Journal of oncology practice
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Brain metastases are the most common intracranial malignancy. Incidence of brain metastases has risen as systemic therapies have improved and patients with metastatic disease live longer. Whole-brain radiation therapy, for many years, has been the standard treatment approach. ⋯ Current uses for stereotactic radiosurgery include delivery as a boost with whole-brain radiation therapy; alone for patients with a limited number of brain metastases; in pre- or postoperative settings; and in combination with systemic, targeted, and immune-based therapies. Mature prospective data on use of stereotactic radiosurgery in combination with whole-brain radiation therapy is available; however, prospective, randomized data on stereotactic radiosurgery for patients with a greater number of brain metastases, its use in pre- and postoperative settings, and its use in combination with systemic therapies are limited. Data from ongoing and future studies are needed to define the appropriate use of stereotactic radiosurgery in these settings.
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Review
Trial Design and Efficacy Thresholds for Granting Breakthrough Therapy Designation in Oncology.
Breakthrough therapy designation (BTD) is a new approach created by the US Congress and the US Food and Drug Administration (FDA) as part of the FDA Innovation and Safety Act of 2012 to expedite the drug development process for serious illness, including cancer. By law, to qualify for BTD, a new molecular entity must demonstrate substantial clinical improvement over existing therapies. ⋯ This literature review evaluates nine oncology new molecular entities granted BTD involved in 10 accelerated approvals and summarizes the key factors in clinical trial design leading to successful BTD applications. This information can be used by oncology research teams to set goals for BTD when developing clinical trial designs and thresholds in expedited drug development programs.