Abstract

This study presents comprehensive real-world data on the use of anti-human epidermal growth factor receptor 2 (HER2) therapies in patients with HER2-positive metastatic breast cancer (MBC). Specifically, it describes therapy patterns with trastuzumab (H), pertuzumab + trastuzumab (PH), lapatinib (L), and trastuzumab emtansine (T-DM1). The PRAEGNANT study is a real-time, real-world registry for MBC patients. All therapy lines are documented. This analysis describes the utilization of anti-HER2 therapies as well as therapy sequences. Among 1936 patients in PRAEGNANT, 451 were HER2-positive (23.3%). In the analysis set (417 patients), 53% of whom were included in PRAEGNANT in the first-line setting, 241 were treated with H, 237 with PH, 85 with L, and 125 with T-DM1 during the course of their therapies. The sequence PH → T-DM1 was administered in 51 patients. Higher Eastern Cooperative Oncology Group (ECOG) scores, negative hormone receptor status, and visceral or brain metastases were associated with more frequent use of this therapy sequence. Most patients received T-DM1 after treatment with pertuzumab. Both novel therapies (PH and T-DM1) are utilized in a high proportion of HER2-positive breast cancer patients. As most patients receive T-DM1 after PH, real-world data may help to clarify whether the efficacy of this sequence is similar to that in the approval study.

Highlights

  • Overexpression of human epidermal growth factor receptor 2 (HER2), or amplification of the HER2 gene, is seen in approximately 15–25% of breast cancer (BC) patients [1]

  • HER2 status was positive in 37% of all patients with metastases who were treated up to 2006, HER2 positivity was seen in 25% and 22% of patients diagnosed with metastases in 2007–2013 and after 2013, respectively (Figure 2)

  • The analysis shows that HER2-positive metastatic breast cancer is a subgroup with a clinically relevant frequency

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Summary

Introduction

Overexpression of human epidermal growth factor receptor 2 (HER2), or amplification of the HER2 gene, is seen in approximately 15–25% of breast cancer (BC) patients [1]. Since the discovery in the late 1980s of HER2 amplifications and their prognostic relevance [2], treatment for HER2-positive BC in this subgroup of patients has greatly improved [3,4,5,6]. Adding the monoclonal anti-HER2 antibody trastuzumab to standard chemotherapy resulted in a significant improvement in the progression-free survival (PFS) and overall survival (OS) in patients with metastatic HER2-positive BC [7]. These results led to the approval of trastuzumab for the treatment of HER2-positive metastatic BC. Lapatinib became the standard of care in the early 2000s [8,9]

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