beta-carotene supplementation in patients radically treated for stage I-II head and neck cancer: results of a randomized trial.

Salvatore Toma, Luigina Bonelli, Alberto Sartoris, Eugenio Mira, Antonio Antonelli, Fabio Beatrice, Carlo Giordano, Marco Benazzo, Angelo Caroggio, Andrea Luigi Cavalot, Sergio Gandolfo, Aldo Garozzo, Giovanni Margarino, Guido Schenone, Nicoletta Spadini, Francesco Zibordi, Fabbrizio Balzarini, Italo Serafini, Piero Miani, Giorgio Cortesina

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)1895-1901
Number of pages7
JournalOncology Reports
Issue number6
Publication statusPublished - Nov 2003

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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