Abstract
Following 22 additional months of post-operative follow-up and 6 further controls (total controls, n= 95) here the final results of a 2:1 control-case retrospective observational study are shown. Controls were ER+HER-2- metastatic breast cancer patients who were given first-line hormone therapy (HT) with aromatase inhibitors (AIs) or fulvestrant. Moreover 28 of them (28.9%) also received biological drugs including cyclin kinase inhibitors (CKis). Cases were 42 ER+ metastatic breast cancer patients who received the addition of interferon beta-interleukin-2 immunotherapy to first-line HT with selective estrogen receptor modulators/down-regulators (SERMs/SERDs). Median PFS and OS maintained significantly longer in the 42 studied patients who received hormone immunotherapy (HIT) than in the 95 controls (median time 33 vs 18 months, p=0.002 and 81 vs 62 months, p=0.019). In the analysis adjusted for disease-free interval (DFI), hormone receptor, HER-2 status, visceral involvement, AIs and biological therapy, the PFS and OS hazard ratio (HR) further increased in favor of the 42 cases (p = 0.004 and p = 0.044 respectively). In the same type of patients treated with AIs plus CKis a median PFS ranging from 25.3 to 28.18 months and a median OS of 37.5 months occurred. Overall, this strongly suggests multi-centre randomised clinical trials to enter our proposed immunotherapy into clinical practice.