ARIA: 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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 307
- 试验地点
- 14
- 主要终点
- Body Mass Index (BMI): All Asian Participants
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
排除标准
- •Enrolled in any interventional clinical study or trial (however, patients enrolled in non-interventional, real world study may still be included).
研究组 & 干预措施
Cohort 1
干预措施: Dacomitinib (Drug)
结局指标
主要结局
Body Mass Index (BMI): All Asian Participants
时间窗: 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
BMI was derived from body weight and height, and it was calculated as weight divided by height\^2.
Number of Participants Classified According to Smoking Status: All Asian Participants
时间窗: 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 smoking status are presented in this outcome measure. Participants were classified into the following categories: current smoker, former smoker, never smoker and unknown.
Number of Participants Classified According to Comorbidities: All Asian Participants
时间窗: 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 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
时间窗: 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
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).
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants
时间窗: 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
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
时间窗: 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 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
时间窗: 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 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.
Number of Participants Classified According to Number of Oral Dose Interruptions: All Asian Participants
时间窗: 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 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
时间窗: 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 with dacomitinib dose discontinuation (dacomitinib treatment permanently stopped) were reported in this outcome measure.
Duration of Dacomitinib Therapy: All Asian Participants
时间窗: 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
Duration of dacomitinib therapy (dacomitinib last dose date - dacomitinib initiation date + 1 day) was reported in this outcome measure.
Time To Treatment Failure (TTF): All Asian Participants
时间窗: 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
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.
次要结局
- Progression-free Survival (PFS): All Asian Participants(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(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(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)
- PFS: Chinese Participants With Common EGFR Mutation(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 AEs: Chinese Participants With Common EGFR Mutation(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)
- Number of Participants Classified According to Starting Dose of Dacomitinib as First-line Therapy: Chinese Participants With Common EGFR Mutation(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 Without Oral Dose Modifications: Chinese Participants With Common EGFR Mutation(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)