N/A
Completed N=80
Evaluate the Impact of Afatinib on Quality of Life and Symptom Burden of Greek Subjects With Advanced NSCLC in Routine Patient Care Settings
Source: ClinicalTrials.gov NCT02440854 ↗Enrolled (actual)
80
Serious AEs
63.6%
Results posted
Apr 2022
Primary outcomePrimary: Number of Patients Who Experienced a Minimum Clinically Important Improvement in Symptoms Over 6 Months of Treatment — 13 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Experienced a Minimum Clinically Important Improvement in Symptoms Over 6 Months of Treatment |
13 | — |
| SECONDARY Patient-rated Average Symptom Burden Index (ASBI) Score of Lung Cancer Symptom Scale (LCSS) |
14.1; 11.5; 9.3; 7.1; 7.6; 7.8 | 0.002 sig |
| SECONDARY Patient-rated Total Lung Cancer Symptom Scale (LCSS) Score |
17.0; 14.7; 12.4; 10.7; 11.7; 11.1 | 0.027 sig |
| SECONDARY Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Loss of Appetite |
17.8; 21.7; 15.9; 14.7; 12.1; 13.6 | <0.001 sig |
| SECONDARY Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Fatigue |
27.4; 22.0; 20.3; 16.7; 17.5; 17.2 | 0.003 sig |
| SECONDARY Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Cough |
14.9; 6.7; 8.5; 4.2; 4.1; 4.1 | <0.001 sig |
| SECONDARY Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Dyspnoea |
10.8; 7.5; 5.5; 3.4; 3.3; 4.4 | <0.001 sig |
| SECONDARY Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Haemoptysis |
1.6; 1.3; 1.0; 0.9; 1.4; 1.2 | <0.001 sig |
| SECONDARY Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Pain |
12.0; 9.7; 4.5; 3.0; 7.2; 6.5 | <0.001 sig |
| SECONDARY Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Overall Symptomatic Distress |
16.2; 15.9; 17.3; 13.8; 14.8; 12.7 | 0.022 sig |
| SECONDARY Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Interference With Normal Activity |
22.8; 19.6; 16.7; 16.3; 18.1; 15.9 | <0.001 sig |
| SECONDARY Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Global Quality of Life (QoL) |
29.6; 27.8; 23.8; 23.5; 26.9; 24.5 | 0.062 |
| SECONDARY Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Mobility |
44.7; 30.4; 22.2; 17.0; 35.0; 30.6 | 0.388 |
| SECONDARY 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 |
22.4; 14.3; 16.7; 14.9; 12.5; 8.3 | >0.999 |
| SECONDARY Percentage of Patients With Reported Problems for theEuropean Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Usual Activities |
39.5; 33.9; 29.6; 21.3; 30.0; 27.8 | 0.774 |
| SECONDARY 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 |
47.4; 25.0; 16.7; 14.9; 30.0; 25.0 | 0.077 |
| SECONDARY 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 |
51.3; 64.3; 59.3; 53.2; 50.0; 55.6 | 0.210 |
| SECONDARY EQ-VAS Score |
75.5; 75.4; 77.2; 77.1; 76.3; 76.6 | 0.098 |
| SECONDARY Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 0 |
59.7; 79.4; 83.1; 76.9; 72.9; 73.8 | — |
| SECONDARY Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 1 |
28.6; 17.5; 11.9; 21.2; 27.1; 26.2 | — |
| SECONDARY Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 2 |
9.1; 3.2; 5.1; 1.9; 0; 0 | — |
| SECONDARY Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 3 |
1.3; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 4 |
1.3; 0; 0; 0; 0; 0 | — |
| SECONDARY Ratio of Afatinib Tablets Actually Taken to Doses Prescribed Over the Study Participation Period |
0.99 | — |
| SECONDARY Number of Patients With a Reason for Missing Afatinib Tablets |
11; 1; 1 | — |
| SECONDARY Number of Patients With a Reason for Discontinuation of Afatinib |
7; 43; 4; 1; 1 | — |
| SECONDARY Number of Patients With a Reason for Treatment Interruptions |
24; 2; 2; 1; 1; 1 | — |
| SECONDARY Number of Participants With Afatinib Interruptions or Dose Modifications |
42; 17; 9; 9 | — |
| SECONDARY Number of Patients With a Reason for Dose Reduction |
23; 1; 1; 1 | — |
| SECONDARY Number of Patients With a Reason for Dose Increase |
2; 1 | — |
Eligibility Criteria
Inclusion criteria
- Adult outpatients (18 years and older) of either gender;
- Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) NSCLC of any histological type with activating EGFR mutation(s) according to local laboratory EGFR testing;
- EGFR- tyrosine kinase inhibitor (TKI) naive patients;
- Patients for whom the decision to prescribe therapy with afatinib (GIOTRIF®) according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study; the assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of afatinib is clearly separated from the physicians decision to include the patient in the current study;
- Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;
Exclusion criteria
- Patients who have initiated treatment with Afatinib more than 7 days prior to their enrolment into the study;
- Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
- Receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with afatinib
Data sourced from ClinicalTrials.gov (NCT02440854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.