scholarly journals 1097O The AXINET trial (GETNE1107): Axitinib plus octreotide LAR improves PFS by blinded central radiological assessment vs placebo plus octreotide LAR in G1-2 extrapancreatic NETs

2021 ◽  
Vol 32 ◽  
pp. S907-S908
Author(s):  
R. Garcia-Carbonero ◽  
M. Benavent ◽  
P. Jiménez Fonseca ◽  
D. Castellano ◽  
T. Alonso-Gordoa ◽  
...  
2000 ◽  
Vol 95 (9) ◽  
pp. 2619-2619 ◽  
Author(s):  
Julio Ayala C ◽  
Manish Tandon ◽  
Latha Alaparthi ◽  
Fred Gorelick

2021 ◽  
Author(s):  
Paula Jimenez-Fonseca ◽  
Alberto Carmona-Bayonas ◽  
Angela Lamarca ◽  
Jorge Barriuso ◽  
Angel Castaño ◽  
...  

Introduction: Somatostatin analogues (SSA) prolong progression-free survival (PFS) in patients with well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs). However, the eligibility criteria in randomized clinical trials (RCTs) have been restricted, which contrasts with the vast heterogeneity found in NETs. Methods: We identified patients with well-differentiated (Ki67% ≤20%), metastatic GEP-NETs treated in first-line with SSA monotherapy from the Spanish R-GETNE registry. The therapeutic effect was evaluated using a Bayesian Cox model. The objective was to compare survival-based outcomes from real world clinical practice versus RCTs. Results: The dataset contained 535 patients with a median age of 62 years (range: 26-89). The median Ki67% was 4 (range: 0-20). The most common primary tumor sites were: midgut, 46%; pancreas, 34%; unknown primary, 10%; and colorectal, 10%. Half of the patients received octreotide LAR (n=266) and half, lanreotide autogel (n=269). The median PFS was 28.0 months (95% CI, 22.1-32.0) for octreotide vs 30.1 months (95% CI, 23.1-38.0) for lanreotide. The overall hazard ratio for lanreotide vs octreotide was 0.90 (95% credible interval, 0.71-1.12). The probability of effect sizes >30% with lanreotide vs octreotide was 2% and 6% for midgut and foregut NENs, respectively. Conclusion: Our study evaluated the external validity of RCTs examining SSAs in the real world, as well as the main effect-modifying factors (progression status, symptoms, tumor site, specific metastases, and analytical data).. Our results indicate that both octreotide LAR and lanreotide autogel had a similar effect on PFS. Consequently, both represent valid alternatives in patients with well-differentiated, metastatic GEP-NENs.


2020 ◽  
Vol 32 (1) ◽  
Author(s):  
Ismael Mohammed Mohammed Saeed ◽  
Muneer Aziz Mohammed Saleh ◽  
Suhairul Hashim ◽  
Younis Mohammed Salih Hama ◽  
Khaidzir Hamza ◽  
...  

Author(s):  
Iris Burck ◽  
Rania A. Helal ◽  
Nagy N. N. Naguib ◽  
Nour-Eldin A. Nour-Eldin ◽  
Jan-Erik Scholtz ◽  
...  

Abstract Objectives To correlate the radiological assessment of the mastoid facial canal in postoperative cochlear implant (CI) cone-beam CT (CBCT) and other possible contributing clinical or implant-related factors with postoperative facial nerve stimulation (FNS) occurrence. Methods Two experienced radiologists evaluated retrospectively 215 postoperative post-CI CBCT examinations. The mastoid facial canal diameter, wall thickness, distance between the electrode cable and mastoid facial canal, and facial-chorda tympani angle were assessed. Additionally, the intracochlear position and the insertion angle and depth of electrodes were evaluated. Clinical data were analyzed for postoperative FNS within 1.5-year follow-up, CI type, onset, and causes for hearing loss such as otosclerosis, meningitis, and history of previous ear surgeries. Postoperative FNS was correlated with the measurements and clinical data using logistic regression. Results Within the study population (mean age: 56 ± 18 years), ten patients presented with FNS. The correlations between FNS and facial canal diameter (p = 0.09), wall thickness (p = 0.27), distance to CI cable (p = 0.44), and angle with chorda tympani (p = 0.75) were statistically non-significant. There were statistical significances for previous history of meningitis/encephalitis (p = 0.001), extracochlear-electrode-contacts (p = 0.002), scala-vestibuli position (p = 0.02), younger patients’ age (p = 0.03), lateral-wall-electrode type (p = 0.04), and early/childhood onset hearing loss (p = 0.04). Histories of meningitis/encephalitis and extracochlear-electrode-contacts were included in the first two steps of the multivariate logistic regression. Conclusion The mastoid-facial canal radiological assessment and the positional relationship with the CI electrode provide no predictor of postoperative FNS. Histories of meningitis/encephalitis and extracochlear-electrode-contacts are important risk factors. Key Points • Post-operative radiological assessment of the mastoid facial canal and the positional relationship with the CI electrode provide no predictor of post-cochlear implant facial nerve stimulation. • Radiological detection of extracochlear electrode contacts and the previous clinical history of meningitis/encephalitis are two important risk factors for postoperative facial nerve stimulation in cochlear implant patients. • The presence of scala vestibuli electrode insertion as well as the lateral wall electrode type, the younger patient’s age, and early onset of SNHL can play important role in the prediction of post-cochlear implant facial nerve stimulation.


2014 ◽  
Vol 89 (7-8) ◽  
pp. 1573-1578 ◽  
Author(s):  
Hiroyasu Tanigawa ◽  
Yoji Someya ◽  
Hideo Sakasegawa ◽  
Takanori Hirose ◽  
Kentaro Ochiai

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