A phase III study of 5-fluorouracil versus 5-fluorouracil plus interferon alpha 2b versus 5-fluorouracil plus leucovorin in patients with advanced colorectal cancer: A Hellenic Cooperative Oncology Group (HeCOG) study
AuthorKalofonos, H. P.
Dimopoulos, M. A.
SourceAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Google Scholar check
MetadataShow full item record
We conducted a phase III study in patients with advanced colorectal carcinoma (ACC). The total number of patients randomized from October 1993 until July 1998 was 192, whereas therapy was started on 179 and 158 (82.3%) have been evaluable. The treatment schedules consisted of weekly bolus administration for 6 weeks of 5-fluorouracil (5-FU), 600 mg/m2 (arm I) versus 5-FU (500 mg/m2) intravenous bolus and interferon-α, 5 MU subcutaneously, three times a week (arm II) versus leucovorin 200 mg/m2 in 2-hour infusion and 5-FU 500 mg/m2 intravenous bolus at the midtime of leucovorin infusion (arm III) followed by a 2-week rest period. Treatment was continued for six cycles or until progression. This study failed to show any superiority of the modulated 5-FU versus single administration of 5-FU. There were no significant differences between the three arms in the overall response rate (10.3% versus 11.3% versus 12.9%, p = 0.95), the time to tumor progression (median, 3.9 versus 3.8 versus 6.0 months, p = 0.59), or survival duration (median, 14.7 versus 12.4 versus 16.3 months, p = 0.71). The incidence of severe (grades III and IV) toxicity was significantly higher in patients in arm II and III (24.5% and 18.6%) versus arm I (6.0%) (p = 0.01). Because modulated 5-FU failed to show superiority versus 5-FU, new agents and new strategies are needed for the treatment of advanced colorectal carcinoma.
Showing items related by title, author, creator and subject.
Pentheroudakis, George; Pavlidis, Nicholas (2010)
Survival and disease-progression benefits with treatment regimens for advanced colorectal cancer: a meta-analysis Golfinopoulos, Vassilis; Salanti, G.; Pavlidis, Nicholas; Ioannidis, J. P. A. (2007)Background: Many randomised trials have compared different systemic treatment regimens in patients with advanced colorectal cancer. While survival advances have apparently been achieved, the magnitude of these incremental ...
Optimal therapeutic management of patients with distinct clinicopathological cancer of unknown primary subsets Pavlidis, Nicholas (2012)Cancer of unknown primary sites (CUP) is a compilation of various malignant entities-the majority of which behave aggressively and carry poor prognosis. CUP is classified into two different clinicopathological groups: the ...