Safety Analysis of Premenopausal Breast Cancer Patients in PALOMA‐3 Study: Is It Worth Mentioning?

I read with great interest the article by Verma et al. [1], in which they reported detailed safety analysis in hormone receptor-positive/HER2-negative advanced metastatic breast cancer receiving palbociclib in combination with fulvestrant (PALOMA-3). They found that treatment with palbociclib in combination with fulvestrant was generally safe and well tolerated in patients with hormone receptor-positive metastatic breast cancer. In the PALOMA-3 study, 21% of all cases were considered premenopausal, as described in a pivotal study [2]. First of all, the use of fulvestrant alone without ovarian suppression is somewhat debatable; however, fulvestrant is used in the PALOMA-3 study without the addition of ovarian suppression in premenopausal patients. Secondly, safety analysis was not described separately in premenopausal patients, although patients younger than 50 years of age were considered part of a different subgroup in the current study. In conclusion, it is worth mentioning the safety analysis of premenopausal breast cancer patients in the PALOMA-3 study.