“Combination therapy with (Opdivo) plus (Yervoy) warrants further studies in the preoperative setting for patients with resectable hepatocellular carcinoma, which could transform the role of immunotherapy from palliative treatment in the metastatic setting to curative treatment in localized disease,” the study authors wrote.
Treatment with Opdivo (nivolumab) and Yervoy (ipilimumab) was safe before and after tumor resection in patients with resectable hepatocellular carcinoma, the most common type of liver cancer, according to data from a recent study.
“Preliminary activity results suggest that patients treated with neoadjuvant immune checkpoint therapy can achieve a major pathological response with longer recurrence-free survival,” Dr. Ahmed Omar Kaseb, a professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, and colleagues wrote in the study published in The Lancet Gastroenterology & Hepatology.
Patients with hepatocellular carcinoma have approximately a 70% increased risk for tumor recurrence within five years after undergoing surgical resection. At this time, no therapies have been approved by the Food and Drug Administration for neoadjuvant (treatment given before surgery to shrink the tumor) or adjuvant use (additional treatment given after surgery to potentially lower the risk for cancer recurrence).
In this phase 2 trial, researchers analyzed data from 27 patients (median age, 64 years, most patients were men) with resectable hepatocellular carcinoma who were assigned either Opdivo and Yervoy (14 patients) or Opdivo alone (13 patients). Both groups were given their assigned treatment before and after undergoing liver resection.
The main focus of this study was to assess the safety and tolerability of Opdivo with or without Yervoy, in addition to overall response (patients with a partial or complete response to treatment within a certain period of time), progression-free survival (the time that a patient lives with cancer without worsening) and time to progression (the length of time it takes cancer to worsen or spread to other parts of the body, which is often a measure that determines how well a treatment works).
No patients in either treatment group had to delay their surgery due to severe or worse side effects. Of the patients in this study, seven cancelled their surgeries, although none were associated with side effects from their assigned treatments.
“The predefined primary endpoint of safety and tolerability was met in both groups, which supports further studies to investigate the efficacy of these regimens,” Kaseb and colleagues wrote.
The estimated median progression-free survival was 19.53 months in patients treated with Opdivo-Yervoy and 9.4 months in patients treated with Opdivo alone. The median time to progression was also 19.53 months in the combination group versus 9.4 in the single-therapy group.
Researchers also performed an analysis to assess patient’s overall response to treatment. Findings from this demonstrated that 23% of patients had an overall response to Opdivo alone compared with no patients treated with Opdivo and Yervoy. A major pathological response to Opdivo monotherapy was observed in three out of nine patients (33%), which was defined as at least 70% necrosis in the resected tumor area. For patients assigned Opdivo plus Yervoy, a major pathological response occurred in three out of 11 patients (27%).
Severe or life-threatening side effects occurred more often in patients treated with Opdivo plus Yervoy compared with Opdivo alone (43% versus 23%). The most common side effect of any severity associated with Opdivo-Yervoy or Opdivo alone increased aspartate aminotransferase (50% versus 23% respectively) and increased alanine aminotransferase (50% versus 23%). Of note, increases in both of these levels may indicate liver damage.
“Combination therapy with (Opdivo) plus (Yervoy) warrants further studies in the preoperative setting for patients with resectable hepatocellular carcinoma, which could transform the role of immunotherapy from palliative treatment in the metastatic setting to curative treatment in localized disease,” the researchers wrote.
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