scholarly journals 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)

BMC Cancer ◽  
2022 ◽  
Vol 22 (1) ◽  
Author(s):  
John Sharp ◽  
Vinay Prasad
Keyword(s):  
Advanced Nsclc ◽  
Standard Of Care ◽  
Drug Approval ◽  
First Line ◽  
Recommended Care ◽  
Nccn Guidelines ◽  
The Us ◽  
Trial Protocols ◽  
Drug Approvals ◽  
Us Fda

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 trials 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 inclusion criteria between January 1, 2015 and September 30, 2020. Of these trials, 8 (57.1%) deviated from NCCN guidelines in their baseline CNS imaging requirement. The frequency of re-assessment of CNS disease was variable amongst trials as well, with 9 (64.3%) 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 guidelines. Many trials permit alternative, substandard methods and the proportion of patients undergoing each modality is uniformly not reported. Nonstandard CNS surveillance protocols are common. To best serve patients with advanced NSCLC in the US, drug approvals by the FDA must be based on trials that mirror clinical practice and have imaging requirements consistent with current US standard of care.

scholarly journals Osimertinib vs standard of care (SoC) EGFR-TKI as first-line therapy in patients (pts) with untreated EGFRm advanced NSCLC: FLAURA post-progression outcomes

2018 ◽  
Vol 29 ◽  
pp. ix150 ◽  
Author(s):  
D. Planchard ◽  
M. Boyer ◽  
J.-S. Lee ◽  
A. Dechaphunkul ◽  
P. Cheema ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Standard Of Care ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Egfr Tki

Gefitinib-induced Acute Kidney Injury in a Patient with Advanced NSCLC Harbouring an EGFR-activating Mutation

2015 ◽  
Vol 11 (1) ◽  
pp. 41 ◽  
Author(s):  
Ourania Romanidou ◽  
Raffaele Califano ◽  
◽  
◽  
◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Advanced Nsclc ◽  
Growth Factor Receptor ◽  
Kidney Injury ◽  
Standard Of Care ◽  
Small Cell Lung ◽  
First Line ◽  
Activating Mutation ◽  
Epidermal Growth ◽  
Egfr Mutant

Gefitinib, erlotinib or afatinib represent standard of care as first-line treatment for advanced non-small cell lung cancer (NSCLC) harbouring an activating mutation of epidermal growth factor receptor (EGFR). The toxicity profile of these drugs is well known with rash, diarrhoea, nausea, anorexia, fatigue and derangement of liver function being the most commonly observed adverse events. We report a case of an 82-year-old patient with EGFR-mutant advanced NSCLC who developed gefitinib-induced acute kidney injury, which slowly improved on discontinuation of the drug.

scholarly journals Osimertinib vs standard of care (SoC) EGFR-TKI as first-line therapy in patients (pts) with EGFRm advanced NSCLC: FLAURA

2017 ◽  
Vol 28 ◽  
pp. v635 ◽  
Author(s):  
S. Ramalingam ◽  
T. Reungwetwattana ◽  
B. Chewaskulyong ◽  
A. Dechaphunkul ◽  
K.H. Lee ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Standard Of Care ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Egfr Tki

scholarly journals Teprotumumab Treatment for Thyroid-Associated Ophthalmopathy

2020 ◽  
Vol 9 (Suppl. 1) ◽  
pp. 31-39
Author(s):  
Terry J. Smith
Keyword(s):  
Paradigm Shift ◽  
Vision Loss ◽  
Standard Of Care ◽  
Autoimmune Process ◽  
First Line ◽  
Thyroid Associated Ophthalmopathy ◽  
The Us ◽  
Fundamental Research ◽  
Line Standard

<b><i>Background:</i></b> Thyroid-associated ophthalmopathy (TAO), an autoimmune process affecting the tissues surrounding the eye, most commonly develops in individuals with Graves’ disease. It is disfiguring, can cause vision loss, and dramatically lessens the quality of life in patients. There has been an absence of approved medical therapies for TAO with proven effectiveness and safety in multicenter, placebo-controlled, and adequately powered clinical trials. <b><i>Summary:</i></b> The following is a brief overview of the rationale for developing a monoclonal antibody inhibitor of the insulin-like growth factor-I receptor into a treatment for TAO. This area of fundamental research has yielded an effective and safe medication, namely teprotumumab, based on two multicenter, placebo-controlled trials. Teprotumumab, marketed as Tepezza, has been approved recently by the US Food and Drug Administration for the treatment of TAO. Given its remarkable effectiveness, Tepezza is poised to become the first-line standard of care for TAO. <b><i>Key Messages:</i></b> Introduction of Tepezza into our armamentarium of therapeutic strategies for TAO represents a paradigm shift in the management of the disease. I proffer that the drug will replace glucocorticoids as a first-line treatment for TAO.

Financial conflicts of interest among the National Comprehensive Cancer Network (NCCN) Clinical Practice Guideline (CPG) Panelists in 2019.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 15-15
Author(s):  
Aakash Desai ◽  
Madhuri Chengappa ◽  
Ronald S. Go ◽  
Thejaswi Poonacha
Keyword(s):  
Expert Witness ◽  
Conflicts Of Interest ◽  
Standard Of Care ◽  
Nccn Guidelines ◽  
Non Hodgkin Lymphoma ◽  
Advisory Boards ◽  
The Us ◽  
Financial Conflicts Of Interest ◽  
Cancer Network ◽  
The Impact

15 Background: CPG are evidence-based guidelines, which serve as a standard of care in practice, quality improvement, and reimbursement. The extent of financial conflicts of Interest (FCOI) in NCCN guidelines has not been recently evaluated. Our study evaluated the extent of FCOI in the NCCN CPG among the 10 most common malignancies in the US. Methods: We examined the latest 2019 version of the NCCN CPG for the 10 most common cancers by incidence in the US. Using disclosure lists, we catalogued the FCOIs for the panelists under various categories outlined in the CPG. We also tabulated the companies/institutions involved in each disclosure. An “episode” describes 1 instance of participation of a panelist in 1 company in 1 category of each guideline. “Affiliation” describes a commercial, industry, or institute affiliation reported by a panelist in each episode. Results: Of the 491 panelists on the CPG, 483 (98.3%) completed FCOI disclosures. 224 (46.38%) reported at least 1 FCOI. A total of 1,103 episodes were disclosed with an average of 4.9 episodes per panelist with FCOI. Being a part of scientific advisory boards, consultant, or expert witness was the most common FCOI category (19.9%). A total of 191 companies were associated with 1,103 episodes of FCOI. The top companies were Bristol Myers Squibb, Merck, Genentech and AstraZeneca. Among the top 10 cancers, the prevalence of FCOI were lung (56%), bladder (52%), pancreatic (52%), non-Hodgkin lymphoma (50%), kidney (49%), colorectal (43%), breast (42%), melanoma (40%), prostate (38%), and uterine (32%). Among the panelists with FCOI, 26%, 17%, and 57% reported 1, 2, and > 3 episodes, respectively. There were 127 episodes among the CPG chairs/vice chairs who reported FCOI (mean 6.4). The chairs/vice chairs of uterine, pancreatic, melanoma, and prostate cancer CPG did not have any FCOI. Conclusions: FCOI are very prevalent among the top 10 NCCN CPG panelists. In almost half of the CPG, the majority of the panelists had at least 1 FCOI. Over half of the CPG chairs/vice chairs reported multiple FCOI. Further studies are necessary to determine the impact of these FCOI.

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