PMID- 30527191
OWN - NLM
STAT- MEDLINE
DCOM- 20190930
LR  - 20190930
IS  - 1872-8332 (Electronic)
IS  - 0169-5002 (Linking)
VI  - 126
DP  - 2018 Dec
TI  - A phase II study of afatinib treatment for elderly patients with previously 
      untreated advanced non-small-cell lung cancer harboring EGFR mutations.
PG  - 41-47
LID - S0169-5002(18)30598-1 [pii]
LID - 10.1016/j.lungcan.2018.10.014 [doi]
AB  - OBJECTIVE: The efficacy and safety of afatinib in elderly patients with 
      EGFR-mutated non-small-cell lung cancer (NSCLC) have not been evaluated. This 
      study aimed to assess the efficacy and safety of afatinib in elderly 
      chemotherapy-naive patients with NSCLC harboring sensitive EGFR mutations. 
      MATERIALS AND METHODS: We prospectively assessed the clinical effects of afatinib 
      as a first-line treatment for elderly (age >/=70 years) NSCLC patients with EGFR 
      mutations (exon 19 deletion or exon 21 L858R mutation). All patients were 
      initially administered afatinib (30 mg/day). RESULTS: Between May 2014 and August 
      2017, 40 patients (13 men, 27 women) with adenocarcinoma were included in our 
      analysis. The median age was 77 years (range, 70-85 years). The dose was reduced 
      in 19 patients. The objective overall response and disease control rates were 
      72.5% and 100%, respectively, and the median progression-free survival and 
      overall survival were 12.9 months and not reached, respectively. Common adverse 
      events (AEs) included diarrhea, rash/acne, and anemia. Major grade 3 or higher 
      toxicities included diarrhea (12.5%), mucositis (7.5%), and pneumonitis (7.5%). 
      Afatinib treatment was discontinued in 8 patients owing to AEs of elevated 
      amylase (n = 1), liver dysfunction (n = 1), rash/acne (n = 1), nail change 
      (n = 1), anorexia (n = 2), pneumonitis (n = 2), and diarrhea (n = 2). Two 
      patients died due to treatment-related pneumonitis. CONCLUSIONS: This is the 
      first study that verified the efficacy and feasibility of first-line chemotherapy 
      with afatinib at 30 mg/day in elderly patients with advanced NSCLC harboring 
      sensitive EGFR mutations. First-line afatinib of 30 mg/day could be a treatment 
      option in this patient population.
CI  - Copyright (c) 2018 Elsevier B.V. All rights reserved.
FAU - Imai, Hisao
AU  - Imai H
AD  - Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Ohta, Gunma, 
      Japan.
FAU - Kaira, Kyoichi
AU  - Kaira K
AD  - Department of Oncology Clinical Development, Gunma University Graduate School of 
      Medicine, Maebashi, Gunma, Japan. Electronic address: kkaira1970@yahoo.co.jp.
FAU - Suzuki, Kensuke
AU  - Suzuki K
AD  - Division of Internal Medicine, Toyama Prefectural Central Hospital, Toyama, 
      Toyama, Japan.
FAU - Anzai, Masaki
AU  - Anzai M
AD  - Third Department of Internal Medicine, Faculty of Medical Sciences, University of 
      Fukui, Eiheiji, Fukui, Japan.
FAU - Tsuda, Takeshi
AU  - Tsuda T
AD  - Division of Internal Medicine, Toyama Prefectural Central Hospital, Toyama, 
      Toyama, Japan.
FAU - Ishizuka, Tamotsu
AU  - Ishizuka T
AD  - Third Department of Internal Medicine, Faculty of Medical Sciences, University of 
      Fukui, Eiheiji, Fukui, Japan.
FAU - Kuwako, Tomohito
AU  - Kuwako T
AD  - Division of Respirology, National Hospital Organization Shibukawa Medical Center 
      Hospital, Shibukawa, Gunma, Japan.
FAU - Naruse, Ichiro
AU  - Naruse I
AD  - Division of Respiratory Medicine, Hidaka Hospital, Takasaki, Gunma, Japan.
FAU - Nemoto, Kenji
AU  - Nemoto K
AD  - Division of Respiratory Medicine, National Hospital Organization Ibarakihigashi 
      National Hospital, Tokai, Ibaraki, Japan.
FAU - Uchino, Junji
AU  - Uchino J
AD  - Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, 
      Kyoto, Kyoto, Japan.
FAU - Morozumi, Nobutoshi
AU  - Morozumi N
AD  - Division of Respiratory Medicine, Saku Central Hospital Advanced Care Center, 
      Saku, Nagano, Japan.
FAU - Ishihara, Shinichi
AU  - Ishihara S
AD  - Division of Internal Medicine, Isesaki Municipal Hospital, Isesaki, Gunma, Japan.
FAU - Minato, Koichi
AU  - Minato K
AD  - Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Ohta, Gunma, 
      Japan.
FAU - Hisada, Takeshi
AU  - Hisada T
AD  - Department of Respiratory Medicine, Gunma University Graduate School of Medicine, 
      Maebashi, Gunma, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20181013
PL  - Ireland
TA  - Lung Cancer
JT  - Lung cancer (Amsterdam, Netherlands)
JID - 8800805
RN  - 0 (Protein Kinase Inhibitors)
RN  - 41UD74L59M (Afatinib)
RN  - EC 2.7.10.1 (EGFR protein, human)
RN  - EC 2.7.10.1 (ErbB Receptors)
SB  - IM
MH  - Afatinib/adverse effects/*therapeutic use
MH  - Aged
MH  - Aged, 80 and over
MH  - Anemia/chemically induced
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/genetics/pathology
MH  - Diarrhea/chemically induced
MH  - ErbB Receptors/antagonists & inhibitors/genetics
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Lung Neoplasms/*drug therapy/genetics/pathology
MH  - Male
MH  - Mucositis/chemically induced
MH  - Mutation, Missense
MH  - Protein Kinase Inhibitors/adverse effects/therapeutic use
OTO - NOTNLM
OT  - Advanced non-small-cell lung cancer
OT  - Afatinib
OT  - EGFR mutations
OT  - Elderly patients
OT  - First-line chemotherapy
EDAT- 2018/12/12 06:00
MHDA- 2019/10/01 06:00
CRDT- 2018/12/12 06:00
PHST- 2018/05/28 00:00 [received]
PHST- 2018/10/08 00:00 [revised]
PHST- 2018/10/12 00:00 [accepted]
PHST- 2018/12/12 06:00 [entrez]
PHST- 2018/12/12 06:00 [pubmed]
PHST- 2019/10/01 06:00 [medline]
AID - S0169-5002(18)30598-1 [pii]
AID - 10.1016/j.lungcan.2018.10.014 [doi]
PST - ppublish
SO  - Lung Cancer. 2018 Dec;126:41-47. doi: 10.1016/j.lungcan.2018.10.014. Epub 2018 
      Oct 13.