A phase II study with 5-fluorouracil, folinic acid and oxaliplatin (FOLFOX-4 regimen) in patients with metastatic renal cell carcinoma.
OBJECTIVE
To investigate the efficacy and safety of the FOLFOX-4 regimen for patients with metastatic renal cell carcinoma (MRCC).


METHODS
Fifty-nine patients (median age 59 years) pre-treated or not by cytokines (29 vs. 30) received the FOLFOX-4 regimen every 2 weeks.


RESULTS
Three minor responses, and no complete or partial responses were obtained. The median progression-free survival was 3 months (95% CI: 2.6-3.4), the median survival 10.6 months (95% CI: 8.7-12.4), with no difference between pre-treated patients and others. Treatment was well tolerated.


CONCLUSIONS
The FOLFOX-4 regimen is ineffective in patients with MRCC. We believe that oxaliplatin should no longer be explored in renal carcinoma.
Bennouna
J
J
Centre René Gauducheau, Nantes, France. j-bennouna@nantes.fnclcc.fr
Delva
R
R
Gomez
F
F
Lesimple
T
T
Geoffrois
L
L
Linassier
C
C
Chevreau
C
C
Douillard
J Y
JY
Négrier
S
S
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002955:Leucovorin / Q000627:therapeutic use*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009944:Organoplatinum Compounds; D011379:Prognosis; D012449:Safety; D016896:Treatment Outcome
D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil