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*Foreword for medical professionals to read only Foreword 2020 is a year of witnessing history.
We have not only experienced the ravages of COVID-19, but also witnessed the popularity of adjuvant targeted therapy.
Under the background that the efficacy of adjuvant chemotherapy may have reached a bottleneck , EGFR mutation-positive non-small cell lung cancer (NSCLC) adjuvant targeted therapy once again made a major breakthrough, and then the National Comprehensive Cancer Network (NCCN) 2021 V1 guidelines were updated again, and for the first time osimertinib was used as a stage IB-IIIB EGFR mutation The "considered" adjuvant treatment plan for positive patients after surgery has also officially announced the arrival of a new era of adjuvant targeted therapy! The evolution of targeted drugs in adjuvant therapy status in domestic and foreign guidelines With the successful listing of gefitinib in 2003, targeted therapy has been updated in major guidelines with each passing day.
When gefitinib first entered China in 2005, EGFR-TKI was only recommended as a late-line treatment for advanced NSCLC.
But now, both domestic and foreign important guidelines have listed EGFR-TKI as the first-line standard treatment for patients with EGFR sensitive mutations.
However, in terms of EGFR-TKI adjuvant targeted therapy, due to the small number of foreign EGFR-TKI adjuvant therapy studies and the research design has certain limitations, no targeted therapy was recommended as an adjuvant before the NCCN 2021 V1 update Treatment options.
In China, the exploration of EGFR-TKI adjuvant therapy is relatively fast.
With the success of ADJUVANT research and EVAN research, EGFR-TKI targeted therapy has entered the adjuvant therapy stage.
The ADJUVANT study is the first prospective randomized controlled phase III clinical trial comparing gefitinib versus vinorelbine combined with cisplatin in NSCLC patients with EGFR mutation-positive and completely resected stage II-IIIA (N1-N2) , A total of 222 patients were enrolled.
The results of the study showed that compared with chemotherapy, gefitinib significantly prolonged the median disease-free survival (DFS) (18.
0 months vs 28.
7 months, HR=0.
60, P=0.
0054).
Subgroup analysis showed that N2 patients There are more benefits from postoperative adjuvant targeted therapy [1].
The EVAN study is a prospective randomized multicenter phase II clinical study comparing the efficacy and safety of erlotinib with platinum-containing two-drug chemotherapy as adjuvant therapy for stage IIIA NSCLC patients with EGFR mutations after complete resection.
The results showed that compared with chemotherapy, erlotinib significantly increased the 2-year DFS rate (44.
6% vs 81.
4%, P<0.
001) and significantly prolonged the median DFS (21.
0 months vs 42.
4 months, HR=0.
268, P< 0.
001) [2].
Based on the similar EGFR-TKI adjuvant treatments in the above two studies with significant DFS benefits, the current "2018 Edition of the Chinese Expert Consensus of Thoracic Surgery for Postoperative Adjuvant Treatment of NSCLC" unanimously recommends EGFR-TKI for postoperative adjuvant treatment of NSCLC.
This consensus It was pointed out that "EGFR-TKI can be used for postoperative adjuvant treatment of patients with stage IIIA EGFR sensitive mutation-positive NSCLC (Class 1B evidence)" [3].
In the "2019 CSCO Guidelines for the Diagnosis and Treatment of Primary Lung Cancer", the content about EGFR-TKI recommended for the adjuvant treatment of NSCLC is also updated.
The guide recommends "for operable stage IIIA or IIIA primary NSCLC, for direct surgery and surgery Patients who were later detected as EGFR mutation-positive, assisted EGFR-TKI targeted therapy after surgery (type 2B evidence)" [4].
However, it is a bit regrettable that the current domestic guidelines recommending EGFR-TKI for adjuvant treatment of NSCLC are mainly based on the results of a first-generation EGFR-TKI study.
The applicable patients are limited to stage IIIA, and the level of evidence is not high. The release of the third-generation EGFR-TKI osimertinib study data, promoting the further update of the guidelines The ADAURA study of the third-generation EGFR-TKI osimertinib [5] is an international multi-center, double-blind, randomized controlled phase III In clinical studies, the main research endpoint is to evaluate the median DFS in patients with stage II-IIIA EGFR sensitive mutations positive for osimertinib adjuvant treatment and undergoing complete resection of NSCLC.
It is worth noting that this study did not use the conventional adjuvant-targeted EGFR-TKI head-to-head adjuvant chemotherapy design, but allowed patients to choose whether to receive adjuvant chemotherapy first according to the actual situation before randomization.
This design can better help Clinicians understand the positioning of adjuvant chemotherapy in adjuvant treatment of EGFR mutation-positive patients.
The secondary study endpoints were DFS in patients with stage IB-IIIA, DFS in 2, 3, 4, and 5 years, overall survival (OS), safety and quality of life, etc.
The ADAURA study was originally planned to publish data in 2020, but because osimertinib was found to have shown an overwhelming efficacy advantage in a routine safety assessment, it is recommended to unblind in advance, so the study announced the results 2 years in advance.
The median DFS of the primary study endpoint of stage II-IIIA patients had a significant benefit, with a DFS HR value of 0.
17 (99.
06%CI 0.
11-0.
26, P<0.
001).
The secondary endpoint of the study also had a median DFS of stage IB-IIIA patients.
There was a significant benefit, with an HR value of 0.
20 (99.
12%CI 0.
14-0.
30, P<0.
001).
Figure 1 ADAURA study DFS results are based on the results of this research, NCCN Guidelines 2021 editions V1, V2 and V3, 3 consecutive editions update recommendations for adjuvant osimertinib, the latest V3 version [6], V1 and V2 The "consideration" of using osimertinib for adjuvant therapy was removed twice, and it is officially recommended that "osimertinib adjuvant treatment of stage IB-IIIB EGFR mutation positive and has used adjuvant chemotherapy in the past or is not suitable for the use of adjuvant platinum-containing dual drugs Patients undergoing chemotherapy", but unfortunately, as of today, China has not yet updated the guidelines based on the ADAURA study.
Figure 2 The NCCN guidelines recommend the early CACA guidelines to fill in the gaps, and the targeted adjuvant therapy for Chinese patients will eventually be "documented.
" This guide [7] fully absorbs the latest global clinical research results, and refers to international guidelines and China's national conditions.
The subject expert group’s repeated discussions aimed to standardize the diagnosis, molecular testing, adjuvant therapy, postoperative management and other issues of patients with stage I-IIIB NSCLC after complete tumor resection, in order to reduce postoperative recurrence rate, prolong patient survival time and improve patients Quality of Life.
Figure 3 Screenshot of the early CACA guidelines.
Compared with other domestic guidelines, the scope of EGFR-TKI adjuvant therapy is expanded and the level of evidence is high.
This guide is the first standard in China based on adjuvant therapy for patients with stage I-IIIB tumors after complete resection.
Documents and incorporate the latest research progress.
Compared with other domestic consensus or guidelines, the applicable patients for postoperative adjuvant treatment of EGFR mutation-positive patients have been expanded from stage IIIA to stage IB-IIIB, and due to the inclusion of ADAURA, an international multicenter registration phase III randomized controlled clinical study, evidence of guidelines The level of evidence has also been greatly improved.
Compared with other domestic consensus or guidelines, the level of evidence has been updated from IB or IIB evidence to IA or IB evidence, especially the recommendation for osimertinib.
The level of evidence is all IA evidence.
Figure 4 Screenshot of CACA Early Guidelines.
Conclusion Postoperative adjuvant treatment is an important component of treatment for reducing recurrence, prolonging survival and improving quality of life after complete resection of early and mid-term NSCLC.
It ranges from classic postoperative adjuvant chemotherapy to recent studies such as ADAURA and ADJUVANT.
EGFR‑TKI adjuvant targeted therapy, adjuvant therapy brings more and more clinical benefits to patients with early and mid-term NSCLC.
According to the current evidence-based evidence, EGFR gene mutation detection should be routinely performed in patients with early and mid-term NSCLC, and corresponding adjuvant treatment strategies should be formulated according to the EGFR mutation status and tumor stage.
Guidelines for Adjuvant Treatment after Complete Resection of Stage I-IIIB Non-small Cell Lung Cancer (2021 Edition) Authoring Expert (in alphabetical order of surnames) Ai Xinghao (Shanghai Pulmonary Tumor Clinical Medical Center, Shanghai Chest Hospital, Shanghai Jiaotong University) Chen Chun (Department of Thoracic Surgery, Union Hospital of Fujian Medical University) Chen Jun (Department of Pulmonary Oncology, Tianjin Medical University General Hospital) Cheng Ying (Department of Oncology, Jilin Provincial Tumor Hospital) He Yong (Department of Respiratory and Critical Care Medicine, Army Special Medical Center) Hu Chengping (Central South Department of Respiratory Medicine, Xiangya Hospital of University) Hu Jian (Department of Thoracic Surgery, The First Affiliated Hospital of Zhejiang University School of Medicine) Li Chenguang (Department of Pulmonary Oncology, Tianjin Medical University Tumor Hospital) Li Danqing (Department of Thoracic Surgery, Peking Union Medical College Hospital) Li Yuan (Department of Shanghai Fudan University Tumor Hospital) Department of Science) Lin Dongmei (Department of Pathology, Peking University Cancer Hospital) Lu Shun (Shanghai Pulmonary Tumor Clinical Medical Center, Shanghai Thoracic Hospital Affiliated to Shanghai Jiaotong University) Ma Haitao (Department of Thoracic Surgery, Dushu Lake Hospital Affiliated to Soochow University) Mao Weimin (University of Chinese Academy of Sciences Cancer Hospital) Thoracic Oncology Surgery) Song Yong (Department of Respiratory Diseases, General Hospital of Eastern Theater Command), Wang Buhai (Department of Oncology, Subei People's Hospital, Jiangsu Province), Wang Jialei (Department of Oncology, Shanghai Fudan University Cancer Hospital), Wang Qiming (Department of Oncology, Henan Cancer Hospital), Wang Qun (Shanghai Fudan University) Department of Thoracic Surgery, Zhongshan Hospital Affiliated) Wang Weiwei (Department of Thoracic Surgery, Peking Union Medical College Hospital) Wang Changli (Department of Pulmonary Oncology, Tianjin Medical University Cancer Hospital) Wang Ziping (First Department of Thoracic Oncology, Peking University Cancer Hospital) Wu Yilong (Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangdong Provincial Institute of Lung Cancer) Xiong Jianping (Department of Oncology, The First Affiliated Hospital of Nanchang University) Xu Shidong (Department of Thoracic Surgery, Harbin Medical University Tumor Hospital) Yang Fan (Department of Thoracic Surgery, Peking University People’s Hospital) Yang Xuening (Department of Pulmonology, Guangdong Provincial People’s Hospital) Yuan Shuanghu (Shandong Tumor Hospital Department of Radiotherapy) Zhang Hao (Department of Thoracic Surgery, Affiliated Hospital of Xuzhou Medical University), Zhu Quan (Department of Thoracic Surgery, Jiangsu Provincial People's Hospital), Zhu Yuming (Department of Thoracic Surgery, Affiliated Pulmonary Hospital of Tongji University, Shanghai) Minglei Zhuo (Department of Thoracic Oncology, Peking University Cancer Hospital) References: [1]Zhong WZ, Wang Q, Mao WM, et al.
Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II-IIIA (N1-N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open -label, phase 3 study.
Lancet Oncol, 2018, 19 (1 ):139-148.
[2]Yue D, Xu S, Wang Q, et al.
Erlotinib versus vinorelbine plus cisplatin as adjuvant therapy in Chinese patients with stage IIIA EGFR mutation-positive non-small -cell lung cancer (EVAN): a randomised, open-label, phase 2 trial.
Lancet Respir Med.
2018 Nov;6(11):863-873.
[3] Consensus Expert Group of Thoracic Surgery for Adjuvant Treatment of Non-Small Cell Lung Cancer.
Consensus of Chinese Thoracic Surgery Experts on Postoperative Adjuvant Treatment of Non-Small Cell Lung Cancer (2018 Edition).
Chinese Journal of Lung Cancer, 2018(10):731-737.
[4] Chinese Society of Clinical Oncology Guidelines Working Committee.
Chinese Society of Clinical Oncology (CSCO) Principles Guidelines for diagnosis, treatment and treatment of primary lung cancer 2019.
[5]Yi-long wu, et al, N Engl J Med.
2020 Oct 29;383(18):1711-1723[6]Version 3.
2021, 2/2/21 © 2020 National Comprehensive Cancer Network® (NCCN®), [7] Chinese Anti-Cancer Association Lung Cancer Professional Committee, Oncology Branch of Chinese Medical Association Lung Cancer Group, Chinese Thoracic Tumor Research Collaborative Group, Chinese Medical Journal, April 27, 2021, Volume 101, Volume 101 Natl Med J China, April 27, 2021, Vol.
101, No.
16Erlotinib versus vinorelbine plus cisplatin as adjuvant therapy in Chinese patients with stage IIIA EGFR mutation-positive non-small-cell lung cancer (EVAN): a randomised, open-label, phase 2 trial.
Lancet Respir Med.
2018 Nov;6(11 ):863-873.
[3] Consensus expert group on thoracic surgery for adjuvant treatment of non-small cell lung cancer.
Consensus of Chinese experts on thoracic surgery for postoperative adjuvant treatment of non-small cell lung cancer (2018 edition).
Chinese Journal of Lung Cancer, 2018(10):731- 737.
[4] Chinese Society of Clinical Oncology Guidelines Working Committee.
Chinese Society of Clinical Oncology (CSCO) Primary Lung Cancer Diagnosis and Treatment Guidelines 2019.
[5] Yi-long wu, et al, N Engl J Med.
2020 Oct 29;383 (18):1711-1723[6]Version 3.
2021, 2/2/21 © 2020 National Comprehensive Cancer Network® (NCCN®), [7] Chinese Anti-Cancer Association Lung Cancer Professional Committee, Chinese Medical Association Oncology Branch Lung Cancer Group , China Thoracic Tumor Research Collaborative Group, Chinese Medical Journal, April 27, 2021, Volume 101, Issue 16, Natl Med J China, April 27, 2021, Vol.
101, No.
16Erlotinib versus vinorelbine plus cisplatin as adjuvant therapy in Chinese patients with stage IIIA EGFR mutation-positive non-small-cell lung cancer (EVAN): a randomised, open-label, phase 2 trial.
Lancet Respir Med.
2018 Nov;6(11 ):863-873.
[3] Consensus expert group on thoracic surgery for adjuvant treatment of non-small cell lung cancer.
Consensus of Chinese experts on thoracic surgery for postoperative adjuvant treatment of non-small cell lung cancer (2018 edition).
Chinese Journal of Lung Cancer, 2018(10):731- 737.
[4] Chinese Society of Clinical Oncology Guidelines Working Committee.
Chinese Society of Clinical Oncology (CSCO) Primary Lung Cancer Diagnosis and Treatment Guidelines 2019.
[5] Yi-long wu, et al, N Engl J Med.
2020 Oct 29;383 (18):1711-1723[6]Version 3.
2021, 2/2/21 © 2020 National Comprehensive Cancer Network® (NCCN®), [7] Chinese Anti-Cancer Association Lung Cancer Professional Committee, Chinese Medical Association Oncology Branch Lung Cancer Group , China Thoracic Tumor Research Collaborative Group, Chinese Medical Journal, April 27, 2021, Volume 101, Issue 16, Natl Med J China, April 27, 2021, Vol.
101, No.
16Consensus of Chinese Thoracic Surgery Experts on Postoperative Adjuvant Treatment of Non-Small Cell Lung Cancer (2018 Edition).
Chinese Journal of Lung Cancer, 2018(10):731-737.
[4] Chinese Society of Clinical Oncology Guidelines Working Committee.
Chinese Society of Clinical Oncology (CSCO) Principles Guidelines for diagnosis, treatment and treatment of primary lung cancer 2019.
[5]Yi-long wu, et al, N Engl J Med.
2020 Oct 29;383(18):1711-1723[6]Version 3.
2021, 2/2/21 © 2020 National Comprehensive Cancer Network® (NCCN®), [7] Chinese Anti-Cancer Association Lung Cancer Professional Committee, Oncology Branch of Chinese Medical Association Lung Cancer Group, Chinese Thoracic Tumor Research Collaborative Group, Chinese Medical Journal, April 27, 2021, Volume 101, Volume 101 16th issue Natl Med J China, April 27, 2021, Vol.
101, No.
16Consensus of Chinese Thoracic Surgery Experts on Postoperative Adjuvant Treatment of Non-Small Cell Lung Cancer (2018 Edition).
Chinese Journal of Lung Cancer, 2018(10):731-737.
[4] Chinese Society of Clinical Oncology Guidelines Working Committee.
Chinese Society of Clinical Oncology (CSCO) Principles Guidelines for diagnosis, treatment and treatment of primary lung cancer 2019.
[5]Yi-long wu, et al, N Engl J Med.
2020 Oct 29;383(18):1711-1723[6]Version 3.
2021, 2/2/21 © 2020 National Comprehensive Cancer Network® (NCCN®), [7] Chinese Anti-Cancer Association Lung Cancer Professional Committee, Oncology Branch of Chinese Medical Association Lung Cancer Group, Chinese Thoracic Tumor Research Collaborative Group, Chinese Medical Journal, April 27, 2021, Volume 101, Volume 101 16th issue Natl Med J China, April 27, 2021, Vol.
101, No.
16
We have not only experienced the ravages of COVID-19, but also witnessed the popularity of adjuvant targeted therapy.
Under the background that the efficacy of adjuvant chemotherapy may have reached a bottleneck , EGFR mutation-positive non-small cell lung cancer (NSCLC) adjuvant targeted therapy once again made a major breakthrough, and then the National Comprehensive Cancer Network (NCCN) 2021 V1 guidelines were updated again, and for the first time osimertinib was used as a stage IB-IIIB EGFR mutation The "considered" adjuvant treatment plan for positive patients after surgery has also officially announced the arrival of a new era of adjuvant targeted therapy! The evolution of targeted drugs in adjuvant therapy status in domestic and foreign guidelines With the successful listing of gefitinib in 2003, targeted therapy has been updated in major guidelines with each passing day.
When gefitinib first entered China in 2005, EGFR-TKI was only recommended as a late-line treatment for advanced NSCLC.
But now, both domestic and foreign important guidelines have listed EGFR-TKI as the first-line standard treatment for patients with EGFR sensitive mutations.
However, in terms of EGFR-TKI adjuvant targeted therapy, due to the small number of foreign EGFR-TKI adjuvant therapy studies and the research design has certain limitations, no targeted therapy was recommended as an adjuvant before the NCCN 2021 V1 update Treatment options.
In China, the exploration of EGFR-TKI adjuvant therapy is relatively fast.
With the success of ADJUVANT research and EVAN research, EGFR-TKI targeted therapy has entered the adjuvant therapy stage.
The ADJUVANT study is the first prospective randomized controlled phase III clinical trial comparing gefitinib versus vinorelbine combined with cisplatin in NSCLC patients with EGFR mutation-positive and completely resected stage II-IIIA (N1-N2) , A total of 222 patients were enrolled.
The results of the study showed that compared with chemotherapy, gefitinib significantly prolonged the median disease-free survival (DFS) (18.
0 months vs 28.
7 months, HR=0.
60, P=0.
0054).
Subgroup analysis showed that N2 patients There are more benefits from postoperative adjuvant targeted therapy [1].
The EVAN study is a prospective randomized multicenter phase II clinical study comparing the efficacy and safety of erlotinib with platinum-containing two-drug chemotherapy as adjuvant therapy for stage IIIA NSCLC patients with EGFR mutations after complete resection.
The results showed that compared with chemotherapy, erlotinib significantly increased the 2-year DFS rate (44.
6% vs 81.
4%, P<0.
001) and significantly prolonged the median DFS (21.
0 months vs 42.
4 months, HR=0.
268, P< 0.
001) [2].
Based on the similar EGFR-TKI adjuvant treatments in the above two studies with significant DFS benefits, the current "2018 Edition of the Chinese Expert Consensus of Thoracic Surgery for Postoperative Adjuvant Treatment of NSCLC" unanimously recommends EGFR-TKI for postoperative adjuvant treatment of NSCLC.
This consensus It was pointed out that "EGFR-TKI can be used for postoperative adjuvant treatment of patients with stage IIIA EGFR sensitive mutation-positive NSCLC (Class 1B evidence)" [3].
In the "2019 CSCO Guidelines for the Diagnosis and Treatment of Primary Lung Cancer", the content about EGFR-TKI recommended for the adjuvant treatment of NSCLC is also updated.
The guide recommends "for operable stage IIIA or IIIA primary NSCLC, for direct surgery and surgery Patients who were later detected as EGFR mutation-positive, assisted EGFR-TKI targeted therapy after surgery (type 2B evidence)" [4].
However, it is a bit regrettable that the current domestic guidelines recommending EGFR-TKI for adjuvant treatment of NSCLC are mainly based on the results of a first-generation EGFR-TKI study.
The applicable patients are limited to stage IIIA, and the level of evidence is not high. The release of the third-generation EGFR-TKI osimertinib study data, promoting the further update of the guidelines The ADAURA study of the third-generation EGFR-TKI osimertinib [5] is an international multi-center, double-blind, randomized controlled phase III In clinical studies, the main research endpoint is to evaluate the median DFS in patients with stage II-IIIA EGFR sensitive mutations positive for osimertinib adjuvant treatment and undergoing complete resection of NSCLC.
It is worth noting that this study did not use the conventional adjuvant-targeted EGFR-TKI head-to-head adjuvant chemotherapy design, but allowed patients to choose whether to receive adjuvant chemotherapy first according to the actual situation before randomization.
This design can better help Clinicians understand the positioning of adjuvant chemotherapy in adjuvant treatment of EGFR mutation-positive patients.
The secondary study endpoints were DFS in patients with stage IB-IIIA, DFS in 2, 3, 4, and 5 years, overall survival (OS), safety and quality of life, etc.
The ADAURA study was originally planned to publish data in 2020, but because osimertinib was found to have shown an overwhelming efficacy advantage in a routine safety assessment, it is recommended to unblind in advance, so the study announced the results 2 years in advance.
The median DFS of the primary study endpoint of stage II-IIIA patients had a significant benefit, with a DFS HR value of 0.
17 (99.
06%CI 0.
11-0.
26, P<0.
001).
The secondary endpoint of the study also had a median DFS of stage IB-IIIA patients.
There was a significant benefit, with an HR value of 0.
20 (99.
12%CI 0.
14-0.
30, P<0.
001).
Figure 1 ADAURA study DFS results are based on the results of this research, NCCN Guidelines 2021 editions V1, V2 and V3, 3 consecutive editions update recommendations for adjuvant osimertinib, the latest V3 version [6], V1 and V2 The "consideration" of using osimertinib for adjuvant therapy was removed twice, and it is officially recommended that "osimertinib adjuvant treatment of stage IB-IIIB EGFR mutation positive and has used adjuvant chemotherapy in the past or is not suitable for the use of adjuvant platinum-containing dual drugs Patients undergoing chemotherapy", but unfortunately, as of today, China has not yet updated the guidelines based on the ADAURA study.
Figure 2 The NCCN guidelines recommend the early CACA guidelines to fill in the gaps, and the targeted adjuvant therapy for Chinese patients will eventually be "documented.
" This guide [7] fully absorbs the latest global clinical research results, and refers to international guidelines and China's national conditions.
The subject expert group’s repeated discussions aimed to standardize the diagnosis, molecular testing, adjuvant therapy, postoperative management and other issues of patients with stage I-IIIB NSCLC after complete tumor resection, in order to reduce postoperative recurrence rate, prolong patient survival time and improve patients Quality of Life.
Figure 3 Screenshot of the early CACA guidelines.
Compared with other domestic guidelines, the scope of EGFR-TKI adjuvant therapy is expanded and the level of evidence is high.
This guide is the first standard in China based on adjuvant therapy for patients with stage I-IIIB tumors after complete resection.
Documents and incorporate the latest research progress.
Compared with other domestic consensus or guidelines, the applicable patients for postoperative adjuvant treatment of EGFR mutation-positive patients have been expanded from stage IIIA to stage IB-IIIB, and due to the inclusion of ADAURA, an international multicenter registration phase III randomized controlled clinical study, evidence of guidelines The level of evidence has also been greatly improved.
Compared with other domestic consensus or guidelines, the level of evidence has been updated from IB or IIB evidence to IA or IB evidence, especially the recommendation for osimertinib.
The level of evidence is all IA evidence.
Figure 4 Screenshot of CACA Early Guidelines.
Conclusion Postoperative adjuvant treatment is an important component of treatment for reducing recurrence, prolonging survival and improving quality of life after complete resection of early and mid-term NSCLC.
It ranges from classic postoperative adjuvant chemotherapy to recent studies such as ADAURA and ADJUVANT.
EGFR‑TKI adjuvant targeted therapy, adjuvant therapy brings more and more clinical benefits to patients with early and mid-term NSCLC.
According to the current evidence-based evidence, EGFR gene mutation detection should be routinely performed in patients with early and mid-term NSCLC, and corresponding adjuvant treatment strategies should be formulated according to the EGFR mutation status and tumor stage.
Guidelines for Adjuvant Treatment after Complete Resection of Stage I-IIIB Non-small Cell Lung Cancer (2021 Edition) Authoring Expert (in alphabetical order of surnames) Ai Xinghao (Shanghai Pulmonary Tumor Clinical Medical Center, Shanghai Chest Hospital, Shanghai Jiaotong University) Chen Chun (Department of Thoracic Surgery, Union Hospital of Fujian Medical University) Chen Jun (Department of Pulmonary Oncology, Tianjin Medical University General Hospital) Cheng Ying (Department of Oncology, Jilin Provincial Tumor Hospital) He Yong (Department of Respiratory and Critical Care Medicine, Army Special Medical Center) Hu Chengping (Central South Department of Respiratory Medicine, Xiangya Hospital of University) Hu Jian (Department of Thoracic Surgery, The First Affiliated Hospital of Zhejiang University School of Medicine) Li Chenguang (Department of Pulmonary Oncology, Tianjin Medical University Tumor Hospital) Li Danqing (Department of Thoracic Surgery, Peking Union Medical College Hospital) Li Yuan (Department of Shanghai Fudan University Tumor Hospital) Department of Science) Lin Dongmei (Department of Pathology, Peking University Cancer Hospital) Lu Shun (Shanghai Pulmonary Tumor Clinical Medical Center, Shanghai Thoracic Hospital Affiliated to Shanghai Jiaotong University) Ma Haitao (Department of Thoracic Surgery, Dushu Lake Hospital Affiliated to Soochow University) Mao Weimin (University of Chinese Academy of Sciences Cancer Hospital) Thoracic Oncology Surgery) Song Yong (Department of Respiratory Diseases, General Hospital of Eastern Theater Command), Wang Buhai (Department of Oncology, Subei People's Hospital, Jiangsu Province), Wang Jialei (Department of Oncology, Shanghai Fudan University Cancer Hospital), Wang Qiming (Department of Oncology, Henan Cancer Hospital), Wang Qun (Shanghai Fudan University) Department of Thoracic Surgery, Zhongshan Hospital Affiliated) Wang Weiwei (Department of Thoracic Surgery, Peking Union Medical College Hospital) Wang Changli (Department of Pulmonary Oncology, Tianjin Medical University Cancer Hospital) Wang Ziping (First Department of Thoracic Oncology, Peking University Cancer Hospital) Wu Yilong (Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangdong Provincial Institute of Lung Cancer) Xiong Jianping (Department of Oncology, The First Affiliated Hospital of Nanchang University) Xu Shidong (Department of Thoracic Surgery, Harbin Medical University Tumor Hospital) Yang Fan (Department of Thoracic Surgery, Peking University People’s Hospital) Yang Xuening (Department of Pulmonology, Guangdong Provincial People’s Hospital) Yuan Shuanghu (Shandong Tumor Hospital Department of Radiotherapy) Zhang Hao (Department of Thoracic Surgery, Affiliated Hospital of Xuzhou Medical University), Zhu Quan (Department of Thoracic Surgery, Jiangsu Provincial People's Hospital), Zhu Yuming (Department of Thoracic Surgery, Affiliated Pulmonary Hospital of Tongji University, Shanghai) Minglei Zhuo (Department of Thoracic Oncology, Peking University Cancer Hospital) References: [1]Zhong WZ, Wang Q, Mao WM, et al.
Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II-IIIA (N1-N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open -label, phase 3 study.
Lancet Oncol, 2018, 19 (1 ):139-148.
[2]Yue D, Xu S, Wang Q, et al.
Erlotinib versus vinorelbine plus cisplatin as adjuvant therapy in Chinese patients with stage IIIA EGFR mutation-positive non-small -cell lung cancer (EVAN): a randomised, open-label, phase 2 trial.
Lancet Respir Med.
2018 Nov;6(11):863-873.
[3] Consensus Expert Group of Thoracic Surgery for Adjuvant Treatment of Non-Small Cell Lung Cancer.
Consensus of Chinese Thoracic Surgery Experts on Postoperative Adjuvant Treatment of Non-Small Cell Lung Cancer (2018 Edition).
Chinese Journal of Lung Cancer, 2018(10):731-737.
[4] Chinese Society of Clinical Oncology Guidelines Working Committee.
Chinese Society of Clinical Oncology (CSCO) Principles Guidelines for diagnosis, treatment and treatment of primary lung cancer 2019.
[5]Yi-long wu, et al, N Engl J Med.
2020 Oct 29;383(18):1711-1723[6]Version 3.
2021, 2/2/21 © 2020 National Comprehensive Cancer Network® (NCCN®), [7] Chinese Anti-Cancer Association Lung Cancer Professional Committee, Oncology Branch of Chinese Medical Association Lung Cancer Group, Chinese Thoracic Tumor Research Collaborative Group, Chinese Medical Journal, April 27, 2021, Volume 101, Volume 101 Natl Med J China, April 27, 2021, Vol.
101, No.
16Erlotinib versus vinorelbine plus cisplatin as adjuvant therapy in Chinese patients with stage IIIA EGFR mutation-positive non-small-cell lung cancer (EVAN): a randomised, open-label, phase 2 trial.
Lancet Respir Med.
2018 Nov;6(11 ):863-873.
[3] Consensus expert group on thoracic surgery for adjuvant treatment of non-small cell lung cancer.
Consensus of Chinese experts on thoracic surgery for postoperative adjuvant treatment of non-small cell lung cancer (2018 edition).
Chinese Journal of Lung Cancer, 2018(10):731- 737.
[4] Chinese Society of Clinical Oncology Guidelines Working Committee.
Chinese Society of Clinical Oncology (CSCO) Primary Lung Cancer Diagnosis and Treatment Guidelines 2019.
[5] Yi-long wu, et al, N Engl J Med.
2020 Oct 29;383 (18):1711-1723[6]Version 3.
2021, 2/2/21 © 2020 National Comprehensive Cancer Network® (NCCN®), [7] Chinese Anti-Cancer Association Lung Cancer Professional Committee, Chinese Medical Association Oncology Branch Lung Cancer Group , China Thoracic Tumor Research Collaborative Group, Chinese Medical Journal, April 27, 2021, Volume 101, Issue 16, Natl Med J China, April 27, 2021, Vol.
101, No.
16Erlotinib versus vinorelbine plus cisplatin as adjuvant therapy in Chinese patients with stage IIIA EGFR mutation-positive non-small-cell lung cancer (EVAN): a randomised, open-label, phase 2 trial.
Lancet Respir Med.
2018 Nov;6(11 ):863-873.
[3] Consensus expert group on thoracic surgery for adjuvant treatment of non-small cell lung cancer.
Consensus of Chinese experts on thoracic surgery for postoperative adjuvant treatment of non-small cell lung cancer (2018 edition).
Chinese Journal of Lung Cancer, 2018(10):731- 737.
[4] Chinese Society of Clinical Oncology Guidelines Working Committee.
Chinese Society of Clinical Oncology (CSCO) Primary Lung Cancer Diagnosis and Treatment Guidelines 2019.
[5] Yi-long wu, et al, N Engl J Med.
2020 Oct 29;383 (18):1711-1723[6]Version 3.
2021, 2/2/21 © 2020 National Comprehensive Cancer Network® (NCCN®), [7] Chinese Anti-Cancer Association Lung Cancer Professional Committee, Chinese Medical Association Oncology Branch Lung Cancer Group , China Thoracic Tumor Research Collaborative Group, Chinese Medical Journal, April 27, 2021, Volume 101, Issue 16, Natl Med J China, April 27, 2021, Vol.
101, No.
16Consensus of Chinese Thoracic Surgery Experts on Postoperative Adjuvant Treatment of Non-Small Cell Lung Cancer (2018 Edition).
Chinese Journal of Lung Cancer, 2018(10):731-737.
[4] Chinese Society of Clinical Oncology Guidelines Working Committee.
Chinese Society of Clinical Oncology (CSCO) Principles Guidelines for diagnosis, treatment and treatment of primary lung cancer 2019.
[5]Yi-long wu, et al, N Engl J Med.
2020 Oct 29;383(18):1711-1723[6]Version 3.
2021, 2/2/21 © 2020 National Comprehensive Cancer Network® (NCCN®), [7] Chinese Anti-Cancer Association Lung Cancer Professional Committee, Oncology Branch of Chinese Medical Association Lung Cancer Group, Chinese Thoracic Tumor Research Collaborative Group, Chinese Medical Journal, April 27, 2021, Volume 101, Volume 101 16th issue Natl Med J China, April 27, 2021, Vol.
101, No.
16Consensus of Chinese Thoracic Surgery Experts on Postoperative Adjuvant Treatment of Non-Small Cell Lung Cancer (2018 Edition).
Chinese Journal of Lung Cancer, 2018(10):731-737.
[4] Chinese Society of Clinical Oncology Guidelines Working Committee.
Chinese Society of Clinical Oncology (CSCO) Principles Guidelines for diagnosis, treatment and treatment of primary lung cancer 2019.
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