Active surveillance versus standard surgery after neoadjuvant chemoradiotherapy for oesophageal cancer: Long-term results of a cluster-randomised controlled trial (SANO)
https://esmocongress.esmo.org
ESMO 2026
2026 年 10 月 23–27 日 · Madrid · 共 2910 条
SANO
★★★晚破14 人 · 16 条 · 1 篇摘要
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食管癌新辅助放化疗(nCRT)后能否对达到完全缓解者豁免手术,是近年食管癌领域的核心争议之一。证据起点是荷兰前瞻性多中心诊断队列 preSANO:在卡铂(AUC 2)联合紫杉醇(50 mg/m²)每周一次、同步 41.4 Gy/23 分割放疗的方案治疗后,鳞癌约一半、腺癌约四分之一在手术标本中达到病理完全缓解,作者据此提出对充分缓解者常规食管切除术的必要性应被重新审视[3];该研究还比较了不同诊断手段及其组合对残留病灶的检出准确性,为以临床完全缓解(cCR)为门槛的去手术策略提供了方法学基础[3]。本次会议反复提到的 41.4 Gy/23 fx,正是源自这一术前放化疗处方[3]。
本次 ESMO26 的 LBA78 报告了在此基础上开展的集群随机对照试验 SANO 的 5 年长期结果,同步论文发表于 Annals of Oncology。研究纳入 309 例 nCRT 后达 cCR 的局部晚期食管癌患者,随机接受主动监视或标准手术,中位随访 76 个月。5 年 OS 为 50% vs 54%(HR 1.17,95% CI 0.77–1.77,p=0.46),差异无统计学意义;DFS HR 1.39(95% CI 0.94–2.06,p=0.10)亦未达显著;而 5 年远处转移累积发生率在监视组显著更高:46% vs 29%(sHR 2.04,p<0.01)。另有 43% 的患者避免了食管切除,需注意该数字既包括持续缓解者,也包括放化疗后 6 个月内即被检出转移的患者。
相对已有认识,这次读数把器官保留问题从可行性层面推进到长期生存层面:在严格选择的 cCR 人群中,主动监视与手术的 5 年 OS 无显著差异,43% 的手术免除率构成其核心获益;但显著升高的远处转移率和跨过 1 的 OS 置信区间,把监视策略下疾病远处播散的风险显性化。多位现场评论者强调,OS 无显著差异并不构成非劣效或等效的证明,且 41.4 Gy/23 fx 属术前、未必根治性的剂量,在约 75% 为腺癌的人群中尤其如此;这一策略在 DFLOT + post-CROSS 时代的适用性也被公开质疑。
总体来看,数据提示上消化道肿瘤的非手术管理比此前希望的更难:无显著 OS 差异不构成等效证据,远处转移显著增加意味着主动监视若要落地,仍需更精细的患者选择与更可靠的监视、补救策略,而放疗剂量与病理构成对结果解读及外推的限制,也应与疗效数字同时被读到。
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Jeff Ryckman@jryckman3 Nicholas Hornstein@GIMedOnc Daisuke Kotani, MD, Ph.D 小谷 大輔@DaisukeKotani Arndt Vogel@ArndtVogel Dr Rishabh Jain@DrRishabhOnco 引用@🚨 ESMO 2026 | TOP 10 GI CANCER TRIALS TO WATCH! From CLDN18.2 ADCs and PD-1/VEGF bispecifics to chemotherapy-free strategies, major GI oncology data are coming at #ESMO26! 🔥 My Top 10 Trials 🔴 GASTRIC / GEJ CANCER CLARITY-Gastric 01 (LBA7) | CLDN18.2 ADC vs investigator’s choice G-HOPE-001 (LBA77) | Novel CLDN18.2 ADC HERIZON-GEA-01 (LBA79) | Zanidatamab + chemotherapy ± tislelizumab GERCOR-GONO DEWI | Dostarlimab and nonoperative management in dMMR disease LOMAC (LBA81) | 4 vs 6 months of adjuvant CAPOX KC-WISE (LBA80) | Anbenitamab + chemotherapy RAMIRIS | FOLFIRI + ramucirumab vs paclitaxel + ramucirumab FORTITUDE-101/102 | FGFR2-targeted therapy and biomarker analysis 🟠 BILIARY TRACT CANCER HARMONi-GI1 (LBA8) | Ivonescimab + chemotherapy vs durvalumab + chemotherapy 🟣 ESOPHAGEAL / GEJ CANCER KEYNOTE-975 (2875O) | Pembrolizumab + definitive chemoradiotherapy ⭐ Two Presidential trials to watch closely: CLARITY-Gastric 01 and HARMONi-GI1. Which GI trial will have the greatest clinical impact? @myesmo @ESMO_open @ASCO @oncoalert #ESMO26 #GICancer #Oncology
Dr Amol Akhade@SuyogCancer 随着远处转移增多,你会为食管癌患者采用观察等待策略吗?我不会。#SANO trial。@myESMO #esmo26 @OncoAlert
引用@🚨 ESMO 2026 | SANO Trial (LBA78): 5-Year Result Active surveillance vs surgery (N=309) 🔹 5-year OS: 50% vs 54% (HR 1.17; 95% CI 0.77–1.77) 🔹 DFS: HR 1.39 (95% CI 0.94–2.06) 🔹 5-year distant metastases: 46% vs 29% (p<0.01) 🔹 43% in the surveillance arm were spared a non-beneficial oesophagectomy. An important organ-preservation strategy, but the higher distant metastasis rate is concerning. Would you recommend active surveillance over surgery for a patient achieving complete clinical response? #ESMO26 #EsophagealCancer #SANO @myESMO @NiuSanford @OncoAlert @OncBrothers
Annals of Oncology@Annals_Oncology Daisuke Kotani, MD, Ph.D 小谷 大輔@DaisukeKotani 引用@#ESMO26 | LBA78 Long-term results from SANO: Active surveillance vs standard surgery after nCRT in EC ▪️5y-OS: 50% vs 54%, HR 1.17 (95% CI 0.77-1.77) ▪️DFS: HR 1.39 (95%CI 0.94-2.06) ▪️5y-distant mets: 46% vs 29%, p<0.01 👉Despite no significant OS or DFS differences, the wide CIs and significantly higher distant mets rate highlight important challenges for implementing active surveillance in clinical practice. Looking forward to the presentation! @myESMO @OncoAlert
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Nieves Martinez Lago MD PhD@DraMartinezLago Mustafa Özdoğan, MD@ozdogan_md KOL Pulse AI@KolPulseAI Jeff Ryckman@jryckman3 暂无中文译文,显示英文原文。
OncoDaily RT@OncoDailyRT ScienceLink@sciencelinkonco VJ Oncology@VJOncology Dr Najeed Aadil@daakhsaab