Use of the folinic acid/5-fluorouracil/irinotecan (FOLFIRI 1) regimen in elderly patients as a first-line treatment for metastatic colorectal cancer: a Phase II study.
BACKGROUND
The aim of this study was to evaluate the effects of a combination of folinic acid, 5-fluorouracil (5FU) and irinotecan (FOLFIRI 1) administered every 2 weeks in a population of elderly subjects with advanced colorectal cancer.


METHODS
Patients with metastatic colorectal cancer included in this study were aged at least 70 years, with a performance status of 0/1, without geriatric syndrome and without previous palliative chemotherapy. They received irinotecan [180 mg/m(2) intravenous (iv) infusion over 90 min] followed by folinic acid (400 mg/m(2) iv over 2 h), then 5FU (400 mg/m(2) iv bolus) and 5FU (2,400 mg/m(2) continuous iv infusion for 46 h) every 2 weeks.


RESULTS
Forty eligible patients were included. The median age was 77.3 years (range 70-84.7). The objective response rate was 40% and the stabilisation rate was 45%. Median progression-free survival was 8 months, overall survival was 17.2 months and cancer-related specific survival was 20.2 months. In total, 300 cycles of chemotherapy were administered with a median number of eight cycles per patient (range 1-18). Tolerance was good; grade 3/4 toxicities included diarrhoea (15%), asthenia (15%), nausea/vomiting (7.5%) and neutropenia (7.5%). One toxic death was observed due to grade 4 diarrhoea.


CONCLUSIONS
The FOLFIRI 1 regimen is a valid therapeutic option for elderly patients in good clinical condition.
François
Eric
E
Centre Antoine-Lacassagne, 33 Ave de Valombrose, 06189, Nice Cedex 2, France. eric.francois@cal.nice.fnclcc.fr
Berdah
Jean-François
JF
Chamorey
Emmanuel
E
Lesbats
Gérard
G
Teissier
Eric
E
Codoul
Jean-François
JF
Badetti
Jean-Luc
JL
Hébert
Christophe
C
Mari
Véronique
V
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D003131:Combined Modality Therapy; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D017202:Myocardial Ischemia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010166:Palliative Care; D010349:Patient Compliance; D011446:Prospective Studies; D011788:Quality of Life; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin