PMID- 24868099
OWN - NLM
STAT- MEDLINE
DCOM- 20150419
LR  - 20211021
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 19
IP  - 7
DP  - 2014 Jul
TI  - Phase II study of Afatinib as third-line treatment for patients in Korea with 
      stage IIIB/IV non-small cell lung cancer harboring wild-type EGFR.
PG  - 702-3
LID - 10.1634/theoncologist.2013-0419 [doi]
AB  - BACKGROUND: This phase II single-arm trial evaluated afatinib, an irreversible 
      inhibitor of the ErbB receptor family as third-line treatment of Korean patients 
      with advanced non-small cell lung cancer (NSCLC) and tumors with wild-type EGFR. 
      Currently, no standard therapy exists for these patients. METHODS: Eligible 
      patients had stage IIIB/IV wild-type EGFR lung adenocarcinoma and had failed to 
      benefit from two previous lines of chemotherapy but had not received anti-EGFR 
      treatment. Patients received oral afatinib at 40 mg per day until disease 
      progression or occurrence of intolerable adverse events (AEs). The primary 
      endpoint was confirmed objective tumor response (OR) rate (confirmed complete 
      response [CR] or partial response [PR]). Secondary endpoints included disease 
      control rate (DCR; OR or stable disease for >/=6 weeks), progression-free survival 
      (PFS), and safety. RESULTS: Forty-two patients received afatinib treatment, and 
      38 of those were included in efficacy analyses. No confirmed CRs or PRs were 
      reported. DCR was 24% (9 of 38 patients), with a median disease control duration 
      of 19.3 weeks. Median PFS was 4.1 weeks (95% confidence interval: 3.9-8.0). 
      Frequently reported AEs (mainly grades 1 and 2) were rash/acne (88%), diarrhea 
      (62%), and stomatitis (57%). CONCLUSION: Heavily pretreated patients with 
      wild-type EGFR NSCLC treated with afatinib monotherapy did not experience an 
      objective response and only 24% had disease stabilization lasting more than 6 
      weeks. AEs were manageable and consistent with the expected safety profile.
CI  - (c)AlphaMed Press; the data published online to support this summary is the 
      property of the authors.
FAU - Ahn, Myung-Ju
AU  - Ahn MJ
AD  - Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 
      Republic of Korea;
FAU - Kim, Sang-We
AU  - Kim SW
AD  - Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of 
      Korea;
FAU - Cho, Byoung-Chul
AU  - Cho BC
AD  - Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of 
      Korea;
FAU - Ahn, Jin Seok
AU  - Ahn JS
AD  - Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 
      Republic of Korea;
FAU - Lee, Dae Ho
AU  - Lee DH
AD  - Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of 
      Korea;
FAU - Sun, Jong-Mu
AU  - Sun JM
AD  - Samsung Medical Center, Seoul, Republic of Korea;
FAU - Massey, Dan
AU  - Massey D
AD  - Boehringer Ingelheim Ltd. UK, Bracknell, United Kingdom;
FAU - Kim, Miyoung
AU  - Kim M
AD  - Boehringer Ingelheim Korea, Seoul, Republic of Korea;
FAU - Shi, Yang
AU  - Shi Y
AD  - Boehringer Ingelheim China, Beijing, China.
FAU - Park, Keunchil
AU  - Park K
AD  - Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 
      Republic of Korea; kpark@skku.edu.
LA  - eng
SI  - ClinicalTrials.gov/NCT01003899
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20140527
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Quinazolines)
RN  - 41UD74L59M (Afatinib)
RN  - EC 2.7.10.1 (EGFR protein, human)
RN  - EC 2.7.10.1 (ErbB Receptors)
SB  - IM
EIN - Oncologist. 2015 May;20(5):570. PMID: 25956899
MH  - Afatinib
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/enzymology/genetics
MH  - Disease-Free Survival
MH  - ErbB Receptors/antagonists & inhibitors/genetics/*metabolism
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/enzymology/genetics
MH  - Male
MH  - Neoplasm Staging
MH  - Quinazolines/adverse effects/*therapeutic use
MH  - Republic of Korea
PMC - PMC4077442
EDAT- 2014/05/29 06:00
MHDA- 2015/04/22 06:00
PMCR- 2014/05/27
CRDT- 2014/05/29 06:00
PHST- 2014/05/29 06:00 [entrez]
PHST- 2014/05/29 06:00 [pubmed]
PHST- 2015/04/22 06:00 [medline]
PHST- 2014/05/27 00:00 [pmc-release]
AID - theoncologist.2013-0419 [pii]
AID - T13419 [pii]
AID - 10.1634/theoncologist.2013-0419 [doi]
PST - ppublish
SO  - Oncologist. 2014 Jul;19(7):702-3. doi: 10.1634/theoncologist.2013-0419. Epub 2014 
      May 27.