Isolated hepatic perfusion effective for isolated uveal melanoma liver metastases
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Key takeaways:
- The regional treatment conferred a significantly higher overall response rate than best alternative care.
- Median PFS also favored the isolated hepatic perfusion group.
Isolated hepatic perfusion conferred superior overall response rates and longer PFS than best alternative care among previously untreated patients with isolated liver metastases from primary uveal melanoma according to study results.
The randomized phase 3 trial findings, published in Journal of Clinical Oncology, also showed isolated hepatic perfusion had a manageable toxicity profile.
Rationale and methodology
Isolated hepatic perfusion with melphalan is a regional treatment in which the liver is surgically isolated from the systemic circulation. This allows hepatic perfusion with high chemotherapy concentrations and minimal systemic exposure, according to study background.
“A previous retrospective analysis indicated that patients in Sweden who had undergone isolated hepatic perfusion had a 14-month prolonged OS. However, whether this was a treatment effect or selection bias was unclear,” Roger Olofsson Bagge, MD, PhD, professor in cancer surgery in the department of surgery at Sahlgrenska University Hospital in Sweden, told Healio. “We, therefore, decided to offer isolated hepatic perfusion on a national level within the phase 3 SCANDIUM trial, and we now have the first available data.”
Researchers sought to determine whether isolated hepatic perfusion could improve outcomes among 87 previously untreated patients with liver metastases from uveal melanoma.
They assigned patients to either a one-time treatment with isolated hepatic perfusion with melphalan (n = 43) or best alternative care (n = 44), including chemotherapy (49%), immune checkpoint inhibitors (39%) or locoregional treatment (9%).
OS at 24 months served as the primary endpoint.
Bagge and colleagues reported on secondary endpoints, which included outcomes of response according to RECIST version 1.1, PFS, hepatic PFS and safety.
Findings
Results of intention-to-treat analysis showed overall response rates of 40% with isolated hepatic perfusion vs. 4.5% with best alternative care (P < .0001).
Researchers reported median PFS of 7.4 months with isolated hepatic perfusion vs. 3.3 months with best alternative care (HR = 0.21; 95% CI, 0.12-0.36) and a median hepatic PFS of 9.1 months vs. 3.3 months (P < .0001).
Researchers observed 11 treatment-related serious adverse events in the isolated hepatic perfusion group vs. seven in the best alternative care group. One treatment-associated death occurred in the isolated hepatic perfusion group. A patient who had a liver artery dissection detected a week after the surgery died of multiorgan failure secondary to liver artery thrombosis causing liver necrosis and aspiration pneumonia, according to the study.
Implications
The findings suggest that isolated hepatic perfusion could offer patients a novel treatment resulting in a significant response and also prolonged PFS, Olofsson Bagge told Healio.
“If this also translates into a prolonged OS is still unclear, but this will be reported as a late-breaking abstract at ASCO 2023,” he said. “We have opened a new trial, SCANDIUM-II, where patients will receive isolated hepatic perfusion and novel immunotherapy. Future treatment for patients with uveal melanoma will very likely consist of different treatments in combination.”
For more information:
Roger Olofsson Bagge, MD, PhD, can be reached at roger.olofsson.bagge@gu.se.
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