PMID- 8874326
OWN - NLM
STAT- MEDLINE
DCOM- 19961112
LR  - 20181130
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 14
IP  - 10
DP  - 1996 Oct
TI  - Phase III randomized study to compare interferon alfa-2a in combination with 
      fluorouracil versus fluorouracil alone in patients with advanced colorectal 
      cancer.
PG  - 2674-81
AB  - PURPOSE: To compare the efficacy and toxicity profiles of a combination of 
      fluorouracil (5-FU) and recombinant human interferon alfa-2a ([IFN alpha 2a] 
      Roferon-A; Hoffmann-LaRoche, Basel, Switzerland) versus 5-FU alone in the 
      treatment of advanced colorectal cancer (ACC). PATIENTS AND METHODS: A total of 
      245 previously untreated ACC patients were randomized to receive either IFN alpha 
      2a (9 million IU) subcutaneously (SC) three times weekly with 5-FU (750 mg/m2/d) 
      by continuous intravenous (CIV) infusion on days 1 to 5 and then, after a 1-week 
      hiatus, as a weekly IV bolus at the same dose (IFN/ 5-FU), or 5-FU alone at the 
      same dose schedule (5-FU). RESULTS: There were no significant differences between 
      IFN/5-FU and 5-FU alone in the overall response rate (24% v 17%, P = .2), 
      duration of response (median, 6.4 v 8.1 months), time to response (plateau at 3 
      months), time to progressive disease ([PD] median, 4.8 v 4.9 months), or survival 
      duration (median, 13.9 v 13.2 months). Toxicity profiles were not statistically 
      different except for constitutional symptoms, which were more frequent and more 
      severe with IFN/5-FU. More patients interrupted treatment for adverse events 
      (AEs) with IFN/ 5-FU (34%) than with 5-FU alone (21%) (P = .03). The number of 
      deaths (mostly unrelated to drug treatment) during the study (8%) was similar 
      with both regimens. CONCLUSION: The combination IFN/5-FU produced a response 
      rate, response duration, and survival duration similar to that of 5-FU alone. The 
      addition of IFN to 5-FU in the doses and schedules used in this study did not 
      provide any further benefit over 5-FU alone and cannot be recommended for 
      patients with metastatic ACC. This study confirms the value of large prospective 
      randomized clinical trials to determine the clinical value of regimens that 
      emerge from smaller single-center phase II studies.
FAU - Greco, F A
AU  - Greco FA
AD  - Roche International Clinical Research Center, Lingolsheim, France.
FAU - Figlin, R
AU  - Figlin R
FAU - York, M
AU  - York M
FAU - Einhorn, L
AU  - Einhorn L
FAU - Schilsky, R
AU  - Schilsky R
FAU - Marshall, E M
AU  - Marshall EM
FAU - Buys, S S
AU  - Buys SS
FAU - Froimtchuk, M J
AU  - Froimtchuk MJ
FAU - Schuller, J
AU  - Schuller J
FAU - Schuchter, L
AU  - Schuchter L
FAU - Buyse, M
AU  - Buyse M
FAU - Ritter, L
AU  - Ritter L
FAU - Man, A
AU  - Man A
FAU - Yap, A K
AU  - Yap AK
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase III
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  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Colorectal Neoplasms/drug therapy/pathology/*therapy
MH  - Female
MH  - Fluorouracil/administration & dosage/adverse effects
MH  - Humans
MH  - Interferon alpha-2
MH  - Interferon-alpha/administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Recombinant Proteins
MH  - Remission Induction
EDAT- 1996/10/01 00:00
MHDA- 1996/10/01 00:01
CRDT- 1996/10/01 00:00
PHST- 1996/10/01 00:00 [pubmed]
PHST- 1996/10/01 00:01 [medline]
PHST- 1996/10/01 00:00 [entrez]
AID - 10.1200/JCO.1996.14.10.2674 [doi]
PST - ppublish
SO  - J Clin Oncol. 1996 Oct;14(10):2674-81. doi: 10.1200/JCO.1996.14.10.2674.