SAN ANTONIO, Tex.—Use of a collaborative team dedicated to managing immune-related adverse events (irAEs) enabled prompt recognition and safe, successful management in patients receiving immunotherapy for cancer, according to an oral presentation at the ONS 41st Annual Congress.1

Advances in immunotherapy have improved the treatment of cancer. Human monoclonal antibodies such as ipilimumab and nivolumab stimulate the immune system to recognize and attack cancerous cells. However, irAEs can be dramatically different than adverse events seen with standard chemotherapy.

The establishment of a management process for irAEs at the designated phase I immunotherapy unit at Memorial Sloan-Kettering Cancer Center (MSKCC) enabled clinicians to successfully assess and manage irAEs in patients receiving immunotherapy.  A standard algorithm for the process was created by a nurse-led collaborative team.

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The algorithm starts with a review of signs and symptoms, leading to classification as skin reaction (dermatitis), gastrointestinal (enterocolitis), liver (hepatitis), endocrine disorders, or lung (pneumonitis). Severity is determined with appropriate laboratory tests and patient assessments, applying NCI CTCAE criteria.

“At MSKCC, we use the Start, Pause, Stop principle to determine the appropriate intervention and assess whether to continue, pause, or discontinue immunotherapy,” explained RuthAnn Gordon, MSN, FNP-BC, OCN.

However, other causes of the symptoms should be excluded before proceeding with irAE management process. If the cause is not immune-related, the strategy is to treat the cause and continue immunotherapy. If symptoms are immune-related, the strategy is to evaluate severity and determine the intervention.

In addition, an established mechanism for reporting side effects in a timely manner is needed as a delay in corticosteroid treatment may result in poor outcomes for some irAEs. Most irAEs will manifest during treatment; therefore, “I tell my patients if you have any symptoms, call me and we can decide together if we need to intervene,” said Gordon.

The Start, Pause, and Stop method begins when immunotherapy is started. When the patient reports a side effect, a review of the symptoms is made. If the irAE is assessed as grade 1, appropriate symptomatic treatment is administered, close monitoring and follow-up are initiated, and immunotherapy is continued.

If the irAE is assessed as grade 2, a pause in immunotherapy is considered while the symptoms are treated. A short course of oral corticosteroids may be considered and a consult with a specialist. When symptoms improve, treatment is tapered over 2 to 4 weeks and immunotherapy can be resumed.

If the irAE is assessed as grade 3, immunotherapy is stopped for treatment of the irAE. When the event is resolved, a determination is made whether to resume or stop immunotherapy.

Early symptom detection, quick clinical assessment, and close evaluation are essential for successful management of patients receiving anticancer immunotherapies. Patient education on specific symptoms and signs of irAEs also enable early intervention, potentially avoiding inpatient management and life-threatening adverse events.


1. Gordon R, Kasler M, Stasi K. Start, pause, stop: a dedicated ambulatory phase I immunotherapy clinic’s approach to managing patients on immune modulators. Oral presentation at: Oncology Nursing Society 41st Annual Congress; April 29-May 1, 2016; San Antonio, TX.