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    Home > Active Ingredient News > Antitumor Therapy > Professor Mao Weimin: The ADAURA study provides confirmation for postoperative adjuvant treatment of osimertinib, and the approval of the indication is of great significance

    Professor Mao Weimin: The ADAURA study provides confirmation for postoperative adjuvant treatment of osimertinib, and the approval of the indication is of great significance

    • Last Update: 2021-06-30
    • Source: Internet
    • Author: User
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    *Only for medical professionals to read and reference Osimitinib adjuvant therapy indications were approved for marketing, bringing good news to Chinese patients
    .

    ADAURA research has laid a solid evidence-based foundation for epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) adjuvant therapy.
    Based on the heavy results of ADAURA research, osimertinib is applied to non-small cells with sensitive EGFR mutations The indications for adjuvant treatment of lung cancer (NSCLC) have been approved for marketing in China, which is a great boon for Chinese patients
    .

    EGFR-TKI postoperative adjuvant treatment research represented by ADAURA will continue to be explored in order to create more survival benefits for patients
    .

    The "medical community" specially invited Professor Mao Weimin from Zhejiang Cancer Hospital to give insights on related topics
    .

    Professor Mao Weimin’s wonderful video The ADAURA study provides confirmation for postoperative adjuvant targeted therapy.
    Professor Mao Weimin said: “Adjuvant therapy is a very important part of early and mid-term NSCLC, because surgical treatment is only a part of local treatment, and tumor is a systemic treatment.
    For diseases, especially for lung cancer, which is highly malignant and very easy to metastasize, surgical treatment alone cannot solve all problems and requires combined postoperative adjuvant treatment
    .

    Adjuvant therapy is very necessary, especially for patients with early and mid-stage NSCLC
    .

    At present .
    It can be seen that the 5-year survival rate of even stage I patients is not particularly optimistic, only about 70%, partly because the accurate staging is not achieved, and another important reason is that even early patients are extremely prone to recurrence and metastasis.
    It is necessary to further eliminate residual lesions through postoperative adjuvant treatment and reduce the rate of postoperative recurrence and metastasis, and the choice of treatment options and individualized differences have a greater impact on it
    .

    "Professor Mao Weimin further pointed out: "Adjuvant therapy can choose radiotherapy, immunotherapy, targeted therapy and traditional Chinese medicine treatment
    .

    For NSCLC patients with genetic mutations, postoperative adjuvant targeted therapy is a very important treatment option
    .

    There are numerous research data on the application of TKI to advanced NSCLC, especially for NSCLC patients with EGFR mutations, EGFR-TKI is the first choice for treatment
    .

    The ADAURA study provides sufficient and solid evidence-based medical evidence for the application of EGFR-TKI in early and mid-term NSCLC
    .

    As a participant in the ADAURA study, during the research development and follow-up process, I also deeply felt the clinical benefits of patients, especially in terms of disease-free survival (DFS), 2 of patients with stage II-IIIB (T3N2, AJCC8) The annual DFS rate was significantly increased (90% vs.
    44%, HR=0.
    17; 99.
    06%CI 0.
    11-0.
    26; P<0.
    001), and the risk of disease recurrence or death was reduced by 83%.
    This result is exciting and very fascinating Attention
    .

    The research data was first disclosed in the American Society of Clinical Oncology (ASCO) in 2020 [1], followed by a stunning appearance at the European Society of Medical Oncology (ESMO) in 2020, and simultaneously published in the New England Journal of Medicine (NEJM) [2]
    .

    This study can be said to be a very sensational clinical study in the field of postoperative adjuvant treatment of NSCLC
    .

    "Based on the ADAURA study, osimertinib is approved as an adjuvant therapy and the indications are of great significance.
    Based on the heavy results of the ADAURA study, osimertinib has been approved in China and has achieved IB-IIIB (T3N2, AJCC8) EGFR sensitive mutation surgery.
    The indication of adjuvant therapy for post-NSCLC patients, regardless of whether the patient has received adjuvant chemotherapy in the past, the approval of this indication is a boon for Chinese patients
    .

    Professor Mao Weimin said that the prerequisite for postoperative adjuvant EGFR-TKI treatment is that patients must be accompanied by EGFR mutations.
    Although not all NSCLC patients are eligible, relatively speaking, Asian patients have a higher EGFR mutation rate, while Caucasians There is no high EGFR mutation rate, so the benefit of the Chinese population is relatively higher
    .

     As the third-generation EGFR-TKI, Osimertinib has high safety and is also effective for patients with brain metastases, which can significantly reduce the risk of brain metastases
    .

    The 2020 ESMO meeting announced the relevant data of the ADAURA study for patients with brain metastases[2], and the results showed that 45 patients had recurrence or death of central nervous system (CNS) related diseases (6 out of 339 cases in the osimertinib group, 2%; 39 out of 343 cases in the placebo group, accounting for 11%)
    .

    In the two groups, 4 cases (1%) and 33 cases (10%) had CNS recurrence
    .

    At 2 years of treatment, 98% and 85% of patients in the osimertinib group and placebo group were still alive without CNS metastasis (HR=0.
    18; 95%CI 0.
    10-0.
    33), and the risk of brain metastasis or death in patients A reduction of 82%, the median CNS DFS of the osimertinib group has not yet reached, and the median CNS DFS of the placebo group is 48.
    2 months.
    The efficacy data is gratifying
    .

    The incidence of brain metastases in lung cancer patients is high, the prognosis is poor, and the natural survival time is short.
    The benefit data for patients with brain metastases in the ADAURA study adds a powerful bargaining chip to the wide application of osimertinib in clinical adjuvant therapy
    .

     EGFR-TKI postoperative adjuvant therapy research will continue to explore Professor Mao Weimin said that according to past evidence-based medicine evidence, including some real-world research data, four cycles of postoperative adjuvant chemotherapy are used.
    Of course, patients can also have poor local disease control In the case of radiotherapy
    .

    With the advent of ADJUVANT study, EVAN study, and ADAURA study, adjuvant therapy after EGFR-TKI began to rise, and the benefits of DFS showed an overwhelming advantage over conventional adjuvant chemotherapy
    .

    Although the same is an adjuvant therapy study, the three have differences in research design, medication time, and population enrollment
    .

     In ADJUVANT study [3] and EVAN study [4], adjuvant chemotherapy was used as a head-to-head control for adjuvant treatment of EGFR-TKI.
    In the ADAURA study, adjuvant chemotherapy was given to patients first and then osimertinib or comfort.
    Adjuvant therapy, this design method allows patients with poor adjuvant chemotherapy to continue to benefit from treatment, and is more beneficial to better clarify the benefits of adjuvant targeted therapy
    .

     In terms of medication time, the ADJUVANT study and EVAN study adjuvant targeted therapy are both 2 years, while the ADAURA study is 3 years
    .

    Although it is necessary to be cautious about whether targeted therapy can be taken for life, the treatment benefit of some patients is related to the treatment time
    .

    Tumor treatment is not necessarily aimed at radical cure, especially for patients with advanced tumors to achieve a radical cure, but it can enable patients to live with tumors and make tumors become chronic diseases like hypertension, hyperlipidemia, and diabetes.
    Long-term medication can make the tumor fall asleep, control the tumor well, ensure the quality of life of the patient, and allow the patient to live and work normally
    .

    Therefore, for patients with genetic mutations, 3 years of targeted drug therapy may be better than 2 years
    .

     In addition, in the enrolled population, the ADJUVANT study and the EVAN study did not include patients with stage IB, and the stage of the enrolled population was relatively late, while the ADAURA study included patients with stage IB-IIIB (T3N2, AJCC8).
    The guidelines point out that existing evidence suggests that For patients with stage I NSCLC, adjuvant chemotherapy is not recommended
    .

    The ADAURA study confirmed that adjuvant targeted therapy can create greater survival benefits for IB patients.
    The 2-year DFS rate of patients is as high as 88% (HR=0.
    39; 95%CI 0.
    18-0.
    76), and the risk of disease recurrence or death is reduced It is expected to further improve the 5-year survival rate of patients with stage I NSCLC
    .

     Finally, Professor Mao Weimin emphasized: “The above three studies are all initiated by our Chinese, and the PIs are all our Chinese.
    From this point of view, we have made significant contributions to the global research field of lung cancer assisted targeted therapy.
    Of course, in the future We will continue to explore related issues related to the use of EGFR-TKI for postoperative adjuvant treatment
    .

    Such as treatment time, dosage, individual differences, as well as the probability of mutation, mutation site and other issues.
    Therefore, the phased results of these studies have also given us strong As a warning, the exploration will never stop
    .

    I hope that with the deepening of research in the future, we will be able to come up with answers in order to choose more reasonable and precise treatments for patients
    .

    "Expert Profile Professor Mao Weimin, Chief Physician, Professor, and Doctoral Supervisor of the Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Zhejiang Province Special Expert, Zhejiang Provincial Key Laboratory of Thoracic Tumor, Executive Director, China Anti-Cancer Association, Deputy Chairman of the Lung Cancer Professional Committee Executive director of the Chinese Association of Clinical Oncology, Vice Chairman of the Expert Committee of Esophageal Cancer, Chairman of Zhejiang Anti-Cancer Association, Professional Committee of Lung Cancer, Chairman, Vice President of Zhejiang Medical Doctor Association, Chairman of Thoracic Surgery Branch Reference materials: [1] Herbst RS, Tsuboi M, John T, et al.
    Osimertinib as adjuvant therapy in patients(pts) with stage IB-IIIA EGFR mutation positive (EGFRm) NSCLC after completetumor resection: ADAURA.
    J Clin Oncol.
    2020;38(suppl 15):LBA5.
    [2] Wu YL, Tsuboi M, He J, et al; ADAURA Investigators.
    Osimertinib in ResectedEGFR-Mutated Non-Small-Cell Lung Cancer.
    N Engl J Med.
    2020 Oct29;383(18):1711-1723.
    [3 ] Zhong WZ, Wang Q, Mao WM, et al.
    Gefitinib Versus Vinorelbine Plus Cisplatin asAdjuvant Treatment for Stage II-IIIA (N1-N2) EGFR-Mutant NSCLC: Final Overall Survival Analysis of CTONG1104 Phase III Trial.
    J Clin Oncol.
    2021 Mar 1;39(7):713-722.
    [4] Yue D, Xu S, Wang Q, et al.
    Erlotinib versus vinorelbine plus cisplatin asadjuvant therapy in Chinese patients with stage IIIA EGFR mutation-positivenon-small-cell lung cancer (EVAN): a randomised, open-label, phase 2 trial.
    Lancet Respir Med.
    2018 Nov;6(11): 863-873.
    *This article is only used to provide scientific information to medical professionals, and does not represent the views of this platform
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