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    Home > Active Ingredient News > Antitumor Therapy > Professor Ning Liao: Summary of key clinical studies on HER2-positive breast cancer

    Professor Ning Liao: Summary of key clinical studies on HER2-positive breast cancer

    • Last Update: 2021-04-23
    • Source: Internet
    • Author: User
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    *Only for medical professionals to read and refer to the 2021 National Breast Cancer Conference and CSCO Breast Cancer Annual Conference.
    Listen to Professor Liao Ning's talk about the progress of HER2+ breast cancer treatment.

    Human epidermal growth factor receptor 2 positive (HER2+) breast cancer is a very aggressive and highly malignant subtype of breast cancer.
    The emergence of anti-HER2 targeted drugs has greatly improved the treatment outcome of this type of breast cancer patients.

    Looking back, what clinical studies have changed the clinical practice of HER2+ breast cancer? How to further optimize the treatment plan in the future? On April 10th, at the 2021 National Breast Cancer Conference and the Chinese Society of Clinical Oncology (CSCO) Breast Cancer Annual Conference, Professor Liao Ning of Guangdong Provincial People’s Hospital reviewed the key research that changed the clinical decision-making of HER2+ breast cancer and introduced the latest in this field Research progress.

    Figure 1.
    The key research history of HER2+ breast cancer.
    The key research of adjuvant/neo-adjuvant therapy for HER2+ early breast cancer.
    1 Adjuvant trastuzumab significantly improves the prognosis of HER2+ early breast cancer.
    It shows that adjuvant trastuzumab therapy can significantly improve the prognosis of HER2+ early breast cancer.

    Figure 2.
    Adjuvant trastuzumab treatment significantly improves the prognosis.
    Five studies including BCIRG 005/006 show that patients with HER2+ early breast cancer can achieve an overall survival similar to that of HER2- patients after receiving trastuzumab adjuvant therapy (OS ).

    Figure 3.
    In HER2+ early breast cancer patients, the OS after trastuzumab treatment is similar to HER2- 2.
    Non-pCR adjuvant intensive treatment after neoadjuvant chemotherapy has a high incidence of pathological complete remission (non-pCR) after neoadjuvant therapy Risk of recurrence. The Techno study, GeparQuinto GBG44 study, NeoALTTO study, and NSABP B-31 study used 3-year disease-free survival (DFS), 3-year event-free survival (DFS), or 5-year recurrence-free interval (RFI) as evaluation indicators, and the results showed non- The prognosis of pCR patients is worse than that of pCR patients.

    Figure 4.
    Non-pCR patients have a high risk of recurrence after neoadjuvant treatment.
    Professor Liao Ning’s team found that there is huge heterogeneity in Chinese HER2+ breast cancer patients.

    Compared with HR-/HER2+ breast cancer, HR+/HER2+ breast cancer has more gene amplification, and patients with non-pCR after neoadjuvant therapy are often low copy number populations.

    In addition, the team also found that the TP53 LOF mutation and the initial state of Ki67 are important biomarkers for predicting the neoadjuvant treatment of HER2+ breast cancer patients to obtain pCR.

    Figure 5.
    There is huge heterogeneity in Chinese HER2+ breast cancer patients.
    The KATHERINE study used T-DM1 instead of trastuzumab for neoadjuvant therapy for patients with a higher risk of recurrence.
    The results show that T-DM1 will increase the risk of breast cancer recurrence or death Reduced by 50%.

    Figure 6.
    Optimization of adjuvant therapy in KATHERINE Study 3 The APHINITY study is a multi-center, randomized, double-blind, phase III study to explore whether adjuvant Pertuzumab + Trastuzumab can improve HER2+ early breast cancer The prognosis of the patient.

    The results showed that the dual target + chemotherapy group significantly improved the 4-year and 6-year invasive disease-free survival (iDFS) rates compared with the single target + chemotherapy group, which brought a new dual target option for adjuvant treatment of HER2+ early breast cancer.

    Figure 7.
    APHINITY study ExteNET study explored the efficacy of trastuzumab sequential nelatinib in adjuvant treatment of HER2+ early breast cancer, and the result is that this adjuvant treatment program can bring clear benefits.

    Figure 8.
    ExteNET study 4 de-escalation treatment strategy (de-anthracycline) The TRAIN-2 study is a representative study of de-escalation, confirming that neoadjuvant chemotherapy + dual-target treatment of HER2+ breast cancer achieves higher results regardless of whether anthracyclines are used or not The pCR rate. Figure 9.
    The second key down-step study of the TRAIN-2 study.
    The APT study is a single treatment of paclitaxel combined with trastuzumab in patients with HER2+ early breast cancer small tumors with negative lymph nodes and tumors ≤ 3 cm.
    In the arm study, the 7-year DFS rate of patients was 93%.

    Figure 10.
    APT study HER2+ advanced breast cancer treatment key study 1 HER2+ advanced breast cancer first-line treatment key study CLEOPATRA study is a phase III, randomized, double-blind, placebo-controlled study, which aims to explore the basis of trastuzumab combined with chemotherapy Above, whether increasing Pertuzumab can further improve the prognosis of HER2+ advanced breast cancer patients.

    The 8-year follow-up results showed that the 8-year OS rate in the dual-target combined chemotherapy group reached 37%, compared with 23% in the control group.

    Figure 11.
    CLEOPATRA study LUX-Breast1 study, NEfERTI-T study, NCIC CTG MA.
    31 study confirmed that trastuzumab is superior to small molecule tyrosine kinase inhibitor (TKI) in the treatment of HER2+ advanced breast cancer.

    Figure 12.
    Trastuzumab is better than small molecule TKIPHOEBE in the treatment of HER2+ advanced breast cancer.
    It is a national multi-center randomized controlled clinical study that included patients with HER2+ advanced breast cancer.
    The patients were randomly assigned to receive pyrrotinib+ in a 1:1 ratio.
    Capecitabine or lapatinib + capecitabine treatment.

    The results showed that the median progression-free survival (PFS) of pyrrotinib + capecitabine was 12.
    5 months, which was 5.
    7 months longer than that of the lapatinib + capecitabine group.

    Figure 13.
    PHOEBE study 2HR+/HER2+ advanced breast cancer For HR+/HER2+ advanced breast cancer, TANDEM study, EGF 30008 study, ELECTRA study, PERTAIN study showed that endocrine therapy + anti-HER2 therapy can significantly prolong PFS in patients. Figure 14.
    Endocrine therapy + anti-HER2 treatment HR+/HER2+ advanced breast cancer significantly prolonged the PFSEMILIA study evaluated the efficacy of T-DM1 in the second-line treatment of HER2+ advanced breast cancer.
    The results showed that the median PFS of the T-DM1 group was 9.
    6 months , The lapatinib+capecitabine group was 6.
    4 months (HR=0.
    65, 95%CI: 0.
    55-0.
    77, P<0.
    001).

    Based on the results of this study, the National Comprehensive Cancer Network (NCCN) guidelines recommend T-DM1 as the preferred second-line treatment for HER2+ advanced breast cancer.

    Figure 15.
    EMILIA study 3HER2+ brain metastasis advanced breast cancer patients with HER2+ advanced breast cancer are prone to brain metastases.

    The NALA study compared the efficacy of neratinib+capecitabine and lapatinib+capecitabine in HER2+ advanced breast cancer patients who had received ≥2 anti-HER2 treatments.
    The results showed that neratinib+ The capecitabine group significantly prolonged PFS by 2.
    2 months, and had better control of brain metastases, which could delay the onset of symptomatic brain metastases that require intervention.

    Figure 16.
    The NALA study HER2CLIMB study evaluated Tucatinib+trastuzumab+capecitabine for HER2+ locally advanced or metastatic breast cancer patients after trastuzumab, Pertuzumab, and T-DM1 treatment Efficacy and safety.

    Subgroup analysis showed that Tucatinib+trastuzumab+capecitabine significantly improved central nervous system (CNS) PFS and OS in people with brain metastases compared with placebo+trastuzumab+capecitabine.

        Figure 17.
    HER2CLIMB study 4 ongoing studies There are currently 482 studies in progress in HER2+ advanced breast cancer.

    In these studies, the DESTINY-Breast 01 study showed that the median PFS of the third-generation antibody-conjugated drug (ADC) Trastuzumab deruxtecan (DS-8201) in the treatment of HER2+ advanced breast cancer with 6-line treatment reached 19.
    4 months . Figure 18.
    The DESTINY-Breast 01 study monarcHER study showed that compared with standard chemotherapy plus trastuzumab, the combination of CDK4/6 inhibitor abesiride + trastuzumab + fulvestrant significantly improved anti-HER2 treatment The PFS of failed HER2+/ER+ advanced breast cancer patients also showed tolerable safety.

    Figure 19.
    The monarcHER study HOPES study aims to evaluate the clinical efficacy and safety of initumab combined with vinorelbine for HER2+ advanced breast cancer in China that has not previously received anti-HER2 therapy.

    The results of the study showed that the median PFS of the initumumab combined with vinorelbine treatment group reached 39.
    6 weeks, which was significantly better than the vinorelbine treatment group.

    Figure 20.
    Summary of the HOPES study: In the neoadjuvant and adjuvant treatments of HER2+ early breast cancer, de-escalation of chemotherapy has become a trend.

    For HER2+ advanced breast cancer, Tucatinib and DS-8201 are most likely to change the order of treatment and obtain overall survival benefits.
    More targeted therapies and immunotherapies are being explored.

    Expert profile Professor Liao Ning, Executive Director, Breast Department, Cancer Center, Guangdong Provincial People's Hospital, Member of the Standing Committee of the Chinese Anti-Cancer Association Breast Cancer Professional Committee (CACA-CBCS), Member of the International Council of the American Society of Oncological Surgeons (SSO), International Director of the International Sentinel Lymph Node Society (ISNS) Council Member, NCCN Breast Cancer Guidelines (Chinese Version) Expert Group Member, St Gallen International Breast Cancer Guidelines (Chinese Version) Expert Group Member Annals of Surgical Oncology Editorial Board Member, National Health and Family Planning Commission, National Health and Family Planning Commission "Breast Cancer Treatment Standards" Member of the country Member of the Expert Group of the "Guidelines for the Diagnosis of Breast Cancer" of the National Health and Family Planning Commission; Member of the Standing Committee of the Chinese Medical Doctor Association Breast Surgery Professional Committee (CMDA) Member of the Standing Committee of the Chinese Society of Clinical Oncology (CSCO) Breast Cancer Expert Committee Chairman of the Breast Cancer Professional Committee of the Guangdong Women Physicians Association Guangdong Pharmaceutical Association Chairman of the Breast Medicine Expert Committee
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