PMID- 28373069
OWN - NLM
STAT- MEDLINE
DCOM- 20180213
LR  - 20221207
IS  - 1938-0690 (Electronic)
IS  - 1525-7304 (Linking)
VI  - 18
IP  - 5
DP  - 2017 Sep
TI  - Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced 
      Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials.
PG  - 472-479
LID - S1525-7304(17)30081-5 [pii]
LID - 10.1016/j.cllc.2017.03.004 [doi]
AB  - INTRODUCTION: Interstitial lung disease (ILD) is a rare, but potentially serious, 
      side effect associated with crizotinib, a tyrosine kinase inhibitor for 
      anaplastic lymphoma kinase-positive (ALK(+)) advanced non-small cell lung cancer. 
      Our objective was to determine the incidence and nature of ILD associated with 
      crizotinib in 4 PROFILE trials (ClinicalTrials.gov identifiers, NCT00585195, 
      NCT00932451, NCT00932893, and NCT01154140). MATERIALS AND METHODS: Grade >/= 3 
      respiratory adverse events (AEs) and serious AEs (SAEs) and any grade AEs/SAEs 
      reported as pneumonitis, ILD, or radiation pneumonitis in trials PROFILE 1001, 
      PROFILE 1005, PROFILE 1007, and PROFILE 1014 were evaluated by an expert 
      independent review committee that included a pulmonologist, medical oncologist, 
      and radiologist. Events were designated as disease progression, de novo ILD 
      possibly or probably related to crizotinib, exacerbation or recurrence of 
      pre-existing ILD, concurrent illness, other toxicity not thought to be related to 
      ILD, or inconclusive. RESULTS: The independent review committee evaluated 446 
      events (in 368 of 1669 patients who had received crizotinib therapy). They 
      classified these events as follows: progressive disease, 77; de novo ILD, 20; 
      pre-existing ILD, 3; concurrent illness, 9; other toxicities, 310; and 
      inconclusive, 27. The incidence of de novo ILD was 1.2% overall, 1.3% in whites, 
      and 1.2% overall in Asians, but greater at 3.7% in Japanese patients. The median 
      onset of ILD from the initiation of crizotinib therapy was 23 days (range, 3-763 
      days). The mortality rate due to ILD was 50%. Survival was improved if crizotinib 
      was discontinued on presentation of ILD (9 of 14 patients) compared with 
      discontinued later or continued (1 of 6 patients). CONCLUSION: ILD associated 
      with crizotinib, although rare, can occur at any time and requires close 
      monitoring.
CI  - Published by Elsevier Inc.
FAU - Yoneda, Ken Y
AU  - Yoneda KY
AD  - Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal 
      Medicine, University of California, Davis, Sacramento, CA. Electronic address: 
      kyyoneda@ucdavis.edu.
FAU - Scranton, Judith R
AU  - Scranton JR
AD  - Pfizer Oncology, Groton, CT.
FAU - Cadogan, Michael A
AU  - Cadogan MA
AD  - Bioclinica, Princeton, NJ.
FAU - Tassell, Vanessa
AU  - Tassell V
AD  - Pfizer Oncology, La Jolla, CA.
FAU - Nadanaciva, Sashi
AU  - Nadanaciva S
AD  - Pfizer Oncology, Groton, CT.
FAU - Wilner, Keith D
AU  - Wilner KD
AD  - Pfizer Oncology, La Jolla, CA.
FAU - Stollenwerk, Nicholas S
AU  - Stollenwerk NS
AD  - Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal 
      Medicine, University of California, Davis, Sacramento, CA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00585195
SI  - ClinicalTrials.gov/NCT00932451
SI  - ClinicalTrials.gov/NCT00932893
SI  - ClinicalTrials.gov/NCT01154140
PT  - Journal Article
DEP - 20170314
PL  - United States
TA  - Clin Lung Cancer
JT  - Clinical lung cancer
JID - 100893225
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Pyrazoles)
RN  - 0 (Pyridines)
RN  - 53AH36668S (Crizotinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*adverse effects
MH  - Asian People/ethnology
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy
MH  - Crizotinib
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Japan/ethnology
MH  - Lung Diseases, Interstitial/*chemically induced/epidemiology/mortality
MH  - Lung Neoplasms/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Pyrazoles/*adverse effects
MH  - Pyridines/*adverse effects
MH  - Randomized Controlled Trials as Topic
MH  - Retrospective Studies
MH  - White People/ethnology
MH  - Young Adult
OTO - NOTNLM
OT  - Adverse event
OT  - Anaplastic lymphoma kinase
OT  - Independent review
OT  - Pneumonitis
OT  - Tyrosine kinase inhibitor
EDAT- 2017/04/05 06:00
MHDA- 2018/02/14 06:00
CRDT- 2017/04/05 06:00
PHST- 2016/12/13 00:00 [received]
PHST- 2017/02/23 00:00 [revised]
PHST- 2017/03/06 00:00 [accepted]
PHST- 2017/04/05 06:00 [pubmed]
PHST- 2018/02/14 06:00 [medline]
PHST- 2017/04/05 06:00 [entrez]
AID - S1525-7304(17)30081-5 [pii]
AID - 10.1016/j.cllc.2017.03.004 [doi]
PST - ppublish
SO  - Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 
      2017 Mar 14.