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This is a retrospective evaluation of the impact of a double dose regimen of immunotherapy use in cancer treatment compared to the single-dose regimen on the occurrence of clinically significant adverse events.
The aim of this study is to provide evidence-based arguments to help clinicians to propose the best treatment regimen for each patient.
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| Measure | Description | Time Frame |
|---|---|---|
| To compare the incidence of clinical significant toxicities | To compare the incidence of clinical significant toxicities reported for patients treated with a cancer immunotherapy on a simple dose regiment versus double dose regimen | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the incidence | To describe the incidence, type and severity of overall toxicities (serious and non-serious) reported with single and double dose cancer immunotherapy regimens | 18 months |
| To identify risk factors for the development of severe toxicity |
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Inclusion criteria:
- Any adult patient with anti-PD-1 or PD-L-1 immune checkpoint inhibitor as monotherapy
Exclusion criteria:
- age < 18
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Any adult patient (over the age of 18) from Montpellier University Hospital or Montpellier Cancer Institute who has initiated an immunotherapy between 01/01/2019 and 31/12/2020 with anti-PD-1 or PD-L-1 immune checkpoint inhibitor as monotherapy (nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab)
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Maria, MD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uhmontpellier | Montpellier | 34295 | France |
NC
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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To identify risk factors for the development of severe toxicity |
| 18 months |
| To describe the management and evolution of toxicities | To describe the management and evolution of toxicities | 18 months |
| To describe the clinical oncologic response | To describe the clinical oncologic response | 18 months |