title: Recommendations for the analysis of ALK gene rearrangements in non-small-cell lung cancer: a consensus of the Italian Association of Medical Oncology and the Italian Society of Pathology and Cytopathology.
abstract: BACKGROUND
  Recent clinical trials led to the approval of crizotinib (PF-02341066; Pfizer) by the U.S. Food and Drug Administration for the treatment of locally advanced or metastatic non-small-cell lung cancer (NSCLC) patients whose tumors are positive for anaplastic lymphoma kinase (ALK) alterations. The European Medicines Agency accepted the regulatory submission of crizotinib for the treatment of these patients. Therefore, ALK gene testing has become mandatory to choose the most appropriate therapy.
  
  
  METHODS
  To help physicians, involved in the management of NSCLC patients to be treated with ALK inhibitors in Italy, the Italian Association of Medical Oncology and the Italian Society of Pathology and Cytopathology identified a large panel of Italian medical oncologists and pathologists that outlined recommendations for ALK testing in NSCLC patients.
  
  
  RESULTS
  The guidelines produced include specific information on the target patient population, the biological material for molecular analysis, a section dedicated to the histocytopathologic diagnosis of NSCLC, and the methods for the assessment of ALK alterations that are summarized in this article.
  
  
  CONCLUSIONS
  Clinicopathologic recommendations were produced to guide the management of NSCLC patients who need to be tested for ALK rearrangements before treatment with ALK inhibitors.
authors: Center of Predictive Molecular Medicine, Center of Excellence on Aging, University-Foundation, Chieti, Italy. amarchetti@unich.it
authors: Antonio
authors: A
authors: Marchetti
authors: Andrea
authors: A
authors: Ardizzoni
authors: Mauro
authors: M
authors: Papotti
authors: Lucio
authors: L
authors: Crinò
authors: Giulio
authors: G
authors: Rossi
authors: Cesare
authors: C
authors: Gridelli
authors: Massimo
authors: M
authors: Barberis
authors: Eugenio
authors: E
authors: Maiorano
authors: Nicola
authors: N
authors: Normanno
authors: Gian Luigi
authors: GL
authors: Taddei
authors: Giorgio
authors: G
authors: Scagliotti
authors: Claudio
authors: C
authors: Clemente
authors: Carmine
authors: C
authors: Pinto
mesh_terms: D000077548:Anaplastic Lymphoma Kinase; D014408:Biomarkers, Tumor / Q000032:analysis* / Q000235:genetics; D002289:Carcinoma, Non-Small-Cell Lung / Q000235:genetics* / Q000473:pathology / Q000628:therapy; D015321:Gene Rearrangement; D006801:Humans; D007558:Italy; D008175:Lung Neoplasms / Q000235:genetics* / Q000473:pathology; D008495:Medical Oncology; D017410:Practice Guidelines as Topic / Q000592:standards*; D011379:Prognosis; D020794:Receptor Protein-Tyrosine Kinases / Q000235:genetics*
chemical_list: D014408:Biomarkers, Tumor; C000626173:ALK protein, human; D000077548:Anaplastic Lymphoma Kinase; D020794:Receptor Protein-Tyrosine Kinases