title: beta-carotene supplementation in patients radically treated for stage I-II head and neck cancer: results of a randomized trial.
abstract: This study was aimed at evaluating the efficacy of beta-carotene in improving survival (S) and in disease-free survival (DFS) and reducing the incidence of second primary tumors (SPT) in patients with a radically treated stage I-II squamous head and neck tumors. Eligible patients were randomly allocated to receive beta-carotene (n=104) or no treatment (n=110). beta-carotene was administered at the dose of 75 mg/day for 3-month cycles within one month intercycle intervals for a 3-year period. The 3-year compliance to the beta-carotene was 68.7%. Only eight patients reported drug-related toxicity (7.8%). The median follow-up of all patients was 59 months. The median follow-up was 61 months (range 1-116 months) in the beta-carotene and 58 months (1-123 months) in the control group. The 10-year DFS was 75.7% for the patients in the beta-carotene and 74.3% for those in the control group (P=0.56). The 10-year S was 85.9% in the beta-carotene group and 80.9% in the control group (P=0.20). beta-carotene supplementation had no significant effect on the incidence of second primary tumors (RR=0.99; 95% C.I. 0.28-3.44). A statistically non-significant 40% reduction in the risk of death among subjects assigned to the beta-carotene compared to the controls was observed (RR=0.60; 95% C.I. 0.26-1.38). No increase in the death from cardiovascular diseases was observed among patients treated with beta-carotene. Our results might support the hypothesis that an adequate beta-carotene treatment could be potentially associated with a decreased risk of death in these patients.
authors.affiliation: Department of Oncology, Biology and Genetic, University of Genova, Genova, Italy. toma@cba.unige.it
authors.forename: Salvatore
authors.initials: S
authors.lastname: Toma
authors.forename: Luigina
authors.initials: L
authors.lastname: Bonelli
authors.forename: Alberto
authors.initials: A
authors.lastname: Sartoris
authors.forename: Eugenio
authors.initials: E
authors.lastname: Mira
authors.forename: Antonio
authors.initials: A
authors.lastname: Antonelli
authors.forename: Fabio
authors.initials: F
authors.lastname: Beatrice
authors.forename: Carlo
authors.initials: C
authors.lastname: Giordano
authors.forename: Marco
authors.initials: M
authors.lastname: Benazzo
authors.forename: Angelo
authors.initials: A
authors.lastname: Caroggio
authors.forename: Andrea Luigi
authors.initials: AL
authors.lastname: Cavalot
authors.forename: Sergio
authors.initials: S
authors.lastname: Gandolfo
authors.forename: Aldo
authors.initials: A
authors.lastname: Garozzo
authors.forename: Giovanni
authors.initials: G
authors.lastname: Margarino
authors.forename: Guido
authors.initials: G
authors.lastname: Schenone
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Spadini
authors.forename: Francesco
authors.initials: F
authors.lastname: Zibordi
authors.forename: Fabbrizio
authors.initials: F
authors.lastname: Balzarini
authors.forename: Italo
authors.initials: I
authors.lastname: Serafini
authors.forename: Piero
authors.initials: P
authors.lastname: Miani
authors.forename: Giorgio
authors.initials: G
authors.lastname: Cortesina
mesh_terms: D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000494:pharmacology*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000628:therapy*; D002318:Cardiovascular Diseases / Q000453:epidemiology; D019587:Dietary Supplements; D018572:Disease-Free Survival; D005260:Female; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome; D019207:beta Carotene / Q000627:therapeutic use*
chemical_list: D000975:Antioxidants; D019207:beta Carotene