1307P - Effectiveness of erlotinib treatment in K-RAS wild type lung adenocarcinomas - results of a Hungarian observational cohort study (MOTIVATE)

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Cytotoxic agents
Non-small-cell lung cancer
Therapy
Biological therapy
Presenter Gyula Ostoros
Authors G. Ostoros1, V. Sárosi2, G. Losonczy3, J. Strausz4, E. Tolnay5, L. Molnár6
  • 1Department Viii., National Korányi Institute of Pulmonology, 1121 - Budapest/HU
  • 21st Department Of Internal Medicine Pulmonology Department, University of Pécs, Pécs/HU
  • 3Department Of Pulmonology, Semmelweis University, Budapest/HU
  • 4Department Vi., National Korányi Institute of Pulmonology, Budapest/HU
  • 52nd Department, Pest County Institution of Pulmonology, Törökbálint/HU
  • 6Pulmonology Department, Borsod County Szent Ferenc Hospital, Miskolc/HU

Abstract

Background

Erlotinib as a targeted therapy is a highly potent inhibitor of epidermal growth factor receptor tyrosine-kinase activity. K-RAS mutations are found in 25-35% of lung adenocarcinomas, and these mutations may be predictive of resistance to treatment with erlotinib. The aim of our analysis was to investigate prospectively the efficacy and safety of second and third line erlotinib treatment in advanced lung adenocarcinoma excluding the K-RAS mutation positive cases.

Materials and methods

This observational study was conducted in 27 Hungarian sites. Enrolled patients were treated with erlotinib. Analyzed patients have histologically or cytologically verified, advanced (IIIB/IV), K-RAS (codon-12, codon-13) mutation negative lung adenocarcinoma, refractory to at least one prior chemotherapy. Primary endpoint was progression-free survival. Secondary endpoints were best tumor response rate according to RECIST, overall survival and safety.

Results

327 patients' data were analyzed, who were enrolled between February 2008 and December 2010. The study closure date was 31. December 2011. Baseline patients' characteristics: median age: 60,3 years; male: 50,2%; stage: III/B: 31,1%, IV: 68,9%; smoking status: former/current/never smoker: 39,1/28,8/31,9%. ECOG PS: 0/1/2/3: 35,9/51,8/11/1,2%. Best tumor response: CR/PR/SD/PD were achieved: 0,9/16,2/41,9/24,5 % of all patients. The disease control rate was 70,48% in patients for whom the best response data were available . The median progression-free survival (PFS) was 3.27 months. The median overall survival was 14,1 months. For ECOG PS 0-1 patients, the median OS was 16,1 months and the median PFS was 3,47 months, while median OS of 2.5 and median PFS of 1,9 months were detected for ECOG PS 2-3 patients.

Conclusions

Our results confirm the favorable efficacy of erlotinib in K-RAS mutation negative lung adenocarcinoma with an OS of 14,1 months in this real-life setting. A remarkable, 16.1 months median OS was identified in patients with ECOG PS 0-1 receiving erlotinib.

Disclosure

G. Ostoros: corporate-sponsored research: investigator in company-sponsored (Roche) trials.

All other authors have declared no conflicts of interest.