Postmarketing Surveillance Study of Erlotinib in Japanese Patients With Non–Small-Cell Lung Cancer (NSCLC): An Interim Analysis of 3488 Patients (POLARSTAR)

Nakagawa, Kazuhiko; Kudoh, Shoji; Ohe, Yuichiro; Johkoh, Takeshi; Ando, Masahiko; Yamazaki, Naoya; Seki, Akihiro; Takemoto, Shinya; Fukuoka, Masahiro

doi:10.1097/jto.0b013e3182598abb

Cited by 72 publications

(63 citation statements)

References 18 publications

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“…However, grade 3-5 ILD was reported in 3 patients (5.8%). In a large-scale surveillance study conducted in Japan, the incidence of ILD was also higher compared to that reported by the BR21 and SATURN trials (1,7,21). Further studies are required to determine whether there are ethnic differences in the incidence of ILD, as suggested by a previous study (22).…”

Section: Discussionmentioning

confidence: 52%

Phase II study of erlotinib for previously treated patients with EGFR wild-type non-small-cell lung cancer, following EGFR mutation status reevaluation with the Scorpion Amplified Refractory Mutation System

Morise

Taniguchi

Sasaki

et al. 2014

Molecular and Clinical Oncology

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While assessing the efficacy of erlotinib in patients with epidermal growth factor receptor (EGFR) wild-type (WT) non-small-cell lung cancer (NSCLC), the sensitivity of the method used for the EGFR mutation analysis may affect the evaluation of the efficacy. We conducted a phase II study of erlotinib for previously treated patients with EGFR WT NSCLC screened by the peptide nucleic acid-locked nucleic acid (PNA-LNA) polymerase chain reaction (PCR) clamp method, which is known to be highly sensitive. The primary endpoint was the objective response rate (ORR). Preplanned reevaluation of the EGFR genotype as an exploratory endpoint was performed using the Scorpion Amplification Refractory Mutation System (S-ARMS) assay. Erlotinib was administered daily until disease progression or development of unacceptable toxicity. A total of 53 evaluable patients were enrolled. The histological subtypes were adenocarcinoma in 40 patients, squamous cell carcinoma in 9 patients and not otherwise specified NSCLC in 4 patients. Partial response (PR) was achieved in 6 patients (4 with adenocarcinoma and 2 with squamous cell carcinoma). The ORR was 11.3% [95% confidence interval (CI): 4.3-23.0]. The median progression-free survival (PFS) was 1.8 months (95% CI: 1.2-2.3). Samples from 26 of the 53 patients (49.0%) were available for EGFR mutation reanalysis with the S-ARMS assay. Of these 26 samples, only 1 sample of adenocarcinoma was found to be EGFR mutation-positive (exon 19 deletion) and the patient achieved a PR. The EGFR WT genotype was reconfirmed by the S-ARMS assay in the remaining 25 patients and 2 of these patients exhibited a PR. This study did not meet the primary endpoint, although erlotinib was found to be moderately effective in pretreated patients with EGFR WT NSCLC, even when the EGFR mutational status was confirmed by the highly sensitive PNA-LNA clamp PCR method.

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Section: Discussionmentioning

confidence: 52%

Phase II study of erlotinib for previously treated patients with EGFR wild-type non-small-cell lung cancer, following EGFR mutation status reevaluation with the Scorpion Amplified Refractory Mutation System

Morise

Taniguchi

Sasaki

et al. 2014

Molecular and Clinical Oncology

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“…The incidence of xerosis due to EGFR inhibitor treatment was reported to vary from 4% to 100%. 1,7,[12][13][14] This wide variation in incidence may be due to dissimilarities in xerosis definition, climate, and duration of drug administration among studies. However and similar to a previous study, we found xerosis to be the most common reaction among Thai patients.…”

Section: Discussionmentioning

confidence: 99%

Cutaneous toxicities of epidermal growth factor receptor inhibitors: A prospective study in 60 Asian patients.

Miao

Liu

et al. 2018

Asian Pac J Allergy Immunol

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“…The inhibition of EGFR can impair such regeneration and result in pulmonary injury. ILD has often been associated with the EGFR-tyrosine kinase inhibitors (TKIs), gefitinib and erlotinib [2,5,6,7,8,9]. Several risk factors for ILD have been identified in non-small cell lung cancer (NSCLC), including male sex, poor PS, smoking history, concurrent interstitial pneumonia, and recent thoracic radiation therapy.…”

Section: Discussionmentioning

confidence: 99%

Panitumumab-Induced Interstitial Lung Disease in a Case of Metastatic Colorectal Cancer

Yamada

Moriwaki²,

Matsuda³

et al. 2013

Oncol Res Treat

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Background: A Japanese postmarketing survey of panitumumab revealed that panitumumab-associated interstitial lung disease (ILD) occurred in approximately 1% (19/1767) of patients, causing death in 36.8% of these cases. Case Report: We report the case of a 60-year-old Japanese man who developed ILD associated with panitumumab therapy (third-line therapy) for metastatic sigmoid colon cancer involving the liver, lymph nodes, and lungs. 2 months after the initiation of panitumumab therapy, he developed a progressive nonproductive cough, dyspnea, and a fever, and was diagnosed with ILD. Intravenous pulse methylprednisolone treatment led to quick recovery. The patient had some risk factors for ILD associated with epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors. Conclusion: Further studies are required to elucidate the association between anti-EGFR antibodies and ILD.

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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)

Abstract: 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.

Cited by 72 publications

References 18 publications

Phase II study of erlotinib for previously treated patients with EGFR wild-type non-small-cell lung cancer, following EGFR mutation status reevaluation with the Scorpion Amplified Refractory Mutation System

Phase II study of erlotinib for previously treated patients with EGFR wild-type non-small-cell lung cancer, following EGFR mutation status reevaluation with the Scorpion Amplified Refractory Mutation System

Cutaneous toxicities of epidermal growth factor receptor inhibitors: A prospective study in 60 Asian patients.

Panitumumab-Induced Interstitial Lung Disease in a Case of Metastatic Colorectal Cancer

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