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October 26, 2011

Gonadotropin-Releasing Hormone Analogue for Premenopausal Women With Breast Cancer—Reply

Author Affiliations

Author Affiliations: Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy (Dr Del Mastro) (lucia.delmastro@istge.il); and Ospedale Sacro Cuore, Negrar (VR), Italy (Dr Venturini).

JAMA. 2011;306(16):1760-1761. doi:10.1001/jama.2011.1517

In Reply: Drs Loibl and Gerber question the inclusion in the PROMISE-GIM6 study of patients with hormone receptor–positive breast cancer and patients aged between 40 and 45 years. The majority of young patients with early breast cancer have hormone receptor–positive tumors.1 Therefore, the exclusion of these patients from the trial would have left unanswered the question of ovarian function preservation for most young breast cancer patients. Our data showed that absolute differences in the occurrence of early menopause with the use of triptorelin were −27.9% (95% CI, −47.4% to −8.4%; P = .005) among 51 hormone receptor–negative patients who did not receive tamoxifen and −14.9% (95% CI, −25.1% to −4.7%; P = .004) among 226 hormone receptor–positive patients who received tamoxifen. Although its magnitude is smaller, the protective effect also existed in hormone receptor–positive patients. Similar to the ZORO trial,2 the upper limit for age in the PROMISE-GIM6 study was 45 years. Although patients aged between 40 and 45 years might not be interested in preserving fertility, they might be interested in avoiding early menopause. Such an interest was suggested by their voluntary participation in the study.

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