scholarly journals 1919P Nintedanib (BIBF1120) after first line therapy in progressive medullary thyroid cancer: A multicenter EORTC prospective randomized double-blind phase II study (NCT01788982)

2020 ◽  
Vol 31 ◽  
pp. S1087-S1088
Author(s):  
K. Newbold ◽  
P. Schoeffski ◽  
B. Hasan ◽  
L.D. Locati ◽  
Y. Godbert ◽  
...  
2017 ◽  
Vol 177 (4) ◽  
pp. 309-317 ◽  
Author(s):  
Jaume Capdevila ◽  
José Manuel Trigo ◽  
Javier Aller ◽  
José Luís Manzano ◽  
Silvia García Adrián ◽  
...  

Background Axitinib, an antiangiogenic multikinase inhibitor (MKI), was evaluated in the compassionate use programme (CUP) in Spain (October 2012–November 2014). Subjects and Methods 47 patients with advanced radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC, n = 34) or medullary thyroid cancer (MTC, n = 13) with documented disease progression were treated with axitinib 5 mg b.i.d. The primary efficacy endpoint was objective response rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Progression-free survival (PFS) and adverse events (AEs) were secondary objectives. Regulatory authorities validated the CUP, and all patients signed informed consent form. Results Axitinib was administered as first-line therapy in 17 patients (36.2%), as second-line in 18 patients (38.3%) and as third/fourth-line in 12 patients (25.5%). With a median follow-up of 11.5 months (0–24.3), ORR was 27.7% (DTC: 29.4% and MTC: 23.1%) and median PFS was 8.1 months (95% CI: 4.1–12.2) (DTC: 7.4 months (95% CI: 3.1–11.8) and MTC: 9.4 months (95% CI: 4.8–13.9)). Better outcomes were reported with first-line axitinib, with an ORR of 53% and a median PFS of 13.6 months compared with 16.7% and 10.6 months as second-line treatment. Twelve (25.5%) patients required dose reduction to 3 mg b.i.d. All-grade AEs included asthenia (53.2%), diarrhoea (36.2%), hypertension (31.9%) and mucositis (29.8%); grade 3/4 AEs included anorexia (6.4%), diarrhoea (4.3%) and cardiac toxicity (4.3%). Conclusion Axitinib had a tolerable safety profile and clinically meaningful activity in refractory and progressive thyroid cancer regardless of histology as first-line therapy. To our knowledge, this is the first time that cross-resistance between MKIs is suggested in thyroid cancer, highlighting the importance of prospective sequential clinical studies.


2011 ◽  
Vol 13 (3) ◽  
pp. 179-184 ◽  
Author(s):  
Cristina Grávalos ◽  
Carlos Gómez-Martín ◽  
Fernando Rivera ◽  
Inmaculada Alés ◽  
Bernardo Queralt ◽  
...  

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