Clinical application of a novel, multidisciplinary pharmacovigilance (PV) clinic in patients (pts) with immune-related adverse events (irAEs).
Abstract
e24091 Background: Multidisciplinary care models can facilitate care of pts with toxicities from cancer therapies. Here, we report the impact of our novel multidisciplinary PV clinic since its inception in 2023. Methods: We performed a retrospective review of pts seen for irAE in PV clinic at Cleveland Clinic Taussig Cancer Center since establishment of PV clinic. PV clinic is housed in the Cancer Center and includes specialties such as medical oncology, rheumatology, pulmonology, endocrinology, nephrology, and hepatology. Pts with toxicity from any cancer systemic therapy can be referred. Referring providers select the specialties needed for the pt when entering the consult order. Same day appointments were offered and virtual appointments used when feasible. Data regarding irAEs were collected using the electronic medical record system. Results: Between September 2023-November 2024, 92 pts (49 male, 43 female) were seen for irAE in the PV clinic. Most common primary malignancies were melanoma (35%, 32/92), genitourinary cancers (20%, 18/92), breast cancer (14%, 13/92), and lung cancer (11%, 10/92). The most common systemic therapy regimens were single-agent PD-1/PD-L1 (33%, 30/92), followed by combination chemoimmunotherapy (30%, 28/92; among these, the most common regimen was carboplatin + paclitaxel + pembrolizumab or durvalumab in 16/92 pts) and anti-CTLA-4 + anti-PD-1/PD-L1 (27%, 25/92). Ten pts (11%) saw 2 or more physicians from different specialties. The most common irAEs were arthritis (25%, 23/92), pneumonitis (20%, 18/92), hepatitis and hypothyroidism (10%, 9/92 each), and polymyalgia rheumatica (9%, 8/92). 47% (44/92) pts had documented irAEs affecting at least 2 organ systems. 14% (13/92) had a pre-existing autoimmune disease or history of organ transplant prior to starting ICI, most commonly rheumatoid arthritis (6/92) or psoriasis/ psoriatic arthritis (4/92). 33% (30/92) received a steroid-sparing agent (SSA) for the irAE for which they were seen in PV clinic. 12 different SSAs were prescribed, most commonly methotrexate (10%, 9/92), tocilizumab (8%, 7/92), hydroxychloroquine (5%, 5/92), infliximab (4%, 4/92), and adalimumab (3%, 3/92). 34% (31/92) received at least 1 dose of anti-PD-1/PD-L1-based therapy after being seen in PV clinic. Conclusions: Our PV clinic allows pts with irAEs to schedule coordinated appointments with physicians from multiple specialties. A high fraction of pts required SSAs for irAE management or had pre-existing autoimmune disease or organ transplant. In addition, a high fraction of pts received rechallenge with anti-PD-1-based therapy, suggesting that this care model can facilitate safe and timely ICI rechallenge in high-risk pts. This novel multidisciplinary PV clinic structure facilities timely and efficient multidisciplinary care for pts with toxicities from cancer systemic therapies.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (18)
Lucy Boyce Kennedy
Cleveland Clinic Foundation - Taussig Cancer Institute, Cleveland, OH
Cassandra Calabrese
Cleveland Clinic Foundation, Cleveland, OH
Keren Zhou
Michael Smith MD
Cleveland Clinic Foundation, Akron, OH
Mamoun Abdoh
Cleveland Clinic Foundation, Cleveland, OH
Shilpa Junna
Cleveland Clinic Foundation, Cleveland, OH
Itunu Owoyemi
Cleveland Clinic Foundation, Cleveland, OH
Abhay Singh
1Cleveland Clinic, Internal Medicine, Cleveland, United States
Amy Kunchok
Cleveland Clinic, Cleveland, OH
Gowri Kabbur
Cleveland Clinic Foundation, Cleveland, OH
Jessica Philpott
Cleveland Clinic, Cleveland, OH
Teodora Kuzmanovic
1Cleveland Clinic, Cleveland, United States
Alex A Adjei
Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH
Thach-Giao Truong
Cleveland Clinic, Cleveland, OH
Shilpa Gupta
Department of Hematology and Medical Oncology Taussig Cancer Institute Cleveland Clinic Cleveland Ohio USA
Halle C. F. Moore
Cleveland Clinic Foundation, Cleveland, OH
Nathan A. Pennell
Wen Wee Ma
Cleveland Clinic Taussig Cancer Institute, Cleveland, OH