Erlotinib as 1st-line therapy for elderly patients (pts) with advanced non-small cell lung cancer (NSCLC)

Abstract

19016 Background: The prognosis for elderly pts with advanced NSCLC is generally poor due to significant co-morbidities that limit treatment options. Furthermore, aggressive treatments are often contra-indicated due to poor performance status. Erlotinib is approved as a 2nd-line therapy for pts with NSCLC, and is a useful treatment option for elderly pts due to its favorable toxicity profile. However, experience with 1st-line erlotinib in chemo-naïve elderly pts is currently limited. Methods: The global open-label TRUST study investigated erlotinib in >6000 pts with advanced stage IIIB/IV NSCLC. Pts were eligible if they had either failed standard treatment or were unsuitable for chemotherapy/radiotherapy. This report focuses on a subgroup of elderly pts (>70 y), who received erlotinib (150 mg/day) as a 1st-line therapy for advanced NSCLC. Results: By August 2007, eligible pts had received at least one dose of erlotinib and interim analysis data were available for 451 pts. Median age was 78 yrs and baseline characteristics (%) were as follows: male/female 57/43; never smoker/current or former smoker/no data 30/69/1; stage IIIB/V 31/68; adenocarcinoma/BAC/ squamous-cell/other 51/12/22/15; Caucasian/Asian/other 76/15/9. Grade 3–5 adverse events (AEs) of any cause were reported by 49% of pts. However, only 7% had ≥1 treatment-related AE, and only 3 pts (<1%) died due to a treatment-related AE (1 as a result of bleeding, 1 from pneumonitis, and 1 from community-acquired pneumonia). Dose reductions were necessary in 16% of pts. Five complete (1%) and 34 partial responses (8%) were noted. Stable disease was seen in 45% of pts for an overall disease control rate of 54%. Progression-free survival (PFS) was 16.4 wks (95% CI: 14.6- 20.0). This compares favorably with recent data, which demonstrated PFS of around 14 wks for pemetrexed or pemetrexed/gemcitabine in chemo-naïve pts >70 yrs [Gridelli et al, J Thorac Oncol 2007;2:221–9]. Overall survival data will be presented. Conclusions: Erlotinib as 1st-line treatment for elderly pts with NSCLC has encouraging efficacy. These results indicate that erlotinib is a valuable 1st-line treatment option for the management of advanced NSCLC in this subgroup and warrants further investigation in the 1st-line setting. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Boehringer Ingelheim, Hoffmann-La Roche, Lilly Bayer HealthCare, Boehringer Ingelheim, Hoffmann-La Roche, Lilly