Ventana ALK (D5F3) in the Detection of Patients Affected by Anaplastic Lymphoma Kinase-positive Non-Small-cell Lung Cancer: Clinical and Budget Effect.

作者: Davide Paolini , Marcello Tiseo , Federica Demma , Gianluca Furneri , Matteo Dionisi

DOI: 10.1016/J.CLLC.2018.05.012

关键词:

摘要: Abstract Background To ensure identification of anaplastic lymphoma kinase-positive (ALK+) patients, the Italian Drug Agency suggested a testing algorithm based on use fluorescence in situ hybridization (FISH) and/or immunohistochemistry. The aim was to evaluate clinical and economic effects adopting an immunohistochemical test (Ventana ALK D5F3) as option for detecting protein expression advanced non–small cell lung cancer (NSCLC) patients. Materials Methods A budget impact model developed by National Health Service (NHS) perspective 5-year period compare 2 scenarios: current D5F3 (28%; scenario) increased (60%; alternative scenario). cost number identified ALK+ patients were evaluated. Results more extensive scenario showed decrease diagnostic costs ∼€468,000 compared with when considering all NSCLC If these savings allocated (75% vs. 53%), incremental per patient €63 would be required, leading overall survival gain (32.4 27.1 months; relative increase, 20%). Conclusion provide NHS owing lower acquisition than FISH comparable detection rate. could reinvested greater efficient identification, targeted therapy, improvement outcomes

参考文章(29)
Patrizia Morbini, Francesca Cemmi, Ernesto Pozzi, Roberto Dore, Simona Inghilleri, Giulia Maria Stella, Michele Zorzetto, Profilo mutazionale degli oncogeni EGFR e KRAS in cellule di carcinoma broncogeno non-a-piccole cellule ottenute da Fine needle aspiration cytology (FNAC) Bollettino della Società Medico Chirurgica di Pavia. ,vol. 123, pp. 231- 281 ,(2010) , 10.6092/2039-1404.123.666
A.B. Sandler, J. Nemunaitis, C. Denham, J. von Pawel, Y. Cormier, U. Gatzemeier, K. Mattson, Ch. Manegold, M.C. Palmer, A. Gregor, B. Nguyen, C. Niyikiza, L.H. Einhorn, Phase III Trial of Gemcitabine Plus Cisplatin Versus Cisplatin Alone in Patients With Locally Advanced or Metastatic Non–Small-Cell Lung Cancer Journal of Clinical Oncology. ,vol. 18, pp. 122- 122 ,(2000) , 10.1200/JCO.2000.18.1.122
Justin F. Gainor, Daniel S.W. Tan, Tomasso De Pas, Benjamin J. Solomon, Aziah Ahmad, Chiara Lazzari, Filippo de Marinis, Gianluca Spitaleri, Katherine Schultz, Luc Friboulet, Beow Y. Yeap, Jeffrey A. Engelman, Alice T. Shaw, Progression-Free and Overall Survival in ALK-Positive NSCLC Patients Treated with Sequential Crizotinib and Ceritinib Clinical Cancer Research. ,vol. 21, pp. 2745- 2752 ,(2015) , 10.1158/1078-0432.CCR-14-3009
Bjoern Schwander, Ravera, Giuliani, Nuijten, Stefan Walzer, Cost comparison of second-line treatment options for late stage non-small-cell lung cancer: cost analysis for Italy. ClinicoEconomics and Outcomes Research. ,vol. 4, pp. 237- 243 ,(2012) , 10.2147/CEOR.S34371
Antonio Marchetti, Massimo Barberis, Mauro Papotti, Giulio Rossi, Renato Franco, Sara Malatesta, Fiamma Buttitta, Andrea Ardizzoni, Lucio Crinò, Cesare Gridelli, Gian Luigi Taddei, Claudio Clemente, Giorgio Scagliotti, Nicola Normanno, Carmine Pinto, ALK rearrangement testing by FISH analysis in non-small-cell lung cancer patients: results of the first italian external quality assurance scheme. Journal of Thoracic Oncology. ,vol. 9, pp. 1470- 1476 ,(2014) , 10.1097/JTO.0000000000000280
J-Y Douillard, G Ostoros, M Cobo, T Ciuleanu, R McCormack, A Webster, T Milenkova, First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm study British Journal of Cancer. ,vol. 110, pp. 55- 62 ,(2014) , 10.1038/BJC.2013.721
Georg Hutarew, Cornelia Hauser-Kronberger, Felix Strasser, Ida C Llenos, Otto Dietze, Immunohistochemistry as a screening tool for ALK rearrangement in NSCLC: evaluation of five different ALK antibody clones and ALK FISH. Histopathology. ,vol. 65, pp. 398- 407 ,(2014) , 10.1111/HIS.12399
Julian R. Molina, Ping Yang, Stephen D. Cassivi, Steven E. Schild, Alex A. Adjei, Non-Small Cell Lung Cancer: Epidemiology, Risk Factors, Treatment, and Survivorship Mayo Clinic proceedings. Mayo Clinic. ,vol. 83, pp. 584- 594 ,(2008) , 10.4065/83.5.584
John Le Quesne, Manisha Maurya, Slaveya G. Yancheva, Mary O’Brien, Sanjay Popat, Andrew C. Wotherspoon, David Gonzalez de Castro, Andrew G. Nicholson, A comparison of immunohistochemical assays and FISH in detecting the ALK translocation in diagnostic histological and cytological lung tumor material. Journal of Thoracic Oncology. ,vol. 9, pp. 769- 774 ,(2014) , 10.1097/JTO.0000000000000157
J. Ying, L. Guo, T. Qiu, L. Shan, Y. Ling, X. Liu, N. Lu, Diagnostic value of a novel fully automated immunochemistry assay for detection of ALK rearrangement in primary lung adenocarcinoma Annals of Oncology. ,vol. 24, pp. 2589- 2593 ,(2013) , 10.1093/ANNONC/MDT295