Neutropenic Sepsis in Patients With Non-Small Cell Lung Cancer Treated With Single-Agent Docetaxel and Associated Resource Use in the UK

Study Overview
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Brief Summary
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This is a multi-center retrospective observational research study collecting data for participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC) up to 6 years before start of data collection and who have completed/stopped docetaxel treatment at least 30 days prior to data collection. The primary goal of this study is to describe the percentage of participants with at least one neutropenic sepsis (NS) episode following initiation of treatment with single-agent docetaxel. Data will be collected until end of docetaxel treatment plus an additional 30 days to allow for presentation with toxicity.

Official Title
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A Retrospective Chart Review to Describe the Rate of Neutropenic Sepsis in Patients With Non-Small Cell Lung Cancer Treated With Single-Agent Docetaxel and Associated Resource Use in the UK

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with locally advanced or metastatic (stage Ill or IV) non-small cell lung cancer (NSCLC) Relapsed disease following, or unable to tolerate, at least one line of prior chemotherapy Initiated on single-agent docetaxel up to a maximum of 6 years prior to date of collection Aged 18 years at date of first docetaxel dose Completed or stopped treatment with docetaxel at least 30 days prior to date of data collection Exclusion Criteria: Receiving docetaxel in an interventional clinical trial For whom no details of absolute neutrophil count are recorded

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 |
| --- | --- |
| Cohort Docetaxel<br>Participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC) | Other: No intervention<br>* No intervention administered in this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Receiving Single-Agent Docetaxel Chemotherapy for Treatment of Relapsed Non-Small Cell Lung Cancer (NSCLC) with an Episode of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 1.0 x 10^9/L |  | Up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency with which Participants Attend Hospital for Management of Specified Hematological Docetaxel-Related Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia |  | Up to 6 years | 
| Percentage of Participants Receiving Single-Agent Docetaxel Chemotherapy for Treatment of Relapsed Non-Small Cell Lung Cancer (NSCLC) with an Episode of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L |  | Up to 6 years | 
| Percentage of Participants with Docetaxel-Related Hematological Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia |  | Up to 6 years | 
| Number of Episodes of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 1.0 x 10^9/L |  | Up to 6 years | 
| Number of Episodes of NS with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L |  | Up to 6 years | 
| Number of Episodes of NS Associated with Death Attributable to NS |  | Up to 6 years | 
| Percentage of Deaths Associated with the Occurrence of an NS Event |  | Up to 6 years |