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

NCT02440854 | Completed Results

• 1 other identifier: 1200.247
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 7

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months following start of treatment.

Secondary Outcomes (29)

• 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 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 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 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 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.

Study Arms (1)

Patients with non-small cell lung cancer (NSCLC) treated with 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.

Drug: afatinib

Interventions

afatinib DRUG

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 with non-small cell lung cancer (NSCLC) treated with afatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

NSCLC EGFR mutation

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (7)

University General Hospital of Evros

Alexandroupoli, 68100, Greece

Location

Chest Hospital of Athens "Sotiria"

Athens, 115 27, Greece

Location

"Attikon" University General Hospital of Attica

Haidari, 12462, Greece

Location

University General Hospital of Heraklion

Heraklion, 71110, Greece

Location

Bioclinic Thessaloniki

Thessaloniki, 54622, Greece

Location

Interbalkan Medical Center of Thessaloniki

Thessaloniki, 57001, Greece

Location

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, 57010, Greece

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Main limitations are attributed to its observational design and mainly involve patient selection bias, information bias and missing data as well as lack of internal validity (no control group). Another factor that may have affected Patient Reported Outcomes was the COVID-19 pandemic, which started shortly after the last patient completed their first visit (18 February 2020) thus spanning one out of the total of five years of the study (last patient last visit: 17 February 2021).

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 12, 2015
• Study Start: February 16, 2016
• Primary Completion: February 17, 2021
• Study Completion: February 17, 2021
• Last Updated: April 27, 2022
• Results First Posted: April 27, 2022

Record last verified: 2022-02

Locations

GR (7)