Erlotinib (ERL) Versus Pemetrexed (MTA) As Second-Line Treatment for Non-Squamous Non-Small Cell Lung Cancer (NSNSCLC): Efficacy and Safety Data

ABSTRACT Background A recently published study shows that ERL and chemotherapy (MTA/docetaxel) offer similar efficacy outcomes in pretreated patients (p) with advanced NSCLC, and a direct comparison of ERL versus MTA in a prospective, randomized phase III trial also shows equivalent efficacy. However, both studies were conducted before the treatment-by-histology interaction effect was observed for MTA and p were not prospectively selected based on histology. Moreover, both studies included p considered optimal candidates for randomized trials, not always representative of the entire patient population. Material and methods P with advanced nsNSCLC treated with ERL (150 mg/d p.o.) or MTA (500 mg/m2 on d1, every 3 weeks) as 2nd-line treatment were included in the study. This single-centre, retrospective, observational study was conducted to compare the efficacy and safety of ERL versus MTA in non-selected p with nsNSCLC who have progressed after 1st-line chemotherapy in a clinical practice scenario. Results From 2006-2011, 67 p fulfill eligibility criteria, ERL (n = 32) and MTA (n = 35). Baseline characteristics ERL/MTA: median age 67/65 yrs.; male 69/80%; smokers 34/40%; PS ≥ 2 22/26%; adenocarcinoma 91/71%; stage IV 81 /77%; EGFR mutation positive 19/3%. No difference in terms of OS, 8.9 m (ERL) vs 7.1 months (MTA) (p = 0.551). Statistically significant differences were recorded for PFS, 3.5 (ERL) and 2.3 months (MTA) (p = 0.02) and a relative reduction in risk of progression of 53.5 % for ERL vs MTA (p = 0.005). SLP differences remained statistically significant when adjusting for EGFR mutation status, histology, prior response to 1st-line treatment and location of metastatic sites. OS showed a non-statistically significant difference after adjusting for each variable. The DCR was 40.6% in the ERL and 31.4 % in the MTA arm (p = 0.46). There was more grade 3-4 hematologic toxicity, anemia (8.5%), thrombopenia (11.4 %) and neutropenia (5.71%), in the MTA arm, and skin rash (9.3%) and diarrhea (6.2%) in the ERL arm. Conclusions These results in real-life setting suggest that ERL offers similar efficacy outcomes as MTA for p with nsNSCLC, with less and easier manageable toxicity. Disclosure All authors have declared no conflicts of interest.