PMID- 31555524
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220410
IS  - 2218-6751 (Print)
IS  - 2226-4477 (Electronic)
IS  - 2218-6751 (Linking)
VI  - 8
IP  - 4
DP  - 2019 Aug
TI  - Rationale and design of a phase II study to evaluate prophylactic treatment of 
      dacomitinib-induced dermatologic adverse events in epidermal growth factor 
      receptor-mutated advanced non-small cell lung cancer (SPIRAL-Daco study).
PG  - 519-523
LID - 10.21037/tlcr.2019.08.03 [doi]
AB  - BACKGROUND: Dacomitinib is the first second-generation epidermal growth factor 
      receptor tyrosine kinase inhibitor (EGFR-TKI) to significantly improve overall 
      survival in the patients of EGFR mutation-positive inoperable or postoperative 
      recurrent non-small cell lung cancer (NSCLC). However, dermatologic adverse 
      events (AEs) increase with dacomitinib treatment, and the management strategy for 
      dermatologic AEs is crucial. In particular, a proactive strategy has become 
      desirable in clinical practice settings. We designed a trial to assess a 
      proactive strategy for dermatologic AEs associated with dacomitinib treatment. 
      METHODS: This is a single-arm, prospective, open-label, multicenter, phase II 
      trial. Patients with advanced NSCLC harboring EGFR-activating mutations will 
      receive dacomitinib and prophylactic treatment as follows: minocycline, skin 
      moisturizer, topical steroid, and sunscreen. Treatment will be continued until 
      progressive disease or any of the discontinuation criteria are met. The primary 
      endpoint is the incidence of dermatologic AEs (>/= grade 2) in the first 8 weeks of 
      dacomitinib treatment. Secondary endpoints are the proportion of dose reduction 
      of dacomitinib, progression-free survival, and safety. DISCUSSION: We are 
      conducting a phase II study to explore the preventive efficacy of prophylactic 
      medication against dacomitinib-induced dermatologic AEs. TRIAL REGISTRATION: 
      jRCTs071190015.
FAU - Iwasaku, Masahiro
AU  - Iwasaku M
AD  - Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, 
      Kyoto, Japan.
FAU - Uchino, Junji
AU  - Uchino J
AD  - Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, 
      Kyoto, Japan.
FAU - Yamada, Tadaaki
AU  - Yamada T
AD  - Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, 
      Kyoto, Japan.
FAU - Chihara, Yusuke
AU  - Chihara Y
AD  - Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, 
      Kyoto, Japan.
FAU - Shimamoto, Takayuki
AU  - Shimamoto T
AD  - Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, 
      Kyoto, Japan.
FAU - Tamiya, Nobuyo
AU  - Tamiya N
AD  - Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, 
      Kyoto, Japan.
FAU - Kaneko, Yoshiko
AU  - Kaneko Y
AD  - Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, 
      Kyoto, Japan.
FAU - Kiyomi, Fumiaki
AU  - Kiyomi F
AD  - Statistics and Data Center, Clinical Research Support Center Kyushu, Fukuoka, 
      Japan.
FAU - Takayama, Koichi
AU  - Takayama K
AD  - Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, 
      Kyoto, Japan.
LA  - eng
PT  - Journal Article
PL  - China
TA  - Transl Lung Cancer Res
JT  - Translational lung cancer research
JID - 101646875
PMC - PMC6749124
OTO - NOTNLM
OT  - Dacomitinib
OT  - dermatologic AE
OT  - phase II study
OT  - prophylactic medication
COIS- Conflicts of Interest: J Uchino reports grants from Eli Lilly Japan K.K. that are 
      outside of the submitted work. T Yamada reports grants from Nippon Boehringer 
      Ingelheim and Ono Pharmaceutical Company that are outside of the submitted work. 
      K Takayama reports grants from Chugai-Roche and Ono Pharmaceutical Company, 
      personal fees from AstraZeneca K.K., Chugai-Roche, MSD-Merck, Eli Lilly, 
      Boehringer-Ingelheim, and Daiichi-Sankyo that are outside of the submitted work. 
      The other authors have no conflicts of interest to declare.
EDAT- 2019/09/27 06:00
MHDA- 2019/09/27 06:01
PMCR- 2019/08/01
CRDT- 2019/09/27 06:00
PHST- 2019/09/27 06:00 [entrez]
PHST- 2019/09/27 06:00 [pubmed]
PHST- 2019/09/27 06:01 [medline]
PHST- 2019/08/01 00:00 [pmc-release]
AID - tlcr-08-04-519 [pii]
AID - 10.21037/tlcr.2019.08.03 [doi]
PST - ppublish
SO  - Transl Lung Cancer Res. 2019 Aug;8(4):519-523. doi: 10.21037/tlcr.2019.08.03.