PMID- 28405961
OWN - NLM
STAT- MEDLINE
DCOM- 20171010
LR  - 20181202
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 34
IP  - 5
DP  - 2017 May
TI  - Treatment Patterns and Early Outcomes of ALK-Positive Non-Small Cell Lung Cancer 
      Patients Receiving Ceritinib: A Chart Review Study.
PG  - 1145-1156
LID - 10.1007/s12325-017-0527-6 [doi]
AB  - INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. FUNDING: Novartis Pharmaceutical Corporation.
FAU - Bendaly, Edmond
AU  - Bendaly E
AD  - Marion General Hospital, Medical Oncology, Marion, IN, USA.
FAU - Dalal, Anand A
AU  - Dalal AA
AD  - Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.
FAU - Culver, Kenneth
AU  - Culver K
AD  - Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.
FAU - Galebach, Philip
AU  - Galebach P
AD  - Analysis Group, Inc., Boston, USA.
FAU - Bocharova, Iryna
AU  - Bocharova I
AD  - Analysis Group, Inc., Boston, USA.
FAU - Foster, Rebekah
AU  - Foster R
AD  - Analysis Group, Inc., Boston, USA.
FAU - Sasane, Medha
AU  - Sasane M
AD  - Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.
FAU - Macalalad, Alexander R
AU  - Macalalad AR
AD  - Analysis Group, Inc., Boston, USA.
FAU - Guerin, Annie
AU  - Guerin A
AD  - Analysis Group, Inc., Boston, USA. annie.guerin@analysisgroup.com.
LA  - eng
PT  - Journal Article
DEP - 20170412
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrazoles)
RN  - 0 (Pyridines)
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfones)
RN  - 53AH36668S (Crizotinib)
RN  - EC 2.7.10.1 (Receptor Protein-Tyrosine Kinases)
RN  - K418KG2GET (ceritinib)
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy
MH  - Crizotinib
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Lung Neoplasms/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Protein Kinase Inhibitors/*therapeutic use
MH  - Pyrazoles/*therapeutic use
MH  - Pyridines/*therapeutic use
MH  - Pyrimidines/*therapeutic use
MH  - Receptor Protein-Tyrosine Kinases/*therapeutic use
MH  - Sulfones/*therapeutic use
MH  - United States
OTO - NOTNLM
OT  - ALK-positive non-small cell lung cancer
OT  - Ceritinib
OT  - Outcomes
OT  - Treatment patterns
EDAT- 2017/04/14 06:00
MHDA- 2017/10/11 06:00
CRDT- 2017/04/14 06:00
PHST- 2017/02/20 00:00 [received]
PHST- 2017/04/14 06:00 [pubmed]
PHST- 2017/10/11 06:00 [medline]
PHST- 2017/04/14 06:00 [entrez]
AID - 10.1007/s12325-017-0527-6 [pii]
AID - 10.1007/s12325-017-0527-6 [doi]
PST - ppublish
SO  - Adv Ther. 2017 May;34(5):1145-1156. doi: 10.1007/s12325-017-0527-6. Epub 2017 Apr 
      12.