2015 美卫生署国立癌症研究院(NCI) 基因速配MATCH药试
本帖最后由 jaydad 于 2015-3-5 11:24 编辑NCI Molecular Analysis for Therapy Choice Program (MATCH) & Pediatric MATCH
NCI will be launching two new precision medicine trials – Molecular Analysis for Therapy Choice Program (MATCH) and Pediatric MATCH.
MATCH
The NCI MATCH Trial will include small, phase II trials that will enroll adults with advanced solid tumors and lymphomas—including up to 25 percent with rare cancers—whose tumors are no longer responding to standard therapy and have begun to grow.
Biopsies from tumors from as many as 3,000 patients will undergo next-generation DNA sequencing to identify individuals whose tumors have genetic abnormalities that may respond to selected targeted drugs. These genetic mutations have been chosen based on the availability of targeted drugs, including those that have been approved by the Food and Drug Administration (FDA) for another indication or that are still investigational, but have shown some efficacy against tumors with one of the genetic alterations.
As many as 1,000 patients will then be assigned to one of the phase II trials, each involving approximately 30 patients, based not on their type of cancer but on the genetic abnormality that is thought to be driving their cancer. In each phase II trial, patients will be treated with one of approximately 20 to 25 drugs initially available for the trial that target the genetic abnormalities that are being tested for in this study. The NCI MATCH Trial is a master protocol, meaning that new treatments can be brought in over time.
Patients’ tumors often have different genetic abnormalities that could be causing their disease to progress. Decisions about which trial/agent patients will be assigned to will be based on predetermined decision rules that dictate treatment according to the genetic abnormality present in the tumor.
The primary endpoint for the MATCH trials will be tumor response, but progression-free survival will also be of interest. Patients whose cancers progress during the first assigned treatment may be able to go on another MATCH trial arm if they have a second actionable molecular target in their tumors. In addition, any patient whose cancer initially shrinks and then progresses during the trial will be eligible to have their tumors re-biopsied and, if they have a genetic change that is targeted by another drug being tested in MATCH, they may be eligible to enroll in one of the other phase II MATCH trials.
Once patients come off the study, their treating physician will receive a report on the results of the tumor DNA analysis, in the hope that the information may be useful for future treatment choices.
The NCI MATCH Trial is expected to launch in late May or early June 2015 and will be open to all members of the four NCTN Adult Groups. The ECOG-ACRIN Cancer Research Group will lead the study, along with NCI.
For questions about this trial, please call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).
Pediatric MATCH
The NCI MATCH Trial will also have a pediatric counterpart that will enroll children with advanced cancers that have progressed on standard therapy.
As in the adult MATCH Trial, DNA sequencing will be used to identify children whose tumors have a genetic abnormality for which either an approved or investigational targeted therapy exists. NCI is working with numerous pharmaceutical companies to make the same drugs available for Pediatric MATCH that will be offered in the adult MATCH trials.
Pediatric MATCH provides a tremendous opportunity to test molecularly targeted therapies in children with advanced cancers who have few other treatment options. With the genomic data captured in the trials, it will also produce an invaluable resource for studying the genetic basis of pediatric cancers.
Pediatric MATCH, which will be led by the NCI-funded Children’s Oncology Group, is still under development and details on a timetable for launch or patient enrollment are not yet available.
Updated: March 2, 2015 英文不懂 谢谢 本帖最后由 jaydad 于 2015-3-5 13:30 编辑
大致是这样 -
美卫生曙国立癌症研究院(NCI)要招收3000名实体癌症及淋巴癌病人, 开辟"只顾基因突变"的靶向治疗. 也就是说, 不管哪个器官部位, 哪种病理分类, 都将不计较, 只要基因检测符合, 就会被分配到合适靶向用药组.
病人的病理组织是关键, 得由NCI来检测.有难治癌但未知基因突变, 特别是疑难, 罕见的, 很适合参加. 感谢先生的最新消息！ 这是在一定要去美国做的吗？
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