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

• 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
• DOI: 10.1093/jjco/hyr079
• EISSN: 1465-3621
• ISSN: 0368-2811

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.