Three Versus 6 Months of Adjuvant Oxaliplatin-Fluoropyrimidine Chemotherapy for Colorectal Cancer: Final Results of SCOT—An International, Randomized, Phase III, Noninferiority Trial
Adjuvant chemotherapy for colorectal cancer (CRC) with oxaliplatin and fluoropyrimidine was traditionally given for 6 months but is associated with cumulative peripheral neuropathy. The SCOT study (ISRCTN59757862) was an international, randomized, phase III, noninferiority trial investigating treatment reduction from 6 to 3 months. It originally reported noninferior disease-free survival with reduced toxicity and improved quality of life for 3 months of treatment in 6,088 patients. Here, we report overall survival (OS) with 38 months of additional follow-up. Patients with high-risk stage II and stage III CRC were assigned (1:1) to receive 3 or 6 months of either capecitabine and oxaliplatin (CAPOX) or infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX; bolus and infused fluorouracil with oxaliplatin) that were selected before random assignment. With a median of 113 months follow-up and 1,255 OS events, 5-year OS for 3 versus 6 months of treatment was 82.4% in both groups (hazard ratio, 0.96; 95% CI, 0.8 to 1.07), proving noninferiority of 3 months of treatment. Noninferiority of 3 months of treatment for OS was also shown in 1,087 patients with rectal cancer. The duration effect is regimen-dependent with noninferiority shown for CAPOX but not for FOLFOX. In summary, SCOT has shown noninferiority for OS with 3 months of adjuvant chemotherapy treatment, which should be recommended for most patients.
Authors
- Stephen Falk (ORCID: https://orcid.org/0000-0001-6106-3062)
- Josep M. Tabernero (ORCID: https://orcid.org/0000-0002-2495-8139)
- A.S. Dhadda (ORCID: https://orcid.org/0000-0003-3561-3811)
- Andrew Briggs (ORCID: https://orcid.org/0000-0002-0777-1997)
- M. Saunders
- Tamas Hickish (ORCID: https://orcid.org/0000-0001-6770-7279)
- Rene K Olesen (ORCID: https://orcid.org/0000-0002-3331-6904)
- David Propper (ORCID: https://orcid.org/0000-0002-4274-5460)
- E. Domingo
- Jim Cassidy (ORCID: https://orcid.org/0000-0003-3917-561X)
- Timothy Iveson (ORCID: https://orcid.org/0000-0002-4681-2712)
- H Wasan
- Niels Henrik Holländer (ORCID: https://orcid.org/0000-0003-2509-2231)
- K. Boyd
- Sarah Pearson (ORCID: https://orcid.org/0000-0001-5386-1953)
- John McQueen (ORCID: https://orcid.org/0000-0001-5950-8819)
- Andrew Haydon (ORCID: https://orcid.org/0000-0002-4631-5855)
- Richard Ellis (ORCID: https://orcid.org/0000-0002-4760-7921)
- David Church
- Bengt Glimelius
- Charlotte Rees
- David Cunningham
- Rachel S. Kerr
- Simon Gollins
- Mark Harrison
- Caroline Kelly
- Ashraf Azzabi
- Karen Allan
- John Bridgewater
- Ashita Waterston
Institutions
- Hebron University (PS)
- Uppsala University (SE)
- Queen Mary University of London (GB)
- Royal Cornwall Hospital Trust (GB)
- Beatson West of Scotland Cancer Centre (GB)
- Royal United Hospital (GB)
- Castle Hill Hospital (GB)
- Newcastle upon Tyne Hospitals NHS Foundation Trust (GB)
- Hammersmith Hospital (GB)
- The Alfred Hospital (AU)
- Aarhus University Hospital (DK)
- University Hospital Southampton NHS Foundation Trust (GB)
- University of Oxford (GB)
- Zealand University Hospital (DK)
- Mount Vernon Cancer Centre (GB)
- Royal Marsden Hospital (GB)
- The Christie Hospital (GB)
- NIHR Bristol Cardiovascular Biomedical Research Unit (GB)
- UCL Biomedical Research Centre (GB)
- Science Oxford (GB)
- Velindre Cancer Centre (GB)
- University of Southampton (GB)
- University College London (GB)
- Imperial College London (GB)
- University of Glasgow (GB)
- Bournemouth University (GB)
Publication Details
- Journal
- Journal of Clinical Oncology
- Published
- 2026-01-09
- DOI
- https://doi.org/10.1200/jco-25-00621
- Primary Topic
- Colorectal Cancer Treatments and Studies
- Type
- article
- Field-Weighted Citation Impact
- 0.00