title: [Lung injury associated with bortezomib therapy in Japan].
abstract: Bortezomib (Velcade(®)), a proteasome inhibitor, was launched for the treatment of relapsed or refractory multiple myeloma in Japan in December 2006. Prior to approval in Japan, high incidence (15.2%) and mortality (6.5%) of bortezomib therapy-related lung disorders were reported with private import treatment. Therefore the Velcade Lung Disorder Panel (the Panel) was established and the cases have been reviewed. A total of 3,556 patients, including 823 post-marketing surveillance (PMS) patients, have received bortezomib since April 25, 2009. The incidence of lung disorders associated with bortezomib therapy was 2.33% (3.77% in case of PMS). The panel reviewed the detailed information of 70 cases and classified the CT and X-ray images as follows: (1)Interstitial pneumonia; diffuse alveolar damage pattern, hypersensitivity pneumonia pattern and others (2)Vascular hyperpermiability; (non-cardiogenic) pulmonary edema pattern and capillary leak syndrome-like pattern (3)Hypoxia. These post-marketing data showed that the incidence of lung disorders in Japan was lower than expected based on private import data.
authors.affiliation: Scientific Affairs Div. Janssen Pharmaceutical K.K.
authors.forename: Harumi
authors.initials: H
authors.lastname: Mukai
authors.forename: Kazuma
authors.initials: K
authors.lastname: Ohyashiki
authors.forename: Takao
authors.initials: T
authors.lastname: Katoh
authors.forename: Masahiko
authors.initials: M
authors.lastname: Kusumoto
authors.forename: Akihiko
authors.initials: A
authors.lastname: Gemma
authors.forename: Humikazu
authors.initials: H
authors.lastname: Sakai
authors.forename: Yukihiko
authors.initials: Y
authors.lastname: Sugiyama
authors.forename: Kiyohiko
authors.initials: K
authors.lastname: Hatake
authors.forename: Yuh
authors.initials: Y
authors.lastname: Fukuda
authors.forename: Shoji
authors.initials: S
authors.lastname: Kudoh
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001897:Boronic Acids / Q000009:adverse effects*; D000069286:Bortezomib; D005260:Female; D006801:Humans; D008171:Lung Diseases / Q000139:chemically induced*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy; D011358:Product Surveillance, Postmarketing; D011719:Pyrazines / Q000009:adverse effects*
chemical_list: D000970:Antineoplastic Agents; D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib