Investigation of disease-free survival as a surrogate endpoint for survival in cancer clinical trials

Communications in Statistics - Theory and Methods

Volumn 27, Issue 6, 1998, Pages 1363-1378

  Chen, T Timothy ^a   Simon, Richard M ^a   Korn, Edward L ^a   Anderson, Stewart J ^b   Lindblad, Anne S ^c   Wieand, Hany Sam ^d   Douglass Jr , Harold O ^e   Fisher, Bernard ^b   Hamilton, J Michael ^a   Friedman, Michael A ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

^b UNIVERSITY OF PITTSBURGH   (United States)

^c EMMES CORPORATION   (United States)

^d MAYO CLINIC   (United States)

^e ROSWELL PARK CANCER INSTITUTE   (United States)

Author keywords

Colorectal adjuvant; Conditional independence; Exponential; Stochastic model

Indexed keywords

EID: 0001565738     PISSN: 03610926     EISSN: None     Source Type: Journal    
DOI: 10.1080/03610929808832163     Document Type: Article

References (26)

1. Early Breast Cancer Trialists' Collaborative Group (1988). "Effects of adjuvant tamoxifh and of cytotoxic therapy on mortality in early breast cancer," New Engl. J. Med., 319, 1681-1692.
2. Fisher, B., Wolmark, N., Rockette, H., Redmond, C., Deutsch, M., Wickerham, D.L., et al. (1988). "Postoperative adjuvant chemotherapy or radiation therapy for rectal cancer: results from NSABP protocol R-01," J. Natl. Cancer Inst., 80, 21-29.
3. Flandre, P. and O'Quigley, J. (1995). "A two-stage procedure for survival studies with surrogate endpoints," Biometrics, 51, 969-976.
4. Friedman, M. (1990). "Point 2: If not now, when?" J. Natl. Cancer Inst., 82, 106.
5. Friedman, M. and Hamilton, J. (1988). "Progress in the adjuvant therapy of large bowel cancer," In Important Advances in Oncology, DeVita VT, Rosenberg S, Hellman S, Eds. Philadelphia, JB Lippincott, 273-297.
6. Gastrointestinal Tumor Study Group (1984). "Adjuvant therapy of colon cancer - results of a prospectively randomized trial," New Engl. J. Med., 310, 737-743.
7. Gastrointestinal Tumor Study Group(1985). "Prolongation of the disease-free interval in surgically treated rectal carcinoma," New Engl. J. Med., 312, 1465-1472.
8. Henderson, I. (1990). "Counterpoint. Shouldn't we see the white flag before we cry victory?" J. Natl. Cancer Inst., 82, 103.
9. Higgins, G.A., Amadeo, J.H., McElhinney, J., McCaughan, J.J., et al. (1984). "Efficacy of prolonged intermittent therapy with combined 5-Fluorouracil and Methyl-CCNU following resection for carcinoma of the large bowel," Cancer, 53, 1-8.
10. International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) (1995). "Efficacy of adjuvant fluorouracil and folinic acid in colon cancer," Lancet, 345, 939-944.
11. Kosorok, M. R. and Fleming, T. R. (1993). "Using surrogate failure time data to increase cost effectiveness in clinical trials," Biometrika, 80, 823-833.
12. Krook, J. E., Moertel, C. G., Gunderson, L. L., Wieand, H. S. Collins, R. T., Beart, R. W., Kubista, T. P., Poon, M. A., Meyers, W. C., et al. (1991). "Effective surgical adjuvant therapy for high risk rectal carcinoma," New Engl. J. Med., 324, 709-715.
13. Lagakos, S. W. (1976). "A stochastic model for censored-survival data in the presence of an auxiliary variable," Biometrics, 32, 551-559.
14. Laurie, J. A., Moertel, C. G., Fleming, T. R., Wieand, H. S., et al. (1989). "Surgical adjuvant therapy of large-bowel carcinoma: an evaluation of Levamisole and the combination of Levamisole and Fluorouracil," J. Clinical Oncology, 7, 1447-1456.
15. Lin, D. Y., Fischl, M. A., and Schoenfeld, D. A. (1993). "Evaluating the role of CD-4 lymphocyte counts as surrogate endpoints in human immunodeficiency virus clinical trials," Statistics in Medicine, 12, 835-842.
16. MacDonald, J. (1990). "Point 1: Sometimes a great notion," J. Natl. Cancer Inst., 82, 102.
17. Mallar, R. and Zhou, X. (1996). Survival Analysis with Long-Term Survivors, John Wiley, New York.
18. Moertel, C.G., Fleming, T.R., MacDonald, J.S., Haller, D.G., Laurie, J.A., Goodman, P.J., Ungerleider, J.S., Emerson, W.A., et al. (1990). "Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma," New Engl. J. Med., 322:352-358.
19. Moertel, C. G., Fleming, T. R., MacDonald, J. S., Haller, D. G., Laurie, J. A., Tangen, C. M., et al. (1995). "Intergroup study of fluorouracil plus levamisole as adjuvant therapy for stage II/Dukes' B2 colon cancer," J. Clinical Oncology, 13, 2936-2943.
20. Panettiere, F. J., Goodman, P. J., Costanzi, J. J., Cruz, A. B., Vaitkevicius, V. K., et al. (1988). "Adjuvant therapy in large bowel adenocarcinoma: long-term results of a Southwest Oncology Group study," J. Clinical Oncology, 6, 947-954.
21. Pepe, M. S. (1992). "Inference using surrogate outcome data and a validation sample," Biometrika, 79, 355-365.
22. Poon, M. A., O'Connell, M. J., Moertel, C. G., et al. (1989). "Biochemical modulation of fluorouracil: Evidence of significant improvement of survival and quality of life in patients with advanced colorectal carcinoma," J. Clinical Oncology, 7, 1407-1417.
23. Prentice, R. L. (1989). "Surrogate endpoints in clinical trials: Definition and operational criteria," Statistics in Medicine, 8, 431-440.
24. Tudor, G. E. and Morgan, T. M. (1995). "Analyzing survival data in conjunction with time-dependent surrogate endpoints in clinical trials," Commu. Statist. - Theory Meth., 24, 2293-2313.
25. Wiesenfeld, M., O'Connell, M. J., Wieand, H. S., Gonchoroff, N. J., Donohue, J. H., et al. (1995). "Controlled clinical trial of interferon-γ as postoperative surgical adjuvant therapy for colon cancer." J. Clinical Oncology, 13, 2324-2329.
26. Wolmark, N., Fisher, B., Rockette, H., Redmond, C., Wickerham, D. L., Fisher, E. R., Jones, J., Glass, A., et al. (1988). "Postoperative adjuvant chemotherapy or BCG for colon cancer: results from NSABP protocol C-01," J. Natl. Cancer Inst., 80, 30-36.