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Non-small cell lung cancer (NSCLC) is the most common cause of cancer death worldwide, with low survival (6--12 months and overall 5-year survival 5--10%), mostly because it is usually diagnosed in advanced stages. In NSCLC, the most common epidermal growth factor receptor (EGFR) mutations are exon 19 and exon 21, highly associated with sensitivity to tyrosine kinase inhibitors (TKI). EGFR mutations are more common in non-smokers, women, adenocarcinomas and Asians patients. Erlotinib is an orally active and potent TKI indicated for first-line and maintenance treatment of patients with locally advanced or metastatic NSCLC with EGFR activating mutations. This study (NCT01260181) was a phase II, nonrandomized, open-label study to evaluate the anti-tumoral activity of erlotinib in patients with locally advanced or metastatic NSCLC with EGFR activating mutations. It was designed to evaluate the efficacy of erlotinib first-line treatment--as a single daily oral dose of 150 mg, until disease progression or unacceptable toxicity, death or withdrawal of consent--evaluated by complete or partial objective response rate (ORR) in Portugal. This event-driven study was set up in 9 hospitals from January 2011 (start of recruitment period) to September 2017 (last safety follow-up visit). There were 216 patients screened, 30 were enrolled, positive for exon 19 (40.0%) and/or exon 21 mutations (60.0%). Twenty-nine (96.7%) completed the treatment. At the end one patient was alive. Patients’ mean age was 66.3 ± 9.21 years, 80% were female. Most were non-smokers (76.7%) with 20 pack-year smoking history. Median disease duration was 1 month (0--32 months) and histology for 96.7% of patients was adenocarcinoma. TNM classification was mostly stage IV (1 patient stage IIIB). Fifty percent of patients had bone metastatic disease and 80% another metastasis location. Two hundred and sixteen comorbidities have been reported and all patients had at least one. At screening, all patients had ECOG performance status 0 (20.0%), 1 (66.7%) or 2 (13.3%). Efficacy results showed an ORR of 63.3% (95% CI: 46.1%--80.6%), in intention-to-treat, and 75.0% (95% CI: 50.1%--99.5%), in per-protocol population. The stable disease was the best overall response for the anti-tumoral activity in 30.0% of patients and progressive disease was the best overall response in 3.3%. The best overall response is summarized in Table 1. Median progression-free survival (PFS) was 10 months (95% CI: 7.8--15.8), and median overall survival was 20.8 months (95% CI: 14--31.2). The median duration of response was 10.4 months (95% CI: 8--15.8). For exon 19 patients, the median PFS was 14.4 months (95% CI: 4.2--41.8) and for exon 21 9.8 months (95% CI: 3.8--13.5). Table 1 Best overall response (RECIST v1.1 criteria) for the study populations.

pulmonology

Results from phase II, open-label study of anti-tumoral activity of first-line erlotinib in advanced/metastatic NSCLC patients with EGFR activating mutations, in Portugal: The MuTAR study