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

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

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 Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
    • Bristol Haematology and Oncology Centre
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Cancer Centre
  • London, United Kingdom, SW10 9NH
    • Chelsea & Westminster Hospital
  • Maidstone, United Kingdom, ME16 0FS
    • Maidstone Hospital; Kent Oncology Centre
  • Oxford, United Kingdom, OX3 7LE
    • Oxford University Hospitals NHS Trust - Churchill Hospital
  • Truro, United Kingdom, TR1 3LQ
    • Royal Cornwall Hospital
  • Wakefield, United Kingdom, WF1 4DG
    • Pinderfields General Hospital; Dept of Haematology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort Docetaxel; Participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC)	Other: No intervention; No intervention administered in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 25, 2016
• Primary Completion (ACTUAL): July 25, 2016
• Study Completion (ACTUAL): July 25, 2016

Study Registration Dates

• First Submitted: January 15, 2016
• First Submitted That Met QC Criteria: January 15, 2016
• First Posted (ESTIMATE): January 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ML30033