PMID- 32559335
OWN - NLM
STAT- MEDLINE
DCOM- 20210618
LR  - 20221005
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 25
IP  - 10
DP  - 2020 Oct
TI  - Phase II Study of Low-Dose Afatinib Maintenance Treatment Among Patients with 
      EGFR-Mutated Non-Small Cell Lung Cancer: North Japan Lung Cancer Study Group 
      Trial 1601 (NJLCG1601).
PG  - e1451-e1456
LID - 10.1634/theoncologist.2020-0545 [doi]
AB  - LESSONS LEARNED: Low-dose afatinib maintenance treatment among patients with 
      EGFR-mutated NSCLC achieved long-time to treatment failure with fewer 
      treatment-related AEs without detracting from the therapeutic efficacy. This 
      modified regimen represents a practical usage that balances effectiveness and 
      safety. BACKGROUND: Although afatinib is an effective therapy for patients with 
      EGFR-mutated non-small cell lung cancer (NSCLC), drug-related adverse events 
      (AEs) have often necessitated dose reductions. In a post hoc analysis of the 
      LUX-Lung 3 and 6 trials, there was no difference in median progression-free 
      survival (PFS) between patients who had the dose of afatinib reduced and those 
      who did not. We thus evaluated the efficacy and tolerability of low-dose afatinib 
      maintenance treatment among patients with NSCLC harboring EGFR mutations who had 
      not been previously treated. METHODS: Eligible patients received afatinib 40 mg 
      orally once daily. When prescribed grade >/= 2 AEs, rash of grade >/= 3, or 
      unacceptable toxicity occurred, the afatinib dose was reduced from 40 to 30 mg 
      and if needed from 30 to 20 mg. The primary endpoint was the 1-year PFS rate. 
      Secondary endpoints were PFS, overall response rate (ORR), and toxicity. RESULTS: 
      Among 30 patients, 93% had adenocarcinoma, 53% had exon 19 deletion, 37% had 
      L858R, and 10% had minor mutations. The 1-year PFS rate was 50% (95% confidence 
      interval [CI], 31.3-66.1) and the median PFS was 11.8 months (95% CI, 7.1-21.4). 
      The incidence rate of grade >/= 3 toxicities was 57%, including elevated aspartate 
      aminotransferase/alanine aminotransferase level (13%), diarrhea (10%), and 
      paronychia (10%). CONCLUSION: Low-dose afatinib maintenance treatment reduced 
      treatment-related AEs without detracting from the therapeutic efficacy.
CI  - (c) AlphaMed Press; the data published online to support this summary are the 
      property of the authors.
FAU - Nakamura, Atsushi
AU  - Nakamura A
AD  - Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
FAU - Tanaka, Hisashi
AU  - Tanaka H
AD  - Department of Respiratory Medicine, Hirosaki University, Hirosaki, Japan.
FAU - Saito, Ryota
AU  - Saito R
AD  - Department of Respiratory Medicine, Tohoku University Hospital, Sendai, Japan.
FAU - Suzuki, Aya
AU  - Suzuki A
AD  - Department of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan.
FAU - Harada, Toshiyuki
AU  - Harada T
AD  - Department of Respiratory Medicine, JCHO Hokkaido Hospital, Sapporo, Japan.
FAU - Inoue, Sumito
AU  - Inoue S
AD  - Department of Cardiology, Pulmonology, and Nephrology, Yamagata University 
      Faculty of Medicine, Yamagata, Japan.
FAU - Yamada, Toru
AU  - Yamada T
AD  - First Department of Internal Medicine, Toyama University Hospital, Toyama, Japan.
FAU - Nakagawa, Taku
AU  - Nakagawa T
AD  - Dapartment of Thoracic Surgery, Omagari Kosei Medical Center, Daisen, Japan.
FAU - Jingu, Daisuke
AU  - Jingu D
AD  - Department of Respiratory Medicine, Saka General Hospital, Shiogama, Japan.
FAU - Sugawara, Shunichi
AU  - Sugawara S
AD  - Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20200707
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Protein Kinase Inhibitors)
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
MH  - Afatinib/therapeutic use
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy/genetics
MH  - ErbB Receptors/genetics
MH  - Humans
MH  - Japan
MH  - *Lung Neoplasms/drug therapy/genetics
MH  - Mutation
MH  - Protein Kinase Inhibitors
MH  - Quinazolines/adverse effects
MH  - Treatment Outcome
PMC - PMC7543297
EDAT- 2020/06/20 06:00
MHDA- 2021/06/22 06:00
PMCR- 2020/10/01
CRDT- 2020/06/20 06:00
PHST- 2020/03/31 00:00 [received]
PHST- 2020/05/31 00:00 [accepted]
PHST- 2020/06/20 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/06/20 06:00 [entrez]
PHST- 2020/10/01 00:00 [pmc-release]
AID - ONCO13422 [pii]
AID - 10.1634/theoncologist.2020-0545 [doi]
PST - ppublish
SO  - Oncologist. 2020 Oct;25(10):e1451-e1456. doi: 10.1634/theoncologist.2020-0545. 
      Epub 2020 Jul 7.