Gefitinib Usage and Outcomes in Routine Treatment

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01818947

Enrollment

157

Registered

2013-03-27

Start date

2013-06-30

Completion date

2013-11-30

Last updated

2014-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Lung cancer, epidermal growth factor receptor mutation, gefitinib, Iressa

Brief summary

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

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Characteristics of patients treated with gefitinib for all patients and stratified by whether gefitinib discontinued treatment before or after three months	6 months	Retrospective population \[2009 to 2013\]
Description of treatment patterns in patients treated with gefitinib (prior chemo, treatment breaks, treatment on discontinuation)	6 months	Retrospective population \[2009 to 2013\]
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	6 months	Retrospective population \[2009 to 2013\]
Overall Survival (OS) in patients stratified by age, gender, stage and performance status.	6 months	Retrospective population \[2009 to 2013\]
Duration of treatment in patients stratified by age, gender, stage and performance status.	6 months	Retrospective population \[2009 to 2013\]
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	6 months	Retrospective population \[2009 to 2013\]

Countries

United Kingdom

Outcome results