Bortezomib therapy-related lung disease in Japanese patients with multiple myeloma: Incidence, mortality and clinical characterization

Cancer Science

Volumn 105, Issue 2, 2014, Pages 195-201

  Yoshizawa, Kazutake ^a   Mukai, Harumi Y ^a   Miyazawa, Michiko ^a   Miyao, Makiko ^a   Ogawa, Yoshimasa ^a   Ohyashiki, Kazuma ^b   Katoh, Takao ^c   Kusumoto, Masahiko ^d   Gemma, Akihiko ^c   Sakai, Fumikazu ^e   Sugiyama, Yukihiko ^f   Hatake, Kiyohiko ^g   Fukuda, Yuh ^c   Kudoh, Shoji ^h  

^a Janssen Pharmaceutical KK   (Japan)

^b TOKYO MEDICAL UNIVERSITY   (Japan)

^c NIPPON MEDICAL SCHOOL   (Japan)

^d NATIONAL CANCER CENTER HOSPITAL   (Japan)

^e SAITAMA MEDICAL UNIVERSITY INTERNATIONAL MEDICAL CENTER   (Japan)

^f JICHI MEDICAL UNIVERSITY   (Japan)

^g CANCER INSTITUTE HOSPITAL   (Japan)

^h FUKUJUJI HOSPITAL   (Japan)

Author keywords

Bortezomib; Lung disease; Mortality; Multiple myeloma; Proteasome inhibitors

Indexed keywords

BORTEZOMIB; LUNG DISEASE; MORTALITY; MULTIPLE MYELOMA; PROTEASOME INHIBITORS;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BORONIC ACIDS; FEMALE; HUMANS; INCIDENCE; JAPAN; LUNG DISEASES; MALE; MIDDLE AGED; MULTIPLE MYELOMA; PYRAZINES; RETROSPECTIVE STUDIES; RISK;

EID: 84893755432     PISSN: 13479032     EISSN: 13497006     Source Type: Journal    
DOI: 10.1111/cas.12335     Document Type: Article

References (25)

1. Roccaro AM, Vacca A, Ribatti D. Bortezomib in the treatment of cancer. Recent Pat Anticancer Drug Discov 2006; 1: 397-403.
2. Richardson PG, Sonneveld P, Schuster MW et al. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med 2005; 352: 2487-98.
3. Ogawa Y, Tobinai K, Ogura M et al. Phase I and II pharmacokinetic and pharmacodynamic study of the proteasome inhibitor bortezomib in Japanese patients with relapsed and refractory multiple myeloma. Cancer Sci 2008; 99: 140-4.
4. Miyakoshi S, Kami M, Yuji K et al. Severe pulmonary complications in Japanese patients after bortezomib treatment for refractory multiple myeloma. Blood 2006; 107: 3492-4.
5. Gotoh A, Ohyashiki K, Oshimi K et al. Lung injury associated with bortezomib therapy in relapsed/refractory multiple myeloma in Japan: a questionnaire-based report from the "lung injury by bortezomib" joint committee of the Japanese Society of Hematology and the Japanese Society of Clinical Hematology. Int J Hematol 2006; 84: 406-12.
6. Narimatsu H, Hori A, Matsumura T et al. Cooperative relationship between pharmaceutical companies, academia and media explains sharp decrease in frequency of pulmonary complications after bortezomib in Japan. J Clin Oncol 2008; 26: 5820-3.
7. FDA Guidance for industry, development and use of risk minimization action plans, March 2005. [Cited 22 Feb 2013.] Available from URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071616.pdf.
8. ICH: Harmonization tripartite guideline, pharmacovigilance planning, E2E, November 2004. [Cited 22 Feb 2013.] Available from URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2E/Step4/E2E_Guideline.pdf.
9. Schwaiblmair M, Behr W, Haeckel T et al. Drug induced interstitial lung disease. Open Respir Med J 2012; 6: 63-74.
10. Papiris SA, Triantafilldou C, Kolilekas L et al. Amiodarone: review of pulmonary effects and toxicity. Drug Saf 2010; 33: 539-58.
11. White DA, Camus P, Endo M et al. Noninfectious pneumonitis after everolimus therapy for advanced renal cell carcinoma. Am J Respir Crit Care Med 2010; 182: 396-403.
12. Maroto JP, Hudes G, Dutcher JP et al. Drug-related pneumonitis in patients with advanced renal cell carcinoma treated with temsirolimus. J Clin Oncol 2011; 29: 1750-6.
13. Gemma A. Drug-induced interstitial lung diseases associated with molecular-targeted anticancer agents. J Nippon Med Sch 2009; 76: 4-8.
14. Pharmaceuticals and Medical Devices Agency, Reports on Iressa Tablets 250 prospective study (special investigation). Pharmaceuticals and Medical Devices Agency Safety Information. No. 206, Oct 2004. [Cited 05 Jun 2006.] Available from: http://www.pmda.go.jp/english/service/pdf/precautions/PMDASI-206.pdf.
15. Cohen MH, Williams GA, Sridhara R et al. FDA drug approval summary: Gefitinib 'ZD1839) (Iressa) tablets. Oncologist 2003; 8: 303-6.
16. Nakagawa K, Kudoh S, Ohe Y et al. Postmarketing surveillance study of erlotinib in Japanese patients with non-small-cell lung cancer (NSCLC): an interim analysis of 3488 patients (POLARSTAR). J Thorac Oncol 2012; 7: 1296-303.
17. Reck M, van Zandwijk N, Gridelli C et al. Erlotinib in advanced non-small cell lung cancer: efficacy and safety findings of the global phase IV Tarceba Lung Cancer Survival Treatment study. J Thorac Oncol 2010; 5: 1616-22.
18. Azuma A, Hagiwara K, Kudoh S. Basis of acute exacerbation of idiopathic pulmonary fibrosis in Japanese patients. Am J Respir Crit Care Med 2008; 177: 1397-8.
19. Horiuchi-Yamamoto Y, Gemma A, Taniquchi H et al. Drug-induced lung injury associated with sorafenib: analysis of all-patient post-marketing surveillance in Japan. Int J Clin Oncol 2013; 18: 743-9.
20. Ishii T, Hagiwara K, Ikeda S et al. Association between genetic variations in surfactant protein D and emphysema, interstitial pneumonia, and lung cancer in a Japanese population. COPD 2012; 9: 409-16.
21. Maruyama D, Watanabe T, Heike Y et al. Stromal cells in bone marrow play important roles in pro-inflammatory cytokine secretion causing fever following bortezomib administration in patients with multiple myeloma. Int J Hematol 2008; 88: 396-402.
22. Pitini V, Arrigo C, Altavilla G et al. Severe pulmonary complications after bortezomib treatment for multiple myeloma: an unrecognized pulmonary vasculitis? Leuk Res 2007; 31: 1027-8.
23. Min CK, Lee S, Kim YJ et al. Cutaneous leucoclastic vasculitis (LV) following bortezomib therapy in a myeloma patient; association with pro-inflammatory cytokines. Eur J Haematol 2006; 76: 265-8.
24. Cullen SJ, Ponnappan S, Ponnappan U et al. Proteasome inhibition up-regulates inflammatory gene transcription induced by an atypical pathway of NF-kappaB activation. Biochem Pharmacol 2010; 79: 706-14.
25. Saito Y, Gemma A. Current status of DILD in molecular targeted therapies. Int J Clin Oncol 2012; 17: 534-41.