Evaluate the Impact of Afatinib on Quality of Life and Symptom Burden of Greek Subjects With Advanced NSCLC in Routine Patient Care Settings

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: afatinib

Registration Number: NCT02440854

Lead Sponsor: Boehringer Ingelheim

Brief Summary: This non-interventional study will include a representative sample of patients with locally advanced or metastatic NSCLC harboring Epidermal Growth Factor Receptor (EGFR)-mutations in Greece. Eligible NSCLC patients, for whom the physician has decided to initiate treatment with the study medication (afatinib, GIOTRIF®) will be treated according to the local prescribing information and standard medical practice in terms of visit frequency and types of assessments performed.

The study will investigate the impact of GIOTRIF (Afatinib) on patients' disease-related symptom burden and Health-Related Quality of Life (HRQoL) in a real world clinical setting in Greece.The Average Symptom Burden Index (ASBI) score of the Lung Cancer Symptom Scale (LCSS) in eligible patients, after 6 months of therapy, will be analyzed.

The overall study duration period is expected to be 60 months, including a 48-month enrollment period and a minimum 12-month follow-up period.

Detailed Description: Study Design:

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with non-small cell lung cancer (NSCLC) treated with afatinib	afatinib	Patients with advanced/metastatic non-small cell lung cancer (NSCLC) in Greece treated with afatinib. Patients were treated as per the routine medical practice in terms of visit frequency, types of assessments performed and with adherence to the local prescribing requirements for afatinib. Patients were observed in the context of the study until the end of study participation, defined as a maximum of 48 months after afatinib treatment initiation or until disease progression, death, withdrawal of consent, unacceptable toxicity, study completion or physician's decision whichever occurred earlier.

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Experienced a Minimum Clinically Important Improvement in Symptoms Over 6 Months of Treatment	Baseline and 6 months following start of treatment.	Number of patients who experience a minimum clinically important improvement in symptoms is reported. A patient was categorized as having an improvement if the mean score of any two consecutive post-baseline Average Symptom Burden Index (ASBI) score of Lung Cancer Symptom Scale (LCSS) assessments for that patient was at least 10 points below the patient's ASBI score of LCSS at enrolment, over 6 months of treatment. The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Each item is scored on a 100-millimeter (mm) Visual Analogue Scale (VAS), with score reported from 0 to 100, with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions was not completed, the ASBI score was not calculated.

Secondary Outcome Measures

Name	Time	Method
Patient-rated Total Lung Cancer Symptom Scale (LCSS) Score	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Patient-rated total LCSS score -defined as the average of the aggregate score of all 9 items that comprise the LCSS- at enrolment and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Each item was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions had not been completed, the ASBI score was not calculated.
Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Anxiety/Depression	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Percentage of patients with reported problems for the EQ-5D-3L utility index score dimension: Anxiety/depression. The EQ-5D-3L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1="no problems"; 2="some problems"; 3= "extreme problems". Reported are the percentage of patients with problem, consisting of both level 2 ("some problems") and level 3 ("extreme problems") with the remaining subjects having reported level 1 ("no problems").
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Fatigue	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Patient-rated LCSS individual item scores: Fatigue at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Fatigue was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Dyspnoea	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Patient-rated LCSS individual item scores: Dyspnoea at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Dyspnoea was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score.
Patient-rated Average Symptom Burden Index (ASBI) Score of Lung Cancer Symptom Scale (LCSS)	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Patient-rated ASBI score of LCSS at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study) is reported. The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Each item was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions had not been completed, the ASBI score was not calculated.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Loss of Appetite	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Patient-rated LCSS individual item scores: Loss of appetite at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Loss of appetite was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Cough	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Patient-rated LCSS individual item scores: Cough at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Cough was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Pain	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Patient-rated LCSS individual item scores: Pain at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Pain was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Overall Symptomatic Distress	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Patient-rated LCSS individual item scores: Overall symptomatic distress at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Overall symptomatic distress was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions had not been completed, the ASBI score was not calculated.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Interference With Normal Activity	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Patient-rated LCSS individual item scores: Interference with normal activity at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Interference with normal activity was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions had not been completed, the ASBI score was not calculated.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Global Quality of Life (QoL)	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Patient-rated LCSS individual item scores: Global Quality of Life (QoL) at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Global Quality of Life (QoL) was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions had not been completed, the ASBI score was not calculated.
Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Mobility	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Percentage of patients with reported problems for the EQ-5D-3L utility index score dimension: Mobility. The EQ-5D-3L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1="no problems"; 2="some problems"; 3= "extreme problems". Reported are the percentage of patients with problem, consisting of both level 2 ("some problems") and level 3 ("extreme problems") with the remaining subjects having reported level 1 ("no problems").
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Haemoptysis	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Patient-rated LCSS individual item scores: Haemoptysis at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Haemoptysis was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score.
Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Self-care	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Percentage of patients with reported problems for the EQ-5D-3L utility index score dimension: Self-care. The EQ-5D-3L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1="no problems"; 2="some problems"; 3= "extreme problems". Reported are the percentage of patients with problem, consisting of both level 2 ("some problems") and level 3 ("extreme problems") with the remaining subjects having reported level 1 ("no problems").
Percentage of Patients With Reported Problems for theEuropean Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Usual Activities	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Percentage of patients with reported problems for the EQ-5D-3L utility index score dimension: Usual activities. The EQ-5D-3L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1="no problems"; 2="some problems"; 3= "extreme problems". Reported are the percentage of patients with problem, consisting of both level 2 ("some problems") and level 3 ("extreme problems") with the remaining subjects having reported level 1 ("no problems").
Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Pain/Discomfort	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Percentage of patients with reported problems for the EQ-5D-3L utility index score dimension: Pain/discomfort. The EQ-5D-3L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1="no problems"; 2="some problems"; 3= "extreme problems". Reported are the percentage of patients with problem, consisting of both level 2 ("some problems") and level 3 ("extreme problems") with the remaining subjects having reported level 1 ("no problems").
EQ-VAS Score	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	EQ-VAS score at enrolment and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). The EQ-VAS is a visual analogue scale (VAS) that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 0	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Percentage of participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0 at baseline and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). ECOG has 6 grades (0-5, where 0 is the best possible score and 5 the worst): 0 = Fully active, able to carry on all pre-disease performance without restriction. 1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. 4. = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. 5. = Dead.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 1	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Percentage of participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 1 at baseline and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). ECOG has 6 grades (0-5, where 0 is the best possible score and 5 the worst): 0 = Fully active, able to carry on all pre-disease performance without restriction. 1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. 4. = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. 5. = Dead.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 2	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Percentage of participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 2 at baseline and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). ECOG has 6 grades (0-5, where 0 is the best possible score and 5 the worst): 0 = Fully active, able to carry on all pre-disease performance without restriction. 1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. 4. = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. 5. = Dead.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 3	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Percentage of participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 3 at baseline and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). ECOG has 6 grades (0-5, where 0 is the best possible score and 5 the worst): 0 = Fully active, able to carry on all pre-disease performance without restriction. 1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. 4. = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. 5. = Dead.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 4	Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.	Percentage of participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 4 at baseline and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). ECOG has 6 grades (0-5, where 0 is the best possible score and 5 the worst): 0 = Fully active, able to carry on all pre-disease performance without restriction. 1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. 4. = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. 5. = Dead.
Ratio of Afatinib Tablets Actually Taken to Doses Prescribed Over the Study Participation Period	Up to 42 months.	Ratio of afatinib tablets actually taken to doses prescribed over the study participation period. Ratio = doses taken / doses prescribed.
Number of Patients With a Reason for Missing Afatinib Tablets	Up to 42 months.	Number of patients with a reason for missing afatinib tablets. One participant can have multiple missing doses for multiple reasons.
Number of Patients With a Reason for Discontinuation of Afatinib	Up to 42 months.	Number of patients with a reason for discontinuation of Afatinib throughout the study observation period.
Number of Patients With a Reason for Treatment Interruptions	Up to 42 months.	Number of patients with a reason for treatment interruptions throughout the study observation period. One participant can have multiple interruptions for multiple reasons.
Number of Participants With Afatinib Interruptions or Dose Modifications	Up to 42 months.	Number of participants with Afatinib interruptions or dose modifications (i.e., a dose increase or decrease).
Number of Patients With a Reason for Dose Reduction	Up to 42 months.	Number of patients with a reason for dose reduction throughout the study observation period.
Number of Patients With a Reason for Dose Increase	Up to 42 months.	Number of patients with a reason for dose increase throughout the study observation period.

Trial Locations

Locations (7): Interbalkan Medical Center of Thessaloniki
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Thessaloniki, Greece
Chest Hospital of Athens "Sotiria"
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Athens, Greece
University General Hospital of Heraklion
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Heraklion, Greece
University General Hospital of Evros
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Alexandroupoli, Greece
"Attikon" University General Hospital of Attica
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Haidari, Greece
Bioclinic Thessaloniki
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Thessaloniki, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
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Thessaloniki, Greece