PMID- 33718026
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220910
IS  - 2218-6751 (Print)
IS  - 2226-4477 (Electronic)
IS  - 2218-6751 (Linking)
VI  - 10
IP  - 2
DP  - 2021 Feb
TI  - Fruquintinib with gefitinib as first-line therapy in patients carrying EGFR 
      mutations with advanced non-small cell lung cancer: a single-arm, phase II study.
PG  - 839-854
LID - 10.21037/tlcr-20-1028 [doi]
AB  - BACKGROUND: Fruquintinib is an oral vascular endothelial growth factor receptor 
      inhibitor. Previous gefitinib studies with anti-angiogenics show promising 
      efficacy. This phase II trial assessed efficacy and safety of fruquintinib in 
      combination with gefitinib, in patients with advanced non-small cell lung cancer 
      (NSCLC). METHODS: Fifty patients with stage IIIB/IV NSCLC and an epidermal growth 
      factor receptor (EGFR) exon-19 deletion or exon-21 L858R mutation were enrolled 
      between January 2017 and June 2019. Per protocol (version 1.0), patients received 
      4 mg fruquintinib once daily (qd) Days 1-21 of Cycle 1, using a 
      3-week-on/1-week-off schedule, plus continuous gefitinib 250 mg qd. If tolerated, 
      patients proceeded to fruquintinib 5 mg qd (fruquintinib 5 mg group, n=26). 
      Following protocol updates, dose escalation of fruquintinib from 4 mg qd to 5 mg 
      qd was not allowed. The primary efficacy endpoint was objective response rate 
      (ORR); secondary endpoints included progression-free survival (PFS), disease 
      control rate (DCR), time to response, duration of response and adverse events 
      (AEs). RESULTS: ORR was 73.5% (95% CI, 58.9-85.1) and DCR was 98.0% (95% CI, 
      89.2-100.0). Median PFS was 14.7 months for both groups; PFS was highest for 
      patients with exon-19 deletion (16.5 months; 95% CI, 12.9-21.2). Grade >/=3 
      treatment-emergent AEs occurred in 17 (65.3%; fruquintinib 5 mg,) and 11 patients 
      (45.8%; 4 mg). Serious AEs were recorded for nine patients (fruquintinib 5 mg, 
      six patients; 4 mg, three). CONCLUSIONS: Fruquintinib and gefitinib treatment 
      showed an acceptable safety profile and promising efficacy in patients with 
      NSCLC.
CI  - 2021 Translational Lung Cancer Research. All rights reserved.
FAU - Lu, Shun
AU  - Lu S
AD  - Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong 
      University, Shanghai, China.
FAU - Zhou, Jian-Ying
AU  - Zhou JY
AD  - The First Affiliated Hospital, College of Medicine, Zhejiang University, 
      Hangzhou, China.
FAU - Niu, Xiao-Min
AU  - Niu XM
AD  - Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong 
      University, Shanghai, China.
FAU - Zhou, Jian-Ya
AU  - Zhou JY
AD  - The First Affiliated Hospital, College of Medicine, Zhejiang University, 
      Hangzhou, China.
FAU - Jian, Hong
AU  - Jian H
AD  - Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong 
      University, Shanghai, China.
FAU - Yin, Hong-Yan
AU  - Yin HY
AD  - Hutchison MediPharma, Shanghai, China.
FAU - Guan, Sha
AU  - Guan S
AD  - Hutchison MediPharma, Shanghai, China.
FAU - Wang, Lin-Fang
AU  - Wang LF
AD  - Hutchison MediPharma, Shanghai, China.
FAU - Li, Ke
AU  - Li K
AD  - Hutchison MediPharma, Shanghai, China.
FAU - He, James
AU  - He J
AD  - Hutchison MediPharma, Shanghai, China.
FAU - Su, Wei-Guo
AU  - Su WG
AD  - Hutchison MediPharma, Shanghai, China.
LA  - eng
PT  - Journal Article
PL  - China
TA  - Transl Lung Cancer Res
JT  - Translational lung cancer research
JID - 101646875
PMC - PMC7947379
OTO - NOTNLM
OT  - Non-small cell lung cancer (NSCLC)
OT  - efficacy
OT  - epidermal growth factor receptor (EGFR)
OT  - fruquintinib
OT  - gefitinib
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at http://dx.doi.org/10.21037/tlcr-20-1028). SL reports grants 
      from Hutchison MediPharma, grants from National Key R&D Program of China, grants 
      from Shanghai Science and Technology Innovation Program during the conduct of the 
      study; other research support from AstraZeneca; Boehringer Ingelheim, Hutchison 
      MediPharma and Roche; other speaker fees from AstraZeneca, Eli Lilly, Roche, and 
      Sanofi; an advisor for AstraZeneca, Boehringer Ingelheim, Hutchison MediPharma 
      and Roche outside the submitted work. HYY, SG, LFW, KL and JH report personal 
      fees from Hutchison MediPharma during the conduct of the study. WGS reports 
      personal fees from Hutchison MediPharma and Hutchison Chi-Med during the conduct 
      of the study. The authors have no other conflicts of interest to declare.
EDAT- 2021/03/16 06:00
MHDA- 2021/03/16 06:01
PMCR- 2021/02/01
CRDT- 2021/03/15 07:07
PHST- 2021/03/15 07:07 [entrez]
PHST- 2021/03/16 06:00 [pubmed]
PHST- 2021/03/16 06:01 [medline]
PHST- 2021/02/01 00:00 [pmc-release]
AID - tlcr-10-02-839 [pii]
AID - 10.21037/tlcr-20-1028 [doi]
PST - ppublish
SO  - Transl Lung Cancer Res. 2021 Feb;10(2):839-854. doi: 10.21037/tlcr-20-1028.