FDA Gives Fast Track Designations to Drugs for AML, Pancreatic Cancer, NSCLC, and Prevention of Oral Mucositis

2015 ◽  
Vol 37 (11) ◽  
pp. 13
HPB ◽  
2021 ◽  
Vol 23 ◽  
pp. S759
Author(s):  
N. de' Liguori Carino ◽  
M. Baltatzis ◽  
F. Maroso ◽  
H. Spiers ◽  
A. Sheen ◽  
...  

HPB ◽  
2016 ◽  
Vol 18 ◽  
pp. e740
Author(s):  
D.K. Manatakis ◽  
D.T. Vassiliadou ◽  
N. Stamos ◽  
I. Sideris ◽  
C. Agalianos ◽  
...  

2021 ◽  
Vol 108 (Supplement_9) ◽  
Author(s):  
Nicola de Liguori Carino ◽  
Minas Baltatzis ◽  
Fabio Maroso ◽  
Harry VM Spiers ◽  
Rahul Deshpande ◽  
...  

Abstract Background Pancreatic cancer is currently the fourth most common cause of cancer-related mortality in the economically developed world and is set to become the second most common cause of cancer-related mortality within the next few years. NICE guidance makes a strong recommendation to offer up-front surgery to people with resectable pancreatic cancer, without preoperative biliary drainage, if sufficiently fit for surgery. The aim of this study was to perform a propensity-matched comparison of patients with pancreatic cancer undergoing surgery, with and without biliary stenting, to examine perioperative outcomes and to perform an intention to treat analysis to evaluate long-term survival between the two groups. Methods This was an observational study of a cohort of consecutive patients presenting with obstructive jaundice and undergoing pancreatoduodenectomy for pancreatic and periampullary malignancies between November 2015 and May 2019. Data related to patient and tumour characteristics, biliary drainage, surgery and histopathology were gathered and analysed from a prospectively maintained electronic database. Post-operative complications were defined and graded according to the definitions of the International Study Group on Pancreatic Surgery (ISGPS) and the Clavien-Dindo system. Data related to adjuvant treatment, disease recurrence and overall survival were also analysed. Results In this retrospective study of 216 consecutive operable patients, 70 followed the fast-track (FT) pathway and 146 had pre-operative biliary drainage (PBD). All 70 patients in the fast-track group and 122 out of 146 in the PBD group proceeded to surgery (100% and 83.6% respectively, p = 0.001). Interval time from diagnostic CT scan to surgery and from MDT decision to treat to surgery was much shorter in the FT group (median range) 8 vs 43 days p < 0.001 and 3 vs 36 days p < 0.001 respectively) as was the overall time from diagnostic CT to adjuvant treatment (88 vs 121 days p < 0.001). Postoperative outcomes including in-hospital stay, number and grading of complications, readmission rate and mortality rates were comparable in the two groups. There was no difference in survival between the two groups. Conclusions These data strengthen the existing evidence that, for a person with pancreatic cancer who is proceeding to surgery, the best approach is to avoid pre-operative biliary drainage. The optimal comparison to the neoadjuvant approach is upfront fast-track surgery without biliary drainage followed by adjuvant therapy.


2001 ◽  
Vol 120 (5) ◽  
pp. A162-A162
Author(s):  
A KUTUP ◽  
S HOSCH ◽  
S PAPE ◽  
P SCHEUNEMANN ◽  
W KNOEFEL ◽  
...  

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