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01-04-2012 | Oncology | Article

TKIs improve survival in EGFR mutation positive lung cancer

Abstract

Free abstract

MedWire News: European patients with mutation-positive epidermal growth factor receptor (EGFR) non small cell lung cancer (NSCLC) should undergo routine baseline tissue-based mutation assessment and treatment with EGFR tyrosine-kinase inhibitors (TKIs), suggest study findings.

Taken together with previous findings from the OPTIMAL study, the research suggests a benefit in progression-free survival (PFS) with first-line erlotinib in a European population and strengthens the rationale for routine baseline assessment of EGFR mutations.

"We recommend that tissue-based screening for EGFR mutations be part of routine clinical practice and that EGFR tyrosine-kinase inhibitors be the standard first-line treatment for patients with NSCLC and EGFR mutations," say Rafael Rosell (Catalan Institute of Oncology, Barcelona, Spain) and colleagues.

The study was a phase III trial including 174 patients with NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) with no history of chemotherapy for metastatic disease who were recruited from 42 hospitals in France, Italy, and Spain.

Patients were randomly assigned to receive oral erlotinib 150 mg/day (median duration 8.2 months) or 3-week cycles of standard intravenous chemotherapy with cisplatin 75 mg/m2 on day 1 plus docetaxel 75 mg/m2 on day 1 or gemcitabine 1250 mg/m2 on days 1 and 8 (median duration 2.8 months).

After a median follow-up of 18.9 months for erlotinib and 14.4 months for standard chemotherapy, the median PFS was significantly greater among patients treated with erlotinib compared with those assigned to standard chemotherapy, at 9.7 versus 5.2 months (hazard ratio [HR]=0.37).

Overall, 1-year PFS was 40% in the erlotinib group and 10% in the chemotherapy group, which decreased to 11% and 0%, respectively, at 2 years.

Stratifying patients according to EGFR mutation type and Eastern Cooperative Oncology Group (ECOG) performance status showed that PFS decreased in line with increasing ECOG score (from 23.9 months to 8.3 months for ECOG 0 to 2) and that patients with exon 19 deletions had longer PFS compared with those with L858R mutations (median of 11.0 vs 8.4 months).

Main grade 3 or 4 toxicities included rash (13 vs 0% for erlotinib vs standard chemotherapy), neutropenia (0 vs 22%), anemia (1 vs 4%), and increased aminotransferase concentrations (2 vs 0%). Severe treatment-related adverse events were significantly more common among those treated with chemotherapy compared with erlotinib, at 20 versus 6%.

Writing in The Lancet, the researchers conclude: "Clinicians now know that they need to screen their patients for EGFR mutations, and if mutations are detected, patients should be started with a tyrosine-kinase inhibitor - either erlotinib or gefitinib, dependent on the standard of care at each institution."

MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2012

By Ingrid Grasmo

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