Folfox 2 regimen in heavily pretreated patients with advanced colorectal cancer.
OBJECTIVE
To determine the efficacy and safety of the FOLFOX 2 regimen in patients with pretreated advanced colorectal cancer.


METHODS
In this single-arm phase II study, 28 patients with heavily pretreated advanced colorectal cancer received the following drug combination: oxaliplatin (100 mg/m2 for 2 hrs on day 1), folinic acid (250 mg/m2 for 2 hrs on day 1) and 5-flluorouracil (1500 mg/m2 for 22 hrs continuous infusion on days 1 and 2) every 2 weeks (one cycle). The treatment was continued until unacceptable toxicity occurred or at most for 10 cycles.


RESULTS
Nine patients (32%) had a partial response and 5 (18%) stable disease, with a median duration of tumor control of 24 weeks (range, 8-44). The median survival of patients with a partial response or stable disease was 32 weeks (range, 12-52), whereas the median overall survival was 32 weeks (range, 8-72). A clinical benefit was achieved in 32% (9/21) of the patients. Severe (grade 3-4) non-hematological toxicity included diarrhea (1 patient), nausea/vomiting (7%) and peripheral neuropathy (1 patient). Severe hematological toxicities were rare (4%).


CONCLUSIONS
Our phase II study confirmed the therapeutic effectiveness and safety of the FOLFOX 2 regimen in pretreated advanced colorectal cancer patients.
Luppi
Gabriele
G
Department of Oncology and Hematology, Policlinico, Modena, Italy. luppi.g@policlinico.mo.it
Zanelli
Francesca
F
Di Stasi
Antonio
A
Bertolini
Federica
F
Pifferi
Micol
M
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D011379:Prognosis
D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil