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Chemotherapy is not superior to erlotinib in pretreated patients with advanced non-small cell lung cancer (NSCLC): A retrospective study
Abstrakt 169P
Conference Paper/Poster - Apr 15, 2016
Neumair P, Krähenbühl S, Baty Florent, Brutsche Martin, Früh Martin, Hitz Felicitas, Ess S, Warschkow Rene, Joos L, Jörger Markus
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Brief description/objective
Background:
Erlotinib is approved for patients with pretreated advanced NSCLC based on a 2-months overall survival (OS) improvement against placebo. Recently, 2 out of 3 prospective clinical studies showed a statistical trend for superior survival in patients with pretreated advanced NSCLC receiving chemotherapy versus erlotinib.
Methods:
We collected data of all patients with advanced NSCLC since the approval of erlotinib in 2005. Data included systemic treatment, prognostic covariates such as age, gender, presence of CNS metastases, smoking status, ECOG performance status, radiological response and survival. Primary study endpoint was OS, secondary study endpoint progression-free survival (PFS). We used Kaplan–Meier statistics, multivariate Cox regression and propensity score matching. The study had a power of 87% to detect a survival superiority of 30%.
Results:
From 827 patients, we excluded 171 patients for potential curative treatment, 189 for treatment outside our hospital, 204 for <2 lines of palliative treatment, 28 with EGFR-mutations and 6 with EML-ALK translocations. The final analysis included 108 chemotherapy patients and 121 patients receiving erlotinib in second (85 patients), third (27) or further-line (9). Women and never smokers were significantly overrepresented in the erlotinib group. OS was similar in erlotinib and chemotherapy patients, both from start of first-line (15.1 vs. 13.8 months, HR=0.95, P=0.70) and from start of second-line treatment (7.8 vs. 5.0 months, HR=0.78, P=0.08). Survival remained similar after adjustment for known prognostic factors. PFS was not different between groups, neither in first-, second- or third-line. EGFR genotyping was not done in 145 patients with squamous-cell histology, and was unknown in 27 out of 84 patients with non squamous-cell histology; all remaining patients were carriers of EGFR wildtype. No radiological response or long-term stabilization was found in patients under treatmentwith erlotinib, suggesting a low probability for the presence of EGFR mutations.
Conclusions:
We found chemotherapy not to be superior to erlotinib in pretreated patients with advanced NSCLC.
Clinical trial identification:
Internal protocol number EKSG 14/157