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Pyrotinib Treatment in Patients with HER2-Positive

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Pyrotinib Treatment in Patients with HER2-Positive Author Manuscript Published OnlineFirst on June 10, 2021; DOI: 10.1158/1078-0432.CCR-21-0474 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. 1 Pyrotinib treatment in patients with HER2-positive 2 metastatic breast cancer and brain metastasis: 3 exploratory final analysis of real-world, multicenter 4 data 5 6 Authors: Munawar Anwar1#, Qitong Chen1#, Dengjie Ouyang1,2, Shouman 7 Wang3, Ning Xie4, Quchang Ouyang4, Peizhi Fan5, Liyuan Qian6, Gannong 8 Chen1, Enxiang Zhou1, Lei Guo3, Xiaowen Gu5, Boning Ding6, Xiaohong 9 Yang7, Liping Liu7, Chao Deng8, Zhi Xiao3, Jing Li9, Yunqi Wang10, Shan 10 Zeng11, Jinhui Hu12, Wei Zhou13, Bo Qiu14, Zhongming Wang15, Jie Weng16, 11 Mingwen Liu17, Yi Li18, Tiegang Tang19, Jianguo Wang20, Hui Zhang21, Bin 12 Dai22, Wuping Tang23, Tao Wu24, Maoliang Xiao25, Xiantao Li26, Hailong 13 Liu27, Lai Li28, and Wenjun Yi1* 14 15 # Munawar Anwar and Qitong Chen share co-first authorship. 16 17 Affiliations: 18 1. Department of General Surgery, The Second Xiangya Hospital, 19 Central South University, Changsha, China 20 2. Department of General Surgery, Xiangya Hospital Central South 21 University, Changsha, China 22 3. Department of Breast Surgery, Xiangya Hospital Central South 23 University, Changsha, China 24 4. Department of Breast Internal Medicine, The Affiliated Cancer 25 Hospital of Xiangya School of Medicine, Central South University, 26 Changsha, China 27 5. Department of Breast and Thyroid Surgery, Hunan Provincial People's 28 Hospital, Changsha, China 29 6. Department of Breast and Thyroid Surgery, Central South University 30 Third Xiangya Hospital, Changsha, China 31 7. Department of Oncology, The Affiliated Cancer Hospital of Xiangya 1 Downloaded from clincancerres.aacrjournals.org on September 28, 2021. © 2021 American Association for Cancer Research. Author Manuscript Published OnlineFirst on June 10, 2021; DOI: 10.1158/1078-0432.CCR-21-0474 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. 1 School of Medicine, Central South University, Changsha, China 2 8. Department of Oncology, The Second Xiangya Hospital, Central 3 South University, Changsha, China 4 9. Department of Breast Medical Oncology, The Affiliated Cancer 5 Hospital of Xiangya School of Medicine, Central South University, 6 Changsha, China 7 10. Department of Traditional Chinese Medicine, The Affiliated Cancer 8 Hospital of Xiangya School of Medicine, Central South University, 9 Changsha, China 10 11. Department of Internal Medicine – Oncology, Xiangya Hospital 11 Central South University, Changsha, China 12 12. Department of Breast Surgery, The First Hospital Hunan University 13 of Chinese Medicine, Changsha, China 14 13. Department of Breast and Thyroid Surgery, The Affiliated ZhuZhou 15 Hospital of Xiangya School of Medicine Central South University, 16 Zhuzhou, China 17 14. Department of Oncology, The Affiliated ZhuZhou Hospital of 18 Xiangya School of Medicine Central South University, Zhuzhou, 19 China 20 15. Department of Breast Surgery, The Third People's Hospital of 21 Yongzhou, Yongzhou, China 22 16. Department of Oncology, The First People's Hospital of Yueyang, 23 Yueyang, China 24 17. Department of Breast and Thyroid Surgery, The First People's 25 Hospital of Xiangtan City, Xiangtan, China 26 18. Department of Oncology, The Third People's Hospital of Changde, 27 Changde, China 28 19. Department of Oncology, Xiangtan Central Hospital, Xiangtan, China 29 20. Department of General Surgery, Xiangtan Central Hospital, Xiangtan, 30 China 31 21. Department of Oncology, Central Hospital of Shaoyang, Shaoyang, 32 China 33 22. Department of Breast and Thyroid Surgery, Central Hospital of 34 Shaoyang, Shaoyang, China 35 23. Department of Breast Surgery, Shaoyang Hospital of Traditional 36 Chinese Medicine, Shaoyang, China 2 Downloaded from clincancerres.aacrjournals.org on September 28, 2021. © 2021 American Association for Cancer Research. Author Manuscript Published OnlineFirst on June 10, 2021; DOI: 10.1158/1078-0432.CCR-21-0474 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. 1 24. Department of Oncology, The First People's Hospital of Changde, 2 Changde, China 3 25. Department of Oncology, The Third Hospital of Hunan University of 4 Chinese Medicine, Zhuzhou, China 5 26. Department of Oncology, The Central Hospital of Yiyang, Yiyang, 6 China 7 27. Department of Internal Medicine – Oncology, The First People's 8 Hospital of Chenzhou, Chenzhou, China 9 28. Department of Breast and Thyroid Surgery, The People's Hospital of 10 Xiangtan County, Xiangtan, China 11 12 Running title: Pyrotinib in HER-positive metastatic breast cancer 13 14 Financial support: Not applicable. 15 16 Correspondence: 17 Prof. Wenjun Yi, Department of General Surgery, The Second Xiangya 18 Hospital, Central South University, No. 139，Renmin Central Road, 19 Changsha, 410011, P.R. China, +8618608403318, [email protected]. 20 21 Keywords: 22 breast cancer, HER2, brain metastasis, pyrotinib, tumor mutation burden 23 24 Word Count: 2731 words 25 26 Tables/Figures: 4 total (1/3) 27 28 Conflicts of Interest: 29 All authors declare that they have no financial or other competing 30 interests. 31 32 3 Downloaded from clincancerres.aacrjournals.org on September 28, 2021. © 2021 American Association for Cancer Research. Author Manuscript Published OnlineFirst on June 10, 2021; DOI: 10.1158/1078-0432.CCR-21-0474 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. 1 Statement of Translational Relevance 2 HER2-positive (HER2+) metastatic breast cancer (MBC) has a poor 3 prognosis and tends to develop brain metastases (BM). Pyrotinib, a 4 pan-HER2 receptor tyrosine kinase inhibitor (TKI), has encouraging 5 antitumor effects on progression-free survival (PFS) in patients with 6 HER2+ MBC. However, overall survival (OS) data from HER2+ patients 7 with BM remain scarce. In this multicenter real-world study, pyrotinib 8 shows promise as a novel pan-HER2 TKI for the treatment of BM. 9 Surgical or radiotherapy in combination with pyrotinib was found to 10 improve OS in our BM cohort statistically. Our results could be a crucial 11 complement to current clinical trials. This work also demonstrates tumor 12 mutation burden (TMB) could be an exploratory biomarker for predicting 13 PFS and OS in patients treated with pyrotinib, which warrants further 14 prospective clinical studies. 15 4 Downloaded from clincancerres.aacrjournals.org on September 28, 2021. © 2021 American Association for Cancer Research. Author Manuscript Published OnlineFirst on June 10, 2021; DOI: 10.1158/1078-0432.CCR-21-0474 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. 1 Abstract 2 Purpose: Patients with HER2-positive (HER2+) metastatic breast 3 cancer (MBC) have poor prognoses. Pyrotinib has shown promising 4 antitumor activity in MBC patients to improve progression-free survival 5 (PFS). However, findings based on real-world data to analyze whether 6 pyrotinib affects overall survival (OS) remain scarce. 7 Experimental design: This real-world study is an exploratory 8 analysis of brain metastasis (BM) and the final update of our preceding 9 study of 168 patients with HER2+ MBC. PFS, OS, tumor mutation 10 burden (TMB), clinical benefit rate (CBR) and overall response rate 11 (ORR) were analyzed. 12 Results: Pyrotinib treatment led to a median PFS time of 8.00 months 13 and a median OS of 19.07 months in the 168 participants. High TMB was 14 associated with poor OS (P = 0.0072) and PFS (P = 0.0028). In the 39 15 patients with BM, the median PFS and OS were 8.67 and 13.93 months, 16 respectively. The surgery/radiation (S/R) group of patients with BM had 17 prolonged survival (PFS: 9.97 vs. 7.73 months P = 0.19; OS: 20.67 vs. 18 12.43 months P = 0.021) compared with the no surgery/no radiation 19 group (NS/NR). The CBR was 58.6% (S/R) vs. 41.4% (NS/NR), while 20 the ORR was 24.1% (S/R) vs. 31.0% (NS/NR). 21 Conclusion: Pyrotinib shows promise as a novel pan-HER2 tyrosine 22 kinase inhibitor (TKI) for the treatment of BM and should be evaluated 23 further. Surgical or radiotherapy in combination with pyrotinib was found 24 to statistically improve OS in our cohort. TMB could be an exploratory 25 biomarker for predicting PFS and OS, but its clinical application still 26 needs further verification. 27 28 5 Downloaded from clincancerres.aacrjournals.org on September 28, 2021. © 2021 American Association for Cancer Research. Author Manuscript Published OnlineFirst on June 10, 2021; DOI: 10.1158/1078-0432.CCR-21-0474 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. 1 Introduction 2 Human epidermal growth factor receptor 2 (HER2) (also referred to 3 as ERBB2) is amplified and/or overexpressed in approximately 15–20% 4 of primary breast cancers (BCs)1. Patients with HER2-positive (HER2+) 5 BC have a poor prognosis and tend to develop metastatic disease in the 6 central nervous system (CNS), and these patients have an especially high 7 risk of brain metastasis (BM)2,3. CNS metastases have been reported in 8 15–25% of BC patients4, and BM occurs in 30–55% of patients with 9 metastatic BC5, highlighting the need for safe and effective BM-targeted 10 treatments. Moreover, the survival of these patients is generally poor, and 11 the median overall survival (OS) after the initial diagnosis of CNS 12 metastases is 13.0 months6. Although anti‐HER2 therapeutic options have 13 steadily enhanced the effect of systemic therapy on patients with HER2+ 14 metastatic breast cancer (MBC), there is an increased awareness that 15 clinical strategies targeting BM are needed for this subtype of BC7. 16 The novel oral pan-ErbB receptor tyrosine kinase inhibitor (TKI) 17 pyrotinib has the advantages of stability, safety and good tolerance, with 18 encouraging antitumor effects observed in patients with HER2+ MBC8-14.
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