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    A narrative review of primary research endpoints of neoadjuvant therapy for lung cancer: past, present and future

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    Authors
    Ren, S.
    Xu, A.
    Lin, Y.
    Camidge, D. R.
    Di Maio, M.
    Califano, Raffaele
    Hida, T.
    Rossi, A.
    Guibert, N.
    Zhu, C
    Shen, J.
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    Affiliation
    Taizhou Hospital, Zhejiang University, Taizhou, China
    Issue Date
    2021
    
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    Abstract
    Objective: This review summarizes the current status of neoadjuvant therapy and discusses the choice of new clinical research endpoints for non-small cell lung cancer. Background: Neoadjuvant chemotherapy is a recognized practice in patients with resectable and locally advanced lung cancer. With the introduction of molecular targeted drugs and immune checkpoint inhibitors (ICIs), the overall survival (OS) of patients with lung cancer has been significantly improved, and the original traditional clinical research endpoints are no longer suitable for existing clinical research. In order to accelerate the process of clinical trials and the development and approval of drugs, it is necessary to find suitable alternative indicators as the main indicators of clinical research. Methods: Therefore, this article focuses on clinical trials using disease-free survival (DFS), progression free survival, and pathological evaluation indicators, pathologic complete response and major pathologic response, as surrogate endpoints. We search related literature through PubMed database and clinical trials through clinicaltrials.gov. Conclusions: Pathologic complete response and major pathologic response are recommended as surrogate endpoints in the era of neoadjuvant immunotherapy, and secondary endpoints are listed for the prediction of pathological results. In addition, the definitions of major pathological response (MPR) and PCR should be standardized, and a new pathological evaluation standard should be developed, which is applicable to all current treatment methods.
    Citation
    Ren S, Xu A, Lin Y, Camidge DR, Di Maio M, Califano R, et al. A narrative review of primary research endpoints of neoadjuvant therapy for lung cancer: past, present and future. Transl Lung Cancer Res. 2021 Jul;10(7):3264–75.
    Journal
    Translational Lung Cancer Research
    URI
    http://hdl.handle.net/10541/624536
    DOI
    10.21037/tlcr-21-259
    PubMed ID
    34430363
    Additional Links
    https://dx.doi.org/10.21037/tlcr-21-259
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.21037/tlcr-21-259
    Scopus Count
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