Gefitinib Usage and Outcomes in Routine Treatment

Study Overview
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Brief Summary
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The purpose of this study is to understand real world gefitinib usage patterns, patient characteristics and outcomes and to present these for a Caucasian population

Detailed Description
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A multicentre, retrospective chart review study to characterise gefitinib usage and outcomes in routine treatment

Official Title
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A Multicentre, Retrospective Chart Review Study to Characterise Gefitinib Usage and Outcomes in Routine Treatment

Conditions
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Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who received gefitinib first line in the UK Single Payment Access (SPA) scheme Locally advanced or metastatic EGFR mutation positive NSCLC Supplied with first pack of gefitinib prior to 1st January 2012 Exclusion Criteria: Patient was treated privately (i.e. outside the NHS) Gefitinib was second-line therapy following treatment failure on a prior therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gefitinib<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of treatment duration, as a surrogate of Clinical Benefit (CB) in a 'Real World' population treated with gefitinib | Retrospective population [2009 to 2013] | 6 months | 
| Assessment of Overall Survival (OS) in a 'Real World' population treated with gefitinib | Retrospective population [2009 to 2013] | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Overall Survival (OS) in the subgroup of patients of Caucasian ethnicity and in the subgroup of patients treated with gefitinib for at least 3 months | Retrospective population [2009 to 2013] | 6 months | 
| Assessment of Treatment duration in the subgroup of patients of Caucasian ethnicity and in the subgroup of patients treated with gefitinib for at least 3 months | Retrospective population [2009 to 2013] | 6 months | 
| Characteristics of patients treated with gefitinib for all patients and stratified by whether gefitinib discontinued treatment before or after three months | Retrospective population [2009 to 2013] | 6 months | 
| Description of treatment patterns in patients treated with gefitinib (prior chemo, treatment breaks, treatment on discontinuation) | Retrospective population [2009 to 2013] | 6 months | 
| Duration of treatment in patients stratified by age, gender, stage and performance status. | Retrospective population [2009 to 2013] | 6 months | 
| Overall Survival (OS) in patients stratified by age, gender, stage and performance status. | Retrospective population [2009 to 2013] | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, epidermal growth factor receptor mutation, gefitinib, Iressa