin (DCF) induction chemotherapy (ICT) and subsequent conversion surgery (CS) for locally advanced unresectable esophageal cancer. This study presents updated 3-year analyses to further characterize the impact of DCF-ICT followed by CS.

METHODS

Esophageal cancer patients with clinical T4 disease, unresectable supraclavicular lymph node metastasis, or both were eligible for this study. The treatment starts with DCF-ICT, followed by CS if the cancer is resectable, or by concurrent chemoradiation if it is not resectable. This updated analysis presents 3-year overall survival (OS), 3-year progression-free survival (PFS), and pattern of relapse.

RESULTS

The median follow-up period for the patients surviving without death was 39.3 months. The estimated 1-year OS was 66.7%, and the lower limit of the 80% confidence interval (CI) was 54.6%. The estimated 3-year OS was 46.6% (95% CI 34.2-63.5%). The OS for the patients who underwent R0 resection (n = 19) was significantly longer than for those who did not (3-year OS: 71.4% vs. 30.1%). The estimated 1-year PFS was 50.6%, and the 3-year PFS was 39.6%. The PFS for R0 was significantly longer than for non-R0 (3-year PFS: 61.3% vs 25.0%). Recurrence or progression at the primary site was observed in 31% of the non-R0 group. The rate of distant metastasis did not differ significantly between the non-R0 and R0 groups (21% vs 16%).

CONCLUSIONS

Long-term follow-up evaluation confirmed that DCF chemoselection aimed at CS is feasible and promising in terms of survival for patients with locally advanced esophageal cancer.

摘要

背景

一项多中心 2 期临床试验分析了多西他赛联合 5-氟尿嘧啶和顺铂(DCF)诱导化疗(ICT)和随后的转化手术(CS)治疗局部晚期不可切除的食管癌的疗效。本研究进一步分析了 DCF-ICT 后行 CS 的 3 年结果。

方法

本研究纳入了临床 T4 疾病、锁骨上区域不可切除淋巴结转移或两者均有的食管癌患者。治疗从 DCF-ICT 开始,如果癌症可切除,则进行 CS,如果不可切除,则进行同期放化疗。本更新分析提供了 3 年总生存率(OS)、3 年无进展生存率(PFS)和复发模式。

结果

无死亡患者的中位随访时间为 39.3 个月。1 年 OS 估计为 66.7%,80%置信区间(CI)下限为 54.6%。3 年 OS 估计为 46.6%(95%CI 34.2-63.5%)。行 R0 切除术(n=19)患者的 OS 明显长于未行切除术患者(3 年 OS:71.4% vs. 30.1%)。1 年 PFS 估计为 50.6%,3 年 PFS 估计为 39.6%。R0 患者的 PFS 明显长于非 R0 患者(3 年 PFS:61.3% vs. 25.0%)。非 R0 组中有 31%的患者出现原发性部位复发或进展。非 R0 和 R0 组之间远处转移率无显著差异(21% vs. 16%)。

结论

长期随访评估证实,针对 CS 的 DCF 化学选择在局部晚期食管癌患者的生存方面是可行且有前景的。

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