Adjuvant immunotherapy in patients with resected gastric and
oesophagogastric junction cancer following preoperative
chemotherapy with high risk for recurrence (ypND and/or R1):
European Organisation of Research and Treatment of Cancer
(EORTC) 1707 VESTIGE study

J 2025

Adjuvant immunotherapy in patients with resected gastric and oesophagogastric junction cancer following preoperative chemotherapy with high risk for recurrence (ypND and/or R1): European Organisation of Research and Treatment of Cancer (EORTC) 1707 VESTIGE study

LORDICK, F.; M. E. MAUER; G. STOCKER; C. A. CELLA; I. BEN-AHARON et al.

Základní údaje

Originální název

Adjuvant immunotherapy in patients with resected gastric and oesophagogastric junction cancer following preoperative chemotherapy with high risk for recurrence (ypND and/or R1): European Organisation of Research and Treatment of Cancer (EORTC) 1707 VESTIGE study

Autoři

Vydání

Annals of Oncology, AMSTERDAM, ELSEVIER, 2025, 0923-7534

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30204 Oncology

Stát vydavatele

Nizozemské království

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 65.400 v roce 2024

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/25:00140728

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

gastric cancer; oesophagogastric junction cancer; perioperative; immunotherapy; chemotherapy

Štítky

14110811, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 3. 3. 2025 12:29, Mgr. Tereza Miškechová

Anotace

V originále

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.

Citovat

LORDICK, F.; M. E. MAUER; G. STOCKER; C. A. CELLA; I. BEN-AHARON; G. PIESSEN; L. WYRWICZ; G. AL-HAIDARI; T. FLEITAS-KANONNIKOFF; V. BOIGE; Radka LORDICK OBERMANNOVÁ; U. M. MARTENS; C. GOMEZ-MARTIN; P. THUSS-PATIENCE; V. ARRAZUBI; A. AVALLONE; K. K. SHIU; P. ARTRU; B. BRENNER; C Buges SANCHEZ; I. CHAU; S. LORENZEN; S. DAUM; M. SINN; B. MERELLI; N. C. T. VAN GRIEKEN; M. NILSSON; M. COLLIENNE; A. GIRAUT a E. SMYTH. Adjuvant immunotherapy in patients with resected gastric and oesophagogastric junction cancer following preoperative chemotherapy with high risk for recurrence (ypND and/or R1): European Organisation of Research and Treatment of Cancer (EORTC) 1707 VESTIGE study. Annals of Oncology. AMSTERDAM: ELSEVIER, 2025, roč. 36, č. 2, s. 197-207. ISSN 0923-7534. Dostupné z: https://doi.org/10.1016/j.annonc.2024.10.829.

@article{2481349,
   author = {Lordick, F. and Mauer, M. E. and Stocker, G. and Cella, C. A. and BenandAharon, I. and Piessen, G. and Wyrwicz, L. and AlandHaidari, G. and FleitasandKanonnikoff, T. and Boige, V. and Lordick Obermannová, Radka and Martens, U. M. and GomezandMartin, C. and ThussandPatience, P. and Arrazubi, V. and Avallone, A. and Shiu, K. K. and Artru, P. and Brenner, B. and Sanchez, C Buges and Chau, I. and Lorenzen, S. and Daum, S. and Sinn, M. and Merelli, B. and van Grieken, N. C. T. and Nilsson, M. and Collienne, M. and Giraut, A. and Smyth, E.},
   article_location = {AMSTERDAM},
   article_number = {2},
   doi = {https://doi.org/10.1016/j.annonc.2024.10.829},
   keywords = {gastric cancer; oesophagogastric junction cancer; perioperative; immunotherapy; chemotherapy},
   language = {eng},
   issn = {0923-7534},
   journal = {Annals of Oncology},
   title = {Adjuvant immunotherapy in patients with resected gastric and oesophagogastric junction cancer following preoperative chemotherapy with high risk for recurrence (ypND and/or R1): European Organisation of Research and Treatment of Cancer (EORTC) 1707 VESTIGE study},
   url = {https://www.sciencedirect.com/science/article/pii/S0923753424049068?via%3Dihub},
   volume = {36},
   year = {2025}
}

TY  - JOUR
ID  - 2481349
AU  - Lordick, F. - Mauer, M. E. - Stocker, G. - Cella, C. A. - Ben-Aharon, I. - Piessen, G. - Wyrwicz, L. - Al-Haidari, G. - Fleitas-Kanonnikoff, T. - Boige, V. - Lordick Obermannová, Radka - Martens, U. M. - Gomez-Martin, C. - Thuss-Patience, P. - Arrazubi, V. - Avallone, A. - Shiu, K. K. - Artru, P. - Brenner, B. - Sanchez, C Buges - Chau, I. - Lorenzen, S. - Daum, S. - Sinn, M. - Merelli, B. - van Grieken, N. C. T. - Nilsson, M. - Collienne, M. - Giraut, A. - Smyth, E.
PY  - 2025
TI  - Adjuvant immunotherapy in patients with resected gastric and oesophagogastric junction cancer following preoperative chemotherapy with high risk for recurrence (ypND and/or R1): European Organisation of Research and Treatment of Cancer (EORTC) 1707 VESTIGE study
JF  - Annals of Oncology
VL  - 36
IS  - 2
SP  - 197-207
EP  - 197-207
PB  - ELSEVIER
SN  - 09237534
KW  - gastric cancer
KW  - oesophagogastric junction cancer
KW  - perioperative
KW  - immunotherapy
KW  - chemotherapy
UR  - https://www.sciencedirect.com/science/article/pii/S0923753424049068?via%3Dihub
N2  - 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.
ER  -

LORDICK, F.; M. E. MAUER; G. STOCKER; C. A. CELLA; I. BEN-AHARON; G. PIESSEN; L. WYRWICZ; G. AL-HAIDARI; T. FLEITAS-KANONNIKOFF; V. BOIGE; Radka LORDICK OBERMANNOVÁ; U. M. MARTENS; C. GOMEZ-MARTIN; P. THUSS-PATIENCE; V. ARRAZUBI; A. AVALLONE; K. K. SHIU; P. ARTRU; B. BRENNER; C Buges SANCHEZ; I. CHAU; S. LORENZEN; S. DAUM; M. SINN; B. MERELLI; N. C. T. VAN GRIEKEN; M. NILSSON; M. COLLIENNE; A. GIRAUT a E. SMYTH. Adjuvant immunotherapy in patients with resected gastric and oesophagogastric junction cancer following preoperative chemotherapy with high risk for recurrence (ypND and/or R1): European Organisation of Research and Treatment of Cancer (EORTC) 1707 VESTIGE study. \textit{Annals of Oncology}. AMSTERDAM: ELSEVIER, 2025, roč.~36, č.~2, s.~197-207. ISSN~0923-7534. Dostupné z: https://doi.org/10.1016/j.annonc.2024.10.829.

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