such side effects, rapid identification and prompt initiation of local or
systemic therapy are keys to improving the outcome of serious irAEs.
autoimmune complications warrants further assessment of safety
and standardization of irAE management in phase IV clinical trials.
Responders to checkpoint inhibitors can remain on therapy for
a long period of time, as response can be durable. The optimal
duration of therapy has not yet been determined and the current
trend is for continuation of treatment until progression of disease.
Efforts have been made to define the range and peak of occurrence
for different irAEs, but for any individual patient, irAEs can happen
outside of this defined time period.
Patients are often advised to get in touch with their oncologist
with any concerning symptoms. We try to communicate with other providers in regards to the type of treatment that our patients
are receiving. We educate our patients to advise other providers,
especially in the case of an emergency, that they are receiving immunotherapy treatment, and not chemotherapy, for their cancer.
Needless to say, it is extremely difficult to keep up with the number
of FDA approved medications, especially in the field of oncology.
Given the wide range of side effects which can affect different organ
systems and generally a broad differential diagnosis (from progression of cancer to infections, etc.) expertise in other subspecialties,
including pulmonology, gastroenterology, endocrinology, nephrology, neurology, rheumatology, etc., is needed for rapid diagnosis
and management of these side effects. In addition, primary care
physicians, who are most familiar with patients and their history,
can have a significant role in identifying these side effects. The key
remains effective communication between and among physicians.
Skin rash and mucosal irritation are the most common immune
related adverse event. Serious side effects can start as vague symptoms. Dry cough and shortness of breath can be the first signs
of pneumonitis. Diarrhea can be a result of colitis. Fatigue is a
common complaint in many cancer patients, but consideration of
endocrinopathies, such as hypothyroidism and hypopituitarism, is
important in patients receiving immunotherapy. Myasthenia gravis,
posterior reversible encephalopathy syndrome (PRES) and Guillain-Barre syndrome have been reported as potential neurological
complications. Myocarditis and myositis, although rare, have also
been reported. This is only a short list of many potential side effects
with this class of cancer treatment.
Laboratory abnormalities can be the first clue to an upcoming
autoimmune clinical syndrome. Abnormal liver function tests can
be a result of hepatitis and a rise in creatinine can mean nephritis.
Hyponatremia and hyperkalemia could be the first signs of hypoadrenalism, and high glucose can signal diabetes. Elevated amylase
and lipase may predict an evolving pancreatitis in the absence of
the clinical syndrome.
Despite dose interruption, side effects can continue to worsen
and may even be fatal if left untreated. Although supportive therapy
is important, it may not be sufficient. Systemic administration of
steroids for reversal of irAEs may become necessary. The current
trend is to initiate steroids early since delay can result in significant
morbidity and mortality. Slow taper of steroids is recommended,
as autoimmune side effects can rebound with rapid taper. Further
immunosuppression with agents such as infliximab and mycophenolate may be indicated in certain steroid refractory cases.
Dr. Arash Rezazedeh Kalebasty practices Oncology/Hematology with
the Norton Cancer Institute.
September 2016 Harding Shymanski quarter page ad GLMS_FINAL.pdf
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The theoretical contraindication for steroid use in the setting of
immunotherapy and attenuation of response is not as concerning
per current available data. Studies have shown that use of steroids
in this setting does not significantly affect response.
CY
We can assess your medical billing process
and make recommendations to help you
gain efficiences and improve profitability.
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Current FDA approved immune checkpoint inhibitors include
ipilimumab (Yervoy®), nivolumab (OPDIVO®), pembrolizumab
(KEYTRUDA®) and the recently approved atezolizumab (TECENTRIQ™). There are several other agents of this family in clinical
trials, both as single-agent and in combination. Having several of
these agents in the market with a new set of side effects caused by
To request a quote, call us or visit
www.hsccpa.com/medical-billing-services
Brenda Wallace, CPA, CMPE
812.491.1347
[email protected]
SEPTEMBER 2016
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