Journal of oncology practice
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Glioblastoma is the most common and most aggressive form of primary brain tumor in adults and contributes to high social and medical burden as a result of its incurable nature and significant neurologic morbidity. Despite ongoing research, there has not been improvement in survival in glioblastoma. ⋯ We review updates in management of newly diagnosed and recurrent glioblastoma, as well as common difficulties in management, such as pseudoprogression and pseudoresponse. Ongoing translational research in targeted therapy and immunotherapy is briefly discussed.
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The treatment of stage I non-small-cell lung cancer has advanced markedly over the past century. The transition from therapeutic nihilism with ensured mortality to radical surgery with pneumonectomy to rational oncologic-based resection has resulted in dramatically improved outcomes and reduced morbidity. The superiority of anatomic resection with lobectomy over sublobar resection for fit patients with stage I disease, where more than one half of all patients should expect to be cured, is backed by level 1 evidence. ⋯ In particular, provocative results with stereotactic body radiotherapy have led to rapid adoption in clinical practice with a resultant decrease in the number of untreated patients. A comparison of outcomes across studies of competing modalities remains challenging given the potential impact of selection bias in single-arm trials, and attempts to conduct randomized studies have been largely unsuccessful. Given the uncertainty in defining optimal therapy, patients are best served by a multidisciplinary team of thoracic surgeons, radiation oncologists, pulmonologists, and chest and interventional radiologists to ensure that they receive the evaluation and treatment best suited not only to their tumor and medical challenges but also to their concerns, fears, and values.
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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.