Dedifferentiated Liposarcoma
Conditions
Brief summary
This study will characterize patients with dedifferentiated liposarcoma (DDLPS) in China, including an understanding of demographic, and clinical characteristics as well as treatment patterns and clinical outcomes associated with the current real-world treatment.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has two or more documented clinical visits in the National Anti-Tumor Drug Surveillance System (NATDSS) network on or after January 1, 2013. * Patient has a confirmed diagnosis of dedifferentiated liposarcoma (DDLPS) during his/her lifetime. * At least 18 years old at the date of initial diagnosis. No
Exclusion criteria
are applied.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Overall Survival | Time from index date until the earliest record of death or end of the study period, up to 10 years. | Overall survival (OS) as an event for each patient in Cohort 1 was defined as the date of death minus the index date or the start day of each line of therapy (LOT). For patients with no record of death, OS was censored at the last activity date before the end of the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1, Cohort 2: Total Number of Treatment Lines | At index date and during follow-up, up to 10 years. | The total number of treatment lines in both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy. |
| Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | At index date and during follow-up, up to 10 years | Number of patients with first line (1L) therapy by treatment type for both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy. |
| Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | At index date and during follow-up, up to 10 years | Number of patients with second line (2L) therapy by treatment type for both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy. |
| Cohort 1, Cohort 2: Survival After Initial Diagnosis | Time from initial diagnosis until the earliest record of death or end of the study period, up to 10 years. | Survival after initial diagnosis for each patient was defined as the date of death minus the date of initial diagnosis. For patients with no record of death, survival after initial diagnosis was censored at the last activity date before the end of the study period. |
| Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Steroid Therapy | At index date and during follow-up, up to 10 years | Number of patients who received treatments with drugs classified as concurrent steroid therapy for both cohorts is reported. |
| Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Immunosuppressant Therapy | At index date and during follow-up, up to 10 years | Number of patients who received treatments with drugs classified as concurrent immunosuppressant therapy for both cohorts is reported. |
| Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Hormone Replacement Therapy | At index date and during follow-up, up to 10 years | Number of patients who received treatments with drugs classified as hormone replacement therapy for both cohorts is reported. |
| Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | At index date and during follow-up, up to 10 years | Number of patients with third line (3L) therapy by treatment type for both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy. |
Countries
China
Participant flow
Recruitment details
This was an observational cohort study conducted to investigate patient characteristics, current treatment patterns and outcomes in Chinese patients with dedifferentiated liposarcoma (DDLPS).
Pre-assignment details
Only patients diagnosed with DDLPS, who met all the inclusion criteria of having at least 2 documented clinical visits in the National Anti-Tumor Drug Surveillance System (NATDSS) on or after January 1, 2013, and were ≥18 years at initial diagnosis, were included.
Participants by arm
| Arm | Count |
|---|---|
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) Patients with unresectable locally advanced or metastatic differentiated liposarcoma (DDLPS) who received at least one line of systemic antineoplastic treatment by the end of cohort identification period (index date = start date of first line (1L) treatment). | 275 |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) Patients with DDLPS who have not initiated 1L systemic antineoplastic treatment by the end of cohort identification period (index date = date of initial DDLPS diagnosis during cohort identification period). Patients who initiated 1L treatment afterwards or patients who received adjuvant and/or neoadjuvant therapy only through follow-up were included in Cohort 2. | 1,115 |
| Total | 1,390 |
Baseline characteristics
| Characteristic | DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Total |
|---|---|---|---|
| Age, Continuous | 56.9 Years STANDARD_DEVIATION 11.5 | 57.4 Years STANDARD_DEVIATION 11.7 | 57.3 Years STANDARD_DEVIATION 11.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 109 Participants | 495 Participants | 604 Participants |
| Sex: Female, Male Male | 166 Participants | 620 Participants | 786 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 175 / 275 | 423 / 1,106 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Cohort 1: Overall Survival
Overall survival (OS) as an event for each patient in Cohort 1 was defined as the date of death minus the index date or the start day of each line of therapy (LOT). For patients with no record of death, OS was censored at the last activity date before the end of the study period.
Time frame: Time from index date until the earliest record of death or end of the study period, up to 10 years.
Population: All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and aged ≥18 years at initial diagnosis. Only patients who received at least one line of systemic antineoplastic treatment by the end of cohort identification period were included in this analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1: Overall Survival | OS after first line (1L) treatment | 13.4 months |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1: Overall Survival | OS after second line (2L) treatment | 11.9 months |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1: Overall Survival | OS after third line (3L) treatment | 8.1 months |
Secondary
Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type
Number of patients with first line (1L) therapy by treatment type for both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy.
Time frame: At index date and during follow-up, up to 10 years
Population: All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and aged ≥18 years at initial diagnosis. Only patients with non-missing data were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | Anthracycline-based regimens | 119 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | Anlotinib-based regimens | 85 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | Apatinib-based regimens | 15 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | Immune checkpoint inhibitor only | 10 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | Palbociclib | 9 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | Other | 36 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | Palbociclib | 0 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | Anthracycline-based regimens | 12 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | Immune checkpoint inhibitor only | 1 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | Anlotinib-based regimens | 12 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | Other | 9 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | Apatinib-based regimens | 1 Participants |
Secondary
Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Immunosuppressant Therapy
Number of patients who received treatments with drugs classified as concurrent immunosuppressant therapy for both cohorts is reported.
Time frame: At index date and during follow-up, up to 10 years
Population: All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and being age ≥18 years at initial diagnosis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Immunosuppressant Therapy | 32 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Immunosuppressant Therapy | 2 Participants |
Secondary
Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Steroid Therapy
Number of patients who received treatments with drugs classified as concurrent steroid therapy for both cohorts is reported.
Time frame: At index date and during follow-up, up to 10 years
Population: All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and aged ≥18 years at initial diagnosis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Steroid Therapy | 1 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Steroid Therapy | 1 Participants |
Secondary
Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Hormone Replacement Therapy
Number of patients who received treatments with drugs classified as hormone replacement therapy for both cohorts is reported.
Time frame: At index date and during follow-up, up to 10 years
Population: All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and being age ≥18 years at initial diagnosis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Hormone Replacement Therapy | 10 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Hormone Replacement Therapy | 0 Participants |
Secondary
Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type
Number of patients with second line (2L) therapy by treatment type for both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy.
Time frame: At index date and during follow-up, up to 10 years
Population: All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and aged ≥18 years at initial diagnosis. Only patients with non-missing data were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | Anlotinib-based regimens | 37 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | Anthracycline-based regimens | 22 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | Immune checkpoint inhibitor only | 13 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | Apatinib-based regimens | 8 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | Gemcitabine, Docetaxel | 4 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | Other | 30 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | Gemcitabine, Docetaxel | 0 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | Anlotinib-based regimens | 4 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | Apatinib-based regimens | 0 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | Anthracycline-based regimens | 2 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | Other | 1 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | Immune checkpoint inhibitor only | 1 Participants |
Secondary
Cohort 1, Cohort 2: Survival After Initial Diagnosis
Survival after initial diagnosis for each patient was defined as the date of death minus the date of initial diagnosis. For patients with no record of death, survival after initial diagnosis was censored at the last activity date before the end of the study period.
Time frame: Time from initial diagnosis until the earliest record of death or end of the study period, up to 10 years.
Population: All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and aged ≥18 years at initial diagnosis. Only patients with an existing diagnosis date were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Survival After Initial Diagnosis | 30.3 months |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Survival After Initial Diagnosis | 38.4 months |
Secondary
Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type
Number of patients with third line (3L) therapy by treatment type for both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy.
Time frame: At index date and during follow-up, up to 10 years
Population: All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and being age ≥18 years at initial diagnosis. Only patients with non-missing data were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | Anlotinib-based regimens | 16 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | Anthracycline-based regimens | 11 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | Apatinib-based regimens | 5 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | Immune checkpoint inhibitor only | 3 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | Gemcitabine, Docetaxel | 2 Participants |
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | Other | 14 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | Gemcitabine, Docetaxel | 0 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | Anlotinib-based regimens | 1 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | Immune checkpoint inhibitor only | 0 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | Anthracycline-based regimens | 1 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | Other | 0 Participants |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | Apatinib-based regimens | 0 Participants |
Secondary
Cohort 1, Cohort 2: Total Number of Treatment Lines
The total number of treatment lines in both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy.
Time frame: At index date and during follow-up, up to 10 years.
Population: All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and being age ≥18 years at initial diagnosis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DDLPS Patients With 1L Treatment at Index Date (Cohort 1) | Cohort 1, Cohort 2: Total Number of Treatment Lines | 1.0 Count of treatment lines per patient |
| DDLPS Patients Without 1L Treatment at Index Date (Cohort 2) | Cohort 1, Cohort 2: Total Number of Treatment Lines | 0.0 Count of treatment lines per patient |