title: Treatment Patterns and Early Outcomes of ALK-Positive Non-Small Cell Lung Cancer Patients Receiving Ceritinib: A Chart Review Study.
abstract: This study aimed to provide the first real-world description of the characteristics, treatments, dosing patterns, and early outcomes of patients with ALK-positive non-small cell lung cancer (NSCLC) who received ceritinib in US clinical practice.
  
  
  
  US oncologists provided data from medical charts of adult patients diagnosed with locally advanced or metastatic ALK-positive NSCLC who received ceritinib following crizotinib. Patient characteristics, treatment patterns, ceritinib dosing, early outcomes, and occurrence of gastrointestinal adverse events (AEs) by dose and instructions on food intake were assessed, and Kaplan-Meier analysis was used to describe clinician-defined progression-free survival (PFS) on ceritinib.
  
  
  
  Medical charts of 58 ALK-positive NSCLC patients treated with ceritinib were reviewed (median age 63 years; 41% male; 21% with prior chemotherapy experience). At ceritinib initiation, 44 patients had multiple distant metastases, most commonly in the liver (60%), bone (53%), and brain (38%). Initial ceritinib dose varied: 71% received 750 mg, 19% 600 mg, and 10% 450 mg. Although median follow-up after ceritinib initiation was short (3.8 months), most patients achieved either a complete or partial response (69%) on ceritinib, regardless of metastatic sites present at initiation or initial dose. Median PFS on ceritinib was 12.9 months. 17% of patients had a gastrointestinal AE reported during follow-up. The majority of events occurred in patients instructed to fast; no patients instructed to take a lower dose of ceritinib with food reported gastrointestinal AEs.
  
  
  
  These early findings of ceritinib use in clinical practice suggest that ceritinib is effective at treating crizotinib-experienced ALK-positive NSCLC patients, regardless of metastatic sites or initial dose, and dosing ceritinib with food may lead to fewer gastrointestinal AEs. Future studies with larger sample size and longer follow-up are warranted, including an ongoing randomized trial to assess the gastrointestinal tolerability of ceritinib 450 and 600 mg with low-fat meals.
  
  
  
  Novartis Pharmaceutical Corporation.
authors.affiliation: Marion General Hospital, Medical Oncology, Marion, IN, USA.
authors.forename: Edmond
authors.initials: E
authors.lastname: Bendaly
authors.affiliation: Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.
authors.forename: Anand A
authors.initials: AA
authors.lastname: Dalal
authors.affiliation: Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Culver
authors.affiliation: Analysis Group, Inc., Boston, USA.
authors.forename: Philip
authors.initials: P
authors.lastname: Galebach
authors.affiliation: Analysis Group, Inc., Boston, USA.
authors.forename: Iryna
authors.initials: I
authors.lastname: Bocharova
authors.affiliation: Analysis Group, Inc., Boston, USA.
authors.forename: Rebekah
authors.initials: R
authors.lastname: Foster
authors.affiliation: Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.
authors.forename: Medha
authors.initials: M
authors.lastname: Sasane
authors.affiliation: Analysis Group, Inc., Boston, USA.
authors.forename: Alexander R
authors.initials: AR
authors.lastname: Macalalad
authors.affiliation: Analysis Group, Inc., Boston, USA. annie.guerin@analysisgroup.com.
authors.forename: Annie
authors.initials: A
authors.lastname: Guérin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D000077547:Crizotinib; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011720:Pyrazoles / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*; D011743:Pyrimidines / Q000627:therapeutic use*; D020794:Receptor Protein-Tyrosine Kinases / Q000627:therapeutic use*; D013450:Sulfones / Q000627:therapeutic use*; D014481:United States
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D011720:Pyrazoles; D011725:Pyridines; D011743:Pyrimidines; D013450:Sulfones; D000077547:Crizotinib; D020794:Receptor Protein-Tyrosine Kinases; C586847:ceritinib
keywords: ALK-positive non-small cell lung cancer; Ceritinib; Outcomes; Treatment patterns