Pyrotinib in the Treatment of Women With HER2-Positive Advanced Breast Cancer: A Multicenter, Prospective, Real-World Study

Abstract

BackgroundHER2-positive breast cancer was aggressive, resulting in a poorer prognosis. This multicenter study analyzed the real-world data of women treated with pyrotinib-based therapy, aiming to describe their characteristics, treatment regimens, and to investigate the clinical outcomes.MethodsA total of 141 patients with HER2-positive breast cancer were enrolled from February 2019 to April 2020. Last follow-up time was February 2021. All patients were treated with pyrotinib-based therapy in 21-day cycles. The primary endpoint was progression-free survival (PFS).ResultsThe median PFS (mPFS) for pyrotinib-based therapy was 12.0 months (95%CI 8.1-17.8) in all patients. Among the patients with liver metastases, mPFS was 8.7 months (95%CI, 6.3-15.4) compared to 12.3 months (95%CI, 8.8-23.3) for patients without liver metastases (P=0.172). In addition, patients receiving pyrotinib-based therapy as their >2 lines treatment had a numerically lower mPFS than those receiving pyrotinib-based therapy as their ≤2 lines treatment [8.4 (95%CI, 5.9-15.4) vs. 15.1 (95%CI, 9.3-22.9) months, P=0.107]. The mPFS was 12.2 months (95%CI, 7.9-18.8) in patients with previous exposure to trastuzumab and 11.8 months (95%CI, 6.8-22.9) in patients without previous exposure to trastuzumab (P=0.732). Moreover, mPFS in patients receiving regimens with and without capecitabine were 15.1 months (95%CI, 10.0-18.8) and 8.4 months (95%CI, 6.7-22.9), respectively (P=0.070). Furthermore, in patients with brain metastases, estimated 6-month PFS rate was 70.0%, and rate at 12 months was 60.0%. Seventy patients with measurable lesions were evaluable for response. The objective response rate was 38.6% and disease control rate was 85.7%. The most common adverse event was diarrhea (85.0%).ConclusionPyrotinib-based therapy showed promising efficacy in patients with HER2-positive breast cancer and was well tolerated, especially in patients treated with pyrotinib as ≤2 lines treatment and receiving regimens with capecitabine. The results of this real-world study further confirmed the intriguing efficacy of pyrotinib.

Pyrotinib for HER2-positive metastatic breast cancer: a systematic review and meta-analysis

“…Among the remaining publications, articles of interest were further reviewed, with twelve duplicate reports and twentyseven ineligible articles excluded. A total of 23 studies were included, including three randomized controlled trials (RCT) (4,5,9), six prospective trials (10)(11)(12)(13)(14)(15), eight retrospective trials (16)(17)(18)(19)(20)(21)(22)(23), and six real-world studies (6,(24)(25)(26)(27)(28). The baseline characteristics of the studies included are summarized in Table 1.…”

Systemic Therapy for Patients with HER2-Positive Breast Cancer and Brain Metastases: A Systematic Review and Meta-Analysis

“…In this meta-analysis, 9 studies investigating pyrotinib in a total of 321 Asian patients were included ( Table 4 ); 1 double blind phase 3 study [ 71 ], 1 single arm phase 2 trial [ 78 ] and 7 retrospective studies [ 70 , 72 , 73 , 74 , 75 , 76 , 77 ]. Pooled ORR was 43% (95% CI 27–59%; I 2 80%) ( Figure 2 E).…”

HER2-positive metastatic breast cancer with brain metastases responds favorably to pyrotinib and trastuzumab-based treatment: A case report and literature review

“…Furthermore, neratinib plus capetabine achieved 8.8 months of median PFS as a third or later line therapy, and neratinib plus paclitaxel achieved 12.9 months of median PFS as a first-line treatment, suggesting the potentially comparable efficacy of pyrotinib to neratinib ( 23 , 24 ). Among patients with brain metastases, pyrotinib was reported to have a better PFS benefit than monoclonal antibodies in real-world study ( 25 , 26 ).…”