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Postmarketing surveillance study of erlotinib in Japanese patients with non-small-cell lung cancer (NSCLC): an interim analysis of 3488 patients (POLARSTAR).
- Source :
-
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer [J Thorac Oncol] 2012 Aug; Vol. 7 (8), pp. 1296-303. - Publication Year :
- 2012
-
Abstract
- Introduction: Interstitial lung disease (ILD) is an adverse drug reaction (ADR) of concern in Japanese patients with non-small-cell lung cancer (NSCLC) receiving erlotinib. To investigate erlotinib safety and efficacy in Japanese patients, a large-scale surveillance study was implemented.<br />Methods: All patients with recurrent/advanced NSCLC receiving erlotinib in Japan were enrolled (December 2007-October 2009). During the 12-month observation period, adverse-event data were collected; any adverse event where erlotinib could not be excluded as a causative factor was termed an ADR. An independent review committee assessed ILD-like events. Overall survival and progression-free survival were also assessed. Interim data were analyzed for patients registered before June 30, 2008.<br />Results: In total, 10,708 patients were enrolled, 3743 by June 30, 2008, with data available for 3488 patients. Overall ADR incidence was 81.8% (mostly grade 1/2); skin disorders (68.5%) including rash (63.0%) were most common. However, 81.8% of patients who experienced rash recovered or improved. ILD-like events, diagnosed by local physicians, were reported in 189 patients. The independent review committee confirmed ILD (all grades) in 158 patients (4.5% of interim population) with a mortality rate of 1.6% (55 patients). Significant ILD risk factors included concomitant or previous ILD, smoking history, concomitant or previous lung infection, and Eastern Cooperative Oncology Group performance status 2 to 4. Median overall survival and progression-free survival were 260 and 64 days, respectively.<br />Conclusions: These interim data support the clinical benefits of erlotinib in Japanese NSCLC patients with no new safety signals. The risk/benefit balance for erlotinib in recurrent/advanced NSCLC remains favorable.
- Subjects :
- Adenocarcinoma drug therapy
Adenocarcinoma mortality
Adolescent
Adult
Aged
Aged, 80 and over
Asian People
Carcinoma, Large Cell drug therapy
Carcinoma, Large Cell mortality
Carcinoma, Non-Small-Cell Lung mortality
Carcinoma, Squamous Cell drug therapy
Carcinoma, Squamous Cell mortality
ErbB Receptors antagonists & inhibitors
ErbB Receptors metabolism
Erlotinib Hydrochloride
Female
Humans
Japan epidemiology
Lung Diseases, Interstitial etiology
Lung Neoplasms mortality
Male
Middle Aged
Neoplasm Recurrence, Local mortality
Neoplasm Staging
Prognosis
Risk Factors
Smoking adverse effects
Survival Rate
Young Adult
Carcinoma, Non-Small-Cell Lung drug therapy
Lung Diseases, Interstitial epidemiology
Lung Neoplasms drug therapy
Neoplasm Recurrence, Local drug therapy
Product Surveillance, Postmarketing
Protein Kinase Inhibitors therapeutic use
Quinazolines therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1556-1380
- Volume :
- 7
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 22610257
- Full Text :
- https://doi.org/10.1097/JTO.0b013e3182598abb