Abstract 288P
Background
Pyrotinib, a novel irreversible EGFR/HER2 dual tyrosine kinase inhibitor, shows promising antitumor activity and acceptable tolerability in phase II and phase III randomized clinical trials. However, the real-world data of pyrotinib have been rarely reported. Here, we assessed the treatment outcomes of pyrotinib in real-world practice in patients with HER2-positive MBC patients.
Methods
This was a China-based, prospective, real-world, observational cohort study. HER-2 Positive MBC Patients treated with pyrobitinib were indentified from the Breast Cancer Information Management System between 2017/06 and 2020/09. Treatment outcomes assessment included provider-reported objective response rate (ORR), progression-free survival (PFS) and overall survival (OS). The responses were determined by RECIST 1.1, and adverse events were assessed using patients and clinical records.
Results
113 pyrotinib-treated patients with an average age of 51 years enrolled in the study. 64 (56.6%) patients had 2 or more sites of metastasis. Distant metastases were in lungs, livers, brains and bones (45.1%, 38.9%, 26.6% and 8.0%, respectively). Pyritinib was used as first-line therapy in 20 (17.7%) patients, second-line in 61 (54.0%) patients, and as third-line and beyond in 30 (28.3%) patients. 102 (90.3%) patients had used anti-HER2 therapy before. By the cut-off day therapy was continued in 47 (41.2%). Complete response, partial response and stable disease were observed in 9 (8.0%), 66 (58.4%), and 17 (15.0%) patients, respectively; progressive disease was recorded in 20 (17.7%) patients. The median PFS was 14.1 months. The median OS was 34.1 months after a median follow up of 17.2 months. Among the patients with brain metastases, the median PFS and OS was 15.2 and 19.8 months, respectively. The most common adverse events of any grade were diarrhea (87.6%), vomiting (31.9%), palmar-plantar erythrodysesthesia syndrome (26.6%).
Conclusions
Compared with phase II and phase III clinical trails of pyrotinib, our real-world data showed simiar clinical effectiveness in HER-2 positive MBC patients and, in particular, improved outcomes in patients with brain metastasis.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.