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dc.contributor.authorIveson, TJen_US
dc.contributor.authorKerr, RSen_US
dc.contributor.authorSaunders, MPen_US
dc.contributor.authorCassidy, Jen_US
dc.contributor.authorHollander, NHen_US
dc.contributor.authorTabernero, Jen_US
dc.contributor.authorHaydon, Aen_US
dc.contributor.authorGlimelius, Ben_US
dc.contributor.authorHarkin, Aen_US
dc.contributor.authorAllan, Ken_US
dc.contributor.authorMcQueen, Jen_US
dc.contributor.authorScudder, Cen_US
dc.contributor.authorBoyd, KAen_US
dc.contributor.authorBriggs, Aen_US
dc.contributor.authorWaterston, Aen_US
dc.contributor.authorMedley, Len_US
dc.contributor.authorWilson, Cen_US
dc.contributor.authorEllis, Ren_US
dc.contributor.authorEssapen, Sen_US
dc.contributor.authorDhadda, ASen_US
dc.contributor.authorHarrison, Men_US
dc.contributor.authorFalk, Sen_US
dc.contributor.authorRaouf, Sen_US
dc.contributor.authorRees, Cen_US
dc.contributor.authorOlesen, RKen_US
dc.contributor.authorPropper, Den_US
dc.contributor.authorBridgewater, Jen_US
dc.contributor.authorAzzabi, Aen_US
dc.contributor.authorFarrugia, Den_US
dc.contributor.authorWebb, Aen_US
dc.contributor.authorCunningham, Den_US
dc.contributor.authorHickish, Ten_US
dc.contributor.authorWeaver, Aen_US
dc.contributor.authorGollins, Sen_US
dc.contributor.authorWasan, HSen_US
dc.contributor.authorPaul, Jen_US
dc.identifier.citationLancet Oncol, 2018, 19 (4), pp. 562 - 578en_US
dc.description.abstractBACKGROUND: 6 months of oxaliplatin-containing chemotherapy is usually given as adjuvant treatment for stage 3 colorectal cancer. We investigated whether 3 months of oxaliplatin-containing chemotherapy would be non-inferior to the usual 6 months of treatment. METHODS: The SCOT study was an international, randomised, phase 3, non-inferiority trial done at 244 centres. Patients aged 18 years or older with high-risk stage II and stage III colorectal cancer underwent central randomisation with minimisation for centre, choice of regimen, sex, disease site, N stage, T stage, and the starting dose of capecitabine. Patients were assigned (1:1) to receive 3 months or 6 months of adjuvant oxaliplatin-containing chemotherapy. The chemotherapy regimens could consist of CAPOX (capecitabine and oxaliplatin) or FOLFOX (bolus and infused fluorouracil with oxaliplatin). The regimen was selected before randomisation in accordance with choices of the patient and treating physician. The primary study endpoint was disease-free survival and the non-inferiority margin was a hazard ratio of 1·13. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who started study treatment. This trial is registered with ISRCTN, number ISRCTN59757862, and follow-up is continuing. FINDINGS: 6088 patients underwent randomisation between March 27, 2008, and Nov 29, 2013. The intended treatment was FOLFOX in 1981 patients and CAPOX in 4107 patients. 3044 patients were assigned to 3 month group and 3044 were assigned to 6 month group. Nine patients in the 3 month group and 14 patients in the 6 month group did not consent for their data to be used, leaving 3035 patients in the 3 month group and 3030 patients in the 6 month group for the intention-to-treat analyses. At the cutoff date for analysis, there had been 1482 disease-free survival events, with 740 in the 3 month group and 742 in the 6 month group. 3 year disease-free survival was 76·7% (95% CI 75·1-78·2) for the 3 month group and 77·1% (75·6-78·6) for the 6 month group, giving a hazard ratio of 1·006 (0·909-1·114, test for non-inferiority p=0·012), significantly below the non-inferiority margin. Peripheral neuropathy of grade 2 or worse was more common in the 6 month group (237 [58%] of 409 patients for the subset with safety data) than in the 3 month group (103 [25%] of 420) and was long-lasting and associated with worse quality of life. 1098 serious adverse events were reported (492 reports in the 3 month group and 606 reports in the 6 month group) and 32 treatment-related deaths occurred (16 in each group). INTERPRETATION: In the whole study population, 3 months of oxaliplatin-containing adjuvant chemotherapy was non-inferior to 6 months of the same therapy for patients with high-risk stage II and stage III colorectal cancer and was associated with reduced toxicity and improved quality of life. Despite the fact the study was underpowered, these data suggest that a shorter duration leads to similar survival outcomes with better quality of life and thus might represent a new standard of care. FUNDING: Medical Research Council, Swedish Cancer Society, NETSCC, and Cancer Research UK.en_US
dc.format.extent562 - 578en_US
dc.subjectAntineoplastic Combined Chemotherapy Protocolsen_US
dc.subjectChemotherapy, Adjuvanten_US
dc.subjectColorectal Neoplasmsen_US
dc.subjectDisease-Free Survivalen_US
dc.subjectMiddle Ageden_US
dc.subjectNeoplasm Stagingen_US
dc.subjectOrganoplatinum Compoundsen_US
dc.subjectPeripheral Nervous System Diseasesen_US
dc.subjectQuality of Lifeen_US
dc.subjectSurvival Rateen_US
dc.subjectTime Factorsen_US
dc.title3 versus 6 months of adjuvant oxaliplatin-fluoropyrimidine combination therapy for colorectal cancer (SCOT): an international, randomised, phase 3, non-inferiority trial.en_US
dc.typeJournal Article
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfLancet Oncolen_US
pubs.notesNot knownen_US
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)/Medicine (RMH Smith Cunningham) (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.embargo.termsNot knownen_US
icr.researchteamMedicine (RMH Smith Cunningham)en_US
dc.contributor.icrauthorCunningham, Daviden_US

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