Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced/Metastatic Lung Cancer: a Retrospective Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 6205
- Locations
- 1
- Primary Endpoint
- Distribution of first-line treatment duration
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of the study is to document real-world pattern of care, outcomes and health resource use for participants diagnosed with and receiving treatment for advanced Non-small cell lung cancer (NSCLC) and extensive disease Small cell lung cancer (SCLC) in China.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed advanced NSCLC (IIIB/IV) and extensive disease SCLC with pathology/cytology record between 1-Dec-2013 and 30-Nov-2014
- •Received inpatient treatment more than twice (inclusive) at a selected site. For hospitals with outpatient records, patients receiving oral TKI therapy and routinely (more than twice a year) followed up outpatient will be included although no inpatient records. For hospitals with outpatient chemotherapy center, patients will be include if they were prescribed with chemotherapy and routinely (more than twice a year, inclusive) followed up outpatient in the hospital
- •18 years of age or older at initial diagnosis of IIIB/IV NSCLC and extensive disease SCLC
Exclusion Criteria
- •Patients who have participated in or are attending clinical trials receiving active LC therapy
- •Unknown initial diagnosis time and initial treatment time.
- •For hospitals without outpatient chemo therapy center, patients who were prescribed with chemo therapy but with no inpatient records will be excluded
- •Patients who received inpatient therapy for one time and were not routinely (more than twice a year, inclusive) followed up outpatient will be excluded
- •Other protocol defined inclusion/exclusion criteria could apply
Outcomes
Primary Outcomes
Distribution of first-line treatment duration
Time Frame: Approximately 36 months
Calculated by the difference between the treatment start date of the first observed drug in the regimen and the last observed date of the regimen
Proportion of participants receiving fourth-line systemic therapy
Time Frame: Approximately 36 months
Proportion of patients receiving fourth-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Proportion of participants receiving first-line systemic therapy
Time Frame: Approximately 36 months
Proportion of patients receiving first-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Proportion of participants receiving second-line systemic therapy
Time Frame: Approximately 36 months
Proportion of patients receiving second-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Distribution of subsequent regimens
Time Frame: Approximately 36 months
All chemotherapy, radiation and/or biologic drugs given to a patient following first-line regimen
Distribution of first-line therapy completion rate
Time Frame: Approximately 36 months
Completion of more than 4 cycles
Distribution of subsequent therapy completion rate
Time Frame: Approximately 36 months
Completion of more than 4 cycles
Proportion of participants receiving third-line systemic therapy
Time Frame: Approximately 36 months
Proportion of patients receiving third-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Distribution of first-line regimens
Time Frame: Approximately 36 months
All chemotherapy, radiation and/or biologic drugs given to a patient during the first 28 days after initiation of treatment
Distribution of subsequent treatment duration
Time Frame: Approximately 36 months
Calculated by the difference between the treatment start date of the first observed drug in the regimen and the last observed date of the regimen
Secondary Outcomes
- Distribution of disease characteristic data(At baseline)
- Distribution of Overall Survival from first observed diagnosis to death(At baseline)
- Distribution of other cancer-directed therapies(Approximately 36 months)
- Distribution of Interval of Therapy(Up to 36 months)
- Distribution of Lung Cancer related direct health care costs(Up to 36 months)
- Distribution of Overall Survival from the initiation of third-line systemic anti-cancer therapy to death(At baseline)
- Distribution of patient demographic data(At baseline)
- Distribution of Overall Survival from the initiation of first-line systemic anti-cancer therapy to death(At baseline)
- Distribution of Overall Survival from the initiation of second-line systemic anti-cancer therapy to death(At baseline)
- Distribution of Overall Survival from the initiation of fourth-line systemic anti-cancer therapy to death(At baseline)