PMID- 7707120
OWN - NLM
STAT- MEDLINE
DCOM- 19950510
LR  - 20181130
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 13
IP  - 4
DP  - 1995 Apr
TI  - Phase III randomized study of two fluorouracil combinations with either 
      interferon alfa-2a or leucovorin for advanced colorectal cancer. Corfu-A Study 
      Group.
PG  - 921-8
AB  - PURPOSE: To compare the efficacy and toxicity profiles of a combination of 
      fluorouracil (5-FU) with recombinant human interferon alfa-2a (Roferon-A; Hoffman 
      La-Roche AG, Basel, Switzerland) versus the combination of 5-FU with leucovorin 
      (LV) in the treatment of advanced colorectal cancer. PATIENTS AND METHODS: A 
      total of 496 previously untreated colorectal cancer patients were randomized to 
      receive either Roferon-A (9 MIU) subcutaneously three times per week, with 5-FU 
      (750 mg/m2/d) by continuous intravenous (i.v.) infusion (CIV) on days 1 to 5, 
      then, after a 9-day hiatus, as a weekly i.v. bolus at the same dose (IFN/5-FU); 
      or LV (200 mg/m2/d) by i.v. infusion plus 5-FU (370 mg/m2/d) by i.v. bolus on 
      days 1 to 5, repeated every 4 weeks (LV/5-FU). RESULTS: There were no significant 
      differences between IFN/5-FU and LV/5-FU in the overall response rate (21% v 
      18%), duration of response (7.3 v 6.2 months), or survival time (median, 11.0 v 
      11.3 months). Toxicity profiles differed; constitutional symptoms and 
      myelosuppression were more frequent and more severe with IFN/5-FU, and 
      gastrointestinal symptoms with LV/5-FU. More patients interrupted treatment for 
      adverse events (AEs) with IFN/5-FU than with LV/5-FU. Five treatment-related 
      deaths occurred with each regimen. CONCLUSION: The combination IFN/5-FU produced 
      response rates, response durations, and survival times similar to those with 
      LV/5-FU. Biochemical modulation of 5-FU by either IFN or LV appears to result in 
      equivalent efficacy; however, fewer patients were able to tolerate the specified 
      IFN/5-FU combination used in this study.
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Interferon alpha-2)
RN  - 0 (Interferon-alpha)
RN  - 0 (Recombinant Proteins)
RN  - Q573I9DVLP (Leucovorin)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Colorectal Neoplasms/drug therapy/mortality/*therapy
MH  - Combined Modality Therapy
MH  - Drug Administration Schedule
MH  - Female
MH  - Fluorouracil/*administration & dosage/adverse effects
MH  - Humans
MH  - Interferon alpha-2
MH  - Interferon-alpha/*administration & dosage/adverse effects
MH  - Leucovorin/administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Recombinant Proteins
MH  - Remission Induction
MH  - Survival Rate
EDAT- 1995/04/01 00:00
MHDA- 1995/04/01 00:01
CRDT- 1995/04/01 00:00
PHST- 1995/04/01 00:00 [pubmed]
PHST- 1995/04/01 00:01 [medline]
PHST- 1995/04/01 00:00 [entrez]
AID - 10.1200/JCO.1995.13.4.921 [doi]
PST - ppublish
SO  - J Clin Oncol. 1995 Apr;13(4):921-8. doi: 10.1200/JCO.1995.13.4.921.