Real World Utilization and Outcomes With Dacomitinib First Line Treatment for EGFR Mutation-positive Advanced Non Small Cell Lung Cancer Among Asian Patients - A Multi Center Chart Review

BMI was derived from body weight and height, and it was calculated as weight divided by height\^2.

Time frame: Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. [approximately] 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

Duration of dacomitinib therapy (dacomitinib last dose date - dacomitinib initiation date + 1 day) was reported in this outcome measure.

Time frame: First dose of dacomitinib till discontinuation/ end of dacomitinib treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

Number of participants classified According to comorbidities are presented in this outcome measure. Participants were classified into the following categories: any comorbidities, none and unknown.

Time frame: Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

ECOG performance classified as: Grade 0: fully active, able to carry on all pre-disease performance without restriction; Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature; Grade 2: ambulatory and capable of all selfcare but unable to carry out any work activities, up and about more than 50% of waking hours; Grade 3: capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: completely disabled, cannot carry on selfcare and totally confined to bed or chair and Grade 5: dead. Higher score indicated worse health status.

Time frame: Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

The number of participants classified according to the disease stages as 3B, 3C, 4A and 4B were reported in this outcome measure. Cancer stages were classified based on tumor size (T), metastasis to regional lymph nodes (LN) \[N\] and distant metastasis (M). Stages were 3B, 3C, 4A and 4B. Stage 3B (T1N3M0, T2N3M0, T3N2M0, T4N2M0). Stage 3C (T3N3M0 and T4N3M0), Stage 4A (anyT, anyN and M1a/M1b), Stage 4B (anyT, anyN and M1c). where T1: \<=3 cm; T2: \>3 to \<=5 cm; T3: \>5 to \<=7 cm; T4: \>7cm. N0: not spread to regional LN; N1: spread to ipsilateral pulmonary or hilar nodes; N2: spread to ipsilateral mediastinal or subcarinal nodes; N3: spread to contralateral mediastinal, hilar, or supraclavicular nodes. M0: no distant metastasis; M1a: malignant pleural or pericardial effusion or pleural or pericardial nodules or separate tumor nodule(s) in a contralateral lobe; M1b: single extrathoracic metastasis; M1c= multiple extrathoracic metastases (1 or \>1 organ).

Time frame: Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

Number of participants with dacomitinib dose interruption (dacomitinib treatment being temporarily stopped) were reported in this outcome measure. Participants were classified into the following categories: no dose interruption, one dose interruption, two dose interruptions and more than two dose interruptions.

Time frame: From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

Number of participants with dacomitinib oral dose modification (any dose change) from initial dacomitinib therapy are presented in this outcome measure. Participants were classified into the following categories: no dose modification, one dose modification, two dose modifications and more than two dose modifications.

Time frame: From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

Number of participants classified according to smoking status are presented in this outcome measure. Participants were classified into the following categories: current smoker, former smoker, never smoker and unknown.

Time frame: Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

Number of participants classified according to type of EGFR mutation were reported in this outcome measure. One participant may have more than one mutation. Participants were classified into the following rows: EGFR exon 19 deletion, EGFR exon 21 L858R substitution, EGFR T790M mutation and other.

Time frame: Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

Number of participants with dacomitinib dose discontinuation (dacomitinib treatment permanently stopped) were reported in this outcome measure.

Time frame: From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

TTF was defined as the time from date of dacomitinib initiation to date of dacomitinib permanent discontinuation (for any reason), first disease progression (PD), or death (from any cause), whichever came first. PD was defined as cancer worsening based on radiologist's interpretation of the imaging and/or clinician's assessment, and after initiation of first-line dacomitinib treatment. Participants who remained on dacomitinib without an event until end of follow-up were censored at the date of last known contact/visit date. Participants lost to follow-up were censored based on the last known contact/visit date. Kaplan-Meier method was used for analysis.

Time frame: From dacomitinib treatment initiation to dacomitinib discontinuation, PD or death due to any cause, whichever came first or censoring date (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

Number of participants classified according to starting dose of dacomitinib (30 mg, 45 mg or other dose) as first-line in Chinese participants with common EGFR mutations are presented in this outcome measure.

Time frame: From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). Here, Overall Number of Participants Analyzed signifies Chinese participants with common EGFR mutation evaluable for this outcome measure.

AE was any untoward medical occurrence in a participant or clinical investigation participant administered sponsor's product and which did not necessarily have a causal relationship with the product.

Time frame: From dacomitinib treatment initiation to death or end of study whichever occurred first (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

AE was any untoward medical occurrence in a participant or clinical investigation participant administered sponsor's product and which did not necessarily have a causal relationship with the product.

Time frame: From dacomitinib treatment initiation to death or end of study whichever occurred first (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). Here, Overall Number of Participants Analyzed signifies Chinese participants with common EGFR mutation evaluable for this outcome measure.

Number of participants without any dacomitinib dose modification (any dose change) from initial dacomitinib therapy in Chinese participants with common EGFR mutations are presented in this outcome measure.

Time frame: From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). Here, Overall Number of Participants Analyzed signifies Chinese participants with common EGFR mutation evaluable for this outcome measure.

PFS was defined as date of dacomitinib initiation to date of first PD or death from any cause, whichever came first. PD was defined as cancer worsening based on radiologist's interpretation of the imaging and/or clinician's assessment, and after initiation of first-line dacomitinib treatment. Participants without PD and remained alive (i.e. no date of death) until end of follow-up were censored at the date of last known contact/visit date. Participants lost to follow-up were censored based on the last known contact/visit date. Kaplan-Meier method was used for analysis.

Time frame: From dacomitinib treatment initiation to PD or death due to any cause, whichever came first or censoring date (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). Here, Overall Number of Participants Analyzed signifies Chinese participants with common EGFR mutation evaluable for this outcome measure.

PFS was defined as date of dacomitinib initiation to date of first PD or death from any cause, whichever came first. PD was defined as cancer worsening based on radiologist's interpretation of the imaging and/or clinician's assessment, and after initiation of first-line dacomitinib treatment. Participants without PD and remained alive (i.e. no date of death) until end of follow-up were censored at the date of last known contact/visit date. Participants lost to follow-up were censored based on the last known contact/visit date. Kaplan-Meier method was used for analysis.

Time frame: From dacomitinib treatment initiation to PD or death due to any cause, whichever came first or censoring date (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

TTF was defined as the time from date of dacomitinib initiation to date of dacomitinib permanent discontinuation (for any reason), first PD, or death (from any cause), whichever came first. PD was defined as cancer worsening based on radiologist's interpretation of the imaging and/or clinician's assessment, and after initiation of first-line dacomitinib treatment. Participants who remained on dacomitinib without an event until end of follow-up were censored at the date of last known contact/visit date. Participants lost to follow-up were censored based on the last known contact/visit date. Kaplan-Meier method was used for analysis.

Time frame: From dacomitinib treatment initiation to dacomitinib discontinuation, PD or death due to any cause, whichever came first or censoring date (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months

Population: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). Here, Overall Number of Participants Analyzed signifies Chinese participants with common EGFR mutation evaluable for this outcome measure.