· 临床获益率(CBR,clinical benefit rate):CR+PR+SD。 · 缓解持续时间(DOR,Duration of Response):是指肿瘤第一次评估为CR或PR开始到第一次评估为PD(Progressive Disease)或任何原因死亡的时间。 区分一下客观缓解率ORR和总缓解率OR的概念: 客观...
缓解率(RR, response rate)达到CR、PR的病人占同期病人总数的百分比。 临床获益率(CBR,clinical benefit rate):CR+PR+SD。 缓解持续时间(DOR,Duration of Response):是指肿瘤第一次评估为CR或PR开始到第一次评估为PD(Progressive Disease)或任何原因死亡的时间。 区分一下客观缓解率ORR和总缓解率OR的概念: 客观...
第一篇我们来看看药物审批的终极大BOSS—FDA在Guidancefor Industry1 Clinical Trial Endpoints for the Approval of Cancer Drugs andBiologics中是如何定义这些研究终点的(以下是“Guidance”内容的精(cu)简(lue)筛(fan)选(yi)版)。 OS是指从病人随机...
[2] Miller K, Wang M, Gralow J, et al:Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breastcancer. N Engl J Med 357:2666-2676, 2007 [3] Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer. Mol Cancer 2023 Jul 06;22(1)[4] Decision ...
patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial. Lancet Oncol. 2016 May;17(5):577-89.[3] Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical ...
临床获益持续时间(DoCB,Duration of clinical benefit)定义为患者获得完全缓解、部分缓解或疾病稳定24周或更长时间从随机分组到疾病进展或死亡的时间。它是临床试验中使用的主要终点,其中疾病稳定以延长生存期是主要目标。 反应持续时间 反应持续时间(DoR,Duration of response)定义为从随机分组到达到完全或部分缓解的患者...
[3] Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer. 2019 May;112:57-65. [4] Nivolumab versus Docetaxel in Advanced Non-squamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627...
[3] Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer. 2019 May;112:57-65. [4] Nivolumab versus Docetaxel in Advanced Non-squamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627...
[2] FDA (2016). Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices. [3] CDE (2021). 罕见疾病药物临床研发技术指导原则,2021年第71号 [4] CDE (2021). 成人用药数据外推至儿科人群的定量方法学指导原则(试行),2023年第27号 ...
[3] Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer. Mol Cancer 2023 Jul 06;22(1) [4] Decision of the commissioner. Proposal to withdraw approval for the breast cancer indication for AVASTIN (Bevacizumab). FDA. 2011 ...