Julian Hipp1, Blin Nagavci2, Claudia Schmoor3, Joerg Meerpohl2,4, Jens Hoeppner5, Christine Schmucker2. 1. Center of Surgery, Department of General and Visceral Surgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany. 2. Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79110 Freiburg, Germany. 3. Clinical Trials Unit, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79110 Freiburg, Germany. 4. Cochrane Germany, Cochrane Germany Foundation, 79110 Freiburg, Germany. 5. Department of Surgery, University Medical Center Schleswig-Holstein, UKSH Campus Lübeck, 23538 Lübeck, Germany.
Abstract
BACKGROUND: A substantial fraction of patients with esophageal cancer show post-neoadjuvant pathological complete response (pCR). Principal esophagectomy after neoadjuvant treatment is the standard of care for all patients, although surveillance and surgery as needed in case of local recurrence may be a treatment alternative for patients with complete response (CR). METHODS: We performed a scoping review to describe key characteristics of relevant clinical studies including adults with non-metastatic esophageal cancer receiving multimodal treatment. Until September 2020, relevant studies were identified through systematic searches in the bibliographic databases Medline, Web of Science, Cochrane Library, Science Direct, ClinicalTrials, the German study register, and the WHO registry platform. RESULTS: In total, three completed randomized controlled trials (RCTs, with 468 participants), three planned/ongoing RCTs (with a planned sample size of 752 participants), one non-randomized controlled study (NRS, with 53 participants), ten retrospective cohort studies (with 2228 participants), and one survey on patients' preferences (with 100 participants) were identified. All studies applied neoadjuvant chemoradiation protocols. None of the studies examined neoadjuvant chemotherapeutic protocols. Studies investigated patient populations with esophageal squamous cell carcinoma, adenocarcinoma, and mixed cohorts. Important outcomes reported were overall, disease-free and local recurrence-free survival. Limitations of the currently available study pool include heterogeneous chemoradiation protocols, a lack of modern neoadjuvant treatment protocols in RCTs, short follow-up times, the use of heterogeneous diagnostic methods, and different definitions of clinical CR. CONCLUSION: Although post-neoadjuvant surveillance and surgery as needed compared with post-neoadjuvant surgery on principle has been investigated within different study designs, the currently available results are based on a wide variation of diagnostic tools to identify patients with pCR, short follow-up times, small sample sizes, and variations in therapeutic procedures. A thoroughly planned RCT considering the limitations in the currently available literature will be of great importance to provide patients with CR with the best and less harmful treatment.
BACKGROUND: A substantial fraction of patients with esophageal cancer show post-neoadjuvant pathological complete response (pCR). Principal esophagectomy after neoadjuvant treatment is the standard of care for all patients, although surveillance and surgery as needed in case of local recurrence may be a treatment alternative for patients with complete response (CR). METHODS: We performed a scoping review to describe key characteristics of relevant clinical studies including adults with non-metastatic esophageal cancer receiving multimodal treatment. Until September 2020, relevant studies were identified through systematic searches in the bibliographic databases Medline, Web of Science, Cochrane Library, Science Direct, ClinicalTrials, the German study register, and the WHO registry platform. RESULTS: In total, three completed randomized controlled trials (RCTs, with 468 participants), three planned/ongoing RCTs (with a planned sample size of 752 participants), one non-randomized controlled study (NRS, with 53 participants), ten retrospective cohort studies (with 2228 participants), and one survey on patients' preferences (with 100 participants) were identified. All studies applied neoadjuvant chemoradiation protocols. None of the studies examined neoadjuvant chemotherapeutic protocols. Studies investigated patient populations with esophageal squamous cell carcinoma, adenocarcinoma, and mixed cohorts. Important outcomes reported were overall, disease-free and local recurrence-free survival. Limitations of the currently available study pool include heterogeneous chemoradiation protocols, a lack of modern neoadjuvant treatment protocols in RCTs, short follow-up times, the use of heterogeneous diagnostic methods, and different definitions of clinical CR. CONCLUSION: Although post-neoadjuvant surveillance and surgery as needed compared with post-neoadjuvant surgery on principle has been investigated within different study designs, the currently available results are based on a wide variation of diagnostic tools to identify patients with pCR, short follow-up times, small sample sizes, and variations in therapeutic procedures. A thoroughly planned RCT considering the limitations in the currently available literature will be of great importance to provide patients with CR with the best and less harmful treatment.
Entities:
Keywords:
esophageal cancer; esophagectomy; neoadjuvant treatment; pathological complete response; surveillance and surgery as needed; watch-and-wait
Authors: Christopher M Jones; Heather O'Connor; Maria O'Donovan; Daniel Hayward; Adrienn Blasko; Ruth Harman; Shalini Malhotra; Irene Debiram-Beecham; Bincy Alias; Adam Bailey; Andrew Bateman; Tom D L Crosby; Stephen Falk; Simon Gollins; Maria A Hawkins; Sudarshan Kadri; Stephanie Levy; Ganesh Radhakrishna; Rajarshi Roy; Raj Sripadam; Rebecca C Fitzgerald; Somnath Mukherjee Journal: EClinicalMedicine Date: 2022-09-23
Authors: Joachim Weis; Andrea Kiemen; Claudia Schmoor; Julian Hipp; Manuel Czornik; Matthias Reeh; Peter P Grimminger; Christiane Bruns; Jens Hoeppner Journal: Front Oncol Date: 2022-01-18 Impact factor: 6.244