陳鵬¹、黃逸修^1,2、張延驊^1,2、魏子鈞^1,2、鍾孝仁^1,2、黃志賢^1,2

¹臺北榮民總醫院 泌尿部；

²國立陽明大學醫學院泌尿學科及書田泌尿科學研究中心

Peng Chen¹, Eric Yi-Hsiu Huang^1,2, Yen-Hwa Chang^1,2, Tzu-Chun Wei^1,2, Hsiao-Jen Chung^1,2,

William J. Huang^1,2

¹ Department of Urology, Taipei Veterans General Hospital;

² Department of Urology, School of Medicine and Shu-Tien Urological Science Research Center,

National Yang-Ming University, Taipei, Taiwan

 

For patients with intermediate and poor International Metastatic RCC Database Consortium (IMDC) risk metastatic renal cell carcinoma (mRCC), combined immune checkpoint inhibitors (ICIs) with nivolumab and ipilimumab is the recommended frontline treatment for clear cell histology according to the current guidelines. It would be interesting to explore the real-world experience of such treatment modality. Hence, we analyzed the treatment response and immune-related adverse events (irAE) of combining ICIs (nivolumab plus ipilimumab) as the first line treatment for metastatic clear cell RCC in our institute.

From September 2015 to September 2019, a total of 9 patients with mRCC were treated with nivolumab (3 mg per kilogram of body weight) plus ipilimumab (1 mg per kilogram) intravenously every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram) every 2 weeks as first line systemic therapy in our institute. The characteristics of the patients, irAE, and the treatment response were evaluated. The treatment response was defined as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD).

Nine patients were included (male: female= 8:1). The mean age was 56.4±10.6 years old. The subtypes were 7 clear cell, 1 Xp11 translocation, and 1 fumarate hydratase-deficient RCC. Three patients had sarcomatoid features while 2 of them were clear cell type. Six patients were intermediate and 3 patients were poor IMDC risk group. Eight patients completed 4 courses of nivolumab plus ipilimumab and 1 patient received only 2 courses because of irAE. Six patients received subsequent maintenance nivolumab, while 1 received sunitinib for second line systemic therapy because of irAE. Mean follow up duration was 12.4±16.1 months (range 2~54 months). Objective response rate (ORR) was 55.6%, with PR in 5 patients (55.6%) but no CR was observed. Besides, 1 patient (11.1%) was in SD but 3 patients (33.3%) showed PD. Overall survival (OS) rate was 66.7% with median OS of 6 months. irAE occurred in 4 patients with 4 events. The irAEs were skin rash (1 patient, Gr. 1), anemia (1 patient, Gr. 2), hypothyroidism (1 patient, Gr. 3), and hypophysitis (1 patient, Gr. 3). All the irAEs were manageable without mortality and severe sequela.