{"title":"医生对乳腺癌临床试验主要终点相关证据的认知","authors":"Yi Zhang, Miao Liu, Houpu Yang, Shu Wang","doi":"10.1159/000518260","DOIUrl":null,"url":null,"abstract":"Objective: To investigate physicians’ perception of the evidence of clinical trials on breast cancer. Methods: A survey was conducted by the Chinese Society of Breast Surgeons. We investigated the physicians’ perception of meaningful endpoints, appropriate follow-up duration, and clinically acceptable benefit through online questionnaires. Results: Among 278 validated questionnaires, the majority of the questions had no consistent answer. For local treatment, 30.6, 28.8, and 28.4% of participants regarded locoregional recurrence (LRR), disease-free survival (DFS), and overall survival (OS) as the most meaningful endpoint, respectively, 47.5% believed that 5-year follow-up can alter clinical practice, and 34.5% thought it should be >10 years. In the adjuvant setting, 45.7, 38.5, and 12.9% regarded DFS, OS, and LRR as the most meaningful endpoint, respectively, 52.5% thought that 10-year follow-up was solid, while 37.4% thought that 5-year follow-up was enough. In the advanced setting, 49.6, 24.1, and 23.7% considered progression-free survival, quality of life, and OS the most meaningful endpoint, respectively, and 39.6 and 28.8% considered that a follow-up of 1 year and 3 years, respectively, was meaningful. Similarly, the clinically acceptable absolute difference was inconsistent. Conclusion: Most Chinese oncologists advocated that surrogate endpoints could be used in certain circumstances, though OS was the most reliable one in breast cancer studies. Doctors’ perceptions of follow-up time and magnitude of benefit vary widely, reflecting the fact that there are many unanswered questions about supporting the use of new cancer treatments; a common understanding needs to be reached, such as a very consensual surrogate endpoint and a meaningful sufficiently large therapeutic benefit.","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"17 1","pages":"180 - 187"},"PeriodicalIF":2.0000,"publicationDate":"2021-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Physicians’ Perception of the Evidence in Relation to Primary Endpoints of Clinical Trials on Breast Cancer\",\"authors\":\"Yi Zhang, Miao Liu, Houpu Yang, Shu Wang\",\"doi\":\"10.1159/000518260\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Objective: To investigate physicians’ perception of the evidence of clinical trials on breast cancer. Methods: A survey was conducted by the Chinese Society of Breast Surgeons. We investigated the physicians’ perception of meaningful endpoints, appropriate follow-up duration, and clinically acceptable benefit through online questionnaires. Results: Among 278 validated questionnaires, the majority of the questions had no consistent answer. For local treatment, 30.6, 28.8, and 28.4% of participants regarded locoregional recurrence (LRR), disease-free survival (DFS), and overall survival (OS) as the most meaningful endpoint, respectively, 47.5% believed that 5-year follow-up can alter clinical practice, and 34.5% thought it should be >10 years. In the adjuvant setting, 45.7, 38.5, and 12.9% regarded DFS, OS, and LRR as the most meaningful endpoint, respectively, 52.5% thought that 10-year follow-up was solid, while 37.4% thought that 5-year follow-up was enough. In the advanced setting, 49.6, 24.1, and 23.7% considered progression-free survival, quality of life, and OS the most meaningful endpoint, respectively, and 39.6 and 28.8% considered that a follow-up of 1 year and 3 years, respectively, was meaningful. Similarly, the clinically acceptable absolute difference was inconsistent. Conclusion: Most Chinese oncologists advocated that surrogate endpoints could be used in certain circumstances, though OS was the most reliable one in breast cancer studies. Doctors’ perceptions of follow-up time and magnitude of benefit vary widely, reflecting the fact that there are many unanswered questions about supporting the use of new cancer treatments; a common understanding needs to be reached, such as a very consensual surrogate endpoint and a meaningful sufficiently large therapeutic benefit.\",\"PeriodicalId\":9310,\"journal\":{\"name\":\"Breast Care\",\"volume\":\"17 1\",\"pages\":\"180 - 187\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2021-08-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Breast Care\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000518260\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Breast Care","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000518260","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
Physicians’ Perception of the Evidence in Relation to Primary Endpoints of Clinical Trials on Breast Cancer
Objective: To investigate physicians’ perception of the evidence of clinical trials on breast cancer. Methods: A survey was conducted by the Chinese Society of Breast Surgeons. We investigated the physicians’ perception of meaningful endpoints, appropriate follow-up duration, and clinically acceptable benefit through online questionnaires. Results: Among 278 validated questionnaires, the majority of the questions had no consistent answer. For local treatment, 30.6, 28.8, and 28.4% of participants regarded locoregional recurrence (LRR), disease-free survival (DFS), and overall survival (OS) as the most meaningful endpoint, respectively, 47.5% believed that 5-year follow-up can alter clinical practice, and 34.5% thought it should be >10 years. In the adjuvant setting, 45.7, 38.5, and 12.9% regarded DFS, OS, and LRR as the most meaningful endpoint, respectively, 52.5% thought that 10-year follow-up was solid, while 37.4% thought that 5-year follow-up was enough. In the advanced setting, 49.6, 24.1, and 23.7% considered progression-free survival, quality of life, and OS the most meaningful endpoint, respectively, and 39.6 and 28.8% considered that a follow-up of 1 year and 3 years, respectively, was meaningful. Similarly, the clinically acceptable absolute difference was inconsistent. Conclusion: Most Chinese oncologists advocated that surrogate endpoints could be used in certain circumstances, though OS was the most reliable one in breast cancer studies. Doctors’ perceptions of follow-up time and magnitude of benefit vary widely, reflecting the fact that there are many unanswered questions about supporting the use of new cancer treatments; a common understanding needs to be reached, such as a very consensual surrogate endpoint and a meaningful sufficiently large therapeutic benefit.
期刊介绍:
''Breast Care'' is a peer-reviewed scientific journal that covers all aspects of breast biology. Due to its interdisciplinary perspective, it encompasses articles on basic research, prevention, diagnosis, and treatment of malignant diseases of the breast. In addition to presenting current developments in clinical research, the scope of clinical practice is broadened by including articles on relevant legal, financial and economic issues.