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.
“This was one of the first studies to describe patient characteristics, treatment patterns and clinical outcomes among patients with mRCC treated with [first-line treatment of Opdivo plus Yervoy] in the community oncology setting,” study authors wrote.
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.
In addition, treatment-related side effect rates were low relative to other clinical trials, suggesting caution when reviewing the data, according to study authors.
Glossary:
Overall survival (OS): the length of time a patient lives after diagnosis.
Real-world progression-free survival (rwPFS): the time from the start of treatment until the cancer progresses or the patient dies.
Eastern Cooperative Oncology Group performance status: measures how well a patient can function physically. A score of 2 indicates a patient is only capable of limited self-care. A score of 0 to 1 indicates a patient is fully active or has only slight limitations.
The International Metastatic Renal Cell Carcinoma Database Consortium (IMDC): a system for classifying mRCC into risk groups to help predict prognosis and guide treatment decisions.
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%).
As mentioned in the study, real-world evidence gathered from routine clinical practice significantly complements findings observed in randomized controlled trials, such as the CheckMate 214 trial. In the CheckMate 214 trial, Opdivo plus Yervoy was associated with improved efficacy versus Sutent (sunitinib) in the first-line treatment of intermediate- or poor-risk mRCC, according to the study; however, such trials do not often reflect real-world patient populations.
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.
Reference:
“Real-World Outcomes in Patients With Metastatic Renal Cell Carcinoma Treated With First-Line Nivolumab Plus Ipilimumab in the United States,” by Dr. Gurjyot K. Doshi et al. JCO Clinical Cancer Infomatics.
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