Phase II Study of Erlotinib as Third-line Monotherapy in Patients with Advanced Non-small-cell Lung Cancer without Epidermal Growth Factor Receptor Mutations

Objective There are few standard therapeutic options beyond second-line treatment. We aimed to evaluate the efficacy and safety of erlotinib monotherapy as third-line chemotherapy in patients with advanced non-small-cell lung cancer without epidermal growth factor receptor mutations. Methods In this...

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Bibliographic Details
Published in:	Japanese journal of clinical oncology Vol. 41; no. 8; pp. 959 - 963
Main Authors:	Matsuura, Shun, Inui, Naoki, Ozawa, Yuichi, Nakamura, Yutaro, Toyoshima, Mikio, Yasuda, Kazumasa, Yamada, Takashi, Shirai, Toshihiro, Suganuma, Hideki, Yokomura, Koji, Suda, Takafumi, Chida, Kingo
Format:	Journal Article
Language:	English
Published:	England Oxford University Press 01-08-2011
Subjects:	Adult Aged Aged, 80 and over Anorexia - chemically induced Brain Neoplasms - secondary Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - genetics Carcinoma, Non-Small-Cell Lung - pathology Carcinoma, Non-Small-Cell Lung - secondary Diarrhea - chemically induced Disease-Free Survival Drug Eruptions - etiology Erlotinib Hydrochloride Female Humans Kaplan-Meier Estimate Lung Neoplasms - drug therapy Lung Neoplasms - genetics Lung Neoplasms - pathology Male Middle Aged Protein Kinase Inhibitors - adverse effects Protein Kinase Inhibitors - therapeutic use Quinazolines - adverse effects Quinazolines - therapeutic use Receptor, Epidermal Growth Factor - genetics Survival Rate Treatment Outcome third-line therapy epidermal growth factor receptor tyrosine kinase inhibitor erlotinib epidermal growth factor receptor mutation non-small-cell lung cancer
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Summary:	Objective There are few standard therapeutic options beyond second-line treatment. We aimed to evaluate the efficacy and safety of erlotinib monotherapy as third-line chemotherapy in patients with advanced non-small-cell lung cancer without epidermal growth factor receptor mutations. Methods In this phase II trial, patients who did not have epidermal growth factor receptor mutations and who had previously received two cytotoxic chemotherapy regimens containing platinum were treated with erlotinib (150 mg, per os) until disease progression or unacceptable toxicity. Results Twenty patients were eligible for the assessment of efficacy and safety. Three cases showed a partial response, and eight cases showed stable disease with an overall response rate of 15.0% (95% confidence interval: 5.2-36.0%) and a disease control rate of 55.0% (95% confidence interval: 34.2-74.2%). Median progression-free survival and overall survival time were 2.1 and 6.7 months, respectively. Although dose reduction was required in one patient because of skin toxicity, grade 3/4 toxicity or pulmonary disease was not observed. Conclusions Erlotinib as third-line therapy showed an acceptable response rate, survival time and toxicity. It could be a potential third-line therapy for patients without epidermal growth factor receptor mutations.
ISSN:	0368-2811 1465-3621
DOI:	10.1093/jjco/hyr079