TY - JOUR
T1 - A prospective cohort study on active surveillance after neoadjuvant chemoradiotherapy for esophageal cancer
T2 - protocol of Surgery As Needed for Oesophageal cancer-2
AU - van der Zijden, Charlène J.
AU - Lagarde, Sjoerd M.
AU - SANO-2 study group
AU - Hermus, Merel
AU - Kranenburg, Leonieke W.
AU - van Lanschot, J. Jan B.
AU - Mostert, Bianca
AU - Nuyttens, Joost J.M.E.
AU - Oudijk, Lindsey
AU - van der Sluis, Pieter C.
AU - Spaander, Manon C.W.
AU - Valkema, Maria J.
AU - Valkema, Roelf
AU - Wijnhoven, Bas P.L.
N1 - Funding:
The SANO-2 study is funded by the Erasmus MC foundation, Zilveren Kruis
Achmea and Theia foundation. The funding body had no role in the design of
the study and collection, analysis, and interpretation of data and in writing the
manuscript.
Publisher Copyright:
© 2023. The Author(s).
PY - 2023/4/10
Y1 - 2023/4/10
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85152093924&partnerID=8YFLogxK
U2 - 10.1186/s12885-023-10747-z
DO - 10.1186/s12885-023-10747-z
M3 - Article
C2 - 37038138
AN - SCOPUS:85152093924
SN - 1471-2407
VL - 23
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 327
ER -
