Double modulation of 5-fluorouracil by methotrexate and high-dose K- leucovorin in advanced colorectal cancer

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 21, Issue 1, 1998, Pages 94-98

  Romero, A O ^a   Perez, J E ^b   Cuevas, M A ^b   Lacava, J A ^b   Sabatini, C L ^b   Dominguez, M E ^b   Rodriguez, R ^b   Barbieri, M R ^b   Ortiz, E H ^b   Salvadori, M A ^b   Romero Acuna L A ^b   Romero Acuna J M ^b   Langhi, M J ^b   Amato, S ^b   Machiavelli, M R ^b   Leone, B A ^b   Vallejo, C T ^b   Lorusso, V ^b   DeLena, M ^b  

^a Rivadavia 360   (Argentina)

^b NONE

Author keywords

5 FU; Biomodulation; Colorectal cancer; L leucovorin

Indexed keywords

FLUOROURACIL; FOLINIC ACID; METHOTREXATE;

ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; FEMALE; HUMAN; INOPERABLE CANCER; INTRAMUSCULAR DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; LEUKOPENIA; MALE; MUCOSA INFLAMMATION; PHASE 2 CLINICAL TRIAL; STOMATITIS; TREATMENT OUTCOME;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; METHOTREXATE; MIDDLE AGED; NEOPLASM STAGING; SURVIVAL ANALYSIS;

EID: 0031891542     PISSN: 02773732     EISSN: None     Source Type: Journal    
DOI: 10.1097/00000421-199802000-00022     Document Type: Article

References (42)

1. Allegra CJ. Biochemical modulation: A modality that has come of therapeutic age. J Clin Oncol 1991;9:1723-6.
2. Leyland-Jones B, O'Dwyer PJ. Biochemical modulation: Application of Laboratory models to the clinic. Cancer Treat Rep 1966;70:219-28.
3. Cadman E, Heimer R, Davis L. Enhanced 5-fluorouracil nucleotide formation after methotrexate administration: explanation for drug synergism. Science 1979;205:113-7.
4. Bertino JR, Mini E, Fernandez DJ. Sequential methotrexate and fluorouracil: mechanisms of synergy. Semin Oncol 1983; 10:2(suppl 2):2-5.
5. Bertino JR, Sawicki WL, Linquist C, et al. Schedule-dependent anti-tumor effects of methotrexate and 5-fluorouracil. Cancer Res 1987;37:327-8.
6. Herrman R, Spehn J, Beyer JH, et al. Sequential methotrexate and 5-fluorouracil: improved response rate in metastatic colorectal cancer. J Clin Oncol 1984;2:591-4.
7. Rabinovich MG, Pérez JE, Machiavelli M, et al. Sequential combination chemotherapy with methotrexate and 5-fluorouracil in advanced colorectal carcinoma. Tumori 1984;70:549-53.
8. Leone BA, Romero A, Rabinovich MG, et al. Sequential therapy with methotrexate and 5-fluorouracil in the treatment of advanced colorectal carcinoma. J Clin Oncol 1986;4:23-7.
9. Nordic Gastrointestinal Tumor Adjuvant Therapy Group. Superiority of sequential methotrexate, fluorouracil, and leucovorin to fluorouracil alone in advanced symptomatic colorectal carcinoma: a randomized trial. J Clin Oncol 1989;7:1437-46.
10. Machiavelli M, Leone BA, Romero A, et al. Advanced colorectal carcinoma. A prospective randomized trial of sequential methotrexate, 5-fluorouracil, and leucovorin versus 5-fluorouracil alone. Am J Clin Oncol 1991;14:211-7.
11. Marsh JC, Bertino JR, Katz KH, et al. The influence of drug interval on the effect of methotrexate and fluorouracil on the treatment of advanced colorectal cancer. J Clin Oncol 1991;9:371-80.
12. Rustum YM, Trave F, Zakrzewski SF, et al. Biochemical and pharmacologic basis for potentiation of 5-fluorouracil action by leucovorin. NCI Monographs 1987;5:165-70.
13. Machover D, Goldschmitdt E, Chollet Ph, et al. Treatment of advanced colorectal and gastric adcnocarcinoma with 5-fluoro-uracil and high-dose folinic acid. J Clin Oncol 1984;4:685-96.
14. Petrelli NJ, Herrera L, Rustum Y, et al. A prospective randomized trial of 5-fluorouracil versus 5-fluorouracil and high-dose leucovorin versus 5-fluorouracil and methotrexate in previously untreated patients with advanced colorectal carcinoma. J Clin Oncol 1987;5:1559-65.
15. Erlichman C, Fine S, Woung A, et al. A randomized trial of fluorouracil and folinic acid in patients with metastatic colorectal carcinoma. J Clin Oncol 1988;6:469-75.
16. 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.
17. Poon MA, O'Connell MJ, Wiland HS, et al. Biochemical modulation of fluorouracil with leucovorin: confirmatory evidence of improved therapy efficacy in advanced colorectal cancer. J Clin Oncol 1991;9:1967-72.
18. Damon LE, Cadman E, Benz C. Enhancement of 5-fluorouracil antitumor effects by the prior administration of methotrexate. Pharmacol Ther 1989;43:155-85.
19. Sirotnak FM, Chello PL, Moccio DM, et al. Steroespecificity at carbon 6 of formyltetrahydrofolate as a competitive inhibitor of transport and cytotoxicity of methotrexate in vitro. Biochem Pharmacol 1979;28:2993-7.
20. Bertrand R, Jolivet J. Lack of interference by the unnatural isomer of 5-formyltetrahydrofolate with the effects of the natural isomer in leucovorin preparations. J Natl Cancer Inst 1989; 81:1175-8.
21. Erlichman C, Fine S, Kerr I, et al. A phase II trial of 5-fluoro-uracil and I-leucovorin in patients with metastatic colorectal cancer. Am J Clin Oncol 1996;19:26-31.
22. Machover D, Grison X, Goldschmidt E, et al. Fluorouracil combined with the pure (6S)-stereoisomer of folinic acid in high doses for treatment of patients with advanced colorectal carcinoma: A phase I - II study. J Natl Cancer Inst 1992;84:321-7.
23. Peters GJ, Hoekman K, Van Groeningen CJ, et al. High dose leukovorin (HD-LV), but not low dose LV (LD-LV) potentiates 5-fluorouracil (5FU) induced inhibition of thymidylate synthetase (TS) in human colon tumors [Abstract]. Proceedings of the American Society of Clinical Oncology 1993;12:135.
24. Leone BA, Romero A, Rabinovich MG, et al. Double modulation of 5-fluorouracil by methotrexate and leucovorin in advanced colorectal carcinoma. Int J of Oncol 1993;3:995-9.
25. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer 1981;47:207-14.
26. Kaplan EL, Meier P. Non-parametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
27. Simes RJ, Zelen M. Exploratory data analysis and the use of the hazards function for interpreting survival data: An investigator's primer. J Clin Oncol 1985;3:1418-31.
28. Hryniuk W, Bush H. The importance of dose intensity in chemotherapy of metastatic breast cancer. J Clin Oncol 1984;2:1281-8.
29. Van der Wilt CL, Braakhuis BJM, Pinedo HM, et al. Addition of Leucovorin in modulation of 5-fluorouracil with methotrexate: potentiating or reversing effect? Int J Cancer 1995;61:672-78.
30. Piedbois P, Buyse M, Rustum Y, et al. Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. Advanced colorectal cancer meta-analysis project. J Clin Oncol 1992;10:896-903.
31. Piedbois P, Buyse M, Blijham GH, et al. Meta-analysis of randomized trials testing the biochemical modulation of 5-fluoro-uracil by methotrexate in metastatic colorectal cancer. Advanced colorectal cancer meta-analysis project. J Clin Oncol 1994; 12:960-9.
32. Abad A, Rosell R, Pastor MC, et al. Sequential combination of methotrexate (MTX), 5-fluorouracil (FU), and high-dose folinic acid (FA) in advanced colorectal cancer: Double Biochemical Modulation? Am J Clin Oncol 1991;14:393-6.
33. Nadal JC, Van Groeningen CJ, Pinedo HM, Peters GJ. Schedule-dependency of in vivo modulation of 5-fluorouracil by leucovorin and uridine in murine colon carcinoma. Invest New Drugs 1989;7:163-72.
34. Sotos GA, Grogan L, Allegra CJ. Preclinical and clinical aspects of biomodulation of 5-fluorouracil. Cancer Treat Rev 1994; 20:11-49.
35. Mayer RJ. Chemotherapy for metastatic colorectal cancer. Cancer 1992;70:1414-32.
36. Romanini A, Li WW, Colofiore JR, Bertino JR. Leucovorin enhances Cytotoxicity of trimetrexate/fluorouracil, but not methotrexate/fluorouracil, in CCRF-CEM cells. J Natl Cancer Inst. 1992;84:1033-8.
37. Danhauser LL, Heimer R, Cadman E. Lack of enhanced cytotoxicity of cultured L1210 cells using folinic acid in combination with sequential methotrexate and fluorouracil. Cancer Chermother Pharmacol 1985;15:214-9.
38. Doroshow JH. Biochemical modulation of fluoropyrimidines: Is there an optimal (6R,S) Leucovorin dose and schedule? J Natl Cancer Inst 1996;88:393-5.
39. Cao S, Frank C, Rustum YM. Role of fluoropyrimidine schedule and (6R,S) leucovorin dose in a preclinical animal model of colorectal carcinoma. J Natl Cancer Inst 1996;88:430-6.
40. Kamen BA, Eibl B, Cashmore AR, Bertino JR. Uptake and efficacy of trimetrexate (TMQ,2,4-diamino-5-methyl-6- [(3,4,5-trimethoxyanilino) methyl] quinazoline), a non-classical antifolate in methotrexate-resistant leukemia cells in vitro. Biochem Pharmacol 1984;33:1697-9.
41. Lin TR, Bertino JR. Update on trimetrexate, a folate antagonist with antineoplastic and antiprotozoal properties. Cancer Invest 1991;9:159-72.
42. Blanke C, Kasimis B, Schein P, Capizzi R, Kurman M. A phase II trial of trimetrexate (TMTX), 5-Fluorouracil (5FU), and Leucovorin (LCV) in patients with unresectable or metastatic colorectal cancer [Abstract]. Proceedings of the American Society of Clinical Oncology 1996;15:198.