Afatinib Osimertinib Sequencing NIS

Time on treatment, which was defined as time in months from the start date of Afatinib (Gi\[l\]otrif®) treatment ('start date of initial dose' for First-Line Treatment) to the end date of Osimertinib treatment (maximum between 'end date of initial dose' and the last 'end date of dose modification' for Second-Line Treatment) or death date due to any cause ('date of death'). Time on treatment (months) = Time on treatment (days)/30.4375. 'Time on treatment was analysed using Kaplan-Meier method, and the median along with two-sided 90% confidence interval was displayed using the Greenwood's formula for estimation of standard errors.

Time frame: Data collected from start of treatment until data entry completion, up to 96.8 months for first analysis and up to 114.1 months for the extension analysis.

Population: Full Analysis Set (FAS): All patients who were enrolled into the study, met all inclusion criteria and did not meet any exclusion criteria and provided a written and signed informed consent. 1 Patient was excluded from extension analysis due to conflicting data on the discontinuation date of osimertinib treatment.

Different types of resistance mutations identified at the time of discontinuation of osimertinib treatment were systematically reviewed and categorised.

Time frame: Data collected from start of treatment until data entry completion; up to 96.8 months.

Population: Patients in the Full Analysis Set (FAS), who discontinued treatment and with positive test results (either EGFR sensitizing Mutation and/or T790M) available.