Effectiveness and response predictive factors of erlotinib in a non-small cell lung cancer unselected European population previously treated: A retrospective, observational, multicentric study

摘要

Aims and background: Erlotinib approval was supported by the positive results of a large multicentric phase III trial(BR.21 study) that included 10% Asiatic patients and the remaining were North-American Caucasian. It is well-knownthat the efficacy of tyrosine kinase inhibitors is strongly influenced by ethnicity and other genetic factors. It is, therefore,relevant to establish whether the same profile of efficacy is seen in an unselected population and whether the results ofBR.21 can be generalized to other patient populations, such as that described here.Methods: In this retrospective, observational, multicentric study, we assessed effectiveness and potentially responsepredictive factors in 222 unselected Italian patients, with stage IIIB/IV non-small-cell lung cancer, with performance statusfrom 0 to 3, who had received at least one line of chemotherapy, treated with the standard dose of erlotinib (150 mgonce daily) until disease progression or unacceptable toxicity.Results: The disease control rate was 60.9% (135 patients). Median progression-free survival and overall survival timeswere 3.1 months and 7.97 months, respectively. The characteristics of non-smoker, female gender, performance status 0or 1 were associated with a significantly better prognosis in terms of disease control rate and were also predictive oflonger overall survival and progression-free survival. The 1-year survival rate was 38.79%. Even though Italian patientsbaseline characteristics were strongly different to those reported in pivotal BR.21 trial in terms of age, performancestatus, line treatment and ethnic group, our study confirms the favorable effectiveness profile in real clinical practice oferlotinib according to results from the pivotal study BR.21.Conclusions: Today, we know that epidermal growth factor receptor (EGFR) status assessment is mandatory beforestarting first-line therapy and that the presence of only certain clinical characteristics initially associated with sensitivity toEGFR-tyrosine kinase inhibitors, as reported in this study, is not sufficient in selecting patients candidates to suchtreatments.