Please note that this summary only contains information from the full scientific abstract: View ESMO Scientific Abstract

Medical problems involving the immune system in people receiving anti-cancer drugs that boost the immune system

Date of summary: September 2019

The full title of this abstract is: Real World Outcomes of Immune-Related Adverse Events (irAEs) among Patients Receiving Immune Checkpoint Inhibitors (ICIs) in Hospital Settings

This summary discusses various drugs being used in hospitals in the United States. The drugs all belong to a group called immune checkpoint inhibitors, but the researchers don’t say which individual drugs are used. In the United States, the study drugs are approved to treat the condition under study that is discussed in this summary, but they may not be approved in the European Union.

 

Researchers must look at the results of many types of studies to understand whether a study drug works, how it works, and whether it is safe to prescribe to patients.

This summary reports the results of only one study. The results of this study might be different from the results of other studies that the researchers look at.

 

More information can be found in the scientific abstract of this study, which you can access here:
View ESMO Scientific Abstract

What did this study look at?

  • People in this study had one of four types of cancer:
    • Non-small cell lung cancer, the most common kind of lung cancer.
    • Renal cell carcinoma, the most common type of kidney cancer.
    • Urothelial carcinoma, which starts in the lining inside the bladder or other parts of the urinary system.
    • Merkel cell carcinoma, a rare type of cancer. It forms on the skin or just beneath the skin.
  • The study looked at a group of drugs called immune checkpoint inhibitors.
    • Immune checkpoint inhibitors are a type of immunotherapy (treatment that uses the body’s own immune system to treat certain types of cancer).
  • Our immune system has ‘checkpoints’ to help it attack only when needed.
    • These checkpoints are the ‘brakes’ of the immune system. They stop the immune system killing our own cells. However, the checkpoints also stop the immune system killing cancer cells.
    • Immune checkpoint inhibitors help block the checkpoints. This releases the brakes on the immune system, allowing it to find and destroy cancer cells.
  • Immune checkpoint inhibitors make the immune system more active. This means that people treated with these drugs can have medical problems involving the immune system.
    • These are called immune-related medical problems.
  • This was a ‘real-world’ study, not a clinical trial.
    • In real-world studies, people receive approved drugs in their normal clinical setting.
    •  The study used information from hospitals in the United States. It looked at information put into a database between March 2015 and December 2017.
  • The researchers looked at how many people receiving immune checkpoint inhibitors had immune-related medical problems that were treated in hospital.
    • The researchers looked at the first immune-related medical problem recorded for each person in the database.
    • They compared people who stayed in hospital (inpatients) with people who had treatment in hospital but did not stay in (outpatients).
  • The researchers then used the database to find out what happened to these people afterwards. In particular, the researchers wanted to know:
    • how many people started their immune checkpoint inhibitor again
    • how many people had another immune-related medical problem as an inpatient, and
    • how many people died in hospital.

Who took part in this study?

What were the results of the study?

  • People with certain immune-related medical problems were more likely to stay in hospital.
    • Everyone who had the following medical problems stayed in hospital:
      • Inflammation of the heart muscle (myocarditis).
      • Inflammation of the spinal cord (transverse myelitis).
      • A severe skin reaction where the skin blisters and peels (toxic epidermal necrolysis).
    • Most people who had the following medical problems didn’t stay in hospital:
      • A condition causing them to bruise and bleed easily (acquired hemophilia).
      • Inflammation of the muscles (polymyalgia-like syndrome).
      • Underactive adrenal glands (adrenal insufficiency).

 

What happened in the next 90 days?

  • For inpatients and outpatients studied as one group:
    • Around half of people who had an immune-related medical problem started their immune checkpoint inhibitor again.
    • Around one-quarter of people had another immune-related medical problem as an inpatient.
    • Around 1 in 10 people died in hospital.
      • The researchers didn’t have information about why these people died. They may have died from their cancer or for another reason.
  • For inpatients and outpatients studied separately:
    • People who were inpatients with their first immune-related medical problem did not seem to do as well as outpatients.
      • They were less likely to start their immune checkpoint inhibitor again.
      • They were more likely to have another immune-related medical problem as an inpatient.
      • They were more likely to die in hospital.
  • People who died in hospital may have died for different reasons. The researchers didn’t have information about why these people died. They may have died from their cancer or for another reason.

More results from this study can be found here:
View ESMO Scientific Abstract

What was the main conclusion reported by the researchers?

  • In this study, about half of the people receiving an immune checkpoint inhibitor had an immune-related medical problem that was treated in hospital.
    • People who had an immune-related medical problem were likely to stop their immune checkpoint inhibitor.
    • People who had an immune-related medical problem as an inpatient did not do as well as outpatients.

Who sponsored this study?

EMD Serono Inc
One Technology Place,
Rockland, MA 02370
Phone (United States): +1 800-283-8088

Pfizer Inc.
235 East 42nd Street NY, NY 10017
Phone (United States): +1 212-733-2323

The sponsors would like to thank all of the people who took part in this study.

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