An observational study in Carcinoma, Non-Small-Cell Lung, sponsored by Boehringer Ingelheim. Completed at 7 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-27.
Sponsored by Boehringer Ingelheim · Observational
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.
Study Design:
6,645 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's enrollment of 80 is below the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
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NSCLC EGFR mutation
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Exclusion criteria:
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.
Drug: 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.
Number of Patients Who Experienced a Minimum Clinically Important Improvement in Symptoms Over 6 Months 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.
Time frame: Baseline and 6 months following start of treatment.
Patient-rated Average Symptom Burden Index (ASBI) Score of Lung Cancer Symptom Scale (LCSS)
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.
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Total Lung Cancer Symptom Scale (LCSS) Score
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.
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Loss of Appetite
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.
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Fatigue
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.
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Cough
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.
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Dyspnoea
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.
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Haemoptysis
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.
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Pain
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.
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Overall Symptomatic Distress
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.
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Interference With Normal Activity
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.
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Global Quality of Life (QoL)
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.
Time frame: 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 European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Mobility
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").
Time frame: 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 European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Self-care
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").
Time frame: 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 theEuropean Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Usual Activities
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").
Time frame: 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 European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Pain/Discomfort
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").
Time frame: 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 European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Anxiety/Depression
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").
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
EQ-VAS Score
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Ratio of Afatinib Tablets Actually Taken to Doses Prescribed Over the Study Participation Period
Ratio of afatinib tablets actually taken to doses prescribed over the study participation period. Ratio = doses taken / doses prescribed.
Time frame: Up to 42 months.
Number of Patients With a Reason for Missing Afatinib Tablets
Number of patients with a reason for missing afatinib tablets. One participant can have multiple missing doses for multiple reasons.
Time frame: Up to 42 months.
Number of Patients With a Reason for Discontinuation of Afatinib
Number of patients with a reason for discontinuation of Afatinib throughout the study observation period.
Time frame: Up to 42 months.
Number of Patients With a Reason for Treatment Interruptions
Number of patients with a reason for treatment interruptions throughout the study observation period. One participant can have multiple interruptions for multiple reasons.
Time frame: Up to 42 months.
Number of Participants With Afatinib Interruptions or Dose Modifications
Number of participants with Afatinib interruptions or dose modifications (i.e., a dose increase or decrease).
Time frame: Up to 42 months.
Number of Patients With a Reason for Dose Reduction
Number of patients with a reason for dose reduction throughout the study observation period.
Time frame: Up to 42 months.
Number of Patients With a Reason for Dose Increase
Number of patients with a reason for dose increase throughout the study observation period.
Time frame: Up to 42 months.
This was a non-interventional, multicentre, cohort study, based on new data collection, which included a representative sample of patients with advanced/metastatic Non-small cell lung cancer (NSCLC) in Greece.
| Milestone | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Started | 80 |
| Analyzed | 77 |
| Completed | 0 |
| Not completed | 80 |
| Withdrew: Relocation of patient | 1 |
| Withdrew: Death | 6 |
| Withdrew: Lost to follow-up | 10 |
| Withdrew: Afatinib discontinuation | 46 |
| Withdrew: Stopped study at earlier timepoint | 14 |
| Withdrew: Study medication not received | 1 |
| Withdrew: Violation of inclusion criteria | 2 |
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.
| Participants | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Number of Patients Who Experienced a Minimum Clinically Important Improvement in Symptoms Over 6 Months of Treatment | 13 |
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.
| score on a scale | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 14.1 ± 12.2 |
| Month 2 | 11.5 ± 10.3 |
| Month 4 | 9.3 ± 9.0 |
| Month 6 | 7.1 ± 8.3 |
| Month 8 | 7.6 ± 7.3 |
| Month 10 | 7.8 ± 8.7 |
| Month 12 | 7.6 ± 10.5 |
| Month 18 | 5.3 ± 6.4 |
| Month 24 | 6.2 ± 6.5 |
| Month 30 | 7.5 ± 8.1 |
| Month 36 | 11.5 ± 6.9 |
| Month 42 | 1.0 ± NA |
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.
| score on a scale | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 17.0 ± 13.1 |
| Month 2 | 14.7 ± 11.3 |
| Month 4 | 12.4 ± 10.1 |
| Month 6 | 10.7 ± 9.2 |
| Month 8 | 11.7 ± 8.6 |
| Month 10 | 11.1 ± 9.3 |
| Month 12 | 10.6 ± 10.6 |
| Month 18 | 8.3 ± 7.8 |
| Month 24 | 9.6 ± 7.7 |
| Month 30 | 10.8 ± 8.8 |
| Month 36 | 13.8 ± 7.1 |
| Month 42 | 4.6 ± NA |
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.
| score on a scale | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 17.8 ± 21.9 |
| Month 2 | 21.7 ± 26.2 |
| Month 4 | 15.9 ± 19.9 |
| Month 6 | 14.7 ± 23.9 |
| Month 8 | 12.1 ± 19.4 |
| Month 10 | 13.6 ± 22.6 |
| Month 12 | 11.7 ± 20.6 |
| Month 18 | 8.9 ± 14.8 |
| Month 24 | 7.4 ± 7.3 |
| Month 30 | 7.6 ± 10.0 |
| Month 36 | 28.3 ± 32.2 |
| Month 42 | 0.0 ± NA |
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.
| score on a scale | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 27.4 ± 26.1 |
| Month 2 | 22.0 ± 21.8 |
| Month 4 | 20.3 ± 18.3 |
| Month 6 | 16.7 ± 20.9 |
| Month 8 | 17.5 ± 19.9 |
| Month 10 | 17.2 ± 17.5 |
| Month 12 | 14.5 ± 17.1 |
| Month 18 | 12.6 ± 16.5 |
| Month 24 | 14.3 ± 15.8 |
| Month 30 | 12.4 ± 12.1 |
| Month 36 | 25.1 ± 20.3 |
| Month 42 | 6.0 ± NA |
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.
| score on a scale | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 14.9 ± 21.5 |
| Month 2 | 6.7 ± 10.9 |
| Month 4 | 8.5 ± 14.5 |
| Month 6 | 4.2 ± 8.1 |
| Month 8 | 4.1 ± 7.5 |
| Month 10 | 4.1 ± 8.1 |
| Month 12 | 6.5 ± 13.5 |
| Month 18 | 2.4 ± 6.1 |
| Month 24 | 4.0 ± 6.6 |
| Month 30 | 10.2 ± 12.2 |
| Month 36 | 5.1 ± 7.6 |
| Month 42 | 0.0 ± NA |
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.
| score on a scale | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 10.8 ± 17.4 |
| Month 2 | 7.5 ± 16.5 |
| Month 4 | 5.5 ± 11.6 |
| Month 6 | 3.4 ± 8.4 |
| Month 8 | 3.3 ± 7.9 |
| Month 10 | 4.4 ± 9.1 |
| Month 12 | 5.2 ± 13.7 |
| Month 18 | 2.3 ± 4.9 |
| Month 24 | 3.9 ± 6.9 |
| Month 30 | 8.5 ± 13.4 |
| Month 36 | 5.9 ± 10.0 |
| Month 42 | 0.0 ± NA |
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.
| score on a scale | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 1.6 ± 5.0 |
| Month 2 | 1.3 ± 6.9 |
| Month 4 | 1.0 ± 4.4 |
| Month 6 | 0.9 ± 2.5 |
| Month 8 | 1.4 ± 3.4 |
| Month 10 | 1.2 ± 2.8 |
| Month 12 | 1.4 ± 3.3 |
| Month 18 | 1.4 ± 6.4 |
| Month 24 | 0.6 ± 1.5 |
| Month 30 | 0.9 ± 1.5 |
| Month 36 | 0.4 ± 1.1 |
| Month 42 | 0.0 ± NA |
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.
| score on a scale | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 12.0 ± 19.4 |
| Month 2 | 9.7 ± 16.3 |
| Month 4 | 4.5 ± 8.6 |
| Month 6 | 3.0 ± 5.4 |
| Month 8 | 7.2 ± 14.2 |
| Month 10 | 6.5 ± 11.4 |
| Month 12 | 6.1 ± 10.9 |
| Month 18 | 4.2 ± 8.7 |
| Month 24 | 7.2 ± 14.0 |
| Month 30 | 5.4 ± 8.3 |
| Month 36 | 4.4 ± 6.9 |
| Month 42 | 0.0 ± NA |
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.
| score on a scale | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 16.2 ± 17.7 |
| Month 2 | 15.9 ± 15.6 |
| Month 4 | 17.3 ± 0.0 |
| Month 6 | 13.8 ± 16.3 |
| Month 8 | 14.8 ± 16.7 |
| Month 10 | 12.7 ± 14.5 |
| Month 12 | 12.1 ± 13.4 |
| Month 18 | 12.0 ± 12.7 |
| Month 24 | 11.7 ± 12.7 |
| Month 30 | 11.0 ± 7.3 |
| Month 36 | 8.6 ± 7.1 |
| Month 42 | 10.0 ± NA |
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.
| score on a scale | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 22.8 ± 26.3 |
| Month 2 | 19.6 ± 20.8 |
| Month 4 | 16.7 ± 17.4 |
| Month 6 | 16.3 ± 16.1 |
| Month 8 | 18.1 ± 17.9 |
| Month 10 | 15.9 ± 16.5 |
| Month 12 | 16.1 ± 15.4 |
| Month 18 | 12.6 ± 17.4 |
| Month 24 | 15.5 ± 12.0 |
| Month 30 | 17.7 ± 14.3 |
| Month 36 | 10.6 ± 16.9 |
| Month 42 | 13.0 ± NA |
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.
| score on a scale | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 29.6 ± 24.8 |
| Month 2 | 27.8 ± 23.0 |
| Month 4 | 23.8 ± 18.6 |
| Month 6 | 23.5 ± 21.8 |
| Month 8 | 26.9 ± 23.0 |
| Month 10 | 24.5 ± 20.6 |
| Month 12 | 21.9 ± 16.0 |
| Month 18 | 18.2 ± 16.8 |
| Month 24 | 22.1 ± 17.1 |
| Month 30 | 23.7 ± 16.0 |
| Month 36 | 36.1 ± 34.1 |
| Month 42 | 12.0 ± NA |
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").
| Percentage of patients | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 44.7 |
| Month 2 | 30.4 |
| Month 4 | 22.2 |
| Month 6 | 17.0 |
| Month 8 | 35.0 |
| Month 10 | 30.6 |
| Month 12 | 28.9 |
| Month 18 | 28.0 |
| Month 24 | 27.3 |
| Month 30 | 10.0 |
| Month 36 | 25.0 |
| Month 42 | 0 |
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 | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 22.4 |
| Month 2 | 14.3 |
| Month 4 | 16.7 |
| Month 6 | 14.9 |
| Month 8 | 12.5 |
| Month 10 | 8.3 |
| Month 12 | 10.5 |
| Month 18 | 12.0 |
| Month 24 | 13.6 |
| Month 30 | 10.0 |
| Month 36 | 12.5 |
| Month 42 | 0 |
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 | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 39.5 |
| Month 2 | 33.9 |
| Month 4 | 29.6 |
| Month 6 | 21.3 |
| Month 8 | 30.0 |
| Month 10 | 27.8 |
| Month 12 | 31.6 |
| Month 18 | 24.0 |
| Month 24 | 13.6 |
| Month 30 | 40.0 |
| Month 36 | 12.5 |
| Month 42 | 0 |
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").
| Percentage of patients | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 47.4 |
| Month 2 | 25.0 |
| Month 4 | 16.7 |
| Month 6 | 14.9 |
| Month 8 | 30.0 |
| Month 10 | 25.0 |
| Month 12 | 28.9 |
| Month 18 | 20.0 |
| Month 24 | 22.7 |
| Month 30 | 30.0 |
| Month 36 | 25.0 |
| Month 42 | 0 |
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").
| Percentage of patients | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 51.3 |
| Month 2 | 64.3 |
| Month 4 | 59.3 |
| Month 6 | 53.2 |
| Month 8 | 50.0 |
| Month 10 | 55.6 |
| Month 12 | 47.4 |
| Month 18 | 48.0 |
| Month 24 | 63.6 |
| Month 30 | 50.0 |
| Month 36 | 50.0 |
| Month 42 | 100 |
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.
| Score on a scale | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 75.5 ± 16.7 |
| Month 2 | 75.4 ± 15.0 |
| Month 4 | 77.2 ± 13.6 |
| Month 6 | 77.1 ± 17.6 |
| Month 8 | 76.3 ± 18.8 |
| Month 10 | 76.6 ± 18.4 |
| Month 12 | 80.0 ± 15.1 |
| Month 18 | 79.0 ± 17.4 |
| Month 24 | 78.6 ± 14.9 |
| Month 30 | 76.2 ± 18.4 |
| Month 36 | 85.4 ± 6.1 |
| Month 42 | 85.0 ± NA |
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 | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 59.7 |
| Month 2 | 79.4 |
| Month 4 | 83.1 |
| Month 6 | 76.9 |
| Month 8 | 72.9 |
| Month 10 | 73.8 |
| Month 12 | 72.5 |
| Month 18 | 80.8 |
| Month 24 | 69.6 |
| Month 30 | 100 |
| Month 36 | 100 |
| Month 42 | 100 |
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 | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 28.6 |
| Month 2 | 17.5 |
| Month 4 | 11.9 |
| Month 6 | 21.2 |
| Month 8 | 27.1 |
| Month 10 | 26.2 |
| Month 12 | 25.0 |
| Month 18 | 15.4 |
| Month 24 | 26.1 |
| Month 30 | 0 |
| Month 36 | 0 |
| Month 42 | 0 |
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 | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 9.1 |
| Month 2 | 3.2 |
| Month 4 | 5.1 |
| Month 6 | 1.9 |
| Month 8 | 0 |
| Month 10 | 0 |
| Month 12 | 2.5 |
| Month 18 | 0 |
| Month 24 | 0 |
| Month 30 | 0 |
| Month 36 | 0 |
| Month 42 | 0 |
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 | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 1.3 |
| Month 2 | 0 |
| Month 4 | 0 |
| Month 6 | 0 |
| Month 8 | 0 |
| Month 10 | 0 |
| Month 12 | 0 |
| Month 18 | 3.8 |
| Month 24 | 4.3 |
| Month 30 | 0 |
| Month 36 | 0 |
| Month 42 | 0 |
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.
| Percentage of participants | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Baseline | 1.3 |
| Month 2 | 0 |
| Month 4 | 0 |
| Month 6 | 0 |
| Month 8 | 0 |
| Month 10 | 0 |
| Month 12 | 0 |
| Month 18 | 0 |
| Month 24 | 0 |
| Month 30 | 0 |
| Month 36 | 0 |
| Month 42 | 0 |
Ratio of afatinib tablets actually taken to doses prescribed over the study participation period. Ratio = doses taken / doses prescribed.
| Ratio | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Ratio of Afatinib Tablets Actually Taken to Doses Prescribed Over the Study Participation Period | 0.99 ± 0.02 |
Number of patients with a reason for missing afatinib tablets. One participant can have multiple missing doses for multiple reasons.
| Participants | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Patients' initiative due to adverse event | 11 |
| Patient's negligence | 1 |
| Travel | 1 |
Number of patients with a reason for discontinuation of Afatinib throughout the study observation period.
| Participants | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Adverse event | 7 |
| Disease progression | 43 |
| Lost to follow-up | 4 |
| Patient's non-compliance | 1 |
| Physician's decision | 1 |
Number of patients with a reason for treatment interruptions throughout the study observation period. One participant can have multiple interruptions for multiple reasons.
| Participants | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Adverse event/Disease progression | 24 |
| Physician's advice due to receipt of antibiotic therapy | 2 |
| Surgery | 2 |
| Travel | 1 |
| Physician's decision while waiting for the liquid biopsy results | 1 |
| Scheduled dental work | 1 |
Number of participants with Afatinib interruptions or dose modifications (i.e., a dose increase or decrease).
| Participants | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| No interruptions/dosage modifications | 42 |
| Interruptions & Dosage modifications | 17 |
| Dosage modifications only | 9 |
| Interruptions only | 9 |
Number of patients with a reason for dose reduction throughout the study observation period.
| Participants | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Adverse event/Disease progression | 23 |
| Physician's decision (with no further specification) | 1 |
| Physician's decision due to patient's impaired general health state | 1 |
| Physician's decision due to patient's impaired performance status | 1 |
Number of patients with a reason for dose increase throughout the study observation period.
| Participants | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Physician's decision (with no further specification) | 2 |
| Adverse event resolution | 1 |
Collected over Each participant was treated with afatinib and observed in the context of the study until the end of study participation, up to 42 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib | 7/80 (8.8%) | 49/77 (63.6%) | 56/77 (72.7%) |
| Event | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 45/77 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 3/77 |
| DiarrhoeaGastrointestinal disorders | 2/77 |
| DeathGeneral disorders | 2/77 |
| Acute kidney injuryRenal and urinary disorders | 2/77 |
| AnaemiaBlood and lymphatic system disorders | 1/77 |
| Abdominal painGastrointestinal disorders | 1/77 |
| NauseaGastrointestinal disorders | 1/77 |
| PyrexiaGeneral disorders | 1/77 |
| Lung abscessInfections and infestations | 1/77 |
| Event | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| DiarrhoeaGastrointestinal disorders | 50/77 |
| RashSkin and subcutaneous tissue disorders | 34/77 |
| ParonychiaInfections and infestations | 15/77 |
| ConjunctivitisInfections and infestations | 6/77 |
| Nail dystrophySkin and subcutaneous tissue disorders | 6/77 |
| FatigueGeneral disorders | 5/77 |
| Mucosal inflammationGeneral disorders | 5/77 |
| Decreased appetiteMetabolism and nutrition disorders | 5/77 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 5/77 |
| DermatitisSkin and subcutaneous tissue disorders | 5/77 |
Full Analysis Set (FAS): all eligible subjects that have received at least one dose of afatinib in the study.
| Age, Continuous(years) | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Mean | 66.9 ± 13.0 |
| Sex: Female, Male(Participants) | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| Female | 48 |
| Male | 29 |
| Race (NIH/OMB)(Participants) | Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 77 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Carcinoma, Non-Small-Cell Lung →