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When clinical practice demands to go beyond statistics: Adjuvant chemotherapy of colon cancer. The 3 vs 6 month story

4129 - Updated results of the SCOT study: An International Phase III Randomised (1:1) Non-inferiority Trial Comparing 3 versus 6 months of oxaliplatin based adjuvant chemotherapy for colorectal cancer

Date

11 Sep 2017

Session

When clinical practice demands to go beyond statistics: Adjuvant chemotherapy of colon cancer. The 3 vs 6 month story

Presenters

Timothy Iveson

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

T. Iveson1, R. Kerr2, M. Saunders3, N. Hollander4, J. Tabernero5, A. Haydon6, B. Glimelius7, A. Harkin8, C. Scudder9, K. Boyd8, A. Waterston10, L. Medley11, C. Wilson12, R. Ellis13, S. Essapen14, A. Dhadda15, M. Harrison16, S. Falk17, S. Abdel-Raouf18, J. Paul19

Author affiliations

  • 1 Dept Of Medical Oncology, University Hospital Southampton, SO16 6YD - Southampton/GB
  • 2 Oncology, Churchill Hospital University of Oxford, OX3 7LE - Oxford/GB
  • 3 Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 4 Oncology, Sygehus Syd Naestved, Naestved/DK
  • 5 Medical Oncology, Vall d’Hebrón Institut d’Oncologia (VHIO), 08035 - Barcelona/ES
  • 6 Medical Oncology, Alfred Health, 3004 - Melbourne/AU
  • 7 Immunology, Genetics And Pathology, University Hospital, SE-751 85 - Uppsala/SE
  • 8 Cruk Ctu, University of Glasgow, Glasgow/GB
  • 9 Oncology, University of Oxford, OX1 3PA - Oxford/GB
  • 10 Medical Oncology, Beatson West of Scotland Cancer Centre, G12 0YN - Glasgow/GB
  • 11 Oncology, Dr. Louise Medley, London/GB
  • 12 Cambridge Breast Unit, Addenbrooke's Hospital, Cb2 0QQ - Cambridge/GB
  • 13 Oncology, Royal Cornwall Hospital, TR1 3LJ - Truro/GB
  • 14 Oncology, Royal Surrey County Hospital St Luke's Cancer Centre, GU2 7XX - Guildford/GB
  • 15 Oncology, Castle Hill Hospital, HU16 5JQ - Cottingham/GB
  • 16 Oncology, Mount Vernon Hospital, Middlesex/GB
  • 17 Oncology, Bristol Haematology and Oncology Centre, BS2 8ED - Bristol/GB
  • 18 Oncology, Queen's Hospital, RM7 0AG - Essex/GB
  • 19 Cancer Research Uk Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow/GB
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Abstract 4129

Background

Results presented at ASCO 2017 gave conflicting results as to whether 3 months adjuvant chemotherapy was non-inferior to 6 months treatment. The effect of treatment duration on DFS appeared to depend on the chemotherapy regimen (Capox or FOLFOX) chosen and on risk group (high-risk [T4 or N2] vs low-risk [T1-3 N1]) stage lll disease.

Methods

SCOT is a non-inferiority randomised study designed to determine whether 3 months of adjuvant chemotherapy with FOLFOX or Capox (physician/patient choice) in Stage lll/high risk Stage ll colorectal cancer is as effective as 6 months treatment. Non-inferiority was determined to be a maximum 2.5% fall in 3-year disease-free survival (DFS) on the 3 month arm (from 78% on the 6 month arm). The study was designed with 90% power at the 2.5% L-sided level of statistical significance and aimed to recruit 9500 patients to observe 2,750 DFS events (relapses/deaths/new colorectal cancers).

Results

6088 patients with Stage lll/high risk Stage ll cancers of the colon or rectum were randomised between 27th March 2008 and 29th November 2013. 1981 patients received FOLFOX and 4107 received Capox. For 3 year DFS there were 1482 events (740 in the 3 month arm and 742 in the 6 month arm). 3 year DFS was 76.7% for the 3 month arm and 77.1% for the 6 month arm (HR 1.008, for non-inferiority p = 0.014). Non-inferiority was stronger for Capox than FOLFOX but the choice of regimen was not randomised. Further analysis looking at dose intensity of chemotherapy received and the effect of age and gender will be presented.

Conclusions

The updated SCOT results will allow further insight into treatment decisions for the duration of adjuvant therapy of colorectal cancer with regard to adjuvant chemotherapy regimen used and the risk of recurrence.

Clinical trial identification

Eudract Ref: 2007-003957-10; ISRCTN No: 23516549

Legal entity responsible for the study

NHS Greater Glasgow & Clyde and University of Glasgow

Funding

Medical Research Council (transferred to NETSCC - Efficacy and Mechanism Evaluation) (Grant Ref:G060170 and Cancer Research UK Core CTU Funding (Funding Ref:C6716/A9894

Disclosure

T. Iveson: Honoraria from Lilly Advisory Role for Servier, Celgene, Roche Travel and Accommodation from Servier, Roche, Bayer All other authors have declared no conflicts of interest.

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