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Poster Display session 2

2735 - Bevacizumab plus Oxaliplatin-Based Chemotherapy as Adjuvant Treatment for Colon Cancer (CC): Updated analysis of stage II disease from the AVANT Phase III Randomized trial by the GERCOR Group

Date

29 Sep 2019

Session

Poster Display session 2

Topics

Tumour Site

Colon and Rectal Cancer

Presenters

Aimery De Gramont

Citation

Annals of Oncology (2019) 30 (suppl_5): v198-v252. 10.1093/annonc/mdz246

Authors

A. De Gramont1, J. Henriques2, B. Baruch3, T.W. Kim4, M. Martinez-Villacampa5, J. Gallego-Plazas6, A. Cervantes7, K. Shim8, D.J. Jonker9, V. Guerin-Meyer10, L. Mineur11, M. Banzi12, A. Dewdney13, T. (Sirisingha) Dejthevaporn14, H.J. Bloemendal15, A.D. Roth16, P. Thompson17, M. Moehler18, E. Aranda Aguilar19, T. André20

Author affiliations

  • 1 Medical Oncology Department, Institut Hospitalier Franco-Britannique, 92300 - Levallois Perret/FR
  • 2 Methodology And Quality Of Life Unit In Oncology, University Hospital of Besançon, INSERM UMR 1098, Besançon/FR
  • 3 Department Of Oncology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, affiliated with Sackler School of Medicine, Tel Aviv/IL
  • 4 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-931 - Seoul/KR
  • 5 Department Of Medical Oncology, Institut Català d'Oncologia-IDIBELL Hospitalet, Barcelona/ES
  • 6 Department Of Medical Oncology, General Universitario de Elche Hospital, Elche/ES
  • 7 Medical Oncology, Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 8 Medical Oncology, Lakeridge Health R.S. McLaughlin Durham Regional Cancer Centre, Oshawa/CA
  • 9 Department Of Medicine, Division Of Medical Oncology, Ottawa Hospital Research Institute, University of Ottawa, K1H8L6 - Ottawa/CA
  • 10 Department Of Gastroenterology And Hepatology, Institut de Cancérologie de l'Ouest Paul Papin, Angers/FR
  • 11 Radiotherapy And Oncology Gi And Liver, Institut Sainte Catherine, Avignon/FR
  • 12 Oncology Unit, Azienda Ospedaliera Arcispedale Santa Maria Nuova – IRCCS, Reggio Emilia/IT
  • 13 Department Of Oncology, Weston Park Hospital Cancer Research Centre, S10 2SJ - Sheffield/GB
  • 14 Medical Oncology, Ramathibodi Hospital, 10400 - Bangkok/TH
  • 15 Department Of Internal Medicine/medical Oncology, Meander Medical Center, Amersfoort/NL
  • 16 Digestive Tumor Unit, Department Of Oncology, Hôpitaux Universitaires de Genève - HUG, 1211 - Geneva/CH
  • 17 Medical Oncology Department, Auckland City Hospital, 1023 - Auckland/NZ
  • 18 Department Of Medical Oncology, Universitätsmedizin Mainz, 55131 - Mainz/DE
  • 19 Department Of Medical Oncology, University Hospital Reina Sofia, 14004 - Cordoba/ES
  • 20 Department Of Medical Oncology, Hôpital Saint-Antoine, 75571 - Paris/FR

Resources

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Abstract 2735

Background

The AVANT study did not demonstrate disease-free survival (DFS) benefit of the addition of bevacizumab to oxaliplatin-based chemotherapy in stage III resected CC and suggested a potential detrimental effect on overall survival (OS) (A. de Gramont et al. Lancet Oncol. 2012). Here, we present the results of the AVANT study for stage II CC patients.

Methods

The primary endpoint of AVANT was DFS for stage III disease. As an exploratory measure, AVANT also included high-risk stage II CC defined by T4, bowel obstruction or perforation, blood and/or lymphatic vascular invasion and/or perineural invasion, age <50 years, less than 12 nodes analyzed. OS and DFS were estimated by the Kaplan Meier method and compared by log-rank test and Cox regression model.

Results

573 patients had stage II CC (arm A: FOLFOX4, n = 192; arm B: FOLFOX4-bevacizumab, n = 194; arm C: XELOX-bevacizumab, n = 187), of whom 38 (19.8%) in arm A, 36 (18.6%) in arm B, and 40 (21.4%) in arm C had relapsed, developed a new CC, or died after a median follow-up of 6.86 years (IQR: 6.13-11.34). The DFS hazard-ratio was 0.94 (95% CI 0.59-1.48; P = 0.78) for arm B vs arm A and 1.07 (95% CI 0.69-1.67; P = 0.76) for arm C vs arm A. The OS hazard ratio was 0.92 (95% CI 0.55-1.55; P = 0.76) for arm B vs arm A and 0.85 (95% CI 0·50-1.44; P = 0.55) for arm C vs arm A. Safety data of stage II and stage III CC have been reported previously. In multivariable analysis, T4 vs T3-1 (P = 0.041), number of examined nodes (P = 0.005), and age (P = 0.0008) were prognostic for DFS. The 3-year DFS and 5-year OS rates of stage II were 88.2% (95% CI 83.7%-93.0%) and 89.7% (95% CI 85.4%-94.2%) in arm A, 86.6% (95% CI 81.8%-91.6%) and 89.7% (95% CI 85.4%-94.2%) in arm B, 86.7% (95% CI 81.8%-91.8%) and 93.2% (95% CI 89.6%-97.0%) in arm C, respectively.

Conclusions

In this exploratory analysis, bevacizumab did not prolong DFS and OS when added to adjuvant oxaliplatin-based chemotherapy in resected high-risk stage II patients with CC.

Clinical trial identification

NCT00112918.

Editorial acknowledgement

Magdalena Benetkiewicz (GERCOR).

Legal entity responsible for the study

GERCOR.

Funding

Roche.

Disclosure

A. De Gramont: Honoraria (self): Yakult; Honoraria (self): Chugai Pharma. T.W. Kim: Research grant / Funding (self): Merck Serono; Research grant / Funding (self): Pfizer; Research grant / Funding (self): AstraZeneca. J. Gallego-Plazas: Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Advisory / Consultancy: Roche; Advisory / Consultancy: Bayer; Advisory / Consultancy: Lilly; Advisory / Consultancy: Celgene; Advisory / Consultancy: Merck; Travel / Accommodation / Expenses: Novartis; Leadership role, Study Coordinator of Agamenon study in advanced gastric cancer: Agamenon study. A. Cervantes: Advisory / Consultancy, Research grant / Funding (institution): Merck Serono; Advisory / Consultancy: Amgen; Advisory / Consultancy, Research grant / Funding (institution): Servier; Advisory / Consultancy: Roche; Advisory / Consultancy, Research grant / Funding (institution): Lilly; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution): Takeda; Advisory / Consultancy, Research grant / Funding (institution): Astellas; Advisory / Consultancy, Research grant / Funding (institution): Roche Beigene; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Advisory / Consultancy: Foundation Medicine; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): Fibrogen; Research grant / Funding (institution): Amcure; Research grant / Funding (institution): Sierra Oncology; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Medimmune; Research grant / Funding (institution): BMS; Research grant / Funding (institution): MSD; Leadership role, Executive Board member of ESMO: not remunerated Chair of Education of ESMO: not remunerated General and Scientific Director of INCLIVA: not remunerated Associate Editor of ESMO Open: not remunerated Associate Editor of Annals of Oncology: remunerated Editor in Chief of Cancer Treatment Reviews: remunerated: Executive Board member of ESMO: not remunerated Chair of Education of ESMO: not remunerated General and Scientific Director of INCLIVA: not remunerated Associate Editor of ESMO Open: not remunerated Associate Editor of Annals of Oncology: remunerated. D.J. Jonker: Research grant / Funding (institution): Hoffman-La Roche; Non-remunerated activity/ies, Chair of the GI Disease Site Committee of the Canadian Cancer Trials Group: Canadian Cancer Trials Group. A. Dewdney: Honoraria (self), Chairing evening meetings: Servier; Honoraria (self): Roche. T. (Sirisingha) Dejthevaporn: Honoraria (self): Roche; Honoraria (self): Eisai; Honoraria (self): Pfizer; Honoraria (self): AstraZeneca; Honoraria (self): Eli Lilly; Leadership role: Thai Society of Clinical Oncology (TSCO). M. Moehler: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Merck; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Bayer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche. T. André: Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD Oncology; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche/Ventana; Honoraria (self): Sanofi; Honoraria (self), Advisory / Consultancy: Servier; Honoraria (self): Chugai; Honoraria (self): Yakult; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: HalioDx. All other authors have declared no conflicts of interest.

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