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The Promise of Cancer Immunotherapy: Why Patient Education Is Critical, Part II

Debra Madden is a 2-time cancer survivor who was diagnosed with Hodgkin's lymphoma as a young adult and breast cancer nearly 20 years later, which was thought to be secondary to the radiation she had received for her original cancer treatment. Debra became an active Cancer Research Advocate following her second cancer diagnosis at the age of 42 years. She is currently a member of the ECOG/ACRIN Cancer Research Group and the Patient-Centered Outcomes Research Institute's Advisory Panel on the Assessment of Prevention, Diagnosis, and Treatment Options. She also serves on multiple grant review panels, including the Congressionally Directed Medical Research Program Breast Cancer Research Program. Debra blogs at "Musings of a Cancer Research Advocate", ( and you can follow her on Twitter at @AdvocateDebM.
In Part I of this article, Ms Madden discussed the enthusiasm concerning new immunotherapies, the need for caution in interpreting results while the data is still young, and the necessity for more mature data on a much larger number of patients. Here in Part II, she continues her discussion on why it is critical to educate patients and their families concerning what to expect from immunotherapy, with a particular focus on the unique spectrum of adverse effects that may be associated with these agents.
In the popular media and elsewhere, when reporting the potential benefits of immunotherapy, some have stated that when compared with traditional cancer treatments, there are “few to no side effects.” Though immunotherapies are typically not associated with the same side effects that result with chemotherapeutic agents the statement “few to no side effects” does not tell the entire story and may be misleading for patients. In fact, it’s the very promise of cancer immunotherapies—ie, the mechanisms of action that harness and enhance the immune system’s abilities to recognize and fight cancer cells—that may also lead to serious harms in some patients. In addition to enabling a continued attack against cancerous cells, increased inflammatory reactions and enhanced immunologic responses with immunotherapies such as the checkpoint inhibitors may impact normal body cells and tissues, resulting in adverse effects. Autoimmune in nature, such effects are collectively known as “immune-related adverse events (irAEs),” and are thought to occur due to general immunologic enhancement. 4,12
  • Serious irAEs are infrequent and treatable, but patient education is crucial, since early recognition of such effects is critical in ensuring effective treatment. Patients and caregivers must be made aware of irAEs before initiating treatment. Healthcare providers should also discuss the concept of pseudo-progression with patients and caregivers, and that associated symptoms may include low-grade fever, a painful and sudden increase in tumor size, rash, and bone pain.
  • In contrast to adverse effects with standard cancer therapies, irAEs may tend to be delayed, with onset of some symptoms potentially developing weeks or months following treatment initiation. Patients must therefore recognize that they may experience such side effects after having previously done well clinically and that some irAEs may develop after completion of treatment.
  • irAEs may involve inflammation of any organ system, may affect more than one organ system, and may impact different organs at different times.
  • The signs of some irAEs may present solely as lab value changes, eg, elevated values of liver function tests due to hepatic inflammation.
  • The medical care team should urge their patients to monitor for any side effects during and in the months following their immunotherapy and to report all symptoms, no matter how subtle they may seem. Patients and their caregivers need to understand the importance of prompt evaluation for such signs and symptoms to determine whether they are due to an immune-mediated toxicity and to ensure that appropriate treatment is promptly initiated.
  • Because no prospective clinical trials have yet been conducted to inform the management of irAEs, treatment is currently based on clinical experience. In addition, general guidelines for irAE treatment due to checkpoint inhibitor therapy are included in the FDA’s REMS for the checkpoint inhibitor ipilimumab. In general, treatment of moderate or severe irAEs includes corticosteroid immunosuppression, symptomatic management based on the specific toxicity and severity, and discontinuation or interruption of checkpoint inhibition.

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