Surrogate endpoints in colorectal cancer

Current Oncology

Volumn 12, Issue 4, 2005, Pages

  Browman, G ^a   Shah, A ^b   Ayoub, J ^c   Wong, R ^d   Maroun, J ^e   Batist, Gerald ^f  

^a TOM BAKER CANCER CENTRE   (Canada)

^b BRITISH COLUMBIA CANCER AGENCY   (Canada)

^c NOTRE DAME HOSPITAL   (Canada)

^d ST BONIFACE GENERAL HOSPITAL   (Canada)

^e OTTAWA REGIONAL CANCER CENTRE   (Canada)

^f MCGILL UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 36849074222     PISSN: None     EISSN: 17187729     Source Type: Journal    
DOI: None     Document Type: Article

References (29)

1. Koopmans PP. Clinical endpoints in trials of drugs for cancer: time for a rethink? BMJ 2002;324:1389-91.
2. Schrag D. The price tag on progress - chemotherapy for colorectal cancer. N Engl J Med 2004;351:317-19.
3. Twelves CJ, Cassidy J. Which endpoints should we use in evaluating the use of novel fluoropyrimidine regimens in colorectal cancer? Br J Cancer 2002;86:1670-6.
4. Prentice RL. Chronic disease prevention: public health potential and research needs. Stat Med 2004;23:3409-20.
5. Baum M, Buzdar A, Cuzick J, et al. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early-stage breast cancer: results of the ATAC (Arimidex, Tamoxifen Alone or in Combination) trial efficacy and safety update analyses. Cancer 2003;98:1802-10.
6. Cook RJ, Major P. Methodology for treatment evaluation in patients with cancer metastatic to bone. J Natl Cancer Inst 2001;93:534-8.
7. Tournigand C, Andre T, Achille E, et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 2004;22:229-37.
8. Cunningham D, Humblet Y, Siena S, et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004;351: 337-45.
9. Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004;350:2335-42.
10. Louvet C, de Gramont A, Tournigand C, Artru P, Maindrault-Goebel F, Krulik M. Correlation between progression free survival and response rate in patients with metastatic colorectal carcinoma. Cancer 2001;91:2033-8.
11. Kitsuki H, Katano M, Morisaki T, Torisu M. CEA-mediated homotypic aggregation of human colorectal carcinoma cells in a malignant effusion. Cancer Lett 1995;88:7-13.
12. Foon KA, Chakraborty M, John WJ, Sherratt A, Kohler H, Bhattacharya-Chatterjee M. Immune response to the carcinoembryonic antigen in patients treated with an anti-idiotype antibody vaccine. J Clin Invest 1995;96:334-42.
13. Soeth E, Wirth T, List HJ, et al. Controlled ribozyme targeting demonstrates an antiapoptotic effect of carcinoembryonic antigen in HT29 colon cancer cells. Clin Cancer Res 2001; 7:2022-30.
14. Hostetter RB, Augustus LB, Mankarious R, et al. Carcino-embryonic antigen as a selective enhancer of colorectal cancer metastasis. J Natl Cancer Inst 1990;82:380-5.
15. Wang WS, Lin JK, Lin TC, et al. Carcinoembryonic antigen in monitoring of response to systemic chemotherapy in patients with metastatic colorectal cancer. Int J Colorectal Dis 2001;16:96-101.
16. Forslund A, Engaras B, Lonnroth C, Lundholm K. Prediction of postoperative survival by preoperative serum concentrations of anti-p53 compared to CEA, CA 50, CA 242 and conventional blood tests in patients with colorectal carcinoma. Int J Oncol 2002;20:1013-18.
17. Buyse M, Thirion P, Carlson RW, Burzykowski T, Molenberghs G, Piedbois P. Relation between tumour response to first-line chemotherapy and survival in advanced colorectal cancer: a meta-analysis. Meta-Analysis Group in Cancer. Lancet 2000;356:373-8.
18. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981;47:207-14.
19. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-16.
20. Miller LL, Elfring GF, Gruia G, et al. A case for time to tumor progression (TTP) as the primary (1°) efficacy endpoint in 1st-line metastatic colorectal cancer (MCRC) therapy: correlation of TTP and overall survival (OS) [abstract]. Proc Am Soc Clin Oncol 2004;23:246.
21. Di Leo A, Buyse M, Bleiberg H. Is overall survival a realistic primary end point in advanced colorectal cancer studies? A critical assessment based on four clinical trials comparing fluorouracil plus leucovorin with the same treatment combined either with oxaliplatin or with CPT-11. Ann Oncol 2004;15: 545-9.
22. Sargent DJ, Wieand S, Benedetti R., et al. Disease-free survival (DFS) vs. overall survival (OS) as a primary endpoint for adjuvant colon cancer studies: individual patient data from 12,915 patients on 15 randomized trials [abstract]. Proc Am Soc Clin Oncol 2004;23:246.
23. Peterson L. FDA Oncologic Drugs Advisory Committee (ODAC) meeting on clinical trial endpoints in colorectal cancer (CRC); Gaithersburg, MD; May 4, 2004 (online newsletter]. Trends in Medicine. May 2004. [Available at: www.trends-in-medicine.com; cited November 24, 2005]
24. Markman M. The myth of measurable disease in ovarian cancer. J Clin Oncol 2003;21:3013-15.
25. Warr D, McKinney S, Tannock I. Influence of measurement error on assessment of response to anticancer chemotherapy: proposal for new criteria of tumor response. J Clin Oncol 1984; 2:1040-6.
26. Norman GR, Streiner DL. Biostatistics: The Bare Essentials. St. Louis: Mosby Yearbooks; 1994.
27. WHO cooperative trial on primary prevention of ischaemic heart disease using clofibrate to lower serum cholesterol: mortality follow-up. Report of the Committee of Principal Investigators. Lancet 1980;2:379-85.
28. Echt DS, Liebson PR, Mitchell LB, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991;324:781-8.
29. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonized tripartite guideline: guideline for good clinical practice. J Postgrad Med 2001;47:45-50.