Abstract
e12516 Background: The discovery of new anti-HER2 targeted therapies has significantly improved the outcomes in the metastatic setting. However, the population enrolled in clinical trials is not always representative of the clinical practice. Moreover, only 7% of breast cancers (BCs) present as metastatic disease at the first clinical observation. In most cases, metastatic disease is diagnosed in pts with a history of BC already treated in the neo/adjuvant setting. This latter subgroup is largely under-represented in clinical trials. The aim of this study was to assess in real-life the efficacy and safety of dual HER2 blockade as 1st line in Trastuzumab-pretreated pts in the neo/adjuvant setting. Methods: This is a multicenter, observational, retrospective study conducted in 6 Oncology Italian Centers. Primary end-points: progression free survival (PFS) and overall survival (OS). Secondary end-points: response rate and cardiac safety. PFS and OS curves were estimated using the Kaplan-Meier method. Tumor response was assessed according to RECIST 1.1 and safety with CTCAE v4.0. Results: We evaluated 35 HER2-positive MBC from November 2013 to December 2016, 60% with tumors Luminal B, 40% HER2-enriched. The most common metastatic sites were: lung (20%), lymph nodes (14.3%) and liver (11.4%). Median (m) age: 50 (range 20-71), mECOG PS 0 (range 0-1). At a m follow-up of 55.6 months (mos) (range 6-170), all pts were evaluable for efficacy and safety. The m number of cycles administrated was 6 (range 2-10). The mPFS was 12 mos (95% CI 2-38). The mOS was 15.2 mos (95% CI 2-36). 14.3% of pts had a complete response, 60% a partial response and 25.7% a stable disease. m baseline LVEF was 65%, final LVEF 61%. Conclusions: Our preliminary data confirmed the efficacy and no increase in cardiac toxicity of the combination Pertuzumab, Trastuzumab and Docetaxel in Trastuzumab-pretreated pts, mirroring the PFS data but not the OS reported in the Cleopatra study. A longer follow-up for OS is needed for a comprehensive evaluation of the antitumor activity of dual-HER2 blockade in Trastuzumab-pretreated pts.
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