Sarcoma, Soft Tissue Sarcoma
Conditions
Keywords
Cyclophosphamide, Administration, Metronomic
Brief summary
Metronomic Cyclophosphamide's use in monotherapy as a palliative treatment against non-resectable and metastatic Soft Tissue Sarcomas relies on small retrospective cohorts' data. Current litterature needs external validation of its efficacy and safety profile in these settings of usually frail patients. The investigators assessed further data and aimed to identify predictive factors of metronomic cyclophosphamide impact in metastatic Soft Tissue Sarcomas.
Interventions
None listed
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients over 18 * with inoperable or metastatic Soft Tissue Sarcoma * treated with Metronomic Cyclophosphamide * in 3 cancer care institutions located in 2 French regions (Bourgogne and Franche-Comté) * between January 2005 and December 2021
Exclusion criteria
* patients with bone, chondral sarcomas, desmoid, or gastrointestinal stromal tumors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Progression-Free Survival is defined as the period from the first day of Metronomic Cyclophosphamide administration until the day of progression or death from any cause Assessment period was from the day of the first day of MCP administration until the first observation of progression or death from any cause. Disease progression is defined according to RECIST Ver. 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of first administration of Metronomic Cyclophosphamide until the date of death from any cause, assessed up to 100 months | Overall Survival is defined as the period from the first day of Metronomic Cyclophosphamide administration until the day of death from any cause Assessment period was from the day of the first day of Metronomic Cyclophosphamide administration until the first observation of death |
| Progression Rate | 3 and 6 Months | Proportions of patients with no reported progression at each time-point (3 and 6 months) |
| Response Rate (RR) | From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Proportion of Complete Response and Partial Response among the study population from the first day of Metronomic Cyclophosphamide administration until the day of progression or death from any cause. |
| Control Rate | From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Included Complete Response, Partial Response, and Stable Disease according to RECIST for at least 12 weeks from the first day of Metronomic Cyclophosphamide administration until the day of progression or death from any cause. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Imputable Toxicity Occurence | From date of first administration of Metronomic Cyclophosphamide until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Occurence, Nature and Grades according to CTCAE 5.0 of clinicians-reported adverse events imputable to metronomic cyclophosphamide |
Outcome results
None listed