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

Hoffmann-La Roche120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Non-Small Cell Lung Cancer

Interventions

No interventionOTHER

No intervention administered in this study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

Velindre Cancer Centre

Cardiff, United Kingdom

Chelsea & Westminster Hospital

London, United Kingdom

Maidstone Hospital; Kent Oncology Centre

Maidstone, United Kingdom

Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford, United Kingdom

Royal Cornwall Hospital

Truro, United Kingdom

Pinderfields General Hospital; Dept of Haematology

Wakefield, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: Up to 6 years

Secondary Outcomes

Frequency with which Participants Attend Hospital for Management of Specified Hematological Docetaxel-Related Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia

Time frame: Up to 6 years

Percentage of Participants with Docetaxel-Related Hematological Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia

Time frame: 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

Time frame: Up to 6 years

Number of Episodes of NS with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L

Time frame: Up to 6 years

Number of Episodes of NS Associated with Death Attributable to NS

Time frame: Up to 6 years

Percentage of Deaths Associated with the Occurrence of an NS Event

Time frame: Up to 6 years