First of Its Kind: Oncology Pharmacovigilance Clinic

By Cassandra Calabrese, DO

The cancer treatment landscape was forever changed in 2011 with approval of the first checkpoint inhibitor, nivolumab. These drugs rev up the immune system to target tumor cells and have provided options for durable treatment responses for patients with previously untreatable cancers.

Unfortunately, due to their mechanism, they are attended by a spectrum of adverse events that mimic immune-mediated diseases (such as rheumatoid arthritis and colitis), and these are called immune-related adverse events (irAEs). With the increasing approval of new checkpoint inhibitor therapies for an ever-expanding list of indications, we are seeing a rise in referrals for irAE diagnosis and management in rheumatology and other specialties.

In 2017, Cleveland Clinic created a multidisciplinary monthly tumor board, which continues to serve as a venue for discussion of challenging cases, review the extant literature and receive input on interprofessional management. In the past year, almost on- third of the cases discussed at irAE tumor board are rheumatologic irAE cases.

Major academic centers have varying triage and referral processes for care of patients with irAEs. Cleveland Clinic is the first to create a multidisciplinary clinic to serve this purpose. In September 2023, the Oncology Pharmacovigilance Clinic was created in the Taussig Cancer Center under the guidance of Wen Wee Ma, MBBS, the inaugural Director of the Novel Cancer Therapeutics Center in Taussig. This clinic is in Taussig and occurs one half-day per week. It is staffed by myself, endocrinologist Keren Zhou, MD, and coordinated with Oncology.

Patients with irAEs are often acutely symptomatic, with symptoms interfering with activities of daily living and disrupting their cancer treatment. Many are experiencing irAEs involving multiple systems. For these reasons, it is important there be timely access for their evaluation by Oncology and appropriate subspecialists, and ideally in a coordinated fashion.

The goal of the Pharmacovigilance Clinic is to serve as a space for exactly that, fostering excellent patient care and in-person interactions between subspecialists. This type of clinic for irAE care exists nowhere else in the world, and we are proud to be involved in this ground-breaking endeavor.

After this initial phase, the goal is to introduce additional specialists such as gastroenterology, cardiology and beyond.