A Prospective Phase II Trial of Radioembolization for Treatment of Uveal Melanoma Hepatic Metastasis

Autor: Misung Yi, Inna Chervoneva, David J. Eschelman, Takami Sato, P. Rani Anne, Carin F. Gonsalves, Robert D. Adamo, Marlana Orloff, Anthony N. Hage, Mizue Terai
Rok vydání: 2019
Předmět:
Zdroj: Radiology
ISSN: 1527-1315
0033-8419
Popis: BACKGROUND: Overall survival (OS) for patients with uveal melanoma (UM) hepatic metastases is extremely poor. Therefore, stabilization of hepatic metastases is essential to prolonging OS. PURPOSE: To assess the safety and effectiveness of radioembolization (RE) for treatment of UM hepatic metastases. MATERIALS AND METHODS: Enrollment for this prospective phase II trial began November 2011 and concluded January 2017. Treatment-naïve participants (group A) and participants who progressed after immunoembolization (group B) with hepatic tumor burden less than 50% underwent RE. Participants were followed for 1 month and every 3 months for acute and delayed toxicities, respectively. MRI, CT, and PET were performed every 3 months to evaluate for tumor response and extrahepatic disease. Participants were followed for at least 2 years or until death. Kaplan-Meier method and multivariable Cox proportional hazard models were used for data analysis. RESULTS: In group A, 24 participants (mean age ± standard deviation, 59 years ± 13; 13 men and 11 women) underwent unilobar (n = 7), fractionated whole-liver (n = 1), or sequential lobar (n = 16) RE. One participant was excluded from the trial. Complete response (n = 0), partial response (n = 9), or stable disease (n = 11) was achieved in 20 of 23 (87.0%; 95% confidence interval [CI]: 66.4%, 97.2%) participants. Median progression-free survival from liver metastasis was 8.1 months (95% CI: 6.4, 11.8; range, 3.3–33.7 months). Median OS was 18.5 months (95% CI: 11.3, 23.5; range, 6.5–73.7 months). In group B, 24 participants (mean age, 58 years ± 10; nine men and 15 women) underwent unilobar (n = 5) or sequential lobar (n = 19) RE. Complete response (n = 0), partial response (n = 8), or stable disease (n = 6) was achieved in 14 of 24 (58.3%; 95% CI: 36.3%, 77.9%) participants. Median progression-free survival from liver metastasis was 5.2 months (95% CI: 3.7, 9.8; range, 2.9–22.0 months). Median OS was 19.2 months (95% CI: 11.5, 24.0; range, 4.8–76.6 months). Grade 3 treatment-related toxicities included transient lymphopenia (group A, n = 1; group B, n = 1), pain (group A, n = 2) and nausea or vomiting (group A, n = 1). CONCLUSION: Radioembolization is a promising treatment for patients with uveal melanoma hepatic metastases. © RSNA, 2019 Online supplemental material is available for this article.
Databáze: OpenAIRE