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

Pfizer307 enrolled

Overview

This is a longitudinal, consecutive case-series, multi-center study with mixed prospective and retrospective data collection. Data will be collected from eligible adults with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) treated with dacomitinib as first-line therapy from the date of advanced NSCLC diagnosis to the date of death, lost to follow-up, withdrawal of consent or end of study, whichever occurs first.

Study Type

OBSERVATIONAL

Enrollment

307

Conditions

Lung Cancer

Interventions

DacomitinibDRUG

This is a non-interventional, real world study of Asian patients being treated with dacomitinib as first-line treatment for EGFR+ NSCLC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult (aged ≥18 years) with histology-confirmed advanced NSCLC (TNM stage IIIB-IV); * Presence of any EGFR-activating mutation (exon 19 deletion or exon 21 L858R substitution) or other uncommon EGFR mutations prior to anti-cancer treatment; * Initiating dacomitinib as first-line treatment after confirmation of EGFR-mutation status (ie, no prior treatment with other EGFR TKI or systemic therapy); Exclusion Criteria: * Enrolled in any interventional clinical study or trial (however, patients enrolled in non-interventional, real world study may still be included).

Locations (14)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Sun Yat-Sen University

Outcomes

Primary Outcomes

Body Mass Index (BMI): All Asian Participants

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

Number of Participants Classified According to Smoking Status: All Asian Participants

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

Number of Participants Classified According to Comorbidities: All Asian Participants

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.

Number of Participants Classified According to NSCLC Staging: All Asian Participants

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).

Data from ClinicalTrials.gov

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Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hunan Provincial Tumor Hospital

Changsha, Hunan, China

The First hospital of Jilin University

Changchun, Jilin, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Internal Medicine, Chinese Academy of Medical Sciences Cancer Hospital

Beijing, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning Province, China

Rajiv Gandhi Cancer Institute And Research Centre

New Delhi, DEL, India

...and 4 more locations

Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants

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.

Number of Participants Classified According to Type of EGFR Mutation: All Asian Participants

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.

Number of Participants Classified According to Number of Oral Dose Modifications: All Asian Participants

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

Number of Participants Classified According to Number of Oral Dose Interruptions: All Asian Participants

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.

Number of Participants With Any Oral Dose Discontinuation: All Asian Participants

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

Duration of Dacomitinib Therapy: All Asian Participants

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

Time To Treatment Failure (TTF): All Asian Participants

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

Secondary Outcomes

Progression-free Survival (PFS): All Asian Participants

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

Number of Participants With Adverse Events (AEs): All Asian Participants

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

TTF: Chinese Participants With Common EGFR Mutation

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.

PFS: Chinese Participants With Common EGFR Mutation

Number of Participants With AEs: Chinese Participants With Common EGFR Mutation

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.

Number of Participants Classified According to Starting Dose of Dacomitinib as First-line Therapy: Chinese Participants With Common EGFR Mutation

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.

Number of Participants Without Oral Dose Modifications: Chinese Participants With Common EGFR Mutation

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.