In hepatocellular carcinoma, also known as liver cancer, patients were found to respond to presurgical treatment with immune checkpoint inhibitors (ICIs), and the extent of tumor regression may be indicative of who will see improved relapse-free survival following liver resection.
“In the largest pooled prospective analysis to date, we were able to show at a patient level that pathological response to neoadjuvant ICI in hepatocellular carcinoma is a robust predictor of improved relapse-free survival, underscoring its potential as a clinical endpoint for future, randomized, phase 3 trials,” researchers concluded in their findings published in The Lancet Oncology.
Researchers pooled data from five phase 1 and 2 clinical trials and standardized observational protocols conducted in a dozen centers across the United States, the United Kingdom and Taiwan. A total of 111 adult patients with hepatocellular carcinoma were enrolled onto the study as of a data cutoff of January 31, 2024, with data available for 104 patients.
Among observed patents, 76, (69%) received combinations of immune checkpoint inhibitors for a median of 1.4 months. Major pathological response was observed among 33 patients (32%), with pathological complete response being reported in 19 patients (18%).
Researchers reported an association between radiological overall response and major pathological response, as 23 of 31, or 74%, of the patents who had radiological response showed a major pathological response, versus 10, or 14%, of the 73 patients who did not experience a radiological response. Of note however was the fact that 30%, or 10 of 33, major pathological responses were not predicted by radiological response, researchers reported.
Glossary
Immune checkpoint inhibitors: According to the American Cancer Society, these treatments help the body’s immune system better find and attack cancer cells.
Major pathological response: Researchers in this study defined pathological response as the percentage of non-viable tumor in the resected surgical specimen, and major pathological response as at least 70% tumor regression.
Relapse-free survival: The time after treatment that a patient lives without signs and symptoms of disease.
Liver resection: Surgical removal of all or part of the liver.
Pathological complete response: The lack of all signs of cancer in tissue samples removed during surgery or biopsy after treatment, according to the American Cancer Society.
Radiological overall response: Patients whose disease partially or completely responded to treatment.
Unresectable: Cannot be removed by surgery.
Metastatic: Cancer that has spread from where it originally started.
In addition, those patients who had a major pathological response did not reach a median relapse-free survival, meaning not enough patients had relapsed to calculate that figure, while patients who did not have a major pathological response had a median relapse-free survival of 28.3 months. The median relapse-free survival among all patients in the study was 43.6 months after a median follow-up of 27.2 months. Additionally, median relapse-free survival was not evaluable among patients with a complete pathological response and 32.8 months among those who did not have a complete pathological response.
Immune checkpoint inhibitors, researchers noted, are currently the standard of care among patients with unresectable or metastatic hepatocellular carcinoma, and Tecentriq (atezolizumab) plus Avastin (bevacizumab) and Imfinzi (durvalumab) plus Imjudo (tremelimumab) having both been approved in recent years for first-line use. While resection may be a curative option among patients with early-stage hepatocellular carcinoma liver, relapse rates are as high as 70% in the first five years after surgery, according to the study.
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Reference: “Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis” by Dr. Antonio D'Alessio, et al., The Lancet Oncology.
