Among patients with intermediate- or poor-risk advanced metastatic renal cell carcinoma (mRCC), new trial data further supports the understanding of the real-world utilization and long-term effectiveness of first line Opdivo (nivolumab) plus Yervoy (ipilimumab), according to study findings published in JCO Clinical Cancer Informatics.
In a retrospective analysis, after a median follow-up of 22.4 months, the median overall survival (OS) and real-world progression-free survival (rwPFS) were 38.4 months and 11.1 months, respectively. In total, 89 patients died, and 120 patients died or developed progressive disease during the study period.
Treatment-related side effects were experienced by 89 (47.6%) patients, which included fatigue (13.4%), rash (10.2%), diarrhea (7%), nausea (6.4%) and colitis (3.7%). Common reasons for the discontinuation of treatment included progressive disease (25.1%), toxicity (21.4%), completed planned treatment (11.8%), hospice (4.8%) and death (4.8%).
Factors that were significantly associated with both OS and rwPFS included an Eastern Cooperative Oncology Group performance status score of 2 or more, stage 4 disease at initial diagnosis and The International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic model poor-risk group.
Out of 187 patients (mean age, 63 years) identified in the analysis, 60.4% had an intermediate IMDC prognostic risk, 74 (39.6%) patients had poor risk, 37 (19.8%) patients had an Eastern Cooperative Oncology Group performance status score of 2 or more and 61% had a score of 0 to 1. Patients receiving second line therapy (86 patients) received Cometriq (cabozantinib) (54.7%) and Votrient (pazopanib) (10.5%).
The most common sites of metastasis were the lung (57.8%), bone (31.6%) and lymph nodes (30.5%). Forty-six percent of patients had metastases in two or more sites. Metastases were also observed in the liver (17.6%) and brain (6.4%).
“In conclusion, this real-world study supports the clinical effectiveness of first-line [Opdivo plus Yervoy] combination therapy for patients with IMDC [intermediate- or poor-risk] mRCC in the community oncology setting,” study authors concluded.
