FDA Approval Summary: Capecitabine Labeling Update under Project Renewal [0.03%]
FDA审批概述：项目续签下的卡培他滨说明书更新
Sundeep Agrawal,Clara Lee,William F Pierce et al.
Sundeep Agrawal et al.
On December 14, 2022, the FDA approved revisions to the United States Prescribing Information (USPI) for capecitabine that revised existing indications and dosage regimens, added new indications and their recommended dosage regimens, revise...
A Preoperative Window-of-Opportunity Study of Oral SERD, Imlunestrant, in Newly Diagnosed ER-Positive, HER2-Negative Early Breast Cancer: Results from the EMBER-2 Study [0.03%]
EMBER-2研究：口服SERD（imlunestrant）在新诊断的雌激素受体阳性、HER2阴性早期乳腺癌中的一项术前窗口试验结果
Patrick Neven,Nicole Stahl,Maria Vidal et al.
Patrick Neven et al.
Purpose: Imlunestrant is an oral selective estrogen receptor degrader with favorable safety and preliminary efficacy in patients with advanced breast cancer. Pharmacodynamic (PD) biomarker data can optimize drug dosing; i...
Determination of MYD88 and CXCR4 Mutations for Clinical Detection and Their Significance in Waldenström Macroglobulinemia [0.03%]
MYD88和CXCR4突变的临床检测及其在沃尔曼氏巨球蛋白血症中的意义测定
Yuting Yan,Ying Yu,Wenjie Xiong et al.
Yuting Yan et al.
Purpose: This study aims to explore the incidence and clinical features of MYD88 and CXCR4 mutations in patients with Waldenström macroglobulinemia (WM) and determine the optimal method for routine clinical practice. Add...
Tissue-Based Profiling Techniques to Achieve Precision Medicine in Cancer: Opportunities and Challenges in Melanoma [0.03%]
基于组织的分析技术在癌症精确诊疗中的应用——以黑色素瘤为例的机会与挑战
Tuba N Gide,Yizhe Mao,Richard A Scolyer et al.
Tuba N Gide et al.
Immunotherapies targeting the programmed cell death 1 (PD-1) and cytotoxic T-lymphocyte antigen 4 (CTLA-4) checkpoint receptors have revolutionized the treatment of metastatic melanoma. However, half of the treated patients do not respond t...
Oncology Combination Drug Development Strategies for Project Optimus [0.03%]
肿瘤组合药物研发策略——代号项目Optimus
Timothy A Yap,Julie Bullock,Susan Chong et al.
Timothy A Yap et al.
The Project Optimus initiative from the FDA introduced a new dose optimization and selection paradigm in oncology drug development. The FDA has outlined approaches to dose optimization for single agents, but multiple oncology drugs are bein...
Phase II Trial of Gemcitabine and Nab-Paclitaxel for Recurrent Osteosarcoma with Serial Monitoring Using Liquid Biopsy: A Report from the National Pediatric Cancer Foundation [0.03%]
国家儿童癌症基金会液体活检下吉西他滨和白蛋白结合型紫杉醇治疗复发性骨肉瘤 II 期临床试验报告
Aditi Dhir,Masanori Hayashi,Avery Bodlak et al.
Aditi Dhir et al.
Purpose: The combination of gemcitabine and docetaxel is often used to treat patients with recurrent osteosarcoma. Nab-paclitaxel has preclinical activity against osteosarcoma and is potentially less myelosuppressive than...
Safety, Efficacy, and Biomarker Analysis of Crizotinib in MET-Mutated Non-Small Cell Lung Cancer-Results from the Drug Rediscovery Protocol [0.03%]
克唑替尼治疗MET突变非小细胞肺癌的安全性、疗效及生物标志物分析：来自药物再发现项目的结果
Karlijn Verkerk,Tijmen J W T van der Wel,Laurien J Zeverijn et al.
Karlijn Verkerk et al.
Purpose: To provide patients with MET-mutated advanced non-small cell lung cancer (METmut aNSCLC) access to crizotinib, further substantiate evidence of its efficacy and safety in this setting, and find potential biomarke...
Phase 2 Trial of Regorafenib in Recurrent/Metastatic Adenoid Cystic Carcinoma [0.03%]
瑞戈非尼治疗复发/转移性腺样囊性癌二期临床试验
Antoine Desilets,Joris L Vos,Nora Katabi et al.
Antoine Desilets et al.
Purpose: There is a significant need for effective therapies to treat recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC). This study evaluated the multitargeted VEGFR tyrosine kinase inhibitor (TKI) regorafenib in ...
Correction: Randomized Phase II Trial of Dendritic Cell/Myeloma Fusion Vaccine with Lenalidomide Maintenance after Upfront Autologous Hematopoietic Cell Transplantation for Multiple Myeloma: BMT CTN 1401 [0.03%]
对多发性骨髓瘤自体造血干细胞移植后利那洛肽维持治疗联合树突状细胞/多发性骨髓瘤融合疫苗的II期随机试验(BMT CTN 1401)的更正
David J Chung,Nina Shah,Juan Wu et al.
David J Chung et al.
Nivolumab in Patients with Metastatic Castration-Resistant Prostate Cancer with and without DNA Repair Defects [0.03%]
用于修复DNA损伤和未发生DNA损伤的转移性去势抵抗性前列腺癌患者的尼伏单抗治疗
Pedro Isaacsson Velho,Diogo Assed Bastos,Pedro Tofani Saint&#x;ana et al.
Pedro Isaacsson Velho et al.
Purpose: Despite the success of immune checkpoint inhibitors (ICI) across various cancers, their efficacy in metastatic castration-resistant prostate cancer (mCRPC) is modest, except for a subset of patients who experienc...