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Adjuvant immunotherapy in patients with resected gastric and oesophagogastric junction cancer following preoperative chemotherapy with high risk for recurrence (ypN+ and/or R1): European Organisation of Research and Treatment of Cancer (EORTC) 1707 VESTIGE study
F. Lordick, ME. Mauer, G. Stocker, CA. Cella, I. Ben-Aharon, G. Piessen, L. Wyrwicz, G. Al-Haidari, T. Fleitas-Kanonnikoff, V. Boige, R. Lordick Obermannová, UM. Martens, C. Gomez-Martin, P. Thuss-Patience, V. Arrazubi, A. Avallone, KK. Shiu, P....
Language English Country England, Great Britain
Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Clinical Trial, Phase II
- MeSH
- Adenocarcinoma * pathology drug therapy therapy MeSH
- Chemotherapy, Adjuvant methods MeSH
- Adult MeSH
- Gastrectomy MeSH
- Esophagogastric Junction * pathology MeSH
- Immunotherapy methods MeSH
- Ipilimumab administration & dosage therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Neoplasm Recurrence, Local * pathology prevention & control drug therapy epidemiology MeSH
- Esophageal Neoplasms * pathology drug therapy therapy MeSH
- Stomach Neoplasms * pathology drug therapy therapy surgery MeSH
- Neoadjuvant Therapy * methods adverse effects MeSH
- Nivolumab administration & dosage therapeutic use MeSH
- Disease-Free Survival MeSH
- Antineoplastic Combined Chemotherapy Protocols * therapeutic use MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: Patients with gastro-oesophageal adenocarcinoma with tumour-positive lymph nodes (ypN+) or positive surgical margins (R1) following neoadjuvant chemotherapy and resection are at high risk of recurrence. Adjuvant nivolumab is effective in oesophageal/oesophagogastric junction cancer and residual pathological disease following chemoradiation and surgery. Immune checkpoint inhibition has shown efficacy in advanced gastro-oesophageal cancer. We hypothesised that nivolumab/ipilimumab would be more effective than adjuvant chemotherapy in high-risk (ypN+ and/or R1) patients with gastro-oesophageal adenocarcinoma following neoadjuvant chemotherapy and resection. PATIENTS AND METHODS: VESTIGE was an academic international, multicentre, open-label, randomised phase II trial evaluating the efficacy of adjuvant nivolumab/ipilimumab versus chemotherapy in gastro-oesophageal adenocarcinoma at high risk of recurrence. Patients were randomised 1 : 1 to receive standard adjuvant chemotherapy (same regimen as neoadjuvant) or nivolumab 3 mg/kg intravenously (i.v.) every 2 weeks plus ipilimumab 1 mg/kg i.v. every 6 weeks for 1 year. Key inclusion criteria included ypN+ and/or R1 status after neoadjuvant chemotherapy plus surgery. The primary endpoint was disease-free survival in the intent-to-treat population. Secondary endpoints included overall survival, locoregional and distant failure rates, and safety according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0. RESULTS: The independent Data Monitoring Committee reviewed data from 189 of the planned 240 patients in June 2022 and recommended stopping recruitment due to futility. At the time of final analysis, median follow-up was 25.3 months for 195 patients (98 nivolumab/ipilimumab and 97 chemotherapy). Median disease-free survival for the nivolumab/ipilimumab group was 11.4 months [95% confidence interval (CI) 8.4-16.8 months] versus 20.8 months (95% CI 15.0-29.9 months) for the chemotherapy group, hazard ratio 1.55 (95% CI 1.07-2.25, one-sided P = 0.99). The 12-month disease-free survival rates were 47.1% and 64.0%, respectively. There were no toxicity concerns or excess early discontinuations. CONCLUSION: Nivolumab/ipilimumab did not improve disease-free survival compared with chemotherapy in patients with ypN+ and/or R1 gastro-oesophageal adenocarcinoma following neoadjuvant chemotherapy and surgery.
Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy
Charité Universitäetsmedizin Berlin Charité Campus Benjamin Franklin Berlin Germany
Charité Universitäetsmedizin Berlin Charité Campus Virchow Klinikum Berlin Germany
CHRU de Lille Hôpital Huriez Lille France
Department of Cancer Medicine Institut Gustave Roussy Villejuif France
Department of Medical Oncology ICO Badalona Barcelona Spain
Department of Medicine Leipzig Germany
Department of Oncology Rambam Health Care Campus Haifa Israel
Department of Oncology SLK Kliniken Heilbronn Heilbronn Germany
Department of Upper Abdominal Diseases Karolinska University Hospital Stockholm Sweden
European Organisation for Research and Treatment of Cancer Headquarters Brussels Belgium
Hôpital Privé Jean Mermoz Lyon France
Hospital Clinico Universitario De Valencia Incliva Biomedical Research Institute Valencia Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario de Navarra Instituto de Investigación Sanitaria de Navarra Pamplona Spain
Istituto Europeo di Oncologia IRCCS Milan Italy
Istituto Nazionale Tumori IRCCS Fondazione G Pascale Naples Italy
Maria Sklodowska Curie National Research Institute of Oncology Warsaw Poland
Oslo University Hospital Ullevaal Hospital Oslo Norway
Oxford NIHR Biomedical Research Centre Churchill Hospital Oxford UK
Rabin Medical Center Beilinson Hospital Petach Tikva Israel
Royal Marsden Hospital London UK
University College Hospital London UK
University Medical Center Hamburg Eppendorf Center of Oncology Hamburg Germany
References provided by Crossref.org
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- $a Adjuvant immunotherapy in patients with resected gastric and oesophagogastric junction cancer following preoperative chemotherapy with high risk for recurrence (ypN+ and/or R1): European Organisation of Research and Treatment of Cancer (EORTC) 1707 VESTIGE study / $c F. Lordick, ME. Mauer, G. Stocker, CA. Cella, I. Ben-Aharon, G. Piessen, L. Wyrwicz, G. Al-Haidari, T. Fleitas-Kanonnikoff, V. Boige, R. Lordick Obermannová, UM. Martens, C. Gomez-Martin, P. Thuss-Patience, V. Arrazubi, A. Avallone, KK. Shiu, P. Artru, B. Brenner, C. Buges Sanchez, I. Chau, S. Lorenzen, S. Daum, M. Sinn, B. Merelli, NCT. van Grieken, M. Nilsson, M. Collienne, A. Giraut, E. Smyth
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- $a BACKGROUND: Patients with gastro-oesophageal adenocarcinoma with tumour-positive lymph nodes (ypN+) or positive surgical margins (R1) following neoadjuvant chemotherapy and resection are at high risk of recurrence. Adjuvant nivolumab is effective in oesophageal/oesophagogastric junction cancer and residual pathological disease following chemoradiation and surgery. Immune checkpoint inhibition has shown efficacy in advanced gastro-oesophageal cancer. We hypothesised that nivolumab/ipilimumab would be more effective than adjuvant chemotherapy in high-risk (ypN+ and/or R1) patients with gastro-oesophageal adenocarcinoma following neoadjuvant chemotherapy and resection. PATIENTS AND METHODS: VESTIGE was an academic international, multicentre, open-label, randomised phase II trial evaluating the efficacy of adjuvant nivolumab/ipilimumab versus chemotherapy in gastro-oesophageal adenocarcinoma at high risk of recurrence. Patients were randomised 1 : 1 to receive standard adjuvant chemotherapy (same regimen as neoadjuvant) or nivolumab 3 mg/kg intravenously (i.v.) every 2 weeks plus ipilimumab 1 mg/kg i.v. every 6 weeks for 1 year. Key inclusion criteria included ypN+ and/or R1 status after neoadjuvant chemotherapy plus surgery. The primary endpoint was disease-free survival in the intent-to-treat population. Secondary endpoints included overall survival, locoregional and distant failure rates, and safety according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0. RESULTS: The independent Data Monitoring Committee reviewed data from 189 of the planned 240 patients in June 2022 and recommended stopping recruitment due to futility. At the time of final analysis, median follow-up was 25.3 months for 195 patients (98 nivolumab/ipilimumab and 97 chemotherapy). Median disease-free survival for the nivolumab/ipilimumab group was 11.4 months [95% confidence interval (CI) 8.4-16.8 months] versus 20.8 months (95% CI 15.0-29.9 months) for the chemotherapy group, hazard ratio 1.55 (95% CI 1.07-2.25, one-sided P = 0.99). The 12-month disease-free survival rates were 47.1% and 64.0%, respectively. There were no toxicity concerns or excess early discontinuations. CONCLUSION: Nivolumab/ipilimumab did not improve disease-free survival compared with chemotherapy in patients with ypN+ and/or R1 gastro-oesophageal adenocarcinoma following neoadjuvant chemotherapy and surgery.
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