TAILIEUCHUNG - An estimate of rate of deviation from NCCN guideline recommendations for central nervous system imaging in trials forming basis for drug approval in first line advanced non-small cell lung cancer (NSCLC)

It is unknown whether and to what degree trials submitted to the US FDA to support drug approval adhere to NCCN guideline-recommended care in their baseline and surveillance CNS imaging protocols. Objective: We sought to characterize the frequency with which the trials cited in US FDA drug approvals for first line advanced NSCLC between 2015 and 2020 deviated from NCCN guideline-recommended care for baseline and surveillance CNS imaging. | Sharp and Prasad BMC Cancer 2022 22 70 https s12885-022-09179-y RESEARCH Open Access An estimate of rate of deviation from NCCN guideline recommendations for central nervous system imaging in trials forming basis for drug approval in first line advanced non-small cell lung cancer NSCLC John Sharp1 and Vinay Prasad2 3 Abstract Importance It is unknown whether and to what degree trials submitted to the US FDA to support drug approval adhere to NCCN guideline-recommended care in their baseline and surveillance CNS imaging protocols. Objective We sought to characterize the frequency with which the trials cited in US FDA drug approvals for first line advanced NSCLC between 2015 and 2020 deviated from NCCN guideline-recommended care for baseline and surveillance CNS imaging. Design setting and participants Retrospective observational analysis using publicly available data of 1 list of tri- als cited by the FDA in drug approvals for first line advanced NSCLC from 2015 to 2020 2 individual trial protocols 3 published trial data and supplementary appendices 4 archived versions of the NCCN guidelines for NSCLC from 2009 to 2018 the years during which the trials were enrolling . Main outcomes and measures Estimated percentage of trials for first line advanced NSCLC leading to FDA approval which deviated from NCCN guideline-recommended care with regards to CNS baseline and surveillance imaging. Results A total of 14 studies that had been cited in FDA drug approvals for first line advanced NSCLC met our inclu- sion criteria between January 1 2015 and September 30 2020. Of these trials 8 deviated from NCCN guide- lines in their baseline CNS imaging requirement. The frequency of re-assessment of CNS disease was variable amongst trials as well with 9 deviating from NCCN recommendations. Conclusions and relevance The trials supporting US FDA drug approvals in first line advanced NSCLC often have CNS imaging requirements that do not adhere to NCCN .

• Y khoa - Dược
• BMC Cancer
• Non small cell lung cancer
• Surveillance central nervous system
• Estimated percentage
• Specific treatment indication
• Cancer patient pathways
• Colorectal cancer
• Lung cancer
• Breast cancer
• Prostate cancer
• Ovarian cancer
• Cancer detection
• Ovarian cancer symptoms
• Ovarian cancer signs
• Ovarian cancer tests
• Cancer biomarkers
• Pediatric cancer
• Familial cancer predisposition
• Hereditary cancer syndrome
• Genetic cancer susceptibility
• Advanced cancer
• Biliary tract cancer
• Multimodal intervention
• Pancreatic cancer
• Physical activity
• Breast cancer screening
• Familial breast cancer
• Young breast cancer survivors
• High risk relatives
• Randomized trial
• Childhood cancer
• Childhood cancer survivor
• Thyroid cancer screening
• Secondary cancer
• Cancer screening
• Community awareness
• Cancer education
• Cervical cancer
• Prior cancer
• Cancer survivors
• Cancer registry
• Second cancer
• Surgical oncology
• Cancer imaging
• Radiation oncologists
• Medical oncologists
• Oesophagogastric cancer
• Liver cancer
• Hepatobiliary cancer
• Multidisciplinary rehabilitation
• EGFR mutation
• Family history of cancer
• Inherited susceptibility
• Cancer predisposition genes
• Lung cancer aetiology
• Cancer stem cells
• Oct4 overexpressing lung cancer
• Human lung cancer xenograft model
• Disease free survivals
• Cancer hallmarks
• Cancer genesis
• Defiant disease
• Mutational signature
• Cancer diagnosis
• Cancer genomics
• Molecular medicine
• Whole genome sequencing
• Cancer susceptibility gene
• Breast cancer prognosis
• Next generation sequencing
• Quality of care
• Quality indicators
• Shifting cancer care
• German cancer society
• Colorectal cancer screening
• Stomach cancer screening
• Lung cancer survivor
• Physician recommendation
• Total number of lymph nodes
• Lymph node ratio
• Left colon cancer
• Right colon cancer
• Overall survival
• Cumulative incidence
• Esophageal cancer
• Head and neck cancer
• Metachronous cancer
• Young onset
• Reproductive cancer
• Risk factor
• Early detection of cancer
• Gastric cancer incidence
• Population based specialized registry
• Gastric cancer survival
• Gastric cancer clinical characteristics
• Gastric cancer pathological characteristics
• Lung Cancer Screening
• Racial disparities
• Lung Cancer diagnosis
• Screening adherence
• Second primary colorectal cancer
• Standardized incidence ratio
• Left sided colon cancer
• Right sided colon cancer
• Quality of cancer care
• Population based study