title: FOLFOX4 in the treatment of metastatic colorectal cancer in elderly patients: a prospective study.
abstract: Elderly patients constitute a subpopulation with special characteristics that differ from those of the general population and have been under-represented in clinical trials. We, prospectively, analyzed the toxicity and efficacy of the original FOLFOX4-regimen in the treatment of elderly patients affected by metastatic (m) colorectal cancer (CRC). Thirty-six consecutive patients aged 67-82 years (median age 72 years), 22 males and 14 females, with mCRC and measurable disease, were enrolled in the study. The primary site of metastases was the liver (36.1% of patients). The median ECOG Performance Status (PS) was 1. The main hematological and extra-hematological (grade 3 or 4) toxicities were neutropenia (38.9%) and neurological (13.9%), respectively. A total of 36 patients, aged 67-82 years were included. Twenty-two and 14 patients were male and female, respectively. The median age was 72 years (range 67-82). The primary site of metastases was the liver (36.1% of patients). The median ECOG Performance Status (PS) was 1. The overall response rate (ORR) was 44.4% and similar to original study. Median progression-free survival (PFS) was 7.5 months and median overall survival (OS) was 16 months. The main hematological and extra-hematological (grade 3 or 4) toxicities were neutropenia (38.9%) and neurological (13.9%), respectively. Tolerability, however, was manageable and no toxic death occurred. FOLFOX4-regimen maintains its efficacy, and safety ratio in elderly patients with mCRC and good performance status. It would be considered the treatment of choice in the treatment of this particular setting of patients.
authors.affiliation: Department of Medical Oncology, Centro di Riferimento Oncologico, IRCCS, Via Franco Gallini 2, I-33081 Aviano (PN), Italy. mberretta@cro.it
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Berretta
authors.forename: Alessandro
authors.initials: A
authors.lastname: Cappellani
authors.forename: Francesco
authors.initials: F
authors.lastname: Fiorica
authors.forename: Guglielmo
authors.initials: G
authors.lastname: Nasti
authors.forename: Sergio
authors.initials: S
authors.lastname: Frustaci
authors.forename: Rossella
authors.initials: R
authors.lastname: Fisichella
authors.forename: Alessandra
authors.initials: A
authors.lastname: Bearz
authors.forename: Renato
authors.initials: R
authors.lastname: Talamini
authors.forename: Arben
authors.initials: A
authors.lastname: Lleshi
authors.forename: Rosa
authors.initials: R
authors.lastname: Tambaro
authors.forename: Alessandro
authors.initials: A
authors.lastname: Cocciolo
authors.forename: Maurizio
authors.initials: M
authors.lastname: Ristagno
authors.forename: Antonio
authors.initials: A
authors.lastname: Bolognese
authors.forename: Francesco
authors.initials: F
authors.lastname: Basile
authors.forename: Nereo
authors.initials: N
authors.lastname: Meneguzzo
authors.forename: Salvatore
authors.initials: S
authors.lastname: Berretta
authors.forename: Umberto
authors.initials: U
authors.lastname: Tirelli
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil