Adjuvant systemic therapy protocol for Dukes' B2 and C resectable colon carcinoma.
OBJECTIVE
Trials of adjuvant systemic therapy in high risk patients with Dukes' B2 and C colon cancer utilizing 5-fluorouracil-based regimens have been ongoing since the 1960s. The aim of this study was to compare the combination of 5-FU and leucovorin with the combination of 5-FU and alfa-2b interferon (IFN) in patients who had undergone "curative" resection foronocarcinoma.


METHODS
A total of 322 patients with histologically proven adenocarcinoma of the colon, Dukes' stage B2 and C, were entered in the study. They were randomized to A) leucovorin 20 mg/m2 rapid intravenous injection and 5-FU 425 mg/m2 IV days 1-5 every 28 days for six cycles or B) 5-FU 600 mg/m2 24-hour infusion for five days, then 600 mg/m2 IV once a week and IFN 5 MU subcutaneously three times a week for six months.


RESULTS
There was no statistically significant difference in either disease-free survival or overall survival. Toxicity was the same in the two groups with the exception of flu-like syndrome, which was universal in IFN-treated patients.


CONCLUSIONS
There was no difference in disease-free survival or overall survival between the two combinations in any patient subset. Toxicity was greater with the 5-FU+IFN combination because of the flu-like syndrome. These data do not support the use of IFN in combination with 5-FU as systemic adjuvant therapy for patients with locally advanced colon carcinoma.
Gennatas
Constantine
C
Second Department of Surgery, Areteion Hospital, University of Athens, Greece. gennatas@compulink.gr
Mouratidou
Despoina
D
Androulakis
George
G
Georgoulias
Vasilios
V
Tsavaris
Nikolaos
N
Philippakis
Michail
M
Michailakis
Emmanouil
E
Kalofonos
Charalampos
C
Mpesmpeas
Stavros
S
Katsos
John
J
Tsitoura
Miranda
M
Retalis
George
G
Mallas
Elias
E
Voros
Dionysios
D
Andreadis
Charalampos
C
Hatzistylianos
George
G
Pisiotis
Christos
C
Kamilarios
Dimitrios
D
Kakoliris
Sotirios
S
Komporozos
Vasilios
V
Kannas
Dimitrios
D
Legakis
Nikolaos
N
Mpatakis
Theodoros
T
Ntamtsios
John
J
Papaevangelou
Evangelos
E
Peros
George
G
Photopoulos
Alexis
A
Pouli
Anastasia
A
Prigouris
Sotirios
S
Samanidis
Lazaros
L
Sakellariou
Vasilios
V
Smyrniotis
Vasilios
V
Polymeneas
George
G
Vasiliou
John
J
Athanasiou
Athanasios
A
Papadimitriou
John
J
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D009367:Neoplasm Staging; D011994:Recombinant Proteins; D015996:Survival Rate; D016896:Treatment Outcome
D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D002955:Leucovorin; D005472:Fluorouracil