A prospective cohort study on active surveillance after neoadjuvant chemoradiotherapy for esophageal cancer: protocol of Surgery As Needed for Oesophageal cancer-2

Abstract

Background Neoadjuvant chemoradiotherapy (nCRT) followed by esophagectomy is a standard treatment for potentially curable esophageal cancer. Active surveillance in patients with a clinically complete response (cCR) 12 weeks after nCRT is regarded as possible alternative to standard surgery. The aim of this study is to monitor the safety, adherence and effectiveness of active surveillance in patients outside a randomized trial. Methods This nationwide prospective cohort study aims to accrue operable patients with non-metastatic histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus or esophagogastric junction. Patients receive nCRT and response evaluation consists of upper endoscopy with bite-on-bite biopsies, endoscopic ultrasonography plus fine-needle aspiration of suspicious lymph nodes and 18F-fluorodeoxyglucose positron emission tomography/computed tomography scan. When residue or regrowth of tumor in the absence of distant metastases is detected, surgical resection is advised. Patients with cCR after nCRT are suitable to undergo active surveillance. Patients can consult an independent physician or psychologist to support decision-making. Primary endpoint is the number and severity of adverse events in patients with cCR undergoing active surveillance, defined as complications from response evaluations, delayed surgery and the development of distant metastases. Secondary endpoints include timing and quality of diagnostic modalities, overall survival, progression-free survival, fear of cancer recurrence and decisional regret. Discussion Active surveillance after nCRT may be an alternative to standard surgery in patients with esophageal cancer. Similar to organ-sparing approaches applied in other cancer types, the safety and efficacy of active surveillance needs monitoring before data from randomized trials are available. Trial registration The SANO-2 study has been registered at ClinicalTrials.gov as NCT04886635 (May 14, 2021) – Retrospectively registered.

Radiotherapy combined with immune checkpoint inhibitors in locally advanced/metastatic esophageal squamous cell carcinoma: clinical trials, efficacy and future directions

“…Multiple retrospective studies have demonstrated that among good responders after neoadjuvant therapy, active surveillance of patients who refused esophagectomy or were ultimately deemed unsuitable for surgery had comparable survival rates to those who underwent surgery ( 173 – 178 ). In the ongoing prospective SANO trial and ESOSTRATE trial, patients with a clinical response assessment of cCR after standard neoadjuvant chemoradiotherapy will be randomly assigned to either the active surveillance group or the immediate surgery group, comparing survival and quality of life for both groups ( 179 – 181 ). Neoadjuvant chemoradiotherapy combined with immunotherapy has achieved a pCR rate exceeding 50% potentially enabling more responders to bypass surgery, thereby retaining their esophageal function and improving survival with a higher quality of life.…”

18F-FDG PET/MRI for restaging esophageal cancer after neoadjuvant chemoradiotherapy

“…All patients underwent five weekly cycles of carboplatin/paclitaxel with concurrent 41.1 Gy of radiotherapy [1]. Patients were consecutively identified between February 2021 and May 2022 from the Surgery As Needed for Oesophageal Cancer (SANO)-2 study, an extension study of the SANO trial [10]. Exclusion criteria were contra-indications for MRI and an 18 F-FDG nonavid tumor at diagnosis.…”

Patients’ Preferences Towards Decision Counseling for Active Surveillance After Neoadjuvant Chemoradiotherapy for Esophageal Cancer

“…This study was performed in the context of the SANO-2 study, a multicenter prospective observational cohort study that monitors the safety and effectiveness of active surveillance while awaiting the results of the randomized trial. 3 The study was initiated by the Erasmus MC Cancer Institute and was conducted at 11 hospitals in The Netherlands. The study was approved by the Medical Ethical Committee of the Erasmus MC (MEC 2021-0068) and was registered at ClinicalTrials.gov (NCT04886635).…”

“…Operable patients above 18 years of age who underwent or were planned to undergo nCRT according to the CROSS regimen followed by surgical resection for histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus or junction at the Erasmus MC Cancer Institute were offered DC. 3 …”

“…Therefore, decision counseling (DC) was integrated in the SANO-2 prospective cohort study, an extension study of the SANO trial. 3 Within this study, DC was offered by a psychologist or medical researcher to all patients who were for nCRT followed by esophagectomy. This method allows clinicians and patients to identify patients’ personal values and preferences, aiding in the selection of the most appropriate treatment option.…”