Lung Cancer
Conditions
Keywords
Small Cell Lung Cancer (SCLC)
Brief summary
Non-interventional, retrospective study of advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom \[UK\]) with the aim to produce evidence across different SCLC treatment lines to characterize the clinical and economic burden of the disease in Europe.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cohort 1 and 2: * Patients 18 years of age or older at SCLC diagnosis * Confirmed diagnosis of SCLC within the patient identification period (between October 2013 and October 2015) * Initiated on first-line treatment (radiotherapy and/or chemotherapy) for their SCLC * Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first) * Signed informed consent (where required as per local requirements) Cohort 3: * Patients 18 years of age or older at SCLC diagnosis * Confirmed diagnosis of SCLC not earlier than October 2013 * Initiated on second-line treatment due to relapse after first-line therapy not later than August 2016 * Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first) * Signed informed consent (where required as per local requirements)
Exclusion criteria
* Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period. Other Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Patient Demographic Characteristics | At baseline | Characteristics include: Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors |
| Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment | At baseline | Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
| Distribution of Patient Clinical Characteristics in patients with LD-SCLC | At baseline | Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
| Distribution of Patient Clinical Characteristics in patients with ED-SCLC | At baseline | Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
| Distribution of treatment patterns in patients with ED-SCLC | Approximately 44 months | Details on patients prior treatment Patterns will be summarized using descriptive statistics |
| Distribution of treatment patterns in patients with LD-SCLC | Approximately 44 months | Details on patients prior treatment Patterns will be summarized using descriptive statistics |
| Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment | Approximately 44 months | Details on patients prior treatment Patterns will be summarized using descriptive statistics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of radiation therapy as cancer-directed therapy | Approximately 44 months | To describe the use of radiation therapy in the management of LD-SCLC and ED-SCLC patients having relapsed |
| Composite of SCLC-related healthcare resource utilization (HCRU) | Approximately 44 months | HCRU will include hospitalizations, emergency visits, outpatient visits, treatments received (including treatments prescribed to manage AEs), diagnostic tests and procedures, surgery, and ancillary services. |
| Incidence of palliative care | Approximately 44 months | To describe the use of palliative care in the management of LD-SCLC and ED-SCLC patients having relapsed |
| Incidence of best supportive care (BSC) | Approximately 44 months | To describe the use of best supportive care (BSC) in the management of LD-SCLC and ED-SCLC patients having relapsed |
| Overall survival (OS) | Approximately 44 months | — |
| Progression-free survival (PFS) | Approximately 44 months | — |
| Objective response rate (ORR) | Approximately 44 months | — |
| Mortality rate | Approximately 44 months | — |
| Treatment-related adverse events (AEs) leading to discontinuation | Approximately 44 months | — |
| Incidence of surgery as cancer-directed therapy | Approximately 44 months | To describe the use of surgery in the management of LD-SCLC and ED-SCLC patients having relapsed |
Countries
Spain, United Kingdom
Outcome results
None listed