The purpose of our retrospective study is to describe which circumstances EGFR TKI is continued despite progression according to the usual Response Evaluation CrIteria in Solid Tumours (RECIST) in patients with EGFR activating mutations and acquired resistance to EGFR TKI .We will collect their social and demographic data (age, sex), first Progression Free Survival ( PFS) - from start of EGFR TKI to 1st progression PFS 1- and - from first progression according to RECIST to second progression : PFS2- , Overall Survival (OS) - from diagnosis OS 1 and from first progression OS 2 -, mutational status. We will analyze more closely the mode of progression (site), the therapeutic approach at disease progression. We will define two subgroups: those for whom EGFR TKI was continued at least three months despite progression defined according to RECIST criteria, and those for whom a second-line treatment (chemotherapy without EGFR TKI) was chosen at disease progression. It will be individualized the subgroup of patients in whom it was continued TKI after progression.
Description: • Primary outcome: the therapeutic management of secondary resistance to EGFR TKI (erlotinib or gefitinib) in patients with advanced NSCLC with EGFR activating mutation. Comparison of demographic, clinical, biological features and outcome of patients continuing EGFR TKI at progression versus interrupting TKI at progression. Composite measures will be performed : demographic and clinical data, Progression Free Survival (PFS), Overall Survival (OS), mutational status, mode of progression, therapeutic approach at progressive disease in patients with EGFR mutation treated in first line by EGFR TKI (all population and subgroups : patients receiving EGFR-TKI at progressive disease - Group 1 -, patients discontinuing EGFR TKI at progressive disease - Group 2- ).
Measure: Proportion of patients continuing TKI at 1st progression and proportion of patients discontinuing EGFR TKI at 1st progression. Analysis of the therapeutic management in the 2 groups. This outcome consists in multiple measures. Time: Patients are followed up to 48 Months maximumDescription: A comparison of clinical data and outcome of patients receiving EGFR-TKI beyond progressive disease (group 1) versus discontinuing EGFR-TKI at progressive disease (group 2) will be made.
Measure: Comparison of clinical data and outcome of patients Time: Patients are followed up to 48 Months maximumDescription: • Median Progression Free Survival (PFS) (months) in group 1 and 2 - from start of EGFR TKI to first progression : PFS 1- and - from first progression to second progression : PFS2 -.
Measure: Median Progression Free Survival (PFS) Time: Patients are followed up to 48 Months maximumDescription: • Univariate an multivariate analysis of OS between the 2 groups will be adjusted using the Cox model. Variables as : age, gender, PS, histology, brain metastasis, EGFR mutations (deletions in exon 19, L858R mutations), TKI continued or TKI stopped at progression, metastasis number and site, will be considered for adjustment.
Measure: Univariate and multivariate analysis of Median over survival (OS) Time: Patients are followed up to 48 Months maximumDescription: • Univariate and multivariate analysis of OS between the 2 groups will be adjusted using the Cox model. Following variables will be considered for adjustment: age, gender, PS, histology, brain metastases, EGFR mutations (deletions in exon 19, L858R mutations), TKI continued to progression or TKI stopped at progression, metastasis number and site
Measure: Univariate and multivariate analysis of OS Time: Patients are followed up to 48 Months maximumThere is one SNP
Variables as : age, gender, PS, histology, brain metastasis, EGFR mutations (deletions in exon 19, L858R mutations), TKI continued or TKI stopped at progression, metastasis number and site, will be considered for adjustment.. Univariate and multivariate analysis of OS. • Univariate and multivariate analysis of OS between the 2 groups will be adjusted using the Cox model. --- L858R ---
Following variables will be considered for adjustment: age, gender, PS, histology, brain metastases, EGFR mutations (deletions in exon 19, L858R mutations), TKI continued to progression or TKI stopped at progression, metastasis number and site. --- L858R ---