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    Home > Active Ingredient News > Antitumor Therapy > King of the world, Abexili combined with endocrine therapy for Chinese patients with early breast cancer, the risk of postoperative recurrence is greatly reduced by 34.3%

    King of the world, Abexili combined with endocrine therapy for Chinese patients with early breast cancer, the risk of postoperative recurrence is greatly reduced by 34.3%

    • Last Update: 2021-06-22
    • Source: Internet
    • Author: User
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    Breast cancer is related to a country’s GDP development and people’s living standards
    .

    In recent years, the incidence of breast cancer in China has increased significantly.
    Breast cancer has become a very common type of tumor in China, and it is also the cancer with the highest incidence in women
    .

    There are approximately 360,000 to 400,000 newly diagnosed breast cancers every year
    .

    Professor Shao Zhimin, Director of General Surgery and Director of Breast Surgery of Fudan University Cancer Hospital, introduced that the current high incidence of breast cancer in China is between 45 and 55 years old, but epidemiological investigations and related models show that the median age of breast cancer in China After gradually moving backward, it is estimated that after 20 or 30 years, the median age of onset of breast cancer will be similar to that of European and American populations.
    As the age is higher, the incidence of breast cancer is also higher
    .

    1.
    Different molecular types to achieve precise treatment of breast cancer.
    Although all breast cancers are breast cancer, according to the expression of hormone receptors and human epidermal growth factor receptor 2 (HER2), breast cancer can be divided into several different subtypes.
    Type
    .

    Figure 1.
    Breast cancer subtypes defined by histology and immunohistochemistry, Professor Shao Zhimin, Director of Surgery and Director of Breast Surgery, Fudan University Cancer Hospital, emphasized the treatment characteristics of different breast cancer subtypes.
    Luminal breast cancer accounts for about 60% of breast cancers in China -65%, accounting for 70% of breast cancer in Europe and America
    .

    This type of breast cancer is characterized by the effective use of endocrine therapy drugs and the low risk of early recurrence, but the risk of recurrence increases significantly as the treatment time is extended
    .

    If the patient has lymph node metastasis, or estrogen receptor-positive but progesterone receptor-negative, or the tumor is relatively large, or the vessel has cancer thrombus, etc.
    , they are all risk factors for high-risk recurrence
    .

    For HER2-positive or triple-negative breast cancer, the risk of early recurrence is often higher, but if these patients survive three to four years, the probability of recurrence and metastasis will be greatly reduced
    .

    In 2019, Professor Shao Zhimin’s team drew the “world’s largest gene map of triple-negative breast cancer” and proposed the “Fudan classification” for the first time in the world, dividing triple-negative breast cancer into 4 different subtypes: immunomodulatory (IM) ), luminal androgen receptor type (LAR), basal-like immunosuppressive type (BLIS), and interstitial type (MES), laying the foundation for the classification and treatment of triple-negative breast cancer
    .

    The FUTURE clinical study led by Professor Shao Zhimin showed that for triple-negative breast cancer that has progressed through a variety of treatment options, it is divided into 7 groups according to the "Fudan classification", and different treatment options are given
    .

    The results showed that immunomodulatory (IM) breast cancer was treated with PD-1 and albumin paclitaxel, and the response rate could reach 52.
    6%
    .

    Basal-like immunosuppressive (BLIS) treatment with anti-angiogenic drugs has a response rate of 26.
    1%
    .

    This is very rare efficacy data
    .

    Immunity-modulated (IM) triple-negative breast cancer after failure of multi-line treatment is very effective in the treatment of immune-modulated (IM) triple-negative breast cancer.
    Then the first-line treatment of immuno-modulated (IM) triple-negative breast cancer after recurrence and metastasis will be effective How? For this reason, Professor Shao Zhimin’s team further designed the FUTURE-C-PLUS study
    .

    The results of the study found that the treatment response rate was as high as 81.
    3%
    .

    This is the best curative effect currently achieved for triple-negative breast cancer
    .

    The FUTURE-C-PLUS study was selected for the 2021 ASCO oral report.
    The FUTURE-C-PLUS study is very inspiring for the treatment of triple-negative breast cancer, and the results of the study are very encouraging
    .

    2.
    70% of breast cancer patients have waited for 20 years.
    How to reduce the risk of recurrence after surgery? Over the past 20 years, we have made great progress in the treatment of breast cancer
    .

    Especially in the targeted therapy of HER2-positive breast cancer, some new drugs have been approved for the market.
    There are also studies similar to FUTURE in triple-negative breast cancer, but for hormone receptor-positive and HER2-negative early breast cancer (also known as For HR+/HER2- subtype), there are almost no breakthrough targeted drugs
    .

    Because this part of breast cancer patients accounts for about 70%, the median age of onset of most breast cancers in China is 45 to 55 years old, which is a very young cancer group
    .

    Based on this, monarchE research came into being as needed, through the combined use of CDK4/6 inhibitors and endocrine therapy drugs for the adjuvant treatment of hormone receptor-positive but HER2-negative breast cancer with a high risk of recurrence
    .

    Figure 2.
    MonarchE study protocol design As shown in the figure above, the hormone receptor-positive and HER2-negative high-recurrence breast cancers included in monarchE include: patients with metastasis of more than 4 axillary lymph nodes, or patients with metastasis of less than 4 axillary lymph nodes but larger tumor lesions 5 cm, or Ki67 expression is greater than 20%
    .

    These patients were treated with endocrine therapy drugs after the operation, combined with the CDK4/6 inhibitor Abexicil
    .

    The 2020 San Antonio Breast Cancer Conference (SABCS) main research endpoint data (Figure 3), in the global intention-to-treat analysis population, the combination of CDK4/6 inhibitor abasiride and endocrine therapy reduced the risk of recurrence by 28.
    7%
    .

    Premenopausal patients decreased by 41.
    6%
    .

    Figure 3.
    Abexicil combined with endocrine therapy reduces the risk of recurrence of breast cancer patients.
    Professor Shao Zhimin introduced that in the monarchE study, the combination of abesili with endocrine therapy was used
    .

    It can be seen that the risk of recurrence after the operation is reduced
    .

    The patient's data such as invasive disease-free survival (IDFS) and distant recurrence-free survival (DRFS) have been significantly improved
    .

    3.
    MonarchE study, Fuze Chinese early breast cancer patients in June 2021, at the annual clinical oncology conference (2021ASCO) held in the United States, as the lead expert of monarchE study in China, Fudan University Cancer Hospital Surgery Director and Breast Gland Professor Shao Zhimin, director of surgery, introduced the efficacy and safety data of monarchE in the study of Chinese patients
    .

    In the entire study, a total of 501 hormone receptor-positive and HER2-negative Chinese breast cancers with a high risk of early recurrence participated
    .

    Among them, 259 patients were treated with abexiride combined with endocrine therapy after the operation, and the dosage of abexiride was 150 mg twice a day
    .

    A total of 242 patients in the control group used endocrine therapy alone
    .

    The results showed that the combination of Abexicil and endocrine therapy reduced the risk of invasive disease or death in Chinese breast cancer patients by 34.
    3% (Figure 4)
    .

    Figure 4.
    Abexicil combined with endocrine therapy reduces the risk of recurrence of Chinese breast cancer patients and at the same time has a clinically significant improvement in 2 years of invasive disease-free survival (IDFS), 95.
    6% in the combined drug group and 92.
    1% in the endocrine therapy group alone
    .

    For the 2-year long-distance recurrence-free survival (DRFS), the 2-year DRFS rate of Abesiride combined with endocrine therapy drugs was 96.
    7%, and the 2-year DRFS rate of endocrine therapy alone was 93.
    4%
    .

    These data indicate that the combination of abexiride and endocrine therapy significantly reduces the risk of recurrence of high-risk breast cancer
    .

    Since abexili and endocrine therapy need to be taken for a long time, everyone is also very concerned about the safety of the combined therapy
    .

    According to the research data introduced by Professor Shao Zhimin, the safety of Abexiride combined with endocrine therapy is mainly manifested in the blood system.
    Some patients may develop mild anemia, or manifest as leukopenia and neutropenia
    .

    The probability of diarrhea in patients with combination medication is also higher
    .

    However, after treatment with symptomatic medications, there was no significant drop in the proportion of medications
    .

    In general, the safety and tolerability of the combination of Abexiride and endocrine therapy are good
    .

    So far, Abexicil is the only targeted drug in the world that has obtained positive results in clinical studies of adjuvant therapy for HR-positive early breast cancer
    .

    From the research data of monarchE, we can see that many Chinese breast cancer patients can benefit from the combination of Abexicil and endocrine therapy
    .

    Previously, CDK4/6 inhibitors have been included in the priority review of CDE.
    In March this year, Abexicil was successfully listed in China.
    If it can be included in medical insurance as soon as possible, this CDK4/6 inhibitor will surely bring a cure for more breast cancer patients Hope
    .

    Professor Shao Zhimin, Fudan Distinguished Professor, the first batch of Yangtze River Scholars Distinguished Professor of the Ministry of Education, Director of Oncology and Breast Cancer Research Institute, Director of General Surgery and Director of Breast Surgery, Fudan University Honorary Chairman, Breast Cancer Professional Committee, Chinese Anti-Cancer Association Vice Chairman, Chinese Medical Association Oncology Branch Honorary Chairman of the Breast Cancer Committee of the Shanghai Anti-Cancer Association Chairman of the Oncology Committee of the Shanghai Medical Association Chairman of the Eighth Asian Breast Cancer Association St.
    Gallen Breast Cancer Conference Expert Group Reference: https://meetinglibrary.
    asco.
    org /record/198438/abstract Click below to learn more about clinical trial projects
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