China Voices Professor Zhou Caicun's team published the results of the postoperative adjuvant targeted therapy EVIDENCE

Professor Zhou Caicun’s team from Shanghai Pulmonary Hospital published the latest postoperative assisted targeting EVIDENCE research results online in The Lancet Respiratory Medicine, the world’s top academic journal The Lancet Respiratory Medicine, in Beijing time On July 17, an online publication led by Professor Caicun Zhou, “Icotinib versus standard adjuvant chemotherapy for stage II-IIIA non-small cell lung cancer (NSCLC) with EGFR sensitive mutations) was published online.
Phase III clinical study (EVIDENCE study)" results
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The EVIDENCE study is the first registered clinical study in the field of postoperative adjuvant treatment of non-small cell lung cancer in China.
It was jointly led by Professor Zhou Caicun and He Jianxing, Dean of the First Affiliated Hospital of Guangzhou Medical University.
A total of 29 centers across the country participated.
The study lasted six years
.

Enrolled 322 EGFR mutation-positive subjects after stage II-IIIA and randomly divided into groups at 1:1.
The test group was given EGFR-TKI 125mg TID orally for 2 years, and the control group was given the standard adjuvant chemotherapy group vinorelbine Follow up after 4 cycles of Bin/cisplatin or pemetrexed/cisplatin chemotherapy until recurrence, intolerance or death
.

The primary research endpoint is disease-free survival (DFS), and the key secondary research endpoints are 3-year and 5-year DFS survival rates, overall survival (OS), and safety
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The results of the study show that the efficacy of icotinib for postoperative adjuvant treatment of NSCLC patients with sensitive EGFR gene mutations is significantly better than that of standard adjuvant chemotherapy.
Postoperative adjuvant targeted therapy significantly prolongs the disease-free survival of patients and is more safe.
Excellent
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The median DFS in the adjuvant targeted therapy group was 47.
0 months, and the median DFS in the standard adjuvant chemotherapy group was 22.
1 months (HR=0.
36, 95%CI 0.
24-0.
55, p<0.
0001); DFS was analyzed by clinical characteristics in each subgroup.
Shows that the adjuvant targeted therapy group is better than the standard adjuvant chemotherapy group
.

The 3-year DFS rates in the adjuvant targeted therapy group and standard adjuvant chemotherapy group were 63.
9% and 32.
5%, respectively
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In terms of safety, the incidence of adverse reactions in the adjuvant targeted therapy group was significantly lower than that in the standard adjuvant chemotherapy group, and the incidence of adverse events of grade 3 and above was 11% vs 61%
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The common adverse reaction in the adjuvant targeted therapy group was skin rash, while the common adverse reaction in the standard adjuvant chemotherapy group was gastrointestinal reactions such as nausea, vomiting and hematological toxicity
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Professor Zhou Caicun gave an oral report on the study at the World Conference on Lung Cancer (WCLC) to be held from January 28 to 31, 2021, which aroused widespread attention from the participants
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For the article published this time, Professor Zhou Caicun of Shanghai Pulmonary Hospital is the corresponding author, and He Jianxing, Dean of the First Affiliated Hospital of Guangzhou Medical University, and Associate Professor Su Chunxia, ​​deputy director of the Oncology Department of Shanghai Pulmonary Hospital, are the co-first authors
.

The EVIDENCE study proved that icotinib is an "efficient and low-toxicity" method for postoperative adjuvant treatment of NSCLC patients with EGFR gene-sensitive mutations, and it also provides important evidence-based evidence for postoperative adjuvant therapy for NSCLC with EGFR-sensitive mutations.
Basis
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As the first postoperative adjuvant targeted therapy registration clinical study in the field of NSCLC, EVIDENCE provides high-level evidence-based medical evidence for the approval of the indications for adjuvant therapy of icotinib
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The biggest highlight of the EVIDENCE study is that the enrolled patients are all postoperative patients with EGFR-sensitive mutations of stage II to IIIA, which is a patient group with a higher probability of recurrence after surgery
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This study is a multi-center registered clinical study for the Chinese population.
Therefore, the success of this study is very important for Chinese lung cancer patients, because this is the data from the Chinese population, and the test results are fully applicable to the national body.
The clinical practice and adjuvant treatment of lung cancer patients in China will be of great significance in the future
.

On June 1, 2021, the National Medical Products Administration (NMPA) issued an approval document, and the new indication for postoperative adjuvant treatment of icotinib based on this study was approved for marketing
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"The Lancet Respiratory Medicine" (impact factor 30.
143) is one of the "Lancet" professional series of sub-journals, continuing the tradition of "The Lancet" publishing high-impact medical practice content, the main journal Post articles in the fields of respiratory medicine and intensive care
.

The publication of the EVIDENCE research results in The Lancet Respiratory Medicine indicates that the clinical research capabilities of Chinese researchers, represented by Professor Zhou Caicun, in the treatment of related diseases have reached the international advanced level, and further confirmed the treatment method The effectiveness and safety in the adjuvant treatment phase have expanded the scope of indications for EGFR-TKI and enhanced the international reputation and influence of the research team led by Chinese experts
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At present, Icotinib has been approved for postoperative adjuvant indications, and we look forward to benefiting more Chinese patients
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· Introduction to Professor Zhou Caicun’s Team The Department of Oncology, Shanghai Pulmonary Hospital, is a lung cancer research team that integrates clinical diagnosis and treatment, translational research, and basic scientific research.
It is a key clinical specialty in Shanghai, a key clinical specialty in Shanghai, and a major clinical specialty in Shanghai.
Collaborative innovation team
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Disciplinary leader Professor Caicun Zhou is a member of the Board of Directors of the International Lung Cancer Alliance, Shanghai Leading Talent, Shanghai Disciplinary Leader, enjoys a special allowance from the State Council, Director of the Non-Small Cell Lung Cancer Special Committee of the Chinese Cancer Society, and the Thoracic Tumor Branch of the China Association for International Exchange and Promotion of Healthcare Chairman
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Under the leadership of Professor Zhou Caicun, this discipline has established a lung cancer research team with reasonable talent echelon, strong academic atmosphere, and extremely influential domestic lung cancer
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The team currently has 3 professors, 6 associate professors, 6 doctoral supervisors, 12 master supervisors, 1 special allowance from the State Council, 1 Shanghai Leading Talent, 1 Silver Snake Award, and 1 Shanghai Talent Development Program , 1 Young Top Talent, 1 Pujiang Talent, 1 Dawn Project, 1 Yang Fan Project, 1 Morning Light Project, 2 Shanghai Outstanding Young Physicians, 1 Shanghai Outstanding Young Physician, Shanghai Anti-Cancer Association Young Eagle There are 2 people in the plan, 2 people in the New Talent Cultivation Program of Shanghai Pulmonary Hospital, and 3 outstanding graduates in Shanghai
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The team has made outstanding achievements in the accurate field of early diagnosis of lung cancer and advanced lung cancer
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In the field of early diagnosis, we have created a precise and rapid early diagnosis strategy, established a new strategy for the first-line treatment of driver gene-positive lung cancer for advanced lung cancer, and established a new standard for the first-line treatment of chemotherapy combined with anti-vascular and immune combined chemotherapy for driver gene-negative lung cancer, which has changed the overall lung cancer in China The diagnosis and treatment model significantly prolongs the overall survival of patients with advanced lung cancer in China
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SourceShanghai Pulmonary Hospital