Fifteen-year results of a randomized phase III trial of fenretinide to prevent second breast cancer

Umberto Veronesi, L. Mariani, A. Decensi, F. Formelli, T. Camerini, R. Miceli, M. G. Di Mauro, A. Costa, E. Marubini, M. B. Sporn, G. De Palo

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Purpose: The synthetic retinoid fenretinide administered for 5 years for prevention of second breast cancer showed no difference after a median of 8 years, but a possible reduction in premenopausal women. We conducted a long-term analysis in a subgroup of women who were regularly followed up in a single center. Patients and methods: We analyzed data after a median follow-up of 14.6 years (IQ range, 12.3-16.3 years) from 1739 women aged 30-70 (872 in the fenretinide arm and 867 in the observation arm), representing 60% of the initial cohort of 2867 women. The main efficacy endpoint was second primary breast cancer (contralateral or ipsilateral). Results: The number of second breast cancers was 168 in the fenretinide arm and 190 in the control arm (hazard ratio = 0.83, 95% CI, 0.67-1.03). There were 83 events in the fenretinide arm and 126 in the observation arm in premenopausal women (HR = 0.62, 95% CI, 0.46-0.83), and 85 and 64 events in postmenopausal women (HR = 1.23, 95% CI, 0.63-2.40). The younger were the women, the greater was the risk reduction associated with fenretinide, which attained 50% in women aged 40 years or younger and disappeared after age 55 (P-age*treatment interaction = 0.023). There was no difference in cancers in other organs, distant metastases or survival. Conclusions: Fenretinide induces a significant risk reduction of second breast cancer in premenopausal women, which is remarkable at younger ages, and persists several years after treatment cessation. Since adverse events are limited, a trial in young women at high-risk is warranted.

Original languageEnglish
Pages (from-to)1065-1071
Number of pages7
JournalAnnals of Oncology
Issue number7
Publication statusPublished - Jul 2006


  • Breast neoplasms
  • Chemoprevention
  • Clinical trial
  • Fenretinide

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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