1345 - Post-progression survival after erlotinib treatment in patients with advanced NSCLC

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer agents
Non-small-cell lung cancer
Biological therapy
Presenter Marta Trojniak
Authors M.P. Trojniak1, A.C. Palozzo2, S. Imbevaro3, P. Rescigno3, D. Pastorelli4, A. Jirillo5
  • 1Pharmacy Department, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 2Istituto Oncologico Veneto, IRCCS, 35128 - Padova/IT
  • 3Evaluation And Introduction Of New Drugs In Cancer Therapy Unit, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 4Istituto Oncologico Veneto IOV-IRCCS, IT-35128 - Padova/IT
  • 5Evaluation And Introduction Of New Drugs In Cancer Therapy Unit, Istituto Oncologico Veneto, IRCCS, 35128 - Padova/IT


Erlotinib is a potent inhibitor of epidermal growth factor receptor tyrosin-kinase activity and its efficacy has been demonstrated for the treatment of advanced NSCLC in large randomized trials. A prospective observational study was run, using institutional data collected through web-based National Oncology registry, from December 2006 to May 2011. The patients with non-small cell lung cancer, unselected for EGFR mutation/amplification and after at least one line chemotherapy, were treated with erlotinib (150 mg/day orally) until disease progression. Every patient was checked prospectively for toxicity, clinical outcomes, previous line treatments, length of treatment and for treatments following erlotinb using hospital databases. In overall study population (130 patients), the median Time to Progression (TTP) and Overall Survival (OS) were 2.4 and 4.4 months, respectively and 1-year survival rate was 25%. 4 patients achieved partial response and 23 patients achieved stable disease, making the disease control rate 21%. Grade 1-2 rash and diarrhoea were the most frequent adverse events. The subgroups analysis showed significantly improved OS for patients with chemotherapy post-erlotinib (pemetrexed, docetaxel) compared to those with no chemotherapy post-erlotinib, 12.7 months and 3.0 months (p < 0.0001), respectively. The main prognostic factors, such as age, sex, histology, ECOG performance status, smoking status, treatment line and the median time to relapse of previous line treatments were equally distributed between these two subgroups. The data of EGFR mutation and EGFR FISH positive status were available for 21% of the patients, however we did not find a significant association between EGRF expression and treatment response in both groups. This evaluation has revealed significantly better survival with chemotherapy post-erlotinib regardless of the EGFR expression, giving evidence of other existing mechanisms. The post-marketing studies in real life practice are needed in order to verify both effectiveness and safety in general population, testing for external validity of the randomized trials. The post-progression survival assessment may be crucial to determine real clinical impact of investigational drug in combination with other treatments as it usually lacks in the approval RCTs.


All authors have declared no conflicts of interest.