Publication: β-carotene supplementation in patients radically treated for stage I-II head and neck cancer: Results of a randomized trial
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| Title | β-carotene supplementation in patients radically treated for stage I-II head and neck cancer: Results of a randomized trial |
| Topic | Vitamin A (beta-carotene) |
| Author | Toma, S, Bonelli, L, Sartoris, A, Mira, E, Antonelli, A, Beatrice, F, Giordano, C, Benazzo, M, Caroggio, A, Cavalot, AL, Gandolfo, S, Garozzo, A, Margarino, G, Schenone, G, Spadini, N, Zibordi, F, Balzarini, F, Serafini, I, Miani, P, Cortesina, G |
| Year | 2003 |
| Journal | Oncology Reports |
| DOI | https://doi.org/10.3892/or.10.6.1895 |
Author's Abstract The abstract and the information and conclusions contained therein were written by the authors of the publication.
| 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. |
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