Gastro Intestinal Stromal Tumor
Conditions
Brief summary
Gastro intestinal stromal tumors (GIST) are rare mesenchymal tumors of the gastrointestinal tract characterized by somatic mutations in the gene encoding the KIT or the PDGFR alpha protein1. Treatment of localized forms relies on adequate surgery without tumor spillage and systemic treatment with imatinib according to risk of relapse defined by localization, tumor size and mitotic count, as well as mutational status. Advanced and relapsing forms are currently treated with oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR such as Imatinib, Sunitinib and Regorafenib. Over two decades significant changes in drug discovery have impacted treatment strategies, notably via patient's access to various clinical trials. The use of focal treatments such as surgery or interventional radiology with mini invasive procedure of oligometastasis is also being proposed in some cases. There is no precise data on patterns of sequential treatments used, especially proportions of patients with metastatic GIST eventually benefiting from access to a clinical trial or a focal treatment strategy in the course of their disease, and their results in terms of survival on a real life national level. Using the French sarcoma Group national database we aim at describing treatments strategies proposed patients with metastatic GIST in the real life setting. Objectives include : (i) Description of clinico-biological profiles, patterns of care and modalities of treatment of patients with metastatic GIST in a real-life national setting and (ii) evaluation of patients outcome in terms of time to next treatment (TNT) and survival
Interventions
DRUGoral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR as per recommendations
oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR
Sponsors
French Sarcoma Group
Institut Bergonié
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* patients ≥ 18 years old * with a diagnosis of metastatic Gastrointestinal Stromal Tumor (metastatic at diagnostic or metastatic relapse) * From 1990 to 2018
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Next Treatment (TNT) | 10 years | time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first. |
| Overall Survival (OS) Time | 10 years | the interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment With a Systemic Therapy | At diagnosis of metastatic disease | Proportion of metastatic patients treated with a systemic therapy |
| Proportion of Participants Included in a Clinical Trial | 5 years | Proportion of participants included in a clinical trial (other than the present study) during the course of their metastatic disease |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Metastatic Gastrointestinal Stromal Tumors (GIST) Participants with metastatic Gastrointestinal stromal tumors (GIST) treated in one of the three national coordinating centers from NETSARC (Institut Bergonié, Centre Léon Berard and Institut Gustave Roussy) from 1990 to 2018. | 492 |
| Total | 492 |
Baseline characteristics
| Characteristic | Participants With Metastatic Gastrointestinal Stromal Tumors (GIST) | — |
|---|---|---|
| Age, Continuous | 59 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 492 participants | — |
| Sex: Female, Male Female | 200 Participants | — |
| Sex: Female, Male Male | 292 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 221 / 492 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Overall Survival (OS) Time
the interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death.
Time frame: 10 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Metastatic Gastrointestinal Stromal Tumors (GIST) | Overall Survival (OS) Time | 83.4 months |
Primary
Time to Next Treatment (TNT)
time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first.
Time frame: 10 years
Population: Participants who received systemic treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Metastatic Gastrointestinal Stromal Tumors (GIST) | Time to Next Treatment (TNT) | 26.7 months |
Secondary
Proportion of Participants Included in a Clinical Trial
Proportion of participants included in a clinical trial (other than the present study) during the course of their metastatic disease
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With Metastatic Gastrointestinal Stromal Tumors (GIST) | Proportion of Participants Included in a Clinical Trial | 269 Participants |
Secondary
Treatment With a Systemic Therapy
Proportion of metastatic patients treated with a systemic therapy
Time frame: At diagnosis of metastatic disease
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With Metastatic Gastrointestinal Stromal Tumors (GIST) | Treatment With a Systemic Therapy | 461 Participants |