OA01.1. Invited Lecture: Organ-Preserving Therapy for Higher Stage Esophageal Cancer Using Endoscopic Submucosal Dissection (ESD): Endoscopic Outcomes From OPERA-RADIO Phase 1 Clinical Trial

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ID: 325644
2026
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Abstract
Abstract Topic Esophageal Cancer: Non-Surgical Treatment of Esophageal Cancer Background Esophagectomy is the mainstay of curative for esophageal cancer but comes with high risk for complications, especially in comorbid and frail patients. The OPERA RADIO trial aimed to assess the feasibility and safety of organ-preserving therapy with combining endoscopic submucosal dissection (ESD) and chemoradiotherapy. We report here the endoscopic/surgical outcomes of this trial. Methods OPERA-RADIO (NCT05667298) is a phase I prospective study investigating organ preservation therapy for patients with early stage esophageal cancer (EC) who decline or are ineligible for esophagectomy. Patients with de novo early-stage (high risk pT1b/pT2N0M0) EC received upfront ESD followed by adjuvant IO-RT consisting of 41.4-45 Gy/23-25# with concurrent and consolidation Durvalumab every 4 weeks x 13 cycles. The protocol was amended to also include patients with locally advanced EC who received neoadjuvant concurrent chemoradiotherapy (CROSS Regimen) with complete clinical response amenable to ESD (induced early stage disease) and declined esophagectomy, who thereafter underwent ESD and received adjuvant Durvalumab only (13 cycles). Five patients underwent upfront ESD for clinical stage 1 cancer, while 6 patients received neoadjuvant CROSS followed by ESD. ESD was performed by 2 thoracic surgeons (BK, n=9; SG, n=2) trained in third space endoscopy. Descriptive analyses were performed. Endoscopic complications were prospectively captured using Clavien-Dindo classification system. Results Eleven patients were enrolled with mean age of 68 (range= 54-78), of whom 4 (36%) were female. Ten (91%) patients had adenocarcinoma, and 1 had squamous cell carcinoma. Most tumours (91%) were located in the lower third of the esophagus/GEJ, while 1 was located in the middle third of the esophagus. This was a comorbid and high-risk population with median age-adjusted Charlson Comorbidty Index of 6 (range=3-10). One grade 3a complication occurred post-ESD with transfusion and re-assessment endoscopy (no interventions) required in a patient who had circumferential ESD post-CROSS; length-of-stay was 4 days. Median hospital length-of-stay was otherwise 0 days (range=0-4). Three patients required outpatient endoscopic dilatations prior to scheduled 3-month endoscopy. Pathologic staging was: pT1bSM1 (n=1), pT1bSM2 (n=1), pT1bSM2/3 (n=3), ypT1bSM3 (n=3), ypT2 (n=2), ypT3 (n=1). Four patients had focal microscopic positive margins, all of whom had ESD post-CROSS. Four patients had lymphovascular invasion. Conclusion This phase I study demonstrates that complex ESD either upfront or following chemoradiotherapy is feasible, safe and can be potentially an effective component of multi-modal organ preservation approach. This was well tolerated with minimal complications and minimal impact on patients and health systems, despite use in highly comorbid and older patient population that had high predicted risks with esophagectomy. There are ongoing plans to develop this approach into a randomized phase 2/3 study.
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openalex_W7203955761 Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Professor Biniam Kidane, Julian Kim, Vivian Lu, Stephen Gowing, Jasvir Dhaliwal, Shantanu Banerji
Journal diseases of the esophagus : official journal of the international society for diseases of the esophagus
Year 2026
DOI
10.1093/dote/doag077.006
URL
https://doi.org/10.1093/dote/doag077.006
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