Long-term efficacy and progression patterns of paclitaxel plus cisplatin and 5-fluorouracil induction chemotherapy for locally advanced borderline-resectable esophageal squamous cell carcinoma: results from a phase II NEOCRTEC1601 study.

IF 12.5 2区 医学 Q1 SURGERY
Jia-Di Wu, Zhi-Qiang Wang, Qiao-Qiao Li, Chao Ren, Sheng Huang, Cai-Yan Fang, De-Shen Wang, Ji-Yang Chen, Qiong Tan, Yu-Hong Li, Hong Yang
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引用次数: 0

Abstract

Introduction: The NEOCRTEC1601 trial aimed to evaluate the efficacy and safety of paclitaxel in combination with cisplatin and 5-fluorouracil (TPF) as induction chemotherapy for BR-ESCC. This study presented an updated 5-year analysis to further elucidate the impact of TPF chemotherapy followed by surgery.

Method: This study was conducted as a single-center, phase II, clinical trial. Eligibility was extended to patients diagnosed with BR-ESCC, characterized by a primary tumor or bulky lymph nodes with potential invasion into adjacent organs. The treatment protocol commenced with TPF chemotherapy, followed by surgery if the tumor was deemed resectable, or by concurrent chemoradiation in cases where resection was not feasible. This updated report delineates the 5-year overall survival and progression-free survival rate.

Result: Surgery was performed for 27 patients (57.4%), and R0 resection was confirmed in 25 patients (53.2%). Pathologic complete response was confirmed in four patients (8.5%). Following a minimum follow-up period exceeding 60 months for all patients, the total number of deaths was 31 (65.96%). The OS and PFS for the R0 group were significantly longer than the non-R0 group (median OS: 53.0 months vs. 13.9 months, HR 0.36, 95%CI 0.17-0.76, p = 0.0032; median PFS: 50.84 months vs. 5.42 months, HR 0.40, 95%CI 0.19-0.84, p = 0.0076). The 5-year OS rate was 50.0% (34.0%-73.4%) for the R0 group compared to 19.0% (7.9%-46.0%) for the non-R0 group (HR 0.36, 95%CI 0.17-0.79, p = 0.0041).

Conclusion: Long-term follow-up evaluation confirmed that the OS and PFS were significantly improved in patients who underwent R0 resection compared to those who did not. The 5-year OS rate for patients who achieved R0 resection was 50.0%. R0 resection might be the independent prognostic factors for OS. To further improve the R0 resection rate and prognosis, more effective induction treatment regimens need to be explored.

紫杉醇联合顺铂和5-氟尿嘧啶诱导化疗治疗局部晚期边缘可切除食管鳞状细胞癌的长期疗效和进展模式:来自NEOCRTEC1601期研究的结果
NEOCRTEC1601试验旨在评价紫杉醇联合顺铂和5-氟尿嘧啶(TPF)诱导化疗治疗BR-ESCC的疗效和安全性。这项研究提出了一项更新的5年分析,以进一步阐明TPF化疗后手术的影响。方法:本研究采用单中心II期临床试验。资格扩展到诊断为BR-ESCC的患者,其特征是原发肿瘤或淋巴结肿大,可能侵犯邻近器官。治疗方案以TPF化疗开始,如果认为肿瘤可切除,则进行手术,或者在无法切除的情况下进行同步放化疗。这份最新报告描述了5年总生存率和无进展生存率。结果:手术27例(57.4%),确认R0切除25例(53.2%)。病理完全缓解4例(8.5%)。在对所有患者进行超过60个月的最短随访期后,总死亡人数为31人(65.96%)。R0组的OS和PFS均明显长于非R0组(中位OS: 53.0个月vs 13.9个月,HR 0.36, 95%CI 0.17-0.76, p = 0.0032;中位PFS: 50.84个月vs. 5.42个月,HR 0.40, 95%CI 0.19-0.84, p = 0.0076)。R0组5年OS为50.0%(34.0% ~ 73.4%),非R0组为19.0% (7.9% ~ 46.0%)(HR 0.36, 95%CI 0.17 ~ 0.79, p = 0.0041)。结论:长期随访评估证实,与未行R0切除术的患者相比,行R0切除术的患者的OS和PFS明显改善。完成R0切除的患者5年OS率为50.0%。R0切除可能是OS的独立预后因素。为进一步提高R0切除率和预后,需要探索更有效的诱导治疗方案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
17.70
自引率
3.30%
发文量
0
审稿时长
6-12 weeks
期刊介绍: The International Journal of Surgery (IJS) has a broad scope, encompassing all surgical specialties. Its primary objective is to facilitate the exchange of crucial ideas and lines of thought between and across these specialties.By doing so, the journal aims to counter the growing trend of increasing sub-specialization, which can result in "tunnel-vision" and the isolation of significant surgical advancements within specific specialties.
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