Phase II Trial of Adjuvant S-1 Following Neoadjuvant Chemotherapy and Surgery in Patients with Locally Advanced Esophageal Squamous Cell Carcinoma: The PIECE Trial.

IF 3.4 2区 医学 Q2 ONCOLOGY
Annals of Surgical Oncology Pub Date : 2025-01-01 Epub Date: 2024-10-07 DOI:10.1245/s10434-024-16325-2
Motoo Nomura, Toshifumi Yamaguchi, Keisho Chin, Shinji Hato, Ken Kato, Eishi Baba, Hisahiro Matsubara, Hidenori Mukaida, Takako Yoshii, Masahiro Tsuda, Yasuhiro Tsubosa, Yuko Kitagawa, Isao Oze, Hideki Ishikawa, Manabu Muto
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引用次数: 0

Abstract

Background: Neoadjuvant chemotherapy followed by surgery (NAC-S) is the standard therapy for locally advanced esophageal squamous cell carcinoma (ESCC) in Japan.

Objective: The aim of this phase II trial was to assess the efficacy and safety of the addition of adjuvant S-1 after R0 resection in ESCC patients who received NAC-S.

Patients and methods: Key eligibility criteria included clinical stage IB-III (without T4 disease) ESCC, age 20-75 years, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients received adjuvant therapy with four cycles of S-1 (80 mg/m2/day) administered orally for 4 weeks of 6-week cycles. The primary endpoint was 3 year relapse-free survival (RFS). If the lower confidence limit for 3 year RFS was >50%, we judged that the primary endpoint of this study was met.

Results: A total of 52 patients were enrolled between January 2016 and January 2019. Two patients were excluded from analysis; five patients were determined to have R1 or R2 resection, and seven patients did not receive adjuvant S-1. The 3-year RFS and overall survival rates in the intention-to-treat population were 72.3% (90% confidence interval [CI] 59.9-81.5) and 85.0% (90% CI 73.9-91.6), indicating that the primary endpoint was met. Grade ≥3 adverse events with an incidence ≥10% included neutropenia (13.2%), anorexia (13.2%), and diarrhea (10.5%). There were no treatment-related deaths.

Conclusion: Adjuvant S-1 after NAC-S showed promising efficacy with a manageable safety profile for patients with resectable ESCC and warrants further evaluation in larger studies.

局部晚期食管鳞状细胞癌患者新辅助化疗和手术后辅助 S-1 的 II 期试验:PIECE 试验。
背景:新辅助化疗后手术(NAC-S)是日本治疗局部晚期食管鳞癌(ESCC)的标准疗法:在日本,手术后新辅助化疗(NAC-S)是局部晚期食管鳞状细胞癌(ESCC)的标准疗法:这项II期试验旨在评估接受NAC-S治疗的ESCC患者在R0切除术后加用S-1辅助治疗的有效性和安全性:主要资格标准包括临床IB-III期(无T4病变)ESCC、年龄20-75岁、东部合作肿瘤学组(ECOG)表现状态为0或1。患者接受4个周期的S-1(80毫克/平方米/天)辅助治疗,口服4周,6周为一个周期。主要终点是3年无复发生存率(RFS)。如果3年无复发生存率的置信区间下限大于50%,我们就判定这项研究的主要终点已经达到:2016年1月至2019年1月期间,共有52名患者入组。2名患者被排除在分析之外;5名患者被确定为R1或R2切除,7名患者未接受S-1辅助治疗。意向治疗人群的3年RFS和总生存率分别为72.3%(90%置信区间[CI] 59.9-81.5)和85.0%(90%置信区间[CI] 73.9-91.6),表明达到了主要终点。发生率≥10%的≥3级不良事件包括中性粒细胞减少(13.2%)、厌食(13.2%)和腹泻(10.5%)。无治疗相关死亡病例:结论:NAC-S治疗后辅助S-1对可切除ESCC患者具有良好的疗效和可控的安全性,值得在更大规模的研究中进一步评估。
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来源期刊
CiteScore
5.90
自引率
10.80%
发文量
1698
审稿时长
2.8 months
期刊介绍: The Annals of Surgical Oncology is the official journal of The Society of Surgical Oncology and is published for the Society by Springer. The Annals publishes original and educational manuscripts about oncology for surgeons from all specialities in academic and community settings.
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