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

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.

Keywords

Neoadjuvant therapy; resectable lung cancer; clinical research endpoint; pathological response.

SUBMITTER: Ren S

PROVIDER: S-EPMC8350086 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Publications

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

Ren Sijia S Xu Anyi A Lin Yilian Y Camidge D Ross DR Di Maio Massimo M Califano Raffaele R Hida Toyoaki T Rossi Antonio A Guibert Nicolas N Zhu Chengchu C Shen Jianfei J

Translational lung cancer research 20210701 7

<h4>Objective</h4>This review summarizes the current status of neoadjuvant therapy and discusses the choice of new clinical research endpoints for non-small cell lung cancer.<h4>Background</h4>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 ...[more]

PMID: 34430363

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Dataset Information

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

Objective

Background

Methods

Conclusions

Keywords

Publications

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

Similar Datasets

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