PMID- 32738416
OWN - NLM
STAT- MEDLINE
DCOM- 20210621
LR  - 20210621
IS  - 1872-8332 (Electronic)
IS  - 0169-5002 (Linking)
VI  - 147
DP  - 2020 Sep
TI  - Afatinib in patients with advanced non-small cell lung cancer harboring HER2 
      mutations, previously treated with chemotherapy: A phase II trial.
PG  - 209-213
LID - S0169-5002(20)30539-0 [pii]
LID - 10.1016/j.lungcan.2020.07.017 [doi]
AB  - BACKGROUND: Despite 1-4 % of NSCLC tumors harboring mutations in the HER2 gene, 
      there are no approved HER2-pathway-targeted treatments available. We report an 
      open-label, single-arm, multicenter phase II study investigating the efficacy and 
      safety of afatinib in Asian patients with HER2-mutation positive (HER2m+) NSCLC. 
      METHODS: Eligible patients for Part A had confirmed stage IIIb/IV HER2m + NSCLC, 
      had failed one or two prior lines of chemotherapy, and were EGFR/HER2-inhibitor 
      naive. Patients received oral afatinib 40 mg/day in continuous 28-day cycles, 
      until disease progression or intolerable adverse events (AEs). Patients qualified 
      for Part B if they had > 12 weeks' clinical benefit and Eastern Cooperative 
      Oncology Group performance status </= 2. In Part B, patients were to receive 
      afatinib at the last received dose, plus paclitaxel 80 mg/m(2) weekly, until 
      disease progression or intolerable AEs. The primary endpoint in Part A was 
      objective response (OR); secondary endpoints included disease control (DC), 
      progression-free survival (PFS), and overall survival (OS). Further exploratory 
      endpoints were OR, DC, and PFS in Part B. RESULTS: Eighteen patients received 
      afatinib in Part A. No patient achieved an OR; 11 patients (61.1 %) achieved 
      stable disease, and six patients (33.3 %) had progressive disease. DC rate was 
      therefore 61.1 % (95 % confidence interval [CI]: 35.7, 82.7). A decrease in tumor 
      size from baseline of > 0 to < 30 % was observed in eight patients. At the time 
      of analysis, 16 patients (88.9 %) had progressed or died. Median PFS was 2.76 
      months (95 % CI: 1.87, 4.60) and median OS was 10.02 months (95 % CI: 8.47, 
      10.08). All patients experienced >/= 1 AE, most commonly diarrhea (66.7 %) and rash 
      (33.3 %). No patients met the inclusion criteria for Part B, and recruitment was 
      slow; therefore, the study was terminated. CONCLUSIONS: This study found no 
      clinical benefit of afatinib for EGFR TKI-naive patients with HER2m + NSCLC.
CI  - Copyright (c) 2020 Elsevier B.V. All rights reserved.
FAU - Fan, Yun
AU  - Fan Y
AD  - Zhejiang Cancer Hospital, Hangzhou, China.
FAU - Chen, Jianhua
AU  - Chen J
AD  - Hunan Cancer Hospital, Changsha, China.
FAU - Zhou, Chengzhi
AU  - Zhou C
AD  - The First Affiliated Hospital of Guangzhou Medical University, Guangdong, China.
FAU - Wang, Huijuan
AU  - Wang H
AD  - Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, 
      Zhengzhou, China.
FAU - Shu, Yongqian
AU  - Shu Y
AD  - The First Affiliated Hospital with Nanjing Medical University, Jiangsu, China.
FAU - Zhang, Jacky
AU  - Zhang J
AD  - Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.
FAU - Hua, Hairui
AU  - Hua H
AD  - Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.
FAU - Huang, Dennis Chin-Lun
AU  - Huang DC
AD  - Boehringer Ingelheim Taiwan Limited, Taipei, Taiwan.
FAU - Zhou, Caicun
AU  - Zhou C
AD  - Medical Oncology, Shanghai Pulmonary Hospital, Shanghai, China. Electronic 
      address: caicunzhoudr@163.com.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200716
PL  - Ireland
TA  - Lung Cancer
JT  - Lung cancer (Amsterdam, Netherlands)
JID - 8800805
RN  - 0 (Quinazolines)
RN  - 41UD74L59M (Afatinib)
RN  - EC 2.7.10.1 (ErbB Receptors)
SB  - IM
MH  - Afatinib/therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy/genetics
MH  - ErbB Receptors/genetics
MH  - Humans
MH  - *Lung Neoplasms/drug therapy/genetics
MH  - Mutation
MH  - Quinazolines/therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Afatinib
OT  - HER2
OT  - NSCLC
EDAT- 2020/08/02 06:00
MHDA- 2021/06/22 06:00
CRDT- 2020/08/02 06:00
PHST- 2020/03/27 00:00 [received]
PHST- 2020/07/08 00:00 [revised]
PHST- 2020/07/13 00:00 [accepted]
PHST- 2020/08/02 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/08/02 06:00 [entrez]
AID - S0169-5002(20)30539-0 [pii]
AID - 10.1016/j.lungcan.2020.07.017 [doi]
PST - ppublish
SO  - Lung Cancer. 2020 Sep;147:209-213. doi: 10.1016/j.lungcan.2020.07.017. Epub 2020 
      Jul 16.