Low-dose erlotinib is not recommended for fit patients with non-small cell lung cancer (NSCLC) who harbor EGFR mutations, according to a Japanese study published in the European Journal of Cancer.

Researchers led by Kazuhiko Yamada, MD, of the Kurume University School of Medicine, in Kurume, Japan, looked at 34 patients from seven institutes who had NSCLC with EGFR mutations and were pretreated with chemotherapy.

Patients received erlotinib at 50 mg daily and were observed until disease progression or unacceptable toxicities, with primary endpoint being the objective response rate.

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Dosage was escalated to 150 mg daily in patients who demonstrated no response without major tumor shrinkage as per the Response Evaluation Criteria in Solid Tumors (RECIST) in initial dose in the first 4 weeks.

In an independent review, the study found that the objective response and disease control rates at the 50 mg dosage was 54.5% and 84.8%, respectively, with four additional patients who achieved partial response when dosage was increased to 150 mg.

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Progression-free and median survival times were 9.5 and 28.5 months, respectively. The study was closed early when no response could be confirmed in 15 patients.

“The primary endpoint was not met,” the authors concluded. “Low-dose erlotinib is not recommended for fit patients with NSCLC harboring EGFR mutations. However, it may merit further evaluation for elderly or frail patients.”


  1. Yamada K, Aono H, Hosomi Y, et al. A prospective, multicentre phase II trial of low-dose erlotinib in non-small cell lung cancer patients with EGFR mutations pretreated with chemotherapy: Thoracic Oncology Research Group 0911. Eur J Cancer. 2015. [epub ahead of print]. doi: 10.1016/j.ejca.2015.06.120.