Randomized trial of 5-fluorouracil and high-dose folinic acid with or without alpha-2B interferon in advanced colorectal cancer

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 19, Issue 3, 1996, Pages 301-304

  Recchia, Francesco ^a,c   Nuzzo, Antonio ^a   Lalli, Angelo ^a   Lombardo, Marco ^a   Di Lullo, Liberato ^a   Fabiani, Francesco ^a   Fanini, Rodolfo ^a   Venturoni, Lanfranco ^a   Torchio, Pierfederico ^b   Peretti, Giancarlo ^a  

^a Ist Oncologico Regione Abruzzo M   (Italy)

^b UNIVERSITY OF L'AQUILA   (Italy)

^c NONE   (Italy)

Author keywords

5 Fluorouracil; Alpha 2b interferon; Folinic acid; Metastatic colorectal cancer

Indexed keywords

CARCINOEMBRYONIC ANTIGEN; FLUOROURACIL; FOLINIC ACID; RECOMBINANT ALPHA2B INTERFERON;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BLOOD CELL COUNT; BLOOD TOXICITY; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG COST; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; RANDOMIZED CONTROLLED TRIAL; SUBCUTANEOUS DRUG ADMINISTRATION;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; FEMALE; FLUOROURACIL; HUMANS; INTERFERON ALFA-2B; LEUCOVORIN; MALE; MIDDLE AGED; SURVIVAL RATE;

EID: 9344221617     PISSN: 02773732     EISSN: None     Source Type: Journal    
DOI: 10.1097/00000421-199606000-00019     Document Type: Article

References (34)

1. Rustum YM, Trave F, Zakrzewski SF, et al. Biochemical and pharmacologic basis for potentiation or 5-fluorouracil action by leucovorin. NCI monograph no. 5:159-163. Innisbrook: NIH Publication No. 87-2901, 1987.
2. Machover D, Goldsmchmidt E, Chollet P, et al. Treatment of advanced colorectal and gastric adenocarcinomas with 5-fluorouracil and high-dose folinic acid. J Clin Oncol 1986;4:685-96.
3. Erilichman C, Fine S, Wong A, et al. A randomised trial of fluorouracil and folinic acid in patients with metastatic colorectal carcinoma. J Clin Oncol 1988;6:469-75.
4. Petrelli N, Herrera L, Rustum Y, et al. A prospective randomised 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.
5. Petrelli N, Douglass H, Herrera L, et al. The modulation of fluorouracil with leucovorin in metastatic colorectal carcinoma: a prospective randomised phase III trial. Gastrointestinal Tumor Study Group. J Clin Oncol 1989;7:1419-26.
6. Poon MA, O'Connel MG, Moertel CG, et al. Biochemical modulation of fluorouracil: evidence of significant improvement of survival and quality of life in patients with advanced colorectal cancer. J Clin Oncol 1989;7:1407-18.
7. 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 randomised trial of the Northern California Oncology Group. J Clin Oncol 1989;7: 1427-36.
8. Di Costanzo F, Bartolucci R, Calabresi F, et al. Fluorouracil-alone versus high dose folinic acid and fluorouracil in advanced colorectal cancer: a randomised trial of the Italian Oncology Group for Clinical Research (GOIRC). Ann Oncol 1992;3: 371-6.
9. La Bianca R, Pancera G, Aitini E, et al. Folinic acid + 5-fluorouracil (5-FU) versus equidose 5-FU in advanced colorectal cancer. Phase III study of GISCAD (Italian Group for the Study of Digestive Tract Cancer). Ann Oncol 1991;2:673-9.
10. Doroshow JH, Multhauf P, Leong L, et al. Prospective randomised comparison of fluorouracil versus 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 1990;8:491-501.
11. Loffler T, Korsten FW. Burghard F. Randomised comparison of 5-FU vs. 5-FU/medium dose leucovorin in metastatic colorectal cancer [Abstract]. In: Proceedings ECCO no. O-0628. London: 5th European Conference on Clinical Oncology, 1989.
12. Wadler S, Schwartz EL. Antineoplastic activity of the combination of interferon and cytotoxic agents against experimental and human malignancies. A review. Cancer Res 1990;50:3473-86.
13. Wadler S, Schwartz EL, Goldman M, et al. Fluorouracil and recombinant alpha- 2a-interferon; an active regimen against advanced colorectal carcinoma. J Clin Oncol 1989;7:1769-75.
14. Wadler S, Lembresky B, Atkins M, et al. Phase II trial of fluorouracil and recombinant interferon alfa-2a in patients with advanced colorectal carcinoma; an Eastern Co-operative Oncology Group Study. J Clin Oncol 1991;9:1806-10.
15. Kemeney N, Younes A, Seiter K, et al. Interferon alpha-2a and 5-fluorouracil for advanced colorectal carcinoma. Cancer 1989;66:2470-5.
16. Pazdur R, Ajani JA, Patt YZ, et al. Phase II trial of 5-fluorouracil and recombinant interferon alpha-2a in previously untreated advanced colorectal cancer. J Clin Oncol 1990;8:2027-31.
17. Borden EC. Progress toward therapeutic applications of interferons, 1979-1983. Cancer 1984;54:2770-6.
18. Gresser I. How does interferon inhibit tumor growth? Phil Trans R Soc Lond (Biol) 1982;299:69-76.
19. Iaffaioli RV, Frasci G, Palmeri G, et al. β-Interferon (Frone) singly or in combination with chemotherapy for the treatment of refractory solid tumors. Presented at the Second World Week of Professional Updating in Surgery and Surgical and Oncological Disciplines of the University of Milan, 1990.
20. Scala S, Pacelli R, Iaffaioli RV, Normanno N, et al. Reversal of adryamicin resistance by recombinant α-interferon in multidrug-resistant human colon carcinoma LoVo-doxorubicin cells. Cancer Res 1991;51:4898-902.
21. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer 1981;47:207-14.
22. Kaplan EL, Meyer P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
23. Mante N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 1966;50:163-70.
24. Alone FH, Friedman MA, Wittlinger PS, et al. Treatment of patients with advanced colorectal cancer with fluorouracil alone, high-dose leucovorin plus fluorouracil, or sequential methotrexate. The Northern California Oncology Group. J Clin Oncol 1989;7:1427-36.
25. Douillard JY, Leborgne J, Danielou JY, et al. Phase II trial of 5-fluorouracil (5FU) and recombinant alpha interferon (Intron A) in metastatic, previously untreated colorectal cancer (CRC) [Abstract]. Proc Am Soc Clin Oncol 1991;10:139.
26. Huberman M, McClay E, Atkins M, et al. Phase II trial of 5-fluorouracil (5FU) and recombinant interferon-alpha-2a (INF) in advanced colorectal cancer [Abstract]. Proc Am Soc Clin Oncol 1991;10:153.
27. Grem JI, McAtee N, Murphy RE, et al. A pilot study of interferon alpha 2a in combination with fluorouracil plus high-dose leucovorin in metastatic gastrointestinal carcinoma. J Clin Oncol 1990;8:1811-20.
28. Punt CJA, de Mulder PHM, Burghouts JTM, et al. A phase I-II study of high-dose 5 fluorouracil (5FU), leucovorin (LV) and alpha-interferon in patients with advanced colorectal cancer [Abstract]. Proc Am Soc Clin Oncol 1991;10:150.
29. Kohne-Wompner CH, Schmoll HJ, Hiddemann W, et al. 5-Fluorouracil (FU), leucovorin (LV) and alpha-2b interferon (INF) in patients with advanced colorectal cancer (CC); a phase I/II study [Abstract]. Proc Am Soc Clin Oncol 1991;10:159.
30. Seymour MT, Johnson PWM, Wringley PFM, et al. 5-Fluorouracil (FU), leucovorin (LV) and alpha-2b interferon (INF); a new regimen suitable for randomised trial [Abstract]. Proc Am Soc Clin Oncol 1991;10-160.
31. Hinoshita G, Yalavarthi P, Murthy S, et al. Phase I trial of 5FU, leucovorin (LV) and rHuINF-alpha-2a in metastatic colorectal cancer [Abstract]. Proc Am Soc Clin Oncol 1991;10:152.
32. Labianca R, Pancera G, Tedeschi L, et al. High dose alpha-2B interferon + folinic acid in the modulation of 5-fluorouracil. A phase II study in advanced colorectal cancer with evidence of unfavourable cost/benefit ratio. Tumori 1992;78:32-4.
33. Schuller J, Czejca M, Miksche M, et al. Influence of interferon α 2b (IFN) ± leucovorin (LV) on pharmacokinetics (PK) of 5-fluorouracil [Abstract]. Proc Am Soc Clin Oncol 1991;10:98.
34. Recchia F, Nuzzo A, Lombardo M, et al. 5-Fluorouracil (5FU) and high-dose folinic acid (HDFA) chemotherapy (CT) with or without alfa 2b interferon (INF) in advanced colorectal cancer (ACC). Preliminary report of a randomised trial [Abstract]. Proc Am Soc Clin Oncol 1992;11:162.