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Background: Erlotinib is a standard of treatment for metastatic non-small-cell lung cancer after failure of initial therapy. Patient selection based on clinical factors is under discussion. Methods: We analyzed the outcome in relation to clinical factors of 121 consecutive Caucasian patients treated with erlotinib in a routine clinical setting in a comprehensive cancer center and 2 regional oncology centers. Results: For patients with erlotinib treatment at the 1st/2nd/3rd/≧4th line, progression-free survival (PFS) was 4.5/3.5/2.5/3.0 months, and overall survival (OS) was 8.0/8.5/7.8/6.5 months. Patients with adenocarcinoma had an improved PFS, but a similar OS. Never-smokers had longer PFS (7 months) and OS (13 months) than smokers and ex-smokers. Male patients had a slightly longer survival than female patients (PFS 3.0 vs. 2.5 months, OS 8.5 vs. 7.0 months). After adjustment for smoking and histology, the gender difference in OS was significant (adjusted hazard ratio 0.57). Patients with clinically relevant skin toxicity (grade 2, 3) had a significantly prolonged PFS and OS. Patients with partial response on 1st radiological evaluation had a significantly prolonged PFS and OS. Conclusion: Among clinical factors, never-smoking status and male gender predicted a prolonged survival. During treatment, skin toxicity and radiological response were related to better survival.

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7572 Background: EGFR-tyrosine kinase inhibitor (TKI) such as erlotinib lead to prolonged disease stabilization in some patients with advanced NSCLC. It is so far not clear how to treat patients who progress after prolonged response to erlotinib. TKI therapy beyond progression with added chemotherapy, radiotherapy or best supportive care (BSC) may improve survival compared to chemotherapy, radiotherapy or BSC alone. Methods: We retrospectively analyzed all NSCLC patients treated with erlotinib at our institutions since 2004 who progressed after at least stable disease on erlotinib for at least six months (n=41). Twenty-seven patients were treated with TKI beyond progression (TKI patients), of whom 24 received erlotinib and 3 afatinib. Fourteen patients did not receive further TKI treatment after progression (controls). Overall survival (OS) from progression on TKI and OS from diagnosis of lung cancer was analyzed for the whole population and case-control subpopulations of pairs matched for gender, smoking status, and histology. Results: Treatment with TKI and chemotherapy was well tolerated with no increase in grade 3 and 4 toxicities. TKI-patients had a significantly longer OS from progression on TKI (case control: median 21.0 vs. 3.0 months, HR 0.175) and longer OS from diagnosis of lung cancer (case control: median 28.5 vs. 15.3 months, HR 0.335). Conclusions: In long-term erlotinib responders, treatment with TKI beyond progression in addition to chemotherapy or radiotherapy is feasible and well tolerated with limited toxicity. TKI-treatment beyond progression improved OS compared to treatment with TKI-free chemotherapy or radiotherapy.

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