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Publications

Journal Article Ahead of print 1 citation

PubMed: 40880294 DOI: 10.1093/jnci/djaf250

Effect of low-dose tamoxifen on benign gynecological and breast conditions in a phase III trial in non-invasive breast cancer.

J Natl Cancer Inst

Authors: Alessio Carbone, Martino Oliva, Matteo Puntoni, Aliana Guerrieri-Gonzaga, Irene Maria Briata, Matteo Lazzeroni, Davide Serrano, Livia Giordano, Maria Digennaro, Laura Cortesi, Francesco Millo, Katia Cagossi, Giuseppe Aprile, Patrizia Serra, Elisa Gallerani, Bernardo Bonanni, Andrea DeCensi

Affiliations

  • EO Ospedali Galliera, Genoa, Italy.
  • Clinical & Epidemiological Research Unit, University Hospital of Parma, Italy.
  • IEO, European Institute of Oncology IRCCS, Milan, Italy.
  • Azienda Ospedaliera-Universitaria Città della Salute e della Scienza, Torino, Italy.
  • IRCCS, Istituto Tumori "Giovanni Paolo II", Bari, Italy.
  • Azienda Ospedaliera-Universitaria Policlinico di Modena, Modena, Italy.
  • Ospedali Riuniti ASL AL-Ospedale SS. Antonio e Margherita, Tortona, AL, Italy, .
  • Division of Medical Oncology, "B.Ramazzini" Hospital, Carpi.
  • Department of Oncology, San Bortolo General Hospital, ULSS8 Berica, Vicenza.
  • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"-IRST S.r.l. Meldola, FC, Italy.
  • Aziende Socio Sanitarie Territoriale dei Sette Laghi, Varese, Italy.

Abstract

Despite the proven efficacy of tamoxifen (T) in breast cancer prevention, its uptake remains limited due to concerns over side effects. A phase III trial showed that low-dose T (5 mg/day for 3 years) significantly reduces recurrence with minimal toxicity. After 10 years of follow-up, we observed no significant differences in benign gynecological or breast events between the tamoxifen and placebo (P) arms. The uterus was the most frequently affected site (30 cases per arm), followed by the breast (18) and ovary (5 vs 3 on T and P, respectively). Endometrial polyps were similarly distributed. Endometrial thickness remained stable in premenopausal women and showed only a mild, non-clinically significant increase in postmenopausal women on T (∼1.5 mm). Compared with data on standard-dose tamoxifen, rates of benign events were lower. These findings reinforce the favorable safety profile of low-dose tamoxifen. ClinicalTrials.gov: NCT01357772.

MeSH

Breast Neoplasms, Neoplasms, Breast, Tamoxifen