PMID- 36175697
OWN - NLM
STAT- MEDLINE
DCOM- 20221003
LR  - 20221101
IS  - 1559-131X (Electronic)
IS  - 1357-0560 (Linking)
VI  - 39
IP  - 12
DP  - 2022 Sep 29
TI  - Evaluation of lung adverse events with trastuzumab using the Japanese 
      pharmacovigilance database.
PG  - 219
LID - 10.1007/s12032-022-01805-w [doi]
AB  - The present study aimed to determine the risk of trastuzumab-induced lung 
      toxicity, time to onset, and post hoc outcomes using the Japanese Adverse Drug 
      Event Report database. We analyzed data for the period between April 2004 and 
      March 2021. Data on lung toxicities were extracted, and relative risk of adverse 
      events (AEs) was estimated using the reporting odds ratio. We analyzed 1,772,494 
      reports and identified 4362 reports of AEs caused by trastuzumab. Of these, 693 
      lung toxicities were reportedly associated with trastuzumab. Signals were 
      detected for seven lung toxicities: interstitial lung disease, pulmonary edema, 
      pleural effusion, lung disorder, acute pulmonary edema, pulmonary fibrosis, and 
      radiation pneumonitis. Among these, interstitial lung disease was the most 
      frequently reported (61.8%). A histogram of times to onset showed occurrence from 
      1 to 105 days, but some cases of interstitial lung disease occurred even more 
      than one year after the start of administration. The AEs showing the highest 
      fatality rates were interstitial lung disease, pulmonary fibrosis, and radiation 
      pneumonitis. This study focused on lung toxicities caused by trastuzumab as 
      post-marketing AEs. Some cases could potentially involve serious outcomes; 
      therefore, patients should be monitored for signs of the onset of these AEs not 
      only at the start of administration, but also over an extended period, especially 
      for interstitial lung disease.
CI  - (c) 2022. The Author(s), under exclusive licence to Springer Science+Business 
      Media, LLC, part of Springer Nature.
FAU - Kanbayashi, Yuko
AU  - Kanbayashi Y
AUID- ORCID: 0000-0002-4680-5133
AD  - Department of Education and Research Center for Clinical Pharmacy, Faculty of 
      Pharmacy, Osaka Medical and Pharmaceutical University, 4-20-1 Nasahara, 
      Takatsuki, Osaka, 569-1094, Japan. yuko.kambayashi@ompu.ac.jp.
FAU - Uchida, Mayako
AU  - Uchida M
AD  - Department of Education and Research Center for Pharmacy Practice, Faculty of 
      Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, 97-1, 
      Kodominamihokotate, Kyotanabe-shi, Kyoto, Japan.
FAU - Kashiwagi, Misui
AU  - Kashiwagi M
AD  - Department of Education and Research Center for Pharmacy Practice, Faculty of 
      Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, 97-1, 
      Kodominamihokotate, Kyotanabe-shi, Kyoto, Japan.
FAU - Akiba, Hitomi
AU  - Akiba H
AD  - Department of Education and Research Center for Pharmacy Practice, Faculty of 
      Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, 97-1, 
      Kodominamihokotate, Kyotanabe-shi, Kyoto, Japan.
FAU - Shimizu, Tadashi
AU  - Shimizu T
AD  - School of Pharmacy, Hyogo Medical University, 1-3-6 Minatojima, Kobe, Hyogo, 
      Japan.
LA  - eng
PT  - Journal Article
DEP - 20220929
PL  - United States
TA  - Med Oncol
JT  - Medical oncology (Northwood, London, England)
JID - 9435512
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology/etiology
MH  - Humans
MH  - Japan/epidemiology
MH  - Lung
MH  - Pharmacovigilance
MH  - *Pulmonary Edema
MH  - *Pulmonary Fibrosis/chemically induced/epidemiology
MH  - *Radiation Pneumonitis
MH  - Trastuzumab/adverse effects
OTO - NOTNLM
OT  - Interstitial lung disease
OT  - Japanese Adverse Drug Reaction Reporting Database
OT  - Lung adverse events
OT  - Signal detection
OT  - Time to onset
OT  - Trastuzumab
EDAT- 2022/09/30 06:00
MHDA- 2022/10/04 06:00
CRDT- 2022/09/29 23:36
PHST- 2022/05/21 00:00 [received]
PHST- 2022/07/18 00:00 [accepted]
PHST- 2022/09/29 23:36 [entrez]
PHST- 2022/09/30 06:00 [pubmed]
PHST- 2022/10/04 06:00 [medline]
AID - 10.1007/s12032-022-01805-w [pii]
AID - 10.1007/s12032-022-01805-w [doi]
PST - epublish
SO  - Med Oncol. 2022 Sep 29;39(12):219. doi: 10.1007/s12032-022-01805-w.