First-line chemotherapy with fluorouracil and folinic acid for advanced colorectal cancer in elderly patients: a phase II study.
BACKGROUND
Colorectal cancer is one of the most common cancers in the elderly. Information on tolerability and efficacy of 5-Fluorouracil-based chemotherapy in such patients is limited. Primary aim of the study was to describe tolerability and activity of chemotherapy with the "de Gramont" schedule (FU bolus [400 mg/m ] + FU continuous infusion [600 mg/m ] + folinic acid [100 mg/m ] on days 1 and 2, every 2 weeks), in patients with advanced colorectal cancer aged 70 or older.


METHODS
Patients aged 70 or more, with stage IV colorectal cancer, ECOG performance status not worse than 2.


RESULTS
Thirty-four patients were treated at two participating centers. Seven (20.6%, 95% exact CI = 8.7-37.9) had an objective response, complete in 3 and partial in 4 patients. Five cases of unacceptable toxicity were registered (2 cardiac, 1 each for liver, anemia and diarrhea). Fitting the statistical model to the observed data indicated that the treatment was sufficiently active and tolerated.


CONCLUSIONS
The de Gramont scheme is active and tolerated in elderly patients with advanced colorectal cancer.
Daniele
Bruno
B
Medical Oncology, Clinical Trial Office, National Cancer Institute of Naples, Italy.
Rosati
Gerardo
G
Tambaro
Rosa
R
Ottaiano
Alessandro
A
De Maio
Ermelinda
E
Pignata
Sandro
S
Iaffaioli
Rosario Vincenzo
RV
Rossi
Antonio
A
Manzione
Luigi
L
Gallo
Ciro
C
Perrone
Francesco
F
D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000453:epidemiology; D015897:Comorbidity; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D011446:Prospective Studies
D000964:Antimetabolites, Antineoplastic; D002955:Leucovorin; D005472:Fluorouracil