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Review The Lancet. Oncology. 2024 Oct;25(10):e489-e500. doi: 10.1016/S1470-2045(24)00264-X Q135.92024

Challenges and opportunities for early phase clinical trials of novel drug-radiotherapy combinations: recommendations from NRG Oncology, the American Society for Radiation Oncology (ASTRO), the American College of Radiology (ACR), the Sarah Cannon Research Institute, and the American College of Radiation Oncology (ACRO)

新型药物-放疗联合疗法一期临床试验面临的挑战与机遇：NRG肿瘤学、美国放射肿瘤学会（ASTRO）、美国放射学会（ACR）、萨拉 cannon 研究所和美国放射肿瘤学学院（ACRO）的推荐意见 翻译改进

Zachary S Zumsteg  1, Siddharth Sheth  2, Salma K Jabbour  3, Krishnan R Patel  4, Randall J Kimple  5, Terence M Williams  6, Meng Xu-Welliver  7, Pedro A Torres-Saavedra  8, Arta M Monjazeb  9, Jyoti Mayadev  10, Steven E Finkelstein  11, John M Buatti  12, Sandip P Patel  13, Steven H Lin  14

作者单位 +展开

作者单位

  • 1 Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Electronic address: zachary.zumsteg@cshs.org.
  • 2 Division of Oncology, University of North Carolina, Chapel Hill, NC, USA.
  • 3 Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
  • 4 Radiation Oncology Branch, National Cancer Institute, Bethesda, MD, USA.
  • 5 Department of Human Oncology, Univeristy of Wisconsin, Madison, WI, USA.
  • 6 Department of Radiation Oncology, City of Hope, Duarte, CA, USA.
  • 7 Department of Radiation Oncology, Mayo Clinic, Rochester, MN, USA.
  • 8 Division of Cancer Treatment and Diagnosis, Biometric Research Program, National Institutes of Health, Bethesda, MD, USA.
  • 9 Department of Radiation Oncology, University of California, San Diego, CA, USA.
  • 10 Department of Radiation Medicine and Applied Sciences, University of California, San Diego, CA, USA.
  • 11 The US Oncology Network, Florida Cancer Affiliates, Panama City, FL, USA; Sarah Cannon Research Institute, Nashville, TN, USA; Associated Medical Professional of NY, US Urology Partners, Syracuse, NY, USA.
  • 12 Department of Radiation Oncology, University of Iowa, Iowa City, IA, USA.
  • 13 Division of Medical Oncology, University of California, San Diego, CA, USA.
  • 14 Department of Thoracic Radiation Oncology, Division of Radiation Oncology, MD Anderson Cancer Center, Houston, TX, USA.

    • DOI: 10.1016/S1470-2045(24)00264-X PMID: 39362260

    摘要 中英对照阅读

    NRG Oncology's Developmental Therapeutics and Radiation Therapy Subcommittee assembled an interdisciplinary group of investigators to address barriers to successful early phase clinical trials of novel combination therapies involving radiation. This Policy Review elucidates some of the many challenges associated with study design for early phase trials combining radiotherapy with novel systemic agents, which are distinct from drug-drug combination development and are often overlooked. We also advocate for potential solutions that could mitigate or eliminate some of these barriers, providing examples of specific clinical trial designs that could help facilitate efficient and effective evaluation of novel drug-radiotherapy combinations.

    Keywords：drug-radiotherapy combinations; clinical trials; radiation oncology

    NRG Oncology的发展型治疗和放射治疗 Subcommittee 组织了一组跨学科的调查人员，以解决涉及放疗的新组合疗法早期临床试验中的成功障碍。本政策审查阐明了一些与将放疗与新系统性药物结合进行早期临床试验的设计相关的许多挑战，这些挑战不同于药物-药物联合开发，并且往往被忽视。我们还提倡可能的解决方案，可以缓解或消除其中一些障碍，并提供了具体临床试验设计的例子，这些例子可以帮助高效和有效地评估新型药物-放射治疗组合。

    关键词：药物-放射治疗组合; 临床试验; 放射肿瘤学

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    期刊名：Lancet oncology

    缩写：LANCET ONCOL

    ISSN：1470-2045

    e-ISSN：1474-5488

    IF/分区：35.9/Q1

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    Challenges and opportunities for early phase clinical trials of novel drug-radiotherapy combinations: recommendations from NRG Oncology, the American Society for Radiation Oncology (ASTRO), the American College of Radiology (ACR), the Sarah Cannon Research Institute, and the American College of Radiation Oncology (ACRO)