Second primary cancers: a retrospective analysis of real world data using the enhanced medical research engine ConSoRe in a French comprehensive cancer center

Author(s):  
Pierre-Etienne Heudel ◽  
Béatrice Fervers ◽  
Thierry Durand ◽  
Sylvie Chabaud ◽  
Anne-Sophie Michallet ◽  
...  
2021 ◽  
Author(s):  
Peter Klimek ◽  
Dejan Baltic ◽  
Martin Brunner ◽  
Alexander Degelsegger-Marquez ◽  
Gerhard Garhöfer ◽  
...  

UNSTRUCTURED Real-world data (RWD) collected in routine healthcare processes and transformed to real-world evidence (RWE) has become increasingly interesting within research and medical communities to enhance medical research and support regulatory decision making. Despite numerous European initiatives, there is still no cross-border consensus or guideline determining which quality RWD must meet in order to be acceptable for decision making within regulatory or routine clinical decision support. An Austrian expert group led by GPMed (Gesellschaft für Pharmazeutische Medizin, Austrian Society for Pharmaceutical Medicine) reviewed drafted guidelines, published recommendations or viewpoints to derive a consensus statement on quality criteria for RWD to be used more effectively for medical research purposes beyond registry-based studies discussed in the European Medicines Agency (EMA) guideline for registry-based studies


2021 ◽  
Vol 69 (1) ◽  
pp. 135
Author(s):  
PaulT Finger ◽  
Abhilasha Maheshwari ◽  
Abhishek Malpani ◽  
Puneet Jain ◽  
AnkitSingh Tomar ◽  
...  

2019 ◽  
Vol Volume 12 ◽  
pp. 543-544
Author(s):  
David J DiBenedetto ◽  
Kelly M Wawrzyniak ◽  
Michael Schatman ◽  
Ronald Kulich ◽  
Matthew Finkelman

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16578-e16578
Author(s):  
Seoyoung Lee ◽  
Seul-Gi Kim ◽  
Sejung Park ◽  
Jeehyun Lee ◽  
Seung-Hoon Beom ◽  
...  

e16578 Background: Cabozantinib is a multitarget tyrosine kinase inhibitor and getting attention in these days through its combination with immune checkpoint inhibitors. In this article, we analyze the efficacy of cabozantinib in patients with metastatic ccRCC in Korean who had progression after 1 or more VEGFR TKI therapies. Methods: Seventy-five patients from Jan.2019 to Dec. 2021 at Yonsei Cancer Center who had received cabozantinib treatment in second to fourth line of therapy were retrospectively reviewed. The primary endpoint was PFS. The secondary outcomes were the response rate, disease control rate (DCR), and OS. The evaluable subjects for efficacy were those who had at least one response evaluation. Results: Among 75 patients, 57 (76.0%) were male and median age was 59 years (range 33-81). Median follow up time was 12.1 months. There were 22 (29.3%) patients of second line, 38 (50.7%) of third line and 15 (20.0%) of fourth line of treatment. Median PFS was 5.6 months (95% CI, 4.6-6.6). Median OS was 13.6 months (95% CI, 5.0-22.2). The PFS based on the line of treatment was 4.7 months for second line, 5.6 months for third line and 12.0 months for 4th line. Proportion of patients who were previously treated with ICI was different between treatment line groups and showed increasing trend toward later line; 13.6% of second line, 31.6% of third line, and 66.7% of fourth line, respectively. The objective response rate was 8.0% with 6 patients of partial response. The DCR was 69.3%. The major toxicities were similar with the western population and most of them were less than CTCAE grade 3. Most common grade 3 or 4 AEs were anemia, hand-foot syndrome, fatigue, and stomatitis. There were no grade 5 AEs. Conclusions: Our results demonstrate that cabozantinib is an effective treatment option after first line TKI in Korean ccRCC patients with manageable toxicities. Notably, its tolerability in the advanced line of treatment and synergy with ICIs are suggested in this study despite heterogeneous patients of real world setting. This is the first real world data with cabozantinib in Asian patients.


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