PMID- 29579334
OWN - NLM
STAT- MEDLINE
DCOM- 20190911
LR  - 20190911
IS  - 1097-0142 (Electronic)
IS  - 0008-543X (Linking)
VI  - 124
IP  - 11
DP  - 2018 Jun 1
TI  - Long-term safety and survival with gefitinib in select patients with advanced 
      non-small cell lung cancer: Results from the US IRESSA Clinical Access Program 
      (ICAP).
PG  - 2407-2414
LID - 10.1002/cncr.31313 [doi]
AB  - BACKGROUND: This is the first report of long-term (>10 years) safety, 
      tolerability, and survival data on patients with non-small cell lung cancer 
      (NSCLC) who received treatment with gefitinib, an epidermal growth factor 
      receptor (EGFR) tyrosine kinase inhibitor. METHODS: Patients with advanced NSCLC 
      (N = 191) who entered the IRESSA Clinical Access Program (ICAP) (June 2011 to 
      January 2013) and had previously obtained a clinical benefit from gefitinib 
      therapy (including patients who had received gefitinib since 2001) were analyzed 
      for adverse events (AEs). A subset of patients (n = 79) underwent retrospective 
      chart review to capture demographic, safety, and survival data. RESULTS: 
      Seventy-five of 191 patients (39%) remained on long-term gefitinib therapy as of 
      September 2016. Overall, serious AEs (SAEs) were reported in 64 patients (34%), 
      the majority of which were attributed to underlying disease or comorbidities; 
      only 3 patients (1.6%) had SAEs that were considered as possibly 
      gefitinib-related. In the retrospective chart review cohort, 70% of patients were 
      women; 58% were former smokers, and 30% were never-smokers; 56% were diagnosed 
      with adenocarcinoma, and 13% were diagnosed with squamous carcinoma. Although 
      EGFR mutational status was tested in only 17 patients (22%), it was assumed that 
      most tumors were EGFR-mutation-positive. The median duration of gefitinib therapy 
      was 11.1 years (7.8 years before and 3.5 years during ICAP), with 10-year and 
      15-year survival rates of 86% and 59%, respectively, from the initiation of 
      therapy. CONCLUSIONS: A subset of long-term NSCLC survivors who were receiving 
      gefitinib had an excellent long-term safety profile. Although it is assumed that 
      most of these patients' tumors harbor EGFR mutations, molecular studies of 
      available tumor specimens are planned to uncover the features that predict 
      long-term survival. Cancer 2018;124:2407-14. (c) 2018 American Cancer Society.
CI  - (c) 2018 American Cancer Society.
FAU - Hirsch, Fred R
AU  - Hirsch FR
AD  - University of Colorado Cancer Center, Denver, Colorado.
FAU - Sequist, Lecia V
AU  - Sequist LV
AD  - Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
FAU - Gore, Ira
AU  - Gore I
AD  - Alabama Oncology-St Vincent's Birmingham, Birmingham, Alabama.
FAU - Mooradian, Meghan
AU  - Mooradian M
AUID- ORCID: 0000-0002-8289-8015
AD  - Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
FAU - Simon, George
AU  - Simon G
AD  - The University of Texas MD Anderson Cancer Center, Houston, Texas.
FAU - Croft, Elisabeth F
AU  - Croft EF
AD  - AstraZeneca Pharmaceuticals, LP, Gaithersburg, Maryland.
FAU - DeVincenzo, Diana
AU  - DeVincenzo D
AD  - AstraZeneca Pharmaceuticals, LP, Wilmington, Delaware.
FAU - Munley, Jiefen
AU  - Munley J
AD  - AstraZeneca Pharmaceuticals, LP, Wilmington, Delaware.
FAU - Stein, Dara
AU  - Stein D
AD  - United BioSource Corporation, Montreal, Quebec, Canada.
FAU - Freivogel, Klaus
AU  - Freivogel K
AD  - United BioSource Corporation, Munich, Germany.
FAU - Sifakis, Frangiscos
AU  - Sifakis F
AD  - AstraZeneca Pharmaceuticals, LP, Gaithersburg, Maryland.
FAU - Bunn, Paul A Jr
AU  - Bunn PA Jr
AD  - University of Colorado Cancer Center, Denver, Colorado.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180326
PL  - United States
TA  - Cancer
JT  - Cancer
JID - 0374236
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Protein Kinase Inhibitors)
RN  - EC 2.7.10.1 (EGFR protein, human)
RN  - EC 2.7.10.1 (ErbB Receptors)
RN  - S65743JHBS (Gefitinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*administration & dosage/adverse effects
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/genetics/mortality/pathology
MH  - Disease-Free Survival
MH  - ErbB Receptors/antagonists & inhibitors/genetics
MH  - Female
MH  - Gefitinib/*administration & dosage/adverse effects
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/genetics/mortality/pathology
MH  - Male
MH  - Middle Aged
MH  - Mutation
MH  - Prospective Studies
MH  - Protein Kinase Inhibitors/*administration & dosage/adverse effects
MH  - Retrospective Studies
MH  - Survival Analysis
MH  - Survival Rate
MH  - Time Factors
MH  - United States/epidemiology
MH  - Young Adult
OTO - NOTNLM
OT  - epidermal growth factor receptor
OT  - gefitinib
OT  - non-small cell lung cancer
OT  - progression-free survival
OT  - safety
OT  - tyrosine kinase inhibitor
EDAT- 2018/03/27 06:00
MHDA- 2019/09/12 06:00
CRDT- 2018/03/27 06:00
PHST- 2017/09/27 00:00 [received]
PHST- 2018/02/01 00:00 [revised]
PHST- 2018/02/05 00:00 [accepted]
PHST- 2018/03/27 06:00 [pubmed]
PHST- 2019/09/12 06:00 [medline]
PHST- 2018/03/27 06:00 [entrez]
AID - 10.1002/cncr.31313 [doi]
PST - ppublish
SO  - Cancer. 2018 Jun 1;124(11):2407-2414. doi: 10.1002/cncr.31313. Epub 2018 Mar 26.