FOLFOX-4 in pre-treated patients with advanced transitional cell carcinoma of the bladder.
BACKGROUND
Despite recent progress in the treatment of advanced urothelial cancer, there continues to be a need to identify new active agents and their toxicity spectra. We conducted a study using FOLFOX-4 (oxaliplatin, fluorouracil, folinic acid) in pre-treated advanced bladder cancer patients.


METHODS
Sixteen eligible patients with advanced disease were treated with oxaliplatin (85 mg/m(3)) on day 1 followed by fluorouracil and folinic acid (De Gramont schedule) on days 1 and 2 every 14 days until disease progression. All patients received nutritional support to increase their caloric intake. Objective responses and toxicity were evaluated. Biochemical responses (reduction of markers) and nutritional parameters (increase in body weight and albumin, and reduction in ferritin and C-reactive protein) were also considered.


RESULTS
Three patients obtained an objective response (overall response rate 19%). Hematological toxicity and stomatitis were the most commonly noted side effects, but we observed only low (3-4) grade toxicity. In four patients (25%), we observed a reduction in tumoral markers (carcinoembryonic antigen and tissutal polypeptide antigen) and modified nutritional parameters.


CONCLUSIONS
Using these doses and schedules of FOLFOX-4 appears to be a promising therapy in patients pre-treated with platinum compounds. More studies are required to assess the possible role of this regimen in the treatment of advanced bladder cancer.
Di Lorenzo
Giuseppe
G
Dipartimento di Endocrinologia e Oncologia Molecolare e Clinica, Seconda Università degli Studi, Naples, Italy. giuseppedilorenzoncol@hotmail.com
Autorino
Riccardo
R
Giordano
Antonio
A
Giuliano
Mario
M
D'Armiento
Massimo
M
Bianco
Angelo R
AR
De Placido
Sabino
S
D000368:Aged; D000369:Aged, 80 and over; D000380:Agranulocytosis / Q000139:chemically induced; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood*; D002272:Carcinoembryonic Antigen / Q000097:blood; D002295:Carcinoma, Transitional Cell / Q000097:blood / Q000188:drug therapy* / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D002149:Energy Intake; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D013280:Stomatitis / Q000139:chemically induced; D043823:Taxoids / Q000008:administration & dosage; D019396:Tissue Polypeptide Antigen / Q000097:blood; D001749:Urinary Bladder Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
D014408:Biomarkers, Tumor; D002272:Carcinoembryonic Antigen; D009944:Organoplatinum Compounds; D043823:Taxoids; D019396:Tissue Polypeptide Antigen; D000077150:Oxaliplatin; D003841:Deoxycytidine; D002955:Leucovorin; D005472:Fluorouracil; D000093542:Gemcitabine