Cancer Patients Treated With Immunotherapy in Intensive Care Unit

Characteristics and Care of Solid Tumor Patients Treated With Immunotherapy Admitted in Intensive Care Unit.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03357861

Acronym

IMMUNO-REA

Enrollment

100

Registered

2017-11-30

Start date

2018-09-01

Completion date

2021-08-23

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Critical Illness, Immunotherapy

Keywords

cancer, intensive care unit, checkpoint inhibitors, adverse event

Brief summary

This work aims to describe the characteristics and methods of management of patients suffering from a solid tumor treated with immunotherapy admitted to intensive care.

Detailed description

The place of checkpoint inhibitors (anti-PD-1 and PD-L-1) is currently validated in the management of melanoma and metastatic non-small cell lung cancer. The toxicity profile is specific with adverse effects related to immunity. Some side effects (myocarditis, colitis, interstitial lung disease, etc.) can be severe and patient could be hospitalized in intensive care unit. The question of immunotherapy's imputability in the acute disease is becoming more frequent.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* \> or = 18 years old; * with a solid tumor; * Treatment with anti-CTLA4 and / or anti-PD-1 / PDL-1 still in progress or up to 6 months after stopping; * Admitted to resuscitation or continuous care in an unprogrammed way, whatever the reason.

Exclusion criteria

* Minors; * Pregnant or lactating woman; * Admission after surgery of a scheduled surgery or for the security of procedure; * Anti-CTLA4 and / or anti-PD-1 / PDL-1 treatment stopped for more than 6 months; * Subject under guardianship or deprivation of liberty; * Refusal of consent; * No affiliation to a health insurance scheme.

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the imputability of immunotherapy in the ICU admission reason for lung cancer patients treated by immunotherapy.	At ICU discharge (maximum 30 days)	Description of ICU admission reason (immunotherapy toxicity versus other) for lung cancer patients treated by immunotherapy

Secondary

Measure	Time frame	Description
Description of the immunosuppressive treatments prescribed during the stay in intensive care for the patient's care.	At ICU discharge (maximum 30 days)	immunosuppressive treatments in intensive care unit
Description of ICU survival	At ICU discharge (maximum 60 days)	ICU survival
Description of hospital survival	At hospital discharge (maximum 60 days)	Hospital survival

Countries

Belgium, France

Outcome results