N. Agrawal, Jack M. Shireman, K. Shiue, A. Kamer, La Keisha Boyd, Y. Zang, Neel Mukherjee, James C. Miller, C. Kulwin, Aaron A. Cohen-Gadol, Troy Payner, Chih-Ta Lin, Jesse J. Savage, Brandon Lane, Bradley Bohnstedt, T. Lautenschlaeger, Naoyuki Saito, Mitesh Shah, G. Watson, Mahua Dey
{"title":"针对一至四个脑转移灶患者的术前立体定向放射外科治疗:单臂 2 期试验结果分析(NCT03398694)","authors":"N. Agrawal, Jack M. Shireman, K. Shiue, A. Kamer, La Keisha Boyd, Y. Zang, Neel Mukherjee, James C. Miller, C. Kulwin, Aaron A. Cohen-Gadol, Troy Payner, Chih-Ta Lin, Jesse J. Savage, Brandon Lane, Bradley Bohnstedt, T. Lautenschlaeger, Naoyuki Saito, Mitesh Shah, G. Watson, Mahua Dey","doi":"10.1093/nop/npae043","DOIUrl":null,"url":null,"abstract":"\n \n \n Stereotactic radiosurgery (SRS) following surgical resection is the standard of care for patients with symptomatic oligo brain metastasis (BM), however, it is associated with 10-15% local failure. Targeting a resection cavity is imprecise, thus pre-operative radiosurgery where the target is well defined may be superior, however, the efficacy of pre-operative SRS has not yet been tested in a clinical trial.\n \n \n \n We conducted a phase II, single-arm trial of pre-operative SRS followed by surgical resection in patients with 1-4 symptomatic oligo BMs (NCT03398694) with the primary objective of measuring 6-month local control (LC). SRS was delivered to all patients utilizing gamma knife or linear accelerator as per RTOG-9005 dosing criteria24 based on tumor diameter with the exception that the largest lesion diameter treated was 5 cm with 15 Gy with all SRS treatment given in single fraction dosing.\n \n \n \n The trial screened 50 patients, 48 patients were treated under the protocol and 32 patients completed the entire follow-up period. Of all the patients who completed the follow-up period, primary endpoint of 6-month LC was 100% (95% CI: 0.891-1.000; p=0.005). Secondary endpoints, presented as medians, were overall-survival (17.6 months), progression-free survival (5.3 months), distant in-brain failure (40.8% at 1 year), leptomeningeal failure (4.8% at 1 year), and radiation necrosis (7.7% at 1 year).\n \n \n \n Our data confirms superior local control in patients who received pre-operative SRS when compared to historical controls. Further study with a larger randomized cohort of patients is warranted to fully understand the benefits of pre-operative SRS.\n","PeriodicalId":2,"journal":{"name":"ACS Applied Bio Materials","volume":" 18","pages":""},"PeriodicalIF":4.6000,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Pre-operative Stereotactic Radiosurgery for Patients with One to Four Brain Metastases: A Single-Arm Phase 2 Trial Outcome Analysis (NCT03398694)\",\"authors\":\"N. Agrawal, Jack M. Shireman, K. Shiue, A. Kamer, La Keisha Boyd, Y. Zang, Neel Mukherjee, James C. Miller, C. Kulwin, Aaron A. Cohen-Gadol, Troy Payner, Chih-Ta Lin, Jesse J. Savage, Brandon Lane, Bradley Bohnstedt, T. Lautenschlaeger, Naoyuki Saito, Mitesh Shah, G. Watson, Mahua Dey\",\"doi\":\"10.1093/nop/npae043\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"\\n \\n \\n Stereotactic radiosurgery (SRS) following surgical resection is the standard of care for patients with symptomatic oligo brain metastasis (BM), however, it is associated with 10-15% local failure. Targeting a resection cavity is imprecise, thus pre-operative radiosurgery where the target is well defined may be superior, however, the efficacy of pre-operative SRS has not yet been tested in a clinical trial.\\n \\n \\n \\n We conducted a phase II, single-arm trial of pre-operative SRS followed by surgical resection in patients with 1-4 symptomatic oligo BMs (NCT03398694) with the primary objective of measuring 6-month local control (LC). SRS was delivered to all patients utilizing gamma knife or linear accelerator as per RTOG-9005 dosing criteria24 based on tumor diameter with the exception that the largest lesion diameter treated was 5 cm with 15 Gy with all SRS treatment given in single fraction dosing.\\n \\n \\n \\n The trial screened 50 patients, 48 patients were treated under the protocol and 32 patients completed the entire follow-up period. Of all the patients who completed the follow-up period, primary endpoint of 6-month LC was 100% (95% CI: 0.891-1.000; p=0.005). Secondary endpoints, presented as medians, were overall-survival (17.6 months), progression-free survival (5.3 months), distant in-brain failure (40.8% at 1 year), leptomeningeal failure (4.8% at 1 year), and radiation necrosis (7.7% at 1 year).\\n \\n \\n \\n Our data confirms superior local control in patients who received pre-operative SRS when compared to historical controls. Further study with a larger randomized cohort of patients is warranted to fully understand the benefits of pre-operative SRS.\\n\",\"PeriodicalId\":2,\"journal\":{\"name\":\"ACS Applied Bio Materials\",\"volume\":\" 18\",\"pages\":\"\"},\"PeriodicalIF\":4.6000,\"publicationDate\":\"2024-05-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"ACS Applied Bio Materials\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1093/nop/npae043\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MATERIALS SCIENCE, BIOMATERIALS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Applied Bio Materials","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/nop/npae043","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MATERIALS SCIENCE, BIOMATERIALS","Score":null,"Total":0}
Pre-operative Stereotactic Radiosurgery for Patients with One to Four Brain Metastases: A Single-Arm Phase 2 Trial Outcome Analysis (NCT03398694)
Stereotactic radiosurgery (SRS) following surgical resection is the standard of care for patients with symptomatic oligo brain metastasis (BM), however, it is associated with 10-15% local failure. Targeting a resection cavity is imprecise, thus pre-operative radiosurgery where the target is well defined may be superior, however, the efficacy of pre-operative SRS has not yet been tested in a clinical trial.
We conducted a phase II, single-arm trial of pre-operative SRS followed by surgical resection in patients with 1-4 symptomatic oligo BMs (NCT03398694) with the primary objective of measuring 6-month local control (LC). SRS was delivered to all patients utilizing gamma knife or linear accelerator as per RTOG-9005 dosing criteria24 based on tumor diameter with the exception that the largest lesion diameter treated was 5 cm with 15 Gy with all SRS treatment given in single fraction dosing.
The trial screened 50 patients, 48 patients were treated under the protocol and 32 patients completed the entire follow-up period. Of all the patients who completed the follow-up period, primary endpoint of 6-month LC was 100% (95% CI: 0.891-1.000; p=0.005). Secondary endpoints, presented as medians, were overall-survival (17.6 months), progression-free survival (5.3 months), distant in-brain failure (40.8% at 1 year), leptomeningeal failure (4.8% at 1 year), and radiation necrosis (7.7% at 1 year).
Our data confirms superior local control in patients who received pre-operative SRS when compared to historical controls. Further study with a larger randomized cohort of patients is warranted to fully understand the benefits of pre-operative SRS.
期刊介绍:
ACS Applied Bio Materials is an interdisciplinary journal publishing original research covering all aspects of biomaterials and biointerfaces including and beyond the traditional biosensing, biomedical and therapeutic applications.
The journal is devoted to reports of new and original experimental and theoretical research of an applied nature that integrates knowledge in the areas of materials, engineering, physics, bioscience, and chemistry into important bio applications. The journal is specifically interested in work that addresses the relationship between structure and function and assesses the stability and degradation of materials under relevant environmental and biological conditions.