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.
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.
Study Type
OBSERVATIONAL
Enrollment
116
Data entered in a secure computer database
CH Côte basque
Bayonne, France
CHU Brest
Brest, France
CH Cherbourg
Cherbourg, France
CHI Créteil
Créteil, France
CHU Lille
Lille, France
Disease control
Disease control rate at 12 weeks
Time frame: 12 weeks
Survival with anti-PD1/PDL1 immunotherapy
Overall survival from treatment with anti-PD1/PDL1 immunotherapy
Time frame: 12 weeks
Duration of treatment
Duration of treatment with PD1/PDL1 immunotherapy
Time frame: 12 weeks
Survival
Overall survival from the start of the first treatment
Time frame: 12 weeks
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by previous immunotherapy
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: which immunotherapy, date of treatment beginning/end
Time frame: 12 weeks
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by adverse event
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: numbers of treatment related adverse events from CTCAE v4.0
Time frame: 12 weeks
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by remarkable event
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: date of best response, date of progression, date of death)
Time frame: 12 weeks
To identify factors predictive of treatment response by immunotherapy in responder patients
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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
Time frame: 12 weeks
To identify factors predictive of the response of immunotherapy treatment of progressive patients
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
Time frame: 12 weeks
To identify factors predictive of the response of immunotherapy treatment of all patients
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
Time frame: 12 weeks
To identify factors predictive of the response of immunotherapy treatment according to follow-up treatment
Identify factors predictive of treatment response by immunotherapy according to type of treatment after PD1/PDL1 immunotherapy
Time frame: 12 weeks