Real-World Data of Pyrotinib-Based Therapy in Metastatic HER2-Positive Breast Cancer: Promising Efficacy in Lapatinib-Treated Patients and in Brain Metastasis

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.

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Real world data on adjuvant treatment of older HER2-positive breast cancer patients - a single institution experience through 8 years

Cancer Treatment and Research Communications ◽

10.1016/j.ctarc.2021.100430 ◽

2021 ◽

pp. 100430

Author(s):

L Klint ◽

A Kovács ◽

E Rönnerman ◽

B Linderholm

Keyword(s):

Breast Cancer ◽

Cancer Patients ◽

Adjuvant Treatment ◽

Real World ◽

Breast Cancer Patients ◽

Single Institution ◽

Her2 Positive ◽

Real World Data ◽

Her2 Positive Breast Cancer ◽

Positive Breast Cancer

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

Frontiers in Oncology ◽

10.3389/fonc.2021.699323 ◽

2021 ◽

Vol 11 ◽

Author(s):

Lili Zhang ◽

Xiaohong Wu ◽

Jun Zhou ◽

Mingzhen Zhu ◽

Hao Yu ◽

...

Keyword(s):

Breast Cancer ◽

Liver Metastases ◽

Real World ◽

Objective Response ◽

Common Adverse Event ◽

Previous Exposure ◽

Her2 Positive ◽

Real World Data ◽

Her2 Positive Breast Cancer ◽

Positive Breast Cancer

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.

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

10.21203/rs.3.rs-505602/v1 ◽

2021 ◽

Author(s):

Lili Zhang ◽

Xiaohong Wu ◽

Jun Zhou ◽

Mingzhen Zhu ◽

Hao Yu ◽

...

Keyword(s):

Breast Cancer ◽

Liver Metastases ◽

Real World ◽

Common Adverse Event ◽

Previous Exposure ◽

Her2 Positive ◽

Real World Data ◽

The Real ◽

Her2 Positive Breast Cancer ◽

Positive Breast Cancer

Abstract Background: HER2-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.Patients and Methods: A 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).Results: The median PFS (mPFS) for pyrotinib-based therapy was 12.0 months (95% CI 8.1-17.8) in all patients. Among the 44 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 the 97 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 vs. 15.1 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 ORR was 38.57% and DCR was 85.71%. Most common adverse event was diarrhea (85.04%).Conclusion: Pyrotinib-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 the real-world study further confirmed the intriguing efficacy of pyrotinib.

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