Subcutaneous Trastuzumab Combined with Pertuzumab and Docetaxel as First-line Treatment of Advanced HER2-positive Breast Cancer

Abstract

Background/Aim: Subcutaneous (s.c.) trastuzumab was introduced in the (neo)adjuvant setting, based on the non-inferiority results and patient preference. In the advanced setting, preliminary safety data have only been reported. We conducted an observational study of s.c. trastuzumab in combination with i.v. pertuzumab and docetaxel in the firstline setting of human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer. Patients and Methods: In this single-institution study, patients received 600 mg s.c. trastuzumab in combination with 840 mg pertuzumab for the first cycle and 420 mg for the following cycles, and 75-100 mg/m 2 docetaxel, followed by maintenance with s.c. trastuzumab and pertuzumab until disease progression or unacceptable toxicity. Endpoints were efficacy and safety. Results: Forty patients were enrolled. The median number of cycles with docetaxel was six, while the median number of maintenance cycles was 21. With a median follow-up of 37 months, median progression-free survival and overall survival were 24 and 35 months. Conclusion: Subcutaneous trastuzumab in combination with pertuzumab and docetaxel is well tolerated and effective in HER2-positive advanced breast cancer.Breast cancer is the most common cancer and the second leading cause of cancer-related death among women worldwide. It is recognized as a heterogeneous disease. Human epidermal growth factor receptor 2 (HER2) overexpression in breast cancer is related to a more aggressive subtype. The addition of pertuzumab to trastuzumab and docetaxel significantly improved the median overall survival (OS) for patients with HER2-positive metastatic breast cancer (MBC). Thus, the combination of intravenous (i.v.) trastuzumab, pertuzumab and docetaxel is considered to be the standard first-line treatment in this setting (1, 2). Subcutaneous (s.c.) trastuzumab was first introduced in the (neo)adjuvant setting based on the results of the HannaH study reporting comparable safety and noninferiority (3, 4), as well as the PrefHer study pointing out patient preference for s.c. trastuzumab versus i.v. administration (5). This transition led to time and cost reductions (6). Based on that, we adopted a combination of s.c. trastuzumab, pertuzumab and docetaxel in patients with HER2-positive MBC. We present the results of our observational study. Patients and MethodsStudy design. This study was a retrospective single-arm analysis of fixed-dose s.c. trastuzumab combined with pertuzumab and docetaxel as first-line treatment in HER2-positive advanced breast cancer (metastatic or locally advanced). The data collected derived from a single center, the Saint-Savvas Anticancer Hospital, Athens, Greece. The primary endpoint of the study was to assess the efficacy of the combination by means of progression-free survival (PFS). Secondary endpoints were: i) Safety profile as determined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 4.03 (7) and ii) overall survival (OS). All patients gave their written in...

Trastuzumab/Hyaluronidase-oysk: A New Option for Patients With HER2-Positive Breast Cancer

“…A single-center, observational study of 40 patients looked at the combination of SQ trastuzumab and IV pertuzumab with docetaxel in the first-line treatment of advanced HER2+ breast cancer. 13 The median progression-free survival and OS were 24 (range = 14.4-33.6) and 35 (range = 27.9-42.1) months, demonstrating that this combination using SQ trastuzumab had comparable efficacy to historical studies with IV trastuzumab.…”

Clinical efficacy of combination of pertuzumab, trastuzumab, and docetaxel for treatment of patients with HER2-positive breast cancer

“…Previous studies have reported PTD can be used to treat HER2-PBC effectively. [19–27] In this study, we will systematically explore the efficacy and safety of PTD for the treatment of patients with HER2-PBC.…”