Relation between tumour response to first-line chemotherapy and survival in advanced colorectal cancer: A meta-analysis

Lancet

Volumn 356, Issue 9227, 2000, Pages 373-378

  Buyse, Marc ^a   Thirion, Pierre ^b   Carlson, Robert W ^c   Burzykowski, Tomasz ^d   Molenberghs, Geert ^e   Piedbois, Pascal ^a  

^a INTERNATIONAL DRUG DEVELOPMENT INSTITUTE   (Belgium)

^b HASSELT UNIVERSITY   (Belgium)

^c HENRI MONDOR HOSPITAL   (France)

^d STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^e INSTITUTE OF ONCOLOGY   (Poland)

Author keywords

[No Author keywords available]

Indexed keywords

FLOXURIDINE; FLUOROPYRIMIDINE; FLUOROURACIL; FOLINIC ACID; METHOTREXATE;

ARTICLE; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; HUMAN; MAJOR CLINICAL STUDY; META ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

EID: 0034729931     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(00)02528-9     Document Type: Article

References (27)

1. Food and Drug Administration. Reinventing the regulation of cancer drugs: accelerating approval and expanding access. Washington DC: National Performance Review, March 1996.
2. Cocchetto DM, Jones DR. Faster access to drugs for serious or lifethreatening illnesses through use of the accelerated approval regulation in the United States. DruglnfJ 1998; 32: 27-35.
3. Fleming TR, Prentice RL, Pepe MS, Glidden D. Surrogate and auxiliary endpoints in clinical trials, with potential applications in cancer and AIDS research. Slat Med 1994; 13: 955-68.
4. Armitage JO. Treatment of non-Hodgkin's lymphoma. N Engl J Med 1993;328:1023-30.
5. The International Non-Hogkin's Lymphoma Prognostic Factors Project. A predictive model for aggressive non-Hodgkin's lymphoma. N Engl J Med 1993; 329: 987-94.
6. Kantarjian HM, Smith TL, O'Brien S, Beran M, Pierce S, Talpaz M, and the Leukemia Service. Prolonged survival in chronic myelogenous leukemia after cytogenetic response to interferon-a therapy. Ann Intern Med 1995; 122:254-61.
7. Oye RK, Shapiro MF. Does response make a difference in patient survival? JAMA 1984; 252: 2722-25.
8. Advanced Colorectal Cancer Meta-Analysis Project. Modulation of 5fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rale. J Clin Oncol 1992; 10: 896-903.
9. Advanced Colorectal Cancer Meta-Analysis Project. Meta-analysis of randomized trials testing the biochemical modulation of 5-fluorouracil by methotrexate in metastatic colorectal cancer. J Clin Oncol 1994; 12: 960-69.
10. Meta-Analysis Group In Cancer. Efficacy of intravenous continuous infusion of 5-fluorouracil compared with bolus administration in patients with advanced colorectal cancer. J Clin Oncol 1998; 16: 301-08.
11. Meta-Analysis Group In Cancer. Reappraisal of hepatic arterial infusion in the treatment of nonresectable liver métastases from colorectal cancer. J Natl Cancer Inst 1996; 88: 252-58.
12. WHO Handbook for Reporting results of Cancer Treatment. WHO Offset Publication number 48. Geneva: WHO, 1979.
13. Anderson JR, Cain KC, Gelber RD. Analysis of survival by tumor response. J Clin Oncol 1983; 1: 710-19.
14. Buyse M, Piedbois P. On the relationship between response to treatment and survival time. S tat Med 1996; 15: 2797-812.
15. Buyse M, Molenberghs G. Validation of surrogate endpoints in randomized clinical trials. Biometrics 1998; 54: 186-201.
16. Burzykowski T, Molenberghs G, Buyse M, Geys H, Renard D. Validation of surrogate endpoints in multiple randomized clinical trials with failure-time endpoints. Proceedings of the Biopharmaceutical Section, American Statistical Association. 1999: 40-45.
17. Buyse M, Molenberghs G, Burzykowski T, Renard D, Geys H. The validation of surrogate endpoints in meta-analyses of randomized experiments. Biostatistics 2000; 1: 49-68.
18. Freedman LS, Graubard BI, Schatzkin A. Statistical validation of intermediate endpoints for chronic diseases. Stat Med 1992; 11: 167-78.
19. Lin DY, Fleming TR, De Gruttola V. Estimating the proportion of treatment effect explained by a surrogate marker. Stat Med 1 997; 16: 1515-27.
20. Graf W, Pahlman L, Bergström R, Glimelius B. The relationship between an objective response to chemotherapy and survival in advanced colorectal cancer. Br J Cancer 1994; 70: 559-63.
21. Weiss GB, Bunce H III, Hokanson JA. Comparing survival of responders and nonresponders after treatment: a potential source of confusion in interpreting cancer clinical trials. Control Clin Trials 1983; 4: 43-52.
22. Johnson JR, Temple R. Food and Drug Administration requirements for approval of new anticancer drugs. Cancer Treat Rep 1985; 69: 1155-57.
23. Lavin P, Mittelman A, Douglass H, Engström P, Klaassen D. Survival and response to chemotherapy for advanced colorectal adenocarcinoma. Cancer 1980; 46: 1536-43.
24. Molenberghs G, Buyse M, Geys H, Renard D, Burzykowski T. Statistical challenges in the evaluation of surrogate endpoints in randomized trials. Stat Med (in press).
25. Wolmark N, Rockette H, Fisher B, et al. The benefit of leucovorinmodulated fluorouracil as postoperative adjuvant therapy for primary colon cancer: results from National Surgical Adjuvant Breast and Bowel Project protocol C-03. J Clin Oncol 1993; 11: 1879-87.
26. International Multicentre Pooled Analysis of Colon Cancer Trials. Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. Lancet 1995; 345: 939-44.
27. O'Connell MJ, Mailliard JA, Kahn MJ, et al. Controlled trial of fluorouracil and low-dose leucovorin given for 6 months as postoperative adjuvant therapy for colon cancer. J Clin Oncol 1997; 15:246-50.