Infusions of fluorouracil and leucovorin: Effects of the timing and semi-intermittency of drug delivery

Oncology

Volumn 57, Issue 3, 1999, Pages 195-201

  Falcone, Alfredo ^a   Allegrini, Giacomo ^a   Antonuzzo, Andrea ^a   Brunetti, Isa ^a   Pfanner, Elisabetta ^a   Lencioni, Monica ^a   Masi, Gianluca ^b   Danesi, Romano ^b   Del Tacca, Mario ^b   Conte, Pierfranco ^a  

^a SANTA CHIARA HOSPITAL   (Italy)

^b Dipartimento di Medicina Interna   (Italy)

Author keywords

5 fluorouracil; Chronoinfusion; Gastrointestinal carcinoma; Leucovorin; Phase I II; Randomized trial

Indexed keywords

FLUOROURACIL; FOLINIC ACID;

ANTINEOPLASTIC ACTIVITY; ARTICLE; CONTINUOUS INFUSION; DERMATITIS; DIARRHEA; DOSE RESPONSE; DRUG TOXICITY; GASTROINTESTINAL CARCINOMA; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MAXIMUM PERMISSIBLE DOSE; PRIORITY JOURNAL; STOMATITIS; VOMITING;

ADENOCARCINOMA; ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHRONOTHERAPY; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; GASTROINTESTINAL NEOPLASMS; HUMANS; INFUSIONS, INTRAVENOUS; LEUCOVORIN; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 0032867880     PISSN: 00302414     EISSN: None     Source Type: Journal    
DOI: 10.1159/000012031     Document Type: Article

References (31)

1. Ahlgren JD: Colorectal cancer: Chemotherapy; in Ahlgren JD, Macdonald JS (eds): Gastrointestinal Oncology. Philadelphia, Lippincott, 1992, pp 339-357.
2. Rothenberg ML, Eckardt JR, Kuhn JG, Burris HA, Nelson J, Hilsenbeck SG, Hisenbeck SG, Rodriguez GI, Thurman AM, Smith LS, Eckhardt SG, Weiss GR, Elfring GL, Rinaldi DA, Schaaf LJ, Von Hoff DD: Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. J Clin Oncol 1996; 14:1128-1135.
3. Seitz JF, Cunningham D, Rath U, Olver IN, Van Custem E, Kerr D, Svensson C, Manga GP, Harper P, Zalcberg J, Lowery K, Azab M: Final results and survival data of a large randomized trial of tomudex in advanced colorectal cancer confirm comparable efficacy to 5-fluorouracil + leucovorin (abstract). Proc Am Soc Clin Oncol 1996;15:201.
4. 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.
5. Advanced Colorectal Cancer Meta-Analysis Project: Meta-analysis of randomized trials testing the biochemical modulation of fluorouracil by methotrexate in metastatic colorectal cancer. J Clin Oncol 1994;2:960-969.
6. Sotos GA, Grogan L, Allegra J: Preclinical and clinical aspects of biomodulation of 5-fluorouracil. Cancer Treat Rev 1994;20:11-49.
7. Falcone A, Danesi R, Dargenio F, Pfanner E, Brunetti I, Del Tacca M, Methersell ABW, Conte PF: Intravenous azidothymidine with fluorouracil and leucovorin: A phase I-II study in previously untreated metastatic colorectal cancer patients. J Clin Oncol 1996;14:729-736.
8. Meta-Analysis Group in Cancer: Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer. J Clin Oncol 1997; 16:301-308.
9. De Gramont A, Bosset JF, Milan C, Rougier P, Bouchè O, Etienne PL, Morvan F, Louvet C, Guillot T, Francois E, Bedenne E: Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly fluorouracil bolus plus continuous infusion for advanced colorectal cancer: A French intergroup study. J Clin Oncol 1997;15:808-815.
10. Falcone A, Cianci C, Pfanner E, Bertuccelli M, Brunetti I, Muttini MP, D'Argenio F, Ricci S, Conte PF: Continuous infusion 5-fluorouracil in metastatic colorectal cancer patients pretreated with bolus 5-fluorouracil: Clinical evidence of incomplete cross-resistance. Ann Oncol 1994;5:291.
11. Thirion P, Cunningham D, Findlay M, Norman A, Falcone A, Logue JP, Tralongo P, Aschele C, Piedbois P: Pooled analysis of phase II trials with low-dose 5-ftuorouracil continuous infusion as second line chemotherapy in advanced colorectal cancer. Proc Am Soc Clin Oncol 1998;17:272.
12. Sobrero AF, Aschele C, Guglielmi AP, Mori A, Melioli G, Rosso R, Bertino JR, Synergism and lack of cross-resistance between short-term and continuous exposure to fluorouracil in human colon adenocarcinoma cells. J Natl Cancer Inst 1994;85:1937-1944.
13. Ardalan B, Chua T, Tian E, Reddy R, Sridhar K, Benedetto P: A phase II study of weekly 24-hour infusion with high-dose fluorouracil with leucovorin in colorrectal carcinoma. J Clin Oncol 1991;9:625-630.
14. Aranda E, Cervantes A, Carrato A, Martos FC, Torres AA, Massuti T, Barneto I, Garcia-Conde J, Baron JM, Diaz-Rubio E: Outpatient weekly high-dose continuous infusion 5-fluorouracil plus oral leucovorin in advanced colorectal cancer: A phase II trial. Ann Oncol 1996; 7:581-585.
15. Tempero M, Berg A, Block M, Hutchins M, Moravec D, Langdon R: A phase Il trial of protracted therapy with 5-fluorouracil and leucovorin in metastatic colorectal cancer. Proc Am Soc Clin Oncol 1992;11:189.
16. Leichman CG, Leichman L, Spears CP, Jeffers S: Phase II study of prolonged infusion 5-fluorouracil with weekly leucovorin in disseminated colorectal cancer. Proc Am Soc Clin Oncol 1991;10:143.
17. Kohne CH, Schoffski P, Wilke H, Kaufer C, Raudschecker H, Andreesen U, Ohl U, Lange HJ, Klassen U, Westerhausen M, Hiddemann W, Schott G, Bade J, Strohmeyer G, Hecker H, Schmoll HJ: Weekly high dose infusional 5-FU plus folinic acid has major impact on survival in patients with advanced colorectal cancer. Results of a multivariate analysis using REC-PAM. Proc Am Soc Clin Oncol 1996;15:445.
18. Beerblock K, Rinaldi Y, Andrè JD, Grangé JD, Louvet C, Tournigand C, Carola E, Favre R, Krulik M, De Gramont A: Bi-weekly high-dose folinic acid and 5-fluorouracil 48h-infusion in metastatic colorectal cancer. Proc Am Soc Clin Oncol 1996;15:21.
19. Hrushesky WJM, Bjarnason GA: Circadian cancer therapy. J Clin Oncol 1993;11:1403-1417.
20. Levi FA, Zidani R, Vannetzel JM, Perpoint B, Focan C, Faggiuolo R, Chollet P, Garufi C, Itzhaki M, Dogliotti L, Iacobelli S, Adam R, Kunstlinger S, Gastiaburu J, Bismuth H, Jasmin C, Missel JL: Chronomodulated versus fixed-infusion-rate delivery of ambulatory chemotherapy with oxaliplatin, fluorouracil, and folinic acid in patients with colorectal cancer metastases: A randomized multi-institutional trial. J Natl Cancer Inst 1994;86:1608-1617.
21. Levi F: Chemotherapy for gastrointestinal cancers. Curr Opin Oncol 1996;8:334-341.
22. Bjamason GA, Kerr IG, Doyle N, Doyle N, MacDonald M, Sone M: Phase I study of 5-fluorouracil and leucovorin by a 14-day circadian infusion in metastatic adenocarcinoma patients. Cancer Chemother Pharmacol 1993; 33:221-228.
23. Levi F, Zidani R, Misset J-L, for the International Organization for Cancer Chronotherapy: Randomised multicentre trial of chemotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. Lancet 1997; 250:681-686.
24. Miller AB, Hoogstraten B, Staquet M: Reporting results of cancer treatment. Cancer 1981; 47:207-214.
25. Simon R: Optimal two-stage designs for phase II clinical trials. Controlled Clin Trials 1989; 10:1-10.
26. Hryniuk WM, Figueredo A, Goodyear M: Application of dose-intensity to problems in chemotherapy of breast and colorectal cancer. Semin Oncol 1987;14:3-11.
27. Von Roemeling R, Hrushesky W: Determination of the therapeutic index of floxuridine by its circadian infusion pattern. J Natl Cancer Inst 1990;82:386-393.
28. Kemeny MM, Alava G, Oliver JM, Smith F: The effects on toxicity of circadian patterning of continuous hepatic artery infusion. HPB Surg 1992;5:185-194.
29. Hrushesky WJM: Circadian timing of cancer chemotherapy. Science 1985;228:73-75.
30. Bertheault-Cvitkovic F, Jami A, Ithzaki M, Brummer PD, Brienza S, Adam R, Kustlinger F, Bismuth H, Misset JL, Levi F: Biweekly intensified ambulatory Chronomodulated chemotherapy with oxaliplatin, fluorouracil, and leucovorin in patients with metastatic colorectal cancer. J Clin Oncol 1996;14:2950-2958.
31. Giacchetti S, Itzahaki M, Adam R, Brummer PD, Zidani R, Brienza S, Bleuzen P, Cvitkovic F, Gruia G, Jasmin C, Bismuth H, Misset JL, Levi F: Long-term seruvival of patients with unrespectable metastatic colorectal cancer treated with chronotherapy. Ann Oncol 1996; 7:34.