Malignant Pleural Mesothelioma
Conditions
Keywords
Immunotherapy, Pleura, Malignant Pleural Mesothelioma
Brief summary
The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy outside of a clinical trial in terms of efficacy and safety.
Detailed description
Immunotherapy is now an option in the treatment of malignant pleural mesothelioma. A French study, Mesothelioma Avastin plus Pemetrexed-cisplatin Study 2 (MAPS 2), prospective in 2nd line or more, found 40% and 52% disease control rate with respectively an anti-PD1 antibody or a combo of anti-PD1 and Cytotoxic T-Lymphocyte-Associated protein 4 (anti-CTLA4). Safety was rather good with 14% and 26% grade 3-4 in the Nivolumab and combo group respectively. Thanks to this trial and data from the literature, Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy became an option in the treatment of malignant pleural mesothelioma, after validation by a multidisciplinary meeting. The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received anti-PD1/PDL1 immunotherapy outside of a clinical trial in terms of efficacy and safety.
Interventions
OTHERData collection
Data entered in a secure computer database
Sponsors
Centre Hospitalier Intercommunal Creteil
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient over 18 years of age, * Diagnosis of malignant pleural mesothelioma affirmed by the anatomo-pathological analysis report of a histological sample of the tumour (re-read by MESOPATH). * Patient who has received at least one injection of anti-PD1 or anti-PDL1 antibodies
Exclusion criteria
* Explicit refusal by the patient to collect data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease control | 12 weeks | Disease control rate at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of treatment | 12 weeks | Duration of treatment with PD1/PDL1 immunotherapy |
| Survival | 12 weeks | Overall survival from the start of the first treatment |
| Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by previous immunotherapy | 12 weeks | Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: which immunotherapy, date of treatment beginning/end |
| Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by adverse event | 12 weeks | Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: numbers of treatment related adverse events from CTCAE v4.0 |
| Survival with anti-PD1/PDL1 immunotherapy | 12 weeks | Overall survival from treatment with anti-PD1/PDL1 immunotherapy |
| To identify factors predictive of treatment response by immunotherapy in responder patients | 12 weeks | Identify factors predictive of treatment response by immunotherapy in responder patients by collecting following data: Demographics data, treatment data, and blood test results and histological data |
| To identify factors predictive of the response of immunotherapy treatment of progressive patients | 12 weeks | Identify factors predictive of treatment response by immunotherapy of progressive by collecting following data: Demographics data, treatment data, and blood test results and histological data |
| To identify factors predictive of the response of immunotherapy treatment of all patients | 12 weeks | Identify factors predictive of treatment response by immunotherapy of all patients by collecting following data: Demographics data, treatment data, and blood test results and histological data |
| To identify factors predictive of the response of immunotherapy treatment according to follow-up treatment | 12 weeks | Identify factors predictive of treatment response by immunotherapy according to type of treatment after PD1/PDL1 immunotherapy |
| Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by remarkable event | 12 weeks | Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: date of best response, date of progression, date of death) |
Countries
France
Outcome results
None listed