3 versus 6 months of adjuvant oxaliplatin-fluoropyrimidine combination therapy for colorectal cancer (SCOT): an international, randomised, phase 3, non-inferiority trial

The Lancet Oncology

Volumn 19, Issue 4, 2018, Pages 562-578

  Iveson, Timothy J ^a   Kerr, Rachel S ^b   Saunders, Mark P ^c   Cassidy, Jim ^d   Hollander, Niels Henrik ^e   Tabernero, Josep ^f   Haydon, Andrew ^g   Glimelius, Bengt ^h   Harkin, Andrea ^d   Allan, Karen ^d   McQueen, John ^d   Scudder, Claire ^b   Boyd, Kathleen Anne ^d   Briggs, Andrew ^d,i   Waterston, Ashita ^j   Medley, Louise ^k   Wilson, Charles ^l   Ellis, Richard ^m   Essapen, Sharadah ⁿ   Dhadda, Amandeep S ^o   Harrison, Mark ^p   Falk, Stephen ^q   Raouf, Sherif ^r   Rees, Charlotte ^a   Olesen, Rene K ^s   Propper, David ^t   Bridgewater, John ^u   Azzabi, Ashraf ^v   Farrugia, David ^w   Webb, Andrew ^x   Cunningham, David ^y   Hickish, Tamas ^z   Weaver, Andrew ^b   Gollins, Simon ^aa   Wasan, Harpreet S ^ab   Paul, James ^d   more..

^a UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c CHRISTIE HOSPITAL   (United Kingdom)

^d UNIVERSITY OF GLASGOW   (United Kingdom)

^e ZEALAND UNIVERSITY HOSPITAL   (Denmark)

^f HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^g Australasian Gastro Intestinal Trials Group   (Australia)

^h UPPSALA UNIVERSITY   (Sweden)

ⁱ MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^j BEATSON WEST OF SCOTLAND CANCER CENTRE   (United Kingdom)

^k ROYAL UNITED HOSPITAL   (United Kingdom)

^l ADDENBROOKE S HOSPITAL   (United Kingdom)

^m ROYAL CORNWALL HOSPITALS NHS TRUST   (United Kingdom)

ⁿ ROYAL SURREY COUNTY HOSPITAL   (United Kingdom)

^o CASTLE HILL HOSPITAL   (United Kingdom)

^p MOUNT VERNON CANCER CENTRE   (United Kingdom)

^q Bristol Cancer Institute   (United Kingdom)

^r HAVERING AND REDBRIDGE UNIVERSITY HOSPITALS NHS TRUST   (United Kingdom)

^s AARHUS UNIVERSITY HOSPITAL   (Denmark)

^t QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^u UNIVERSITY COLLEGE LONDON   (United Kingdom)

^v NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^w CHELTENHAM GENERAL HOSPITAL   (United Kingdom)

^x Worthing Hospital   (United Kingdom)

^y ROYAL MARSDEN HOSPITAL   (United Kingdom)

^z BOURNEMOUTH UNIVERSITY   (United Kingdom)

^aa GLAN CLWYD HOSPITAL   (United Kingdom)

^ab HAMMERSMITH HOSPITAL   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

FLUOROPYRIMIDINE; OXALIPLATIN; ANTINEOPLASTIC AGENT; CAPECITABINE; FLUOROURACIL; FOLINIC ACID; PLATINUM COMPLEX;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER STAGING; COLORECTAL CANCER; COMPARATIVE EFFECTIVENESS; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DISEASE FREE SURVIVAL; DOSAGE SCHEDULE COMPARISON; DRUG SAFETY; EPIPHORA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HAZARD RATIO; HIGH RISK PATIENT; HUMAN; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; PAIN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; SENSORY NEUROPATHY; TASTE DISORDER; THROMBOCYTOPENIA; TREATMENT DURATION; VOMITING; ADENOCARCINOMA; ADJUVANT CHEMOTHERAPY; CHEMICALLY INDUCED; CLINICAL TRIAL; COLORECTAL TUMOR; COMPARATIVE STUDY; MIDDLE AGED; PATHOLOGY; PERIPHERAL NEUROPATHY; QUALITY OF LIFE; SURVIVAL RATE; TIME FACTOR;

ADENOCARCINOMA; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAPECITABINE; CHEMOTHERAPY, ADJUVANT; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; NEOPLASM STAGING; ORGANOPLATINUM COMPOUNDS; OXALIPLATIN; PERIPHERAL NERVOUS SYSTEM DISEASES; QUALITY OF LIFE; SURVIVAL RATE; TIME FACTORS;

EID: 85044544250     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(18)30093-7     Document Type: Article

References (29)

1. Ferlay, J, Soerjomataram, I, Ervik, M, et al. GLOBOCAN 2012 v1.0, cancer incidence and mortality worldwide: IARC cancer base no. 11. 2013, International Agency for Research on Cancer, Lyon.
2. Moertel, CG, Fleming, TR, Macdonald, JS, et al. Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N Engl J Med 322 (1990), 352–358.
3. Andre, T, Boni, C, Mounedji-Boudiaf, L, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med 350 (2004), 2343–2351.
4. Kuebler, JP, Wieand, HS, O'Connell, MJ, et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol 25 (2007), 2198–2204.
5. Haller, DG, Tabernero, J, Maroun, J, et al. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol 29 (2011), 1465–1471.
6. Schmoll, HJ, Van Cutsem, E, Stein, A, et al. ESMO Consensus Guidelines for management of patients with colon and rectal cancer. a personalized approach to clinical decision making. Ann Oncol 23 (2012), 2479–2516.
7. National Comprehensive Cancer Network. Colon cancer (version 2.2107). http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf (accessed June 24, 2017).
8. Land, SR, Kopec, JA, Cecchini, RS, et al. Neurotoxicity from oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: NSABP C-07. J Clin Oncol 25 (2007), 2205–2211.
9. Pachman, DR, Qin, R, Seisler, DK, et al. Clinical course of oxaliplatin-induced neuropathy: results from the randomized phase III trial N08CB (Alliance). J Clin Oncol 33 (2015), 3416–3422.
10. Chau, I, Norman, AR, Cunningham, D, et al. A randomised comparison between 6 months of bolus fluorouracil/leucovorin and 12 weeks of protracted venous infusion fluorouracil as adjuvant treatment in colorectal cancer. Ann Oncol 16 (2005), 549–557.
11. Paul, J, Iveson, T, Midgely, R, et al. Choice of randomisation time-point in non-inferiority studies of reduced treatment duration: experience from the SCOT study. Trials, 12(suppl 1), 2011, A30.
12. Dolan, P, Modeling valuations for EuroQol health states. Med Care 35 (1997), 1095–1108.
13. Osoba, D, Rodrigues, G, Myles, J, Zee, B, Pater, J, Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 16 (1998), 139–144.
14. Aaronson, NK, Ahmedzai, S, Bergman, B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85 (1993), 365–376.
15. Rubin, DB, Multiple imputation for nonresponse in surveys. 1987, J Wiley & Sons, New York.
16. Qian, W, Parmar, MK, Sambrook, RJ, Fayers, PM, Girling, DJ, Stephens, RJ, Analysis of messy longitudinal data from a randomized clinical trial. MRC Lung Cancer Working Party. Stat Med 19 (2000), 2657–2674.
17. Hochberg, Y, A sharper Bonferroni procedure for multiple tests of significance. Biometrika 75 (1988), 800–802.
18. Demets, DL, Futility approaches to interim monitoring by data monitoring committees. Clin Trials 3 (2006), 522–529.
19. Andre, T, Boni, C, Navarro, M, et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol 27 (2009), 3109–3116.
20. Andre, T, de Gramont, A, Vernerey, D, et al. Adjuvant fluorouracil, leucovorin, and oxaliplatin in stage II to III colon cancer: updated 10-year survival and outcomes according to BRAF Mutation and mismatch repair status of the MOSAIC study. J Clin Oncol 33 (2015), 4176–4187.
21. Pickard, AS, Neary, MP, Cella, D, Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer. Health Qual Life Outcomes, 5, 2007, 70.
22. Tournigand, C, Andre, T, Bonnetain, F, et al. Adjuvant therapy with fluorouracil and oxaliplatin in stage II and elderly patients (between ages 70 and 75 years) with colon cancer: subgroup analyses of the Multicenter International Study of Oxaliplatin, Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer trial. J Clin Oncol 30 (2012), 3353–3360.
23. Sargent, DJ, Marsoni, S, Monges, G, et al. Defective mismatch repair as a predictive marker for lack of efficacy of fluorouracil-based adjuvant therapy in colon cancer. J Clin Oncol 28 (2010), 3219–3226.
24. Majithia, N, Temkin, SM, Ruddy, KJ, et al. National Cancer Institute-supported chemotherapy-induced peripheral neuropathy trials: outcomes and lessons. Support Care Cancer 24 (2016), 1439–1447.
25. Mols, F, Beijers, T, Lemmens, V, van den Hurk, CJ, Vreugdenhil, G, van de Poll-Franse, LV, Chemotherapy-induced neuropathy and its association with quality of life among 2- to 11-year colorectal cancer survivors: results from the population-based PROFILES registry. J Clin Oncol 31 (2013), 2699–2707.
26. Andre, T, Iveson, T, Labianca, R, et al. The IDEA (International Duration Evaluation of Adjuvant Chemotherapy) Collaboration: prospective combined analysis of phase III Trials investigating duration of adjuvant therapy with the FOLFOX (FOLFOX4 or Modified FOLFOX6) or XELOX (3 versus 6 months) regimen for patients with stage III colon cancer: trial design and current status. Curr Colorectal Cancer Rep 9 (2013), 261–269.
27. Grothey A, Sobrero AF, Shields AF, et al. Duration of adjuvant chemotherapy for stage III colon cancer. N Engl J Med (in press).
28. Twelves, C, Wong, A, Nowacki, MP, et al. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med 352 (2005), 2696–2704.
29. Hooper, R, The Bayesian interpretation of a p-value depends only weakly on statistical power in realistic situations. J Clin Epidemiol 62 (2009), 1242–1247.