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290P From the CLEOPATRA study to real life: Final results from the G.O.N.O. SUPER trial

2020; Elsevier BV; Volume: 31; Linguagem: Inglês

10.1016/j.annonc.2020.08.392

1569-8041

Ornella Garrone, Tommaso Giarratano, Andrea Michelotti, Chiara Saggia, Loretta D’Onofrio, Laura Merlini, Eva Blondeaux, Alessandra Beano, Luigi Coltelli, Marina Elena Cazzaniga, Filippo Montemurro, A. Farnesi, N.M. La Verde, Anna Maria Vandone, Elena Collovà, Livio Blasi, Raffaele Ardito, E. DeConciliis, Mario Airoldi, Marco Merlano,

Advanced Breast Cancer Therapies

The association of Trastuzumab (T) and Pertuzumab (P) plus taxane is the standard first line therapy for HER2 positive (HER2+) metastatic breast cancer (MBC) patients (pts). Results from CLEOPATRA have underlined huge advantage both in PFS and OS in pts treated with T+P and docetaxel (D) over T and D. In order to describe the applicability of CLEOPATRA results in real world pts, we performed a multicenter, retrospective-prospective, observational study, in HER-2+ MBC pts. We analyzed the outcome of all HER-2+ MBC pts treated with P+T and taxanes as first line therapy since the availability of P in Italy, at 18 general and university hospitals. Up to March 2019, 347 pts were recorded. 5 were excluded due to incomplete data. Data on 342 pts are presented. Main pts characteristics were: median (m) age 55 y (19-80), m ECOG PS 0 (0-2). 170 pts (49.7%) had metastatic disease at presentation. HR+ 230 pts (67%); 96/172 pts (56%) received neo/adjuvant CT + T and 119/129 HR+ pts (92%) received adjuvant ET. Visceral involvement was present in 216 pts (63%). Most common metastatic sites:bone 185 pts (54%), liver 138 pts (40%), lung 108 pts (38%), soft tissues 244 pts (71%); 14 pts (4%) had CNS involvement. 205 pts (60%) and 136 pts (40%) received D and paclitaxel (Pa) respectively. 1 pt received vinorelbine. M number of CT cycles was 6 for both drugs (D range 1-14; Pa range 1-24). 148 pts (43%) are on maintenance, 177 pts (52%) received ET concomitantly with P+T maintenance. ORR is 77% (CR and PR in 79 and 184 pts respectively), PD in 22 pts. With 194 events recorded (57%), M PFS is 26.9 months (95% CI 20 – 33.8). In 96 pts previously exposed to adjuvant T, with 65 events (68%), m PFS is 20.7 months (95% CI 15.6 - 25.8). Any grade leucopenia and neutropenia were recorded in 24% and 26% of pts respectively; febrile neutropenia in 11 pts. 30 pts developed cardiac toxicity leading to discontinuation of P+T maintenance in 14 pts. Any grade non-hematological toxicities: diarrhea 162 pts (47%), asthenia 212 pts (62%), peripheral neuropathy 133 pts (39%). Our results support the activity and safety of the combination of CT (D or Pa) plus P and T in real world HER2+ MBC pts. The advantage is also evident in pts previously exposed to adjuvant T. No new concerns about toxicity. Final results on OS will be presented.