Pathological response and predictive role of tumour-infiltrating lymphocytes in HER2-positive early breast cancer treated with neoadjuvant pyrotinib plus trastuzumab and chemotherapy (Panphila): a multicentre phase 2 trial

Liu, Zhenzhen; Wang, Chengzheng; Chen, Xiuchun; Zhu, Jiujun; Sun, Xiaofeng; Xia, Qingxin; Lu, Zhenwei; Qiao, Jie; Zhou, Yong; Wang, Haixue; Wang, Yi; Yan, Min

doi:10.1016/j.ejca.2022.01.022

Cited by 26 publications

(37 citation statements)

References 49 publications

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“…The incidence of TRAEs in our study was 92.8%, and the most common TRAEs were diarrhea (63.9%), decreased hemoglobin (58.8%), increased alanine transaminase (37.1%), nausea (35.1%), decreased neutrophil count (32.0%), and decreased white blood cell count (30.9%). The AE profile was consistent with previous neoadjuvant trials of pyrotinib ( 20 – 22 ) and the phase 3 results of pyrotinib in advanced breast cancer ( 19 , 31 ). The incidence of hand-foot syndrome was 7.2%, and only grade 1 events occurred.…”

Section: Discussionsupporting

confidence: 87%

“…However, data on its activity in the neoadjuvant setting are still lacking. We supplemented real-world evidence on the basis of previous phase 2 neoadjuvant trials ( 20 – 22 ). The bpCR rate in 97 patients was 54.6% (95% CI, 44.2%-64.7%), and the tpCR rate was 48.5% (95% CI, 38.2%-58.8%).…”

Section: Discussionmentioning

confidence: 99%

“…The phase 3 PHOEBE study confirmed the superiority of pyrotinib over lapatinib when combined with capecitabine in the treatment of HER2-positive relapsed or metastatic breast cancer, with significantly better objective response rate (ORR, 67.2% vs. 51.5%) and progression-free survival (12.5 months vs. 6.8 months) ( 19 ). Pyrotinib as a component of HER2-targeted neoadjuvant therapy has been investigated in small phase 2 clinical trials ( 20 – 22 ). We did a multicenter retrospective analysis to assess effectiveness and safety of pyrotinib-containing regimens as neoadjuvant therapy for patients with HER2-positive breast cancer in the real-world setting.…”

Section: Introductionmentioning

confidence: 99%

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Pyrotinib-Containing Neoadjuvant Therapy in Patients With HER2-Positive Breast Cancer: A Multicenter Retrospective Analysis

Mao

Yang

et al. 2022

Front. Oncol.

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BackgroundPyrotinib, a small-molecule tyrosine kinase inhibitor, has been investigated as a component of neoadjuvant therapy in phase 2 trials of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. This study aimed to evaluate the effectiveness and safety of pyrotinib-containing neoadjuvant therapy for patients with HER2-positive early or locally advanced breast cancer in the real-world setting.MethodsData of 97 patients with HER2-positive breast cancer from 21 centers across China treated with pyrotinib-containing neoadjuvant therapy were reviewed. Neoadjuvant therapy consisted of taxane/carboplatin/trastuzumab plus pyrotinib (TCbH+Py, 30 [30.9%]), anthracycline/cyclophosphamide followed by taxane/trastuzumab plus pyrotinib (AC-TH+Py) or taxane followed by anthracycline/cyclophosphamide/trastuzumab plus pyrotinib (T-ACH+Py, 29 [29.9%]), taxane/trastuzumab plus pyrotinib (TH+Py, 23 [23.7%]), and other pyrotinib-containing neoadjuvant treatment (15 [15.5%]). The primary outcome was breast pathological complete response (bpCR, ypT0/is) rate. Secondary outcomes included total pathological complete response (tpCR, ypT0/is ypN0) rate, objective response rate (ORR), and the incidence of preoperative adverse events.ResultsThe ORR of pyrotinib-containing neoadjuvant therapy was 87.6% (85/97). The bpCR and tpCR rates were 54.6% (95% confidence interval [CI], 44.2%-64.7%) and 48.5% [95% CI, 38.2%-58.8%], respectively. The most common grade 3 or 4 treatment-related adverse events included diarrhea (15 [15.5%]), decreased hemoglobin (nine [9.3%]), and decreased neutrophil count (eight [8.2%]). No treatment-related deaths occurred.ConclusionPyrotinib-containing neoadjuvant therapy for patients with HER2-positive early or locally advanced breast cancer shows favorable effectiveness with manageable toxicity in the real-world setting. Trastuzumab plus pyrotinib may be a novel option of dual HER2-targeted blockade.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Pyrotinib-Containing Neoadjuvant Therapy in Patients With HER2-Positive Breast Cancer: A Multicenter Retrospective Analysis

Mao

Yang

et al. 2022

Front. Oncol.

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“…Data on patients receiving neoadjuvant TCH + Py were from our previous Panphila study (NCT 03735966) [ 18 ]. The clinical records of patients with HER2-positive breast cancer who received neoadjuvant TCH (docetaxel, carboplatin, and trastuzumab) or TCHP (docetaxel, carboplatin, trastuzumab, and pertuzumab) were retrospectively reviewed at Henan Cancer Hospital between January 2014 and May 2021.…”

Section: Methodsmentioning

confidence: 99%

“…Significant clinical benefits have been demonstrated when pyrotinib was utilized for patients with HER2-positive metastatic breast cancer in the phase III PHOEBE and PHENIX studies [ 16 , 17 ]. In our previous Panphila study, we found a pCR rate of 55.1% in the modified intention-to-treat population (n = 69) treated with TCH + Py (docetaxel, carboplatin, trastuzumab, and pyrotinib) [ 18 ]. The phase III PHEDRA study has also demonstrated that the dual-targeted neoadjuvant regimen with pyrotinib and trastuzumab plus chemotherapy can provide clinical benefits in patients with HER2-positive breast cancer [ 19 ].…”

Section: Introductionmentioning

confidence: 99%

Neoadjuvant Efficacy of Three Targeted Therapy Strategies for HER2-Positive Breast Cancer Based on the Same Chemotherapy Regimen

Zhu

Jiao

Wang

et al. 2022

Cancers

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(1) Background: The objective of our study was to provide evidence for choosing the optimal neoadjuvant therapy strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. Three neoadjuvant targeted therapy strategies (H + Py, trastuzumab plus pyrotinib; H, trastuzumab; HP, trastuzumab plus pertuzumab) based on the same chemotherapy regimen (TC, docetaxel and carboplatin) were included in the present study; (2) Methods: We retrospectively analyzed patients with HER2-positive breast cancer who were treated with neoadjuvant TCH + Py, TCH or TCHP, followed by surgery. The outcome was the pathological complete response (pCR) rate; (3) Results: In total, 545 patients were enrolled. The pCR rate was 55.6% (35/63) in the TCH + Py cohort, 32.7% (93/284) in the TCH cohort, and 56.6% (112/198) in the TCHP cohort. The multivariate analysis showed that patients who received TCH had less possibility to achieve pCR than those who received TCH + Py (odds ratio (OR) = 0.334, 95% confidence interval (CI): 0.181–0.619, p < 0.001), while patients who received TCHP had comparable possibility to those who received TCH + Py (OR = 1.043, 95%CI: 0.554–1.964, p = 0.896); (4) Conclusions: TCH + Py provides a better pCR rate compared with TCH, and a comparable pCR rate with TCHP among patients with HER2-positive breast cancer in the neoadjuvant setting. The present study supports a novel potential treatment option for these patients. Further studies need to be explored in the future.

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A multicenter single‐arm trial of neoadjuvant pyrotinib and trastuzumab plus chemotherapy for HER2‐positive breast cancer

Shi,

Qi,

Tang

et al. 2023

MedComm

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The objective of this multicenter, single‐arm trial (ChiCTR1900022293) was to explore the efficacy and safety of neoadjuvant therapy with epirubicin, cyclophosphamide, and pyrotinib followed by docetaxel, trastuzumab, and pyrotinib (ECPy‐THPy) in the treatment of patients with stage II–III HER2‐positive breast cancer. The present study enrolled patients with stage II–III HER2‐positive breast cancer. Epirubicin and cyclophosphamide were administrated for four 21‐day cycles, followed by four cycles of docetaxel and trastuzumab. Pyrotinib was taken orally once per day throughout the treatment period. The primary endpoint was total pathological complete response (tpCR, ypT0/is ypN0) rate in the modified intention‐to‐treat (mITT) population. In total, 175 patients were included. The tpCR rate was 68.6% (95% CI, 60.7–75.8%), while the objective response rate was 89.1%. In the post‐hoc subgroup analysis, no association between clinical characteristics and the tpCR rate was observed. The most common grade ≥3 adverse events were diarrhea (54.3%), followed by white blood cell count decreased (5.1%), and neutrophil count decreased (4.6%). In conclusion, the neoadjuvant regimen with ECPy‐THPy showed promising pathological response and clinical benefits with an acceptable safety profile in patients with stage II–III HER2‐positive breast cancer.

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Pathological response and predictive role of tumour-infiltrating lymphocytes in HER2-positive early breast cancer treated with neoadjuvant pyrotinib plus trastuzumab and chemotherapy (Panphila): a multicentre phase 2 trial

Cited by 26 publications

References 49 publications

Pyrotinib-Containing Neoadjuvant Therapy in Patients With HER2-Positive Breast Cancer: A Multicenter Retrospective Analysis

Pyrotinib-Containing Neoadjuvant Therapy in Patients With HER2-Positive Breast Cancer: A Multicenter Retrospective Analysis

Neoadjuvant Efficacy of Three Targeted Therapy Strategies for HER2-Positive Breast Cancer Based on the Same Chemotherapy Regimen

A multicenter single‐arm trial of neoadjuvant pyrotinib and trastuzumab plus chemotherapy for HER2‐positive breast cancer

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