Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: Individual patient data from 20,898 patients on 18 randomized trials

Journal of Clinical Oncology

Volumn 23, Issue 34, 2005, Pages 8664-8670

  Sargent, Daniel J ^a   Wieand, Harry S ^b   Haller, Daniel G ^b   Gray, Richard ^b   Benedetti, Jacqueline K ^b   Buyse, Marc ^b   Labianca, Roberto ^b   Seitz, Jean Francois ^b   O'Callaghan, Christopher J ^b   Francini, Guido ^b   Grothey, Axel ^b   O'Connell, Michael ^b   Catalano, Paul J ^b   Blanke, Charles D ^b   Kerr, David ^b   Green, Erin ^b   Wolmark, Norman ^b   Andre, Thierry ^b   Goldberg, Richard M ^b   De Gramont, Aimery ^b  

^a MAYO CLINIC   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA2A INTERFERON; BEVACIZUMAB; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; LEVAMISOLE; OXALIPLATIN; SEMUSTINE; VINCRISTINE; ANTINEOPLASTIC AGENT;

ADJUVANT CHEMOTHERAPY; ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER RESEARCH; CANCER SURVIVAL; CANCER THERAPY; CLINICAL TRIAL; COLON CANCER; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG MEGADOSE; FEMALE; HAZARD RATIO; HUMAN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RECURRENT CANCER; SURVIVAL RATE; TREATMENT OUTCOME; TREATMENT PLANNING; COLON TUMOR; COMPARATIVE STUDY; DISEASE FREE SURVIVAL; FOLLOW UP; MIDDLE AGED; MULTIMODALITY CANCER THERAPY; REGRESSION ANALYSIS; TUMOR RECURRENCE;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; COLONIC NEOPLASMS; COMBINED MODALITY THERAPY; DISEASE-FREE SURVIVAL; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; RANDOMIZED CONTROLLED TRIALS; REGRESSION ANALYSIS; TREATMENT OUTCOME;

EID: 33644834827     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.01.6071     Document Type: Article

References (38)

1. National Institutes of Health: Adjuvant therapy for patients with colon and rectum cancer: NIH Consensus Statement (vol 8). Bethesda, MD, National Institutes of Health, 1990, pp 1-25
2. Sargent DJ, Goldberg RM, Jacobson SD, et al: A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients. N Engl J Med 345:1091-1097, 2001
3. Benson AB 3rd, Schrag D, Somerfield MR, et al: American Society of Clinical Oncology recommendations on adjuvant chemotherapy for stage II colon cancer. J Clin Oncol 22:3408-3419, 2004
4. Gray RG, Barnwell J, Hills R, et al: QUASAR: A randomized study of adjuvant chemotherapy (CT) vs. observation including 3238 colorectal cancer patients. J Clin Oncol 23:245s, 2004 (abstr 3501)
5. Gill S, Loprinzi CL, Sargent DJ, et al: Pooled analysis of fluorouracil-based adjuvant therapy for stage II and III colon cancer: Who benefits and by how much? J Clin Oncol 22: 1797-1806, 2004
6. Prentice RL: Surrogate endpoints in clinical trials: Definition and operational criteria. Stat Med 8:431-440, 1989
7. Fleming TR, DeMets DL: Surrogate end points in clinical trials: Are we being misled? Ann Intern Med 125:605-613, 1996
8. Buyse M, Molenberghs G, Burzykowski T, et al: The validation of surrogate endpoints in meta-analyses of randomized experiments. Biostatistics 1:49-67, 2000
9. Begg CB, Leung DHY: On the use of surrogate end points in randomized trials. J R Stat Soc (Ser A) 163:15-24, 2000
10. Cox DR: Regression models and life tables (with discussion). J R Stat Soc B 34:187-220, 1972
11. Freedman LS, Graubard BI, Schatzkin A: Statistical validation of intermediate endpoints for chronic diseases. Stat Med 11:167-178, 1992
12. Burzykowski T, Molenberghs G, Buyse M, et al: Validation of surrogate end points in multiple randomized clinical trials with failure time end points. Appl Stat 50:405-422, 2001
13. Efron B, Gong G: A leisurely look at the bootstrap, the jackknife, and cross-validation. Am Stat 37:36-48, 1983
14. Wolmark N, Fisher B, Rockette H: Postoperative adjuvant chemotherapy or BCG for colon cancer: Results from NSABP protocol C-01. J Natl Cancer Inst 80:30-36, 1988
15. Laurie JA, Moertel CG, Fleming TR, et al: Surgical adjuvant therapy of large-bowel carcinoma: An evaluation of levamisole and the combination of levamisole and fluorouracil. J Clin Oncol 7:1447-1456, 1989
16. International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) investigators: Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. Lancet 345:939-944, 1995
17. Wolmark N, Rockette H, Wickerham DL, et al: Adjuvant therapy of Dukes' A, B, and C adenocarcinoma of the colon with portal-vein fluorouracil hepatic infusion: Preliminary results of National Surgical Adjuvant Breast and Bowel Project Protocol C-02. J Clin Oncol 8:1466-1475, 1990
18. Moertel CG, Fleming TR, Macdonald JS, et al: Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N Engl J Med 322:352-358, 1990
19. Francini G, Petrioli R, Lorenzini L, et al: Folinic acid and 5-fluorouracil as adjuvant chemotherapy in colon cancer. Gastroenterology 106: 899-906, 1994
20. Wolmark N, Rockette H, Fisher B, et al: The benefit of leucovorin-modulated fluorouracil as postoperative adjuvant therapy for primary colon cancer: Results from National Surgical Adjuvant Breast and Bowel Project protocol C-03. J Clin Oncol 11:1879-1887, 1993
21. O'Connell MJ, Mailliard JA, Kahn MJ, et al: Controlled clinical trial of fluorouracil and low-dose leucovorin given for 6 months as postoperative adjuvant therapy for colon cancer. J Clin Oncol 15:246-250, 1997
22. O'Connell MJ, Laurie JA, Kahn M, et al: Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. J Clin Oncol 16:295-300, 1998
23. Wolmark N, Rockette H, Mamounas E, et al: Clinical trial to assess the relative efficacy of fluorouracil and leucovorin, fluorouracil and levamisole, and fluorouracil, leucovorin, and levamisole in patients with Dukes' B and C carcinoma of the colon: Results from National Surgical Adjuvant Breast and Bowel Project C-04. J Clin Oncol 17: 3553-3559, 1999
24. Haller DG, Catalano PJ, Macdonald JS, et al: Fluorouracil (FU), leucovorin (LV), and levamisole (LEV) adjuvant therapy for colon cancer: Five-year final report of INT-0089. Proc Am Soc Clin Oncol 17:256a, 1998 (abstr 992)
25. Wolmark N, Bryant J, Smith R, et al: Adjuvant 5-fluorouracil and leucovorin with or without interferon alfa-2a in colon carcinoma: National Surgical Adjuvant Breast and Bowel Project protocol C-05. J Natl Cancer Inst 90: 1810-1816, 1998
26. O'Connell M, Skillings J, Windschitl H, et al: Phase III trial of high dose levamisole (LEV) + 5-fluorouracil (5FU) + leucovorin (CF) as adjuvant treatment (Adj) for high risk colon cancer (CC): An NCCTG/NCIC study. Proc Am Soc Clin Oncol 20:132a, 2001 (abstr 525)
27. Poplin E, Benedetti J, Estes N, et al: Phase III randomized trial of bolus 5-FU/leucovorin/ levamisole versus 5-FU continuous infusion/ levamisole as adjuvant therapy for high risk colon cancer (SWOG 8415/INT-0153). Proc Am Soc Clin Oncol 19:240a, 2000 (abstr)
28. Andre T, Colin P, Louvet C, et al: Semi-monthly versus monthly regimen of fluorouracil and leucovorin administered for 24 or 36 weeks as adjuvant therapy in stage II and III colon cancer: Results of a randomized trial. J Clin Oncol 21:2896-2903, 2003
29. QUASAR Collaborative Group: Comparison of fluorouracil with additional levamisole, higher-dose folinic acid, or both, as adjuvant chemotherapy for colorectal cancer: A randomized trial. Lancet 355:1588-1596, 2000
30. Korn EL, Albert PS, McShane LM: Assessing surrogates as trial endpoints using mixed models. Stat Med 24:163-182, 2005
31. Benson III AB, Desch CE, Flynn PJ, et al: 2000 update of American Society of Clinical Oncology colorectal cancer surveillance guidelines. J Clin Oncol 18:3586-3588, 2000
32. Chau I, Allen MJ, Cunningham D, et al: The value of routine serum carcino-embryonic antigen measurement and computed tomography in surveillance of patients after adjuvant chemotherapy for colorectal cancer. J Clin Oncol 22:1420-1429, 2004
33. Saltz LB, Cox JV, Blanke C, et al: Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 343:905-914, 2000
34. Goldberg RM, Sargent DJ, Morton RF, et al: A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 22:23-30, 2004
35. Hurwitz H, Fehrenbacher L, Novotny W, et al: Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350:2335-2342, 2004
36. Grothey A, Sargent D, Goldberg RM, et al: Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol 22:1209-1214, 2004
37. Andre T, Boni C, Mounedji-Boudiaf L, et al: Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med 350:2343-2351, 2004
38. United States Food and Drug Administration: 3 year DFS vs. 5 year OS as an endpoint for adjuvant colon cancer studies: Data from randomized trials. http://www.fda.gov/cder/drug/cancer_ endpoints/Sargent/index.htm