PMID- 33000490 OWN - NLM STAT- MEDLINE DCOM- 20210621 LR - 20220531 IS - 1549-490X (Electronic) IS - 1083-7159 (Print) IS - 1083-7159 (Linking) VI - 25 IP - 12 DP - 2020 Dec TI - Neoadjuvant Pyrotinib plus Trastuzumab and Chemotherapy for Stage I-III HER2-Positive Breast Cancer: A Phase II Clinical Trial. PG - e1909-e1920 LID - 10.1002/onco.13546 [doi] LID - e13546 AB - LESSONS LEARNED: This is the first trial to explore the neoadjuvant therapy of pyrotinib in HER2-positive operable and locally advanced breast cancer, in combination with epirubicin plus cyclophosphamide followed by docetaxel plus trastuzumab. Results primarily showed that pyrotinib in combination with epirubicin plus cyclophosphamide followed by docetaxel plus trastuzumab was effective and safe in HER2-positive operable and locally advanced breast cancer. A subsequent randomized controlled trial is still warranted to confirm these results. BACKGROUND: The efficacy and safety of neoadjuvant therapy of pyrotinib, a new irreversible tyrosine kinase inhibitor (TKI), was first estimated in patients with HER2-positive breast cancer in this phase II study, in combination with trastuzumab and chemotherapy. METHODS: Between February 19, 2019, and November 20, 2019, 20 female Chinese patients with stage I-III HER2-positive breast cancer were assigned to receive eight cycles of neoadjuvant pyrotinib (P) in combination with four cycles of epirubicin (E) and cyclophosphamide (C) followed by four cycles of docetaxel (T) and trastuzumab (H), once every 3 weeks, referred to as P + EC-TH. RESULTS: A total of 19 patients completed the therapy and final surgery. The total pathological complete response (tpCR) rate was 73.7% (95% confidence interval [CI], 48.8-90.9), and no recurrence or metastasis occurred during the short-term follow-up period. The objective response rate (ORR) was 100% (95% CI, 82.4-100). The most common adverse events (AEs) were diarrhea and leukopenia in 18 of 20 patients (90%), but no grade 5 AEs were reported. CONCLUSION: This study showed that in HER2-positive operable or locally advanced breast cancer, the tpCR rate of P + EC-TH neoadjuvant therapy was about twice as high as that of EC-TH neoadjuvant therapy reported in other trials, with tolerable side effects. CI - (c) 2020 The Authors. The Oncologist published by Wiley Periodicals LLC on behalf of AlphaMed Press. FAU - Xuhong, Juncheng AU - Xuhong J AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Qi, Xiaowei AU - Qi X AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Tang, Peng AU - Tang P AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Fan, Linjun AU - Fan L AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Chen, Li AU - Chen L AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Zhang, Fan AU - Zhang F AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Tan, Xuanni AU - Tan X AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Yan, Wenting AU - Yan W AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Zhong, Ling AU - Zhong L AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - He, Cheng AU - He C AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Liang, Yan AU - Liang Y AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Ren, Lin AU - Ren L AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Wang, Minghao AU - Wang M AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Zhang, Yi AU - Zhang Y AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Jiang, Jun AU - Jiang J AUID- ORCID: 0000-0002-8931-9872 AD - Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20201020 PL - England TA - Oncologist JT - The oncologist JID - 9607837 RN - 0 (Acrylamides) RN - 0 (Aminoquinolines) RN - 0 (pyrotinib) RN - 8N3DW7272P (Cyclophosphamide) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - P188ANX8CK (Trastuzumab) SB - IM MH - Acrylamides MH - Aminoquinolines MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - *Breast Neoplasms/drug therapy MH - Cyclophosphamide/therapeutic use MH - Female MH - Humans MH - *Neoadjuvant Therapy MH - Neoplasm Recurrence, Local/drug therapy MH - Receptor, ErbB-2/therapeutic use MH - Trastuzumab/therapeutic use MH - Treatment Outcome PMC - PMC8108050 OTO - NOTNLM OT - HER2-positive breast cancer OT - Neoadjuvant therapy OT - Phase II trial OT - Pyrotinib OT - Trastuzumab OT - Tyrosine kinase inhibitor EDAT- 2020/10/02 06:00 MHDA- 2021/06/22 06:00 PMCR- 2020/12/01 CRDT- 2020/10/01 05:41 PHST- 2020/09/28 00:00 [received] PHST- 2020/09/07 00:00 [accepted] PHST- 2020/10/02 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2020/10/01 05:41 [entrez] PHST- 2020/12/01 00:00 [pmc-release] AID - ONCO13546 [pii] AID - 10.1002/onco.13546 [doi] PST - ppublish SO - Oncologist. 2020 Dec;25(12):e1909-e1920. doi: 10.1002/onco.13546. Epub 2020 Oct 20.