నైరూప్య

A phase-2 study of high-dose pineal antitumor hormone Melatonin as an adjuvant therapy in triple negative breast cancer.

Paolo Lissoni*, Franco Rovelli, Giusy Messina, Vezika Cenaj, Giorgio Porro, Giuseppe Di Fede

It is known that triple negative breast cancer (TNBC) is the most prognostically negative mammary tumor, because of its lack of sensitivity to the main growth factors for breast cancer, including estrogens and EGF. However, at least three other hormones would have to be considered, consisting of prolactin (PRL), oxytocin (OT), and the pineal hormone melatonin (MLT). PRL would stimulate TNBC growth, whereas MLT and OT would play an inhibitory action in several tumor histotypes, including TNBC, even though at present only clinical studies with MLT have been performed, by demonstrating that it?s in human anticancer activity is a dose-dependent phenomenon. On these bases, a study was planned to evaluate the effects of high-dose MLT chronic administration as an adjuvant therapy on the percent of 3-year progression-free period (PSF) in TNBC after adjuvant chemotherapy. The study included 14 consecutive TNBC patients, who were treated with MLT at 40 mg/day orally in the evening every day without interruption, by comparing the results to those observed in a control group of 16 TNBC patients with comparable clinical characteristics. The 3-year PFS percentage achieved in MLT group was significantly higher than that found in the control group, either in patients with or without node involvement. No MLT-related biological toxicity occurred. On the contrary, most patients referred a mood improvement. These preliminary results justify further randomized study with or without high-dose MLT in TNBC patients, in an attempt to prolong their survival.