The impact of adding low-dose leucovorin to monthly 5-fluorouracil in advanced colorectal carcinoma: Results of a phase III trial

Annals of Oncology

Volumn 9, Issue 5, 1998, Pages 535-541

  Borner, M M ^a   Castiglione, M ^b   Bacchi, M ^b   Weber, W ^b   Herrmann, R ^b   Fey, M F ^b   Pagani, O ^b   Leyvraz, S ^b   Morant, R ^b   Pestalozzi, B ^b   Hanselmann, S ^b   Goldhirsch, A ^b  

^a UNIVERSITY OF BERN   (Switzerland)

^b NONE

Author keywords

colorectal cancer; Fluorouracil; Low dose leucovorin; Phase III trial; Survival benefit

Indexed keywords

FLUOROURACIL; FOLINIC ACID;

ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED STUDY; DOSE RESPONSE; DRUG EFFECT; DRUG EFFICACY; FEMALE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; META ANALYSIS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA; COLORECTAL NEOPLASMS; DRUG INTERACTIONS; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; SURVIVAL ANALYSIS;

EID: 7144227957     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1008270916325     Document Type: Article

References (18)

1. Sobrero A, Aschele C, Bertino J. Fluorouracil in colorectal cancer - a tale of two drugs: Implications for biochemical modulation. J Clin Oncol 1997; 15: 368-81.
2. The Advanced Colorectal Cancer Meta-Analysis Project: Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: Evidence in terms of response rate. J Clin Oncol 1992; 10: 896-903.
3. Buroker T, O'Connell M, Wieand H et al. Randomized comparison of two schedules of fluorouracil and leucovorin in the treatment of advanced colorectal cancer. J Clin Oncol 1994; 12: 14-20.
4. Poon MA, O'Connell MJ, Moertel CG et al. Biochemical modulation of fluorouracil: Evidence of significant improvement of survival and quality of life in patients with advanced colorectal carcinoma. J Clin Oncol 1989; 7: 1407-17.
5. Poon MA, O'Connell MJ, Wieand HS et al. Biochemical modulation of fluorouracil with leucovorin: Confirmatory evidence of improved therapeutic efficacy in advanced colorectal cancer. J Clin Oncol 1991; 9: 1967-72.
6. Jäger E, Heike M, Bernhard H et al. Weekly high-dose leucovorin versus low-dose leucovorin combined with fluorouracil in advanced colorectal cancer: Results of a randomized multicenter trial. J Clin Oncol 1996; 14: 2274-9.
7. Petrelli N, Douglass HO, Herrera L et al. The modulation of fluorouracil with leucovorin in metastatic colorectal carcinoma: A prospective randomized phase III trial. J Clin Oncol 1989; 7: 1419-26.
8. Borner M, Brand B, Lang M et al. Low-dose leucovorin (Id-LV) significantly changes the effect of fluorouracil (FU): Results of a randomized pilot study in advanced colorectal carcinoma. Proc Am Soc Clin Oncol 1992; 11: 183.
9. Alberto P, Mermillod B, Germano G et al. A randomized comparison of doxifluridine and fluororuracil in colorectal carcinoma. Eur J Cancer 1988; 24: 559-63.
10. World Health Organization. Handbook for Reporting Results of Cancer Treatment. WHO offset publication no. 48. Geneva: WHO 1979.
11. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-81.
12. SAS Program Institute. The PHREG Procedure. SAS Technical Report (sixth ed). Cary, NC 1991; 1-217.
13. Cox DR. Regression models and life tables. J R Stat Soc B 1972; 34: 187-220.
14. Nordic Gastrointestinal Tumor Adjuvant Therapy Group. Expectancy or primary chemotherapy in patients with advanced asymptomatic colorectal cancer: A randomized trial. J Clin Oncol 1992; 10: 904-11.
15. Leichman CG, Fleming T, Muggia F et al. Phase II study of fluorouracil and its modulation in advanced colorectal cancer: A Southwest Oncology Group Study. J Clin Oncol 1995; 13: 1303-11.
16. Hamilton J. Multiple confirmatory trials. How can additional studies be ol'value'? Ann Oncol 1991; 2: 625-7.
17. Valone FH, Friedman MA. Wittlinger PS et al. Treatment of patients with advanced colorectal carcinomas with fluorouracil alone, high-dose leucovorin plus fluorouracil, or sequential methotrexate, fluorouracil, and leucovorin: A randomized trial of the Northern California Oncology Group. J Clin Oncol 1989; 7: 1427-36.
18. Laufman L, Bukowski R, Collier M et al. A randomized, double-blind trial of fluorouracil plus placebo versus fluorouracil plus oral leucovorin in patients with metastatic colorectal cancer. J Clin Oncol 1993; 11: 1888-93.