Fluorouracil and leucovorin with or without interferon alfa-2b in advanced colorectal cancer: Analysis of a prospective randomized phase III trial

Journal of Clinical Oncology

Volumn 14, Issue 10, 1996, Pages 2682-2687

  Kosmidis, P A ^a   Tsavaris, N ^a   Skarlos, D ^a   Theocharis, D ^a   Samantas, E ^a   Pavlidis, N ^a   Briassoulis, E ^a   Fountzilas, G ^a  

^a METAXA CANCER HOSPITAL   (Greece)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA2B INTERFERON; FLUOROURACIL; FOLINIC ACID;

ADULT; ADVANCED CANCER; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; GASTROINTESTINAL TOXICITY; GRANULOCYTOPENIA; HUMAN; MAJOR CLINICAL STUDY; MALE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SUBCUTANEOUS DRUG ADMINISTRATION; THROMBOCYTOPENIA; TREATMENT OUTCOME;

EID: 0029743089     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1996.14.10.2682     Document Type: Article

References (33)

1. Mayer RJ: Chemotherapy for metastatic colorectal cancer. Cancer 70:1414-1424, 1992
2. Moertel CG: Chemotherapy for colorectal cancer. N Engl J Med 330:1136-1142, 1994
3. Machover D, Schwarzeberg L, Goldsmith E, et al: Treatment of advanced colorectal and gastric adenocarcinoma with 5-FU combined with high dose folinic acid: A pilot study. Cancer Treat Rep 66:1803-1807, 1982
4. Petrelli N, Douglass HO Jr, Herrera L, et al: The modulation of fluorouracil with leucovorin in metastasic colorectal carcinoma: A prospective randomized phase III trial. J Clin Oncol 7:1419-1426, 1989
5. Petrelli N, Herrera L, Rustumy, et al: A prospective randomized trial of 5-fluorouracil vs. 5-fluorouracil and high dose leucovorin versus 5-fluorouracil and methotrexate in previously untreated patients with advanced colorectal carcinoma. J Clin Oncol 5:1559-1565, 1987
6. Doroshow JH, Multhauf P, Leong L, et al: Prospective randomized comparison of fluorouracil vs fluorouracil and high-dose continuous infusion leucovorin calcium for the treatment of advanced measurable colorectal cancer in patients previously unexposed to chemotherapy. J Clin Oncol 8:491-501, 1990
7. Poon MA, O'Connell MJ, Wicand MS, et al: Biochemical modulation of fluorouracil with leucovorin. Confirmation evidence of improved therapeutic efficacy in advanced colorectal cancer. J Clin Oncol 9:1967-1972, 1991
8. Buroker JR, O'Connell MJ, Wieand HS, et al: Randomized comparison of two schedules of fluorouracil and leucovorin in the treatment of advanced colorectal cancer. J Clin Oncol 12:14-20, 1994
9. Tsavaris N, Bacoyannis CH, Milonakis N, et al: Folinic acid plus high-dose 5-fluorouracil, allopurinol protection in the treatment of advanced colorectal carcinoma. Eur J Cancer 26:1054-1056, 1990
10. Fountzilas G, Zisiadis A, Kosmidis P, et al: High-dose leucovorin, fluorouracil and oral dipyridamole in the treatment of advanced colorectal cancer. Anticancer Res 11:865-868, 1991
11. Silgals RM, Ahlren JD, Neefe JR, et al: A phase II trial of high-dose intravenous interferon alfa-2a in advanced colorectal cancer. Cancer 54:2257-2261, 1984
12. Wadler S, Schwartz EL: Antineoplastic activity of the combination of interferon and cytotoxic agents against experimental and human malignacies. A review. Cancer Res 50:3473-3486, 1990
13. Wadler S, Wiernik PH: Clinical update on the role of fluorouracil and recombinant interferon alfa-2a in the treatment of colorectal carcinoma. Semin Oncol 17:16-21, 1990 (suppl)
14. Pazdur R, Ajani JA, Patt YZ, et al: Phase II study of fluorouracil and recombinant interferon alfa-2a in previously untreated advanced colorectal carcinoma. J Clin Oncol 8:2027-2031, 1990
15. Kemeny N, Younes A, Seiter K, et al: Interferon alfa-2a and 5-fluorouracil for advanced colorectal carcinoma: Assessment of activity and toxicity. Cancer 66:2470-2475, 1990
16. Elias L, Sandoval J: Interferon effects upon fluorouracil metabolism by HL-60 cells. Biochem Biophys Res Commun 163:867-874, 1989
17. Woolson RF: in Statistical Methods for the Analysis of Biomedical Data. New York, NY, Wiley, 1987
18. Kaplan EL, Meier P: Nonparametric estimation for incomplete observations. J Am Stat Assoc 53:457-481, 1958
19. Cox DR: Regression models and life tables. J R Stat Soc 34:187-220, 1972
20. Dixon WJ, Brown MB, Engelman L, et al: BMDP Statistical Software Manual. Los Angeles, CA, University of California Press, 1990
21. Hosmer DW, Lemeshow S: Applied Logistic Regression. New York, NY, Wiley, 1989
22. Srivastara MS, Carter EM: in Introduction to Applied Multivariate Statistics. North Holland, 1983
23. 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 10:896-903, 1992
24. Mahna MG, Middemann W, Schuller P, et al: Failure of orally administered dipyridamole to enhance the antineoplastic activity of fluorouracil in combination with leucovorin in patients with advanced colorectal cancer: A prospective randomized trial. J Clin Oncol 13:1201-1208, 1995
25. Raderer M, Scheithaker W: Treatment of advanced colorectal cancer with 5-fluorouracil and interferon-α: An overview of clinical trials. Eur J Cancer 31:1002-1008, 1995
26. Labianca R, Giaccon G, Barni S, et al: Double modulation of 5-fluorouracil in advanced colorectal cancer with low-dose interferon-α-2b and folinic acid. The "GISCAD" experience. Eur J Cancer 30:1611-1616, 1994
27. Sinnige HAM, Mulder NH, Sleijfer DTH, et al: In vitro and clinical modulation of 5-fluorouracil and/or alfa-2a interferon in colorectal cancer. Proc Am Soc Clin Oncol 11:464, 1991 (abstr)
28. Grem JL, McAtee N, Murphy RF, et al: A pilot study of interferon alfa-2a in combination with 5-fluorouracil plus high dose leucovorin in metastatic gastrointestinal carcinoma. J Clin Oncol 9:1811-1820, 1991
29. Grem JL, Jordan R, Robson M, et al: A phase II study of Interferon alfa-2a (IFN) in combination with 5-fluorouracil (5FU) and leucovorin in advanced colorectal cancer. Proc Am Soc Clin Oncol 12:600, 1993 (abstr)
30. Cascinu S, Fedeli A, Luzi Fedeli S, et al: Double biochemical modulation of 5-fluorouracil by leucovorin and cyclic low dose interferon alfa-2a in advanced colorectal cancer patients. Ann Oncol 3:489-491, 1992
31. Quan WDY, Madajewicz S, Skeel RT: Phase I trial of ALF: Alfa interferon, leucovorin and 5-fluorouracil in advanced colon cancer. Proc Am Soc Clin Oncol 10:153, 1991 (abstr)
32. Schmoll HJ, Kohne-Wompner W, Hiddemann W, et al: Interferon alfa-2b, 5-fluorouracil and folinic acid combination therapy in advanced colorectal cancer: Preliminary results of a phase I-II trial. Semin Oncol 19:191-196, 1992 (suppl)
33. Kosmidis P, Tsavaris N, Skarlos D, et al: Fluorouracil and folinic acid with or without α2b-interferon in advanced colorectal cancer. A prospective randomized trial. Proc Am Soc Clin Oncol 12:211, 1993 (abstr)