From the CLEOPATRA study to real life: preliminary results from the G.O.N.O. SUPER trial

Abstract

Background: Approximately 20% of breast cancers (BC) are HER-2+. Trastuzumab (T) has dramatically changed the outcome of HER2+ BC patients (pts), both in early and in advanced settings. Pertuzumab (P), combined with T and taxanes, significantly improved progression free survival (PFS) and overall survival (OS) in the phase III CLEOPATRA study. In order to verify the results of the trial in unselected pts, we performed a multicenter, retrospective-prospective, observational study, in HER-2+ metastatic BC (MBC) pts. Methods: We analyze the outcome of all HER-2+ MBCpts treated with P+T and taxanes, as first line therapy since the availability of P in Italy, at 14 general and university hospitals. Results: Up to May 10th data from 180 HER-2+ MBC pts were recorded. Main pts' characteristics were: median (M) age 55 y (28-79), MECOG PS 0 (0-2), ER/PgR positive 125 pts (69.4%), 45 pts (25%) received neo/adjuvant chemotherapy (CT) +T and 62 pts (34.4%) adjuvant endocrine therapy. Most common metastatic sites: bone 106 pts (56.3%), liver 79 pts (43.8%), lung 48 pts (26.6%), soft tissues 106 pts (56.3%). Sixty-one pts (33.8%) had bone and/or soft tissues disease only; 91 pts (50.5%) had metastatic disease on presentation. Mnumber of metastatic sites was 2 (1-8). 118 pts (65.5%) and 62 pts (34.4%) received docetaxel (D) and paclitaxel (P) respectively.M number of CT cycles was 6 for both drugs (D range 2-12; P range 1-18). Up to now 18 pts are still on CT and 115 on maintenance; ORR is 76.1% (40 and 97 pts obtained CR and PR respectively), 7 pts experienced PD during CT; 85 pts (47.2%) received endocrine therapy during maintenance. MPFS is 14.9 months (0.2+ - 42+). Among hematological toxicities leucopenia (any grade) was recorded in 37 pts (20.5%), neutropenia (any grade) in 42 pts (23.3%) and febrile neutropenia in 7 pts (3.8%). Two pts interrupted CT due to symptomatic drop of left ventricular ejection fraction (LVEF); 9 pts interrupted maintenance P, 8 due to drop in LVEF and 1 due to rash. Diarrhea, nail changes, nausea, stomatitis, alopecia, rash, neurotoxicity and arthro-myalgia were the most common non-hematological toxicities. Conclusions: Our preliminary results highlight the activity and safety of the combination of CT plus P and T in unselected HER2+ MBC patients. The study is ongoing and updated results will be presented.