Real-World Adjuvant Nivolumab Utilization in Surgically Treated Muscle-Invasive Bladder Cancer Patients within U.S. Community Oncology Practice
Author(s)
Patrick J. Squires, PharmD, PhD1, Francesca Coutinho, MBBS, MPH2, Jon G. Tepsick, MS2, Jennifer Stuart, MSc, ScD1, Chethan Ramamurthy, MD1, Haojie Li, PhD1, Todd M. Morgan, MD3;
1Merck & Co., Inc., Rahway, NJ, USA, 2ConcertAI, LLC, Cambridge, MA, USA, 3University of Michigan, Ann Arbor, MI, USA
1Merck & Co., Inc., Rahway, NJ, USA, 2ConcertAI, LLC, Cambridge, MA, USA, 3University of Michigan, Ann Arbor, MI, USA
Presentation Documents
OBJECTIVES: Adjuvant nivolumab was approved in 2021 for the treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical cystectomy, and we do not yet know the current pattern of utilization. This contemporary study aimed to describe adjuvant nivolumab use among surgically treated muscle-invasive bladder cancer (MIBC) patients in the U.S. community oncology setting.
METHODS: The ConcertAI Patient360TM Bladder Dataset, derived from electronic medical records, was used to identify adult patients with MIBC (T2-T4aN0M0, T1-T4aN1M0) undergoing radical cystectomy between February 19, 2021 (six-months before nivolumab approval) and October 31, 2023. Patients with a history of other primary cancers, non-bladder systemic antineoplastic therapies, prior partial cystectomy, or neoadjuvant radiation were excluded. Patients were considered to be at high risk of recurrence if they met one of two criteria: a) received neoadjuvant cisplatin-based therapy and pT2-T4a or pN+; or, b) if patient did not receive neoadjuvant cisplatin-based therapy, pT3-4a or pN+. Neoadjuvant and adjuvant treatment utilization was described among all MIBC patients and then further among those with high risk of recurrence following surgery.
RESULTS: A total of 138 eligible patients were identified (median age 69 years; 71% male; 81% White; 82% de novo; 91% urothelial histology). Of these, the majority (72%; 100/138) received neoadjuvant therapy, while 15% (21/138) received adjuvant treatment, with 13% (18/138) receiving adjuvant nivolumab. Further, 13% (18/138) of patients received neoadjuvant and adjuvant treatment. About half of the patients were at high risk of recurrence following surgery (57/108 patients with complete pathologic staging). Of these, 68% (39/57) received neoadjuvant treatment and 28% (16/57) received adjuvant treatment with 26% (15/57) receiving adjuvant nivolumab.
CONCLUSIONS: In the era of adjuvant nivolumab, most patients with radically resected MIBC are receiving neoadjuvant treatment. Conversely, adjuvant nivolumab use was limited, even among patients with high risk of recurrence at radical cystectomy.
METHODS: The ConcertAI Patient360TM Bladder Dataset, derived from electronic medical records, was used to identify adult patients with MIBC (T2-T4aN0M0, T1-T4aN1M0) undergoing radical cystectomy between February 19, 2021 (six-months before nivolumab approval) and October 31, 2023. Patients with a history of other primary cancers, non-bladder systemic antineoplastic therapies, prior partial cystectomy, or neoadjuvant radiation were excluded. Patients were considered to be at high risk of recurrence if they met one of two criteria: a) received neoadjuvant cisplatin-based therapy and pT2-T4a or pN+; or, b) if patient did not receive neoadjuvant cisplatin-based therapy, pT3-4a or pN+. Neoadjuvant and adjuvant treatment utilization was described among all MIBC patients and then further among those with high risk of recurrence following surgery.
RESULTS: A total of 138 eligible patients were identified (median age 69 years; 71% male; 81% White; 82% de novo; 91% urothelial histology). Of these, the majority (72%; 100/138) received neoadjuvant therapy, while 15% (21/138) received adjuvant treatment, with 13% (18/138) receiving adjuvant nivolumab. Further, 13% (18/138) of patients received neoadjuvant and adjuvant treatment. About half of the patients were at high risk of recurrence following surgery (57/108 patients with complete pathologic staging). Of these, 68% (39/57) received neoadjuvant treatment and 28% (16/57) received adjuvant treatment with 26% (15/57) receiving adjuvant nivolumab.
CONCLUSIONS: In the era of adjuvant nivolumab, most patients with radically resected MIBC are receiving neoadjuvant treatment. Conversely, adjuvant nivolumab use was limited, even among patients with high risk of recurrence at radical cystectomy.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HSD64
Topic
Health Service Delivery & Process of Care
Disease
SDC: Oncology