Goserelin e tamoxifen in pazienti in premenopausa con carcinoma mammario avanzato

Nell’ottobre 1990 é stato avviato uno studio sul carcinoma avanzato della mammella in donne in premenopausa.

Lo studio (Protocollo 90/5) aveva l’obiettivo di valutare l’efficacia terapeutica di una ormonoterapia comprendente l’impiego contemporaneo di Gn-RH agonisti e di antiestrogeni, sia in termini di risposte obiettive che di durata e di valutare le modificazioni dell’assetto ormonale, durante e dopo il trattamento, rispetto ai valori basali e correlarli all’andamento clinico.

Sono state arruolate 64 pazienti.

Lo studio ha dimostrato che la combinazione ormonale ha indotto risposte obiettive nel 41% dei casi con una durata mediana di 13 mesi. La terapia è stata ottimamente tollerata e non sono stati riportati effetti collaterali di rilievo.

Centri partecipanti :                     Spedali Civili di BRESCIA

Ospedale di CREMONA

Ospedale Generale di LEGNAGO (VR)

Ospedale Civile di MANTOVA

Istituto Nazionale Tumori – OMB,  MILANO

Fatebenefratelli, MILANO

Ospedale Buzzi, MILANO

Ospedale S. Gerardo, MONZA (MI)

Ospedale Civile di PADOVA

Ospedali Riuniti di PESARO

Ospedale Civile di SARONNO (VA)

Ospedale Trescore, SERIATE (BG)

Ospedale S. Bartolo di VICENZA

Riferimento Bibliografico:

  • Combination goserelin and tamoxifen therapy in premenopausal advanced breast cancer: a multicentre study by the ITMO group. Italian Trials in Medical Oncology.
    (Buzzoni R, Biganzoli L, Bajetta E, Celio L, Fornasiero A, Mariani L, Zilembo N, Di Bartolomeo M, Di Leo A, Arcangeli G, et al.).
    Br J Cancer. 1995 May;71(5):1111-4.

    Abstract
    It has been suggested that tamoxifen may improve the efficacy of medical castration with luteinising hormone-releasing hormone analogues, but very few data have so far been published concerning the clinical and endocrinological activity of this therapeutic modality. In this phase II multicentre trial conducted by the Italian Trials in Medical Oncology group (ITMO), 64 premenopausal patients with hormone receptor-positive or unknown breast cancer were treated with monthly s.c. injections of goserelin 3.6 mg, in association with a tamoxifen daily dose of 20 mg, as first-line therapy for their advanced disease. All of the patients were evaluable for efficacy and there was an overall response rate of 41% (95% confidence interval 28-52%), with 7 of the 26 responders achieving complete remission. The median time to response was 4 months (range 2-17), and the median response duration was 13 months (range 6-37 +). Better responses were observed in soft tissues (51%); the response in visceral and bone metastases was respectively 19% and 37%. Serum concentrations of gonadotrophins and oestradiol were significantly decreased by the treatment, oestrogen levels being constantly suppressed to within the range observed in post-menopausal women. No significant change was detected in serum testosterone levels. In our experience, although it was not associated with any increased clinical efficacy, the concurrent use of goserelin and tamoxifen proved to be a feasible approach in the management of premenopausal advanced breast cancer.

    PMID: 7734310   [PubMed – indexed for MEDLINE] PMCID: PMC2033795

    Download articolo: Br J Cancer 1995