PMID- 32495514
OWN - NLM
STAT- MEDLINE
DCOM- 20210812
LR  - 20210812
IS  - 1759-7714 (Electronic)
IS  - 1759-7706 (Print)
IS  - 1759-7706 (Linking)
VI  - 11
IP  - 8
DP  - 2020 Aug
TI  - Afatinib + bevacizumab combination therapy in EGFR-mutant NSCLC patients with 
      osimertinib resistance: Protocol of an open-label, phase II, multicenter, 
      single-arm trial.
PG  - 2125-2129
LID - 10.1111/1759-7714.13503 [doi]
AB  - INTRODUCTION: As most patients with epidermal growth factor receptor 
      (EGFR)-mutant non-small cell lung cancer (NSCLC) develop progressive disease 
      after treatment with osimertinib, it is important to develop more effective 
      treatment options. Afatinib has been shown to be more effective in in vitro 
      studies than osimertinib when used in cancer cell lines containing some specific 
      EGFR mutations. Therefore, afatinib may be an effective solution, especially when 
      used in combination with an anti-VEGF agent such as bevacizumab. METHODS: A phase 
      II multicenter, open-label, single-arm trial has been initiated to evaluate the 
      efficacy and safety of afatinib and bevacizumab combination as salvage therapy 
      for EGFR-mutated lung cancer in patients previously treated with osimertinib. The 
      primary endpoint will be the objective response rate (ORR) and secondary 
      endpoints are progression-free survival (PFS), overall survival (OS), disease 
      control rate (DCR), and adverse events (AEs). DISCUSSION: A previous study 
      indicated that afatinib inhibits lung cancer cells with specific EGFR mutations 
      more effectively than other EGFR-TKIs such as osimertinib. Therefore, we expect 
      that combination therapy using afatinib and bevacizumab will be effective in 
      patients previously treated with osimertinib (registration no. jRCTs031190077).
CI  - (c) 2020 The Authors. Thoracic Cancer published by China Lung Oncology Group and 
      John Wiley & Sons Australia, Ltd.
FAU - Kobayashi, Nobuaki
AU  - Kobayashi N
AUID- ORCID: 0000-0002-7064-320X
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Hashimoto, Hisashi
AU  - Hashimoto H
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Kamimaki, Chisato
AU  - Kamimaki C
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Nagasawa, Ryo
AU  - Nagasawa R
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Tanaka, Katsushi
AU  - Tanaka K
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Kubo, Sousuke
AU  - Kubo S
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Katakura, Seigo
AU  - Katakura S
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Chen, Hao
AU  - Chen H
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Hirama, Nobuyuki
AU  - Hirama N
AD  - Respiratory Disease Center, Yokohama City University Medical Center, Yokohama, 
      Japan.
FAU - Ushio, Ryota
AU  - Ushio R
AD  - Respiratory Disease Center, Yokohama City University Medical Center, Yokohama, 
      Japan.
FAU - Aoki, Ayako
AU  - Aoki A
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Nakashima, Kentaro
AU  - Nakashima K
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Teranishi, Shuhei
AU  - Teranishi S
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Manabe, Saki
AU  - Manabe S
AD  - Respiratory Disease Center, Yokohama City University Medical Center, Yokohama, 
      Japan.
FAU - Watanabe, Hiroki
AU  - Watanabe H
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Horita, Nobuyuki
AU  - Horita N
AUID- ORCID: 0000-0002-8200-0340
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Watanabe, Keisuke
AU  - Watanabe K
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Hara, Yu
AU  - Hara Y
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Yamamoto, Masaki
AU  - Yamamoto M
AUID- ORCID: 0000-0001-7056-4192
AD  - Respiratory Disease Center, Yokohama City University Medical Center, Yokohama, 
      Japan.
FAU - Kudo, Makoto
AU  - Kudo M
AD  - Respiratory Disease Center, Yokohama City University Medical Center, Yokohama, 
      Japan.
FAU - Piao, Hongmei
AU  - Piao H
AD  - Department of Respiratory Medicine, Affiliated Hospital of Yanbian University, 
      Yanji, China.
FAU - Kaneko, Takeshi
AU  - Kaneko T
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20200603
PL  - Singapore
TA  - Thorac Cancer
JT  - Thoracic cancer
JID - 101531441
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - 41UD74L59M (Afatinib)
RN  - EC 2.7.10.1 (ErbB Receptors)
SB  - IM
MH  - Afatinib/pharmacology/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/pharmacology/*therapeutic use
MH  - Bevacizumab/pharmacology/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/pathology
MH  - ErbB Receptors/*metabolism
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/mortality/pathology
MH  - Progression-Free Survival
PMC - PMC7396380
OTO - NOTNLM
OT  - Afatinib
OT  - EGFR
OT  - bevacizumab
OT  - non-small cell lung cancer
OT  - osimertinib
EDAT- 2020/06/05 06:00
MHDA- 2021/08/13 06:00
PMCR- 2020/08/01
CRDT- 2020/06/05 06:00
PHST- 2020/03/04 00:00 [received]
PHST- 2020/05/08 00:00 [revised]
PHST- 2020/05/09 00:00 [accepted]
PHST- 2020/06/05 06:00 [pubmed]
PHST- 2021/08/13 06:00 [medline]
PHST- 2020/06/05 06:00 [entrez]
PHST- 2020/08/01 00:00 [pmc-release]
AID - TCA13503 [pii]
AID - 10.1111/1759-7714.13503 [doi]
PST - ppublish
SO  - Thorac Cancer. 2020 Aug;11(8):2125-2129. doi: 10.1111/1759-7714.13503. Epub 2020 
      Jun 3.