Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: a multicenter study of the Gruppo Oncologico Dell'Italia Meridionale.
OBJECTIVE
We performed this phase III study to compare the irinotecan, leucovorin (LV), and fluorouracil (FU) regimen (FOLFIRI) versus the oxaliplatin, LV, and FU regimen (FOLFOX4) in previously untreated patients with advanced colorectal cancer.


METHODS
A total of 360 chemotherapy-naive patients were randomly assigned to receive, every 2 weeks, either arm A (FOLFIRI: irinotecan 180 mg/m(2) on day 1 with LV 100 mg/m(2) administered as a 2-hour infusion before FU 400 mg/m(2) administered as an intravenous bolus injection, and FU 600 mg/m(2) as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [LV5FU2]) or arm B (FOLFOX4: oxaliplatin 85 mg/m(2) on day 1 with LV5FU2 regimen).


RESULTS
One hundred sixty-four and 172 patients were assessable in arm A and B, respectively. Overall response rates (ORR) were 31% in arm A (95% CI, 24.6% to 38.3%) and 34% in arm B (95% CI, 27.2% to 41.5%; P = .60). In both arms A and B, median time to progression (TTP; 7 v 7 months, respectively), duration of response (9 v 10 months, respectively), and overall survival (OS; 14 v 15 months, respectively) were similar, without any statistically significant difference. Toxicity was mild in both groups: alopecia and gastrointestinal disturbances were the most common toxicities in arm A; thrombocytopenia and neurosensorial were the most common toxicities in arm B. Grade 3 to 4 toxicities were uncommon in both arms, and no statistical significant difference was observed.


CONCLUSIONS
There is no difference in ORR, TTP, and OS for patients treated with the FOLFIRI or FOLFOX4 regimen. Both therapies seemed effective as first-line treatment in these patients. The difference between these two combination therapies is mainly in the toxicity profile.
Colucci
Giuseppe
G
Medical and Experimental Oncology Unit, Oncology Institute, Via Amendola 209, 70126 Bari, Italy. colucci@goim.it
Gebbia
Vittorio
V
Paoletti
Giancarlo
G
Giuliani
Francesco
F
Caruso
Michele
M
Gebbia
Nicola
N
Cartenì
Giacomo
G
Agostara
Biagio
B
Pezzella
Giuseppe
G
Manzione
Luigi
L
Borsellino
Nicola
N
Misino
Andrea
A
Romito
Sante
S
Durini
Ernesto
E
Cordio
Stefano
S
Di Seri
Marisa
M
Lopez
Massimo
M
Maiello
Evaristo
E
Montemurro
Severino
S
Cramarossa
Antonio
A
Lorusso
Vito
V
Di Bisceglie
Maurizio
M
Chiarenza
Maurizio
M
Valerio
Maria Rosaria
MR
Guida
Teresa
T
Leonardi
Vita
V
Pisconti
Salvatore
S
Rosati
Gerardo
G
Carrozza
Francesco
F
Nettis
Giuseppe
G
Valdesi
Matteo
M
Filippelli
Gianfranco
G
Fortunato
Santo
S
Mancarella
Sergio
S
Brunetti
Cosimo
C
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D016019:Survival Analysis; D016896:Treatment Outcome
D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin