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Clinical features and risk factors of panitumumab-induced interstitial lung disease: a postmarketing all-case surveillance study.

Osawa M, Kudoh S, Sakai F, Endo M, Hamaguchi T, Ogino Y, Yoneoka M, Sakaguchi M, Nishimoto H, Gemma A - Int. J. Clin. Oncol. (2015)

Bottom Line: The clinical features of ILD and the associated risk factors therefore need investigation.A history/complication of ILD, male sex, poor general condition, and 65 years or older were identified as ILD risk factors, and no history of previous drug treatment was an apparent risk factor.Panitumumab-induced ILD can occur at any time after initiation, and close and regular monitoring is needed.

View Article: PubMed Central - PubMed

Affiliation: Pharmacovigilance Department, Takeda Pharmaceutical Company Limited, 4-9, Hiranomachi 2-chome, Chuo-ku, Osaka, 541-0046, Japan. Vectibix_TakedaSafety@takeda.co.jp.

ABSTRACT

Background: Drug-induced interstitial lung disease (ILD) is one of the most serious adverse reactions associated with the molecularly targeted drugs. Panitumumab has been approved for advanced or recurrent colorectal cancer. Although there were no adverse reaction reports of ILD in panitumumab monotherapy, 4 cases in combination chemotherapy were reported prior to its approval in Japan in 2010. Several studies also reported that the incidence of drug-induced ILD was higher in Japan than in other countries. The clinical features of ILD and the associated risk factors therefore need investigation.

Methods: We analyzed the data from 3085 unresectable, advanced or recurrent colorectal cancer patients enrolled in a postmarketing all-case surveillance study of panitumumab in Japan. ILD case reports were assessed based on the clinical and radiologic findings by a committee of external experts. Multivariate analysis using Cox's hazard model identified the risk factors.

Results: ILD incidence (1.3 %) and mortality rates (51.3 %) were similar to those of patients receiving another anti-epidermal growth factor receptor (EGFR) monoclonal antibody in Japan. No specific onset timing was determined. Although panitumumab-specific ILD findings were not observed in computed tomography images or clinical practice, panitumumab can induce ILD with diffuse alveolar damage, as do the other anti-EGFR targeting drugs. A history/complication of ILD, male sex, poor general condition, and 65 years or older were identified as ILD risk factors, and no history of previous drug treatment was an apparent risk factor.

Conclusion: Panitumumab-induced ILD can occur at any time after initiation, and close and regular monitoring is needed.

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Related in: MedlinePlus

Diagnosis of ILD. ILD cases were evaluated and determined according to the flowchart. The ILD review subcommittee assessed each ILD case report based on the clinical and radiographic findings. ILD interstitial lung disease
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Fig1: Diagnosis of ILD. ILD cases were evaluated and determined according to the flowchart. The ILD review subcommittee assessed each ILD case report based on the clinical and radiographic findings. ILD interstitial lung disease

Mentions: The Vectibix ILD review subcommittee (hereafter referred to as the committee) was established before this survey was performed. The committee consisted of the following 5 external experts to assess ILD case reports appropriately: 2 experts in radiology, 2 in pulmonology, and 1 in medical oncology. ILD and potential ILD case reports were then evaluated according to the flowchart shown in Fig. 1. Radiologic images were analyzed in the current study according to the diagnostic criteria determined by the American Thoracic Society/European Thoracic Society. The committee gave not only evaluations of each individual case, but also advice on further investigations and safety measures. The committee was convened 10 times from November 2010 to December 2012.Fig. 1


Clinical features and risk factors of panitumumab-induced interstitial lung disease: a postmarketing all-case surveillance study.

Osawa M, Kudoh S, Sakai F, Endo M, Hamaguchi T, Ogino Y, Yoneoka M, Sakaguchi M, Nishimoto H, Gemma A - Int. J. Clin. Oncol. (2015)

Diagnosis of ILD. ILD cases were evaluated and determined according to the flowchart. The ILD review subcommittee assessed each ILD case report based on the clinical and radiographic findings. ILD interstitial lung disease
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4666285&req=5

Fig1: Diagnosis of ILD. ILD cases were evaluated and determined according to the flowchart. The ILD review subcommittee assessed each ILD case report based on the clinical and radiographic findings. ILD interstitial lung disease
Mentions: The Vectibix ILD review subcommittee (hereafter referred to as the committee) was established before this survey was performed. The committee consisted of the following 5 external experts to assess ILD case reports appropriately: 2 experts in radiology, 2 in pulmonology, and 1 in medical oncology. ILD and potential ILD case reports were then evaluated according to the flowchart shown in Fig. 1. Radiologic images were analyzed in the current study according to the diagnostic criteria determined by the American Thoracic Society/European Thoracic Society. The committee gave not only evaluations of each individual case, but also advice on further investigations and safety measures. The committee was convened 10 times from November 2010 to December 2012.Fig. 1

Bottom Line: The clinical features of ILD and the associated risk factors therefore need investigation.A history/complication of ILD, male sex, poor general condition, and 65 years or older were identified as ILD risk factors, and no history of previous drug treatment was an apparent risk factor.Panitumumab-induced ILD can occur at any time after initiation, and close and regular monitoring is needed.

View Article: PubMed Central - PubMed

Affiliation: Pharmacovigilance Department, Takeda Pharmaceutical Company Limited, 4-9, Hiranomachi 2-chome, Chuo-ku, Osaka, 541-0046, Japan. Vectibix_TakedaSafety@takeda.co.jp.

ABSTRACT

Background: Drug-induced interstitial lung disease (ILD) is one of the most serious adverse reactions associated with the molecularly targeted drugs. Panitumumab has been approved for advanced or recurrent colorectal cancer. Although there were no adverse reaction reports of ILD in panitumumab monotherapy, 4 cases in combination chemotherapy were reported prior to its approval in Japan in 2010. Several studies also reported that the incidence of drug-induced ILD was higher in Japan than in other countries. The clinical features of ILD and the associated risk factors therefore need investigation.

Methods: We analyzed the data from 3085 unresectable, advanced or recurrent colorectal cancer patients enrolled in a postmarketing all-case surveillance study of panitumumab in Japan. ILD case reports were assessed based on the clinical and radiologic findings by a committee of external experts. Multivariate analysis using Cox's hazard model identified the risk factors.

Results: ILD incidence (1.3 %) and mortality rates (51.3 %) were similar to those of patients receiving another anti-epidermal growth factor receptor (EGFR) monoclonal antibody in Japan. No specific onset timing was determined. Although panitumumab-specific ILD findings were not observed in computed tomography images or clinical practice, panitumumab can induce ILD with diffuse alveolar damage, as do the other anti-EGFR targeting drugs. A history/complication of ILD, male sex, poor general condition, and 65 years or older were identified as ILD risk factors, and no history of previous drug treatment was an apparent risk factor.

Conclusion: Panitumumab-induced ILD can occur at any time after initiation, and close and regular monitoring is needed.

Show MeSH
Related in: MedlinePlus