Immunotherapy treatments are not without side effects. What do patients and their families need to know so they are more aware?
Published Online: February 15, 2017
Surabhi Dangi-Garimella, PhD
The promise of immunotherapy is fraught with challenges—with an increase in indications for these immuno-oncology (I-O) agents, healthcare providers and patients are slowly realizing the balance they must strike with I-O. At the 5th annual Patient-Centered Oncology Care® (PCOC®) meeting, held November 17-18, 2016, in Baltimore, cancer research advocate Debra L. Madden discussed the importance of educating patients and caregivers on the variety of adverse events associated with I-O.
Being a systemic treatment, I-O agents provide a significant boost to the patient’s immune system, and also impact its long-term memory and duration of response, Madden told the audience. While I-O agents have the potential to benefit patients across a variety of cancer types, managing patient and family expectations on these treatments is crucial. Debra emphasized that patients should understand the limitations of this treatment. “Those who have an autoimmune disorder, have undergone an organ transplant, or need to be on steroid treatment, for example, are not ideal candidates for immunotherapy,” she said.
Despite all the necessary exclusions and precautions, translating trial results into the clinic often yields unexpected patient responses, which makes it imperative to consider each patient on a case-by-case basis. While patients with autoimmune disorders are excluded from receiving immunotherapy—due to concerns of a bigger flare-up (see Table)—a recent study1 has raised some hope for these patients, Madden said. The study, conducted in Australia, found that patients with advanced melanoma who had preexisting autoimmune disorders or those who had a major immune-related adverse event (irAE) with the early next-generation immunotherapy, ipilimumab, could potentially be treated with a programmed death ligand-1 (PD-1) inhibitor, with manageable immune toxicities.
Madden heard the presentation from that study’s senior author, Alexander M. Menzies, PhD, at the 2016 annual meeting of the American Society of Clinical Oncology. “Dr Menzies said that the results of their study could be applied to other cancers, as well, that are now treated with I-O drugs,” she told the audience at PCOC®. This study has raised hopes of cancer clinicians who can now expand the population of patients that receive treatment with PD-1 inhibitors. Madden believes that a cautious approach, which includes considering the individual patient characteristics and an open discussion with the patient, can make immune-based treatments available to those patients who did not qualify to participate in the clinical trial.
Madden also drew attention to the fact that patients may have a variable response (time to response, type of clinical response, etc) to I-O, and some may experience a phenomenon described as “pseudo-progression.” Pseudo-progression is the initial period following treatment initiation when a tumor might actually grow in size before it shrinks. “These variations in response led to the creation of new immune-related Response Criteria for I-O agents—the criteria require confirmation of suspected disease progression about 4 weeks following treatment initiation, with subsequent radiographic testing,” she added.
Madden then walked the audience through some of the most commonly observed adverse effects with immunotherapy, emphasizing the importance of a thorough explanation of these for the patients and family members. “It is critical for healthcare providers to urge their patients to monitor for any side effects during and in the months following immunotherapy, and to report all symptoms no matter how subtle they may seem,” Madden added.
Menzies AM, Johnson DB, Ramanujam S, et al. Anti-PD-1 therapy in patients with advanced melanoma and preexisting autoimmune disorders or major toxicity with ipilimumab [published online September 29, 2016]. Ann Oncol. doi: 10.1093/annonc/mdw443.