Velcade Linked to Severe Lung Toxicity in Japanese Study

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Blood First Edition Paper, prepublished online January 12, 2006

Submitted November 16, 2005

Accepted December 29, 2005

Severe pulmonary complications in Japanese patients after bortezomib

treatment for refractory multiple myeloma

Shigesaburo Miyakoshi*, Masahiro Kami, Koichiro Yuji, Tomoko

Matsumura, Masaaki Takatoku, Makoto Sasaki, Hiroto Narimatsu, Takeshi

Fujii, Masateru Kawabata, Shuichi Taniguchi, Keiya Ozawa, and Kazuo

Oshimi

Department of Hematology, Toranomon Hospital, Tokyo, Japan

Division of Exploratory Research, Institute of Medical Science, the

University of Tokyo, Tokyo, Japan

Department of Hematology, Toranomon Hospital, Tokyo, Japan; Division

of Exploratory Research, Institute of Medical Science, the University

of Tokyo, Tokyo, Japan

Division of Hematology, Department of Medicine, Jichi Medical School,

Tochigi, Japan

Division of Hematology, Juntendo University School of Medicine,

Tokyo, Japan

Department of Pathology, Toranomon Hospital, Tokyo, Japan

Department of Respiratory Medicine, Toranomon Hospital, Tokyo, Japan

Bortezomib (Velcade) is a novel proteasome inhibitor with significant

anti-myeloma activity. Its frequent adverse effects are manageable,

including gastrointestinal symptoms, peripheral neuropathy, and

thrombocytopenia. Severe lung toxicity has not previously been

reported.

Between June 2004 and September 2005, 13 Japanese patients with

multiple myeloma were treated with bortezomib in Toranomon Hospital,

Juntendo University School of Medicine, and Jichi Medical School.

Four of them developed severe pulmonary complications, and two died

of respiratory failure without progression of underlying disease.

To our knowledge, this is the first report on life-threatening

pulmonary adverse effects after bortezomib therapy. Previous clinical

studies on bortezomib, mostly in the US and Europe, have shown low

incidences of pulmonary adverse effects.

Our study suggests that bortezomib can cause serious lung injury and

that its incidence might vary among different ethnicities. Clinicians

need to be alert to the possibility.