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Medientyp:
E-Artikel
Titel:
First interim analysis of the SirTac trial: A randomized phase II study of SIRT and DSM-TACE in patients with liver metastases from uveal melanoma
Beteiligte:
Peuker, Caroline-Anna Anna;
De Bucourt, Maximilian;
Gebauer, Bernhard;
Amthauer, Holger;
Erxleben, Christoph;
Eucker, Jan;
Keller, Ulrich;
Leyvraz, Serge;
Joussen, Antonia M.;
Keilholz, Ulrich;
Ochsenreither, Sebastian
Erschienen:
American Society of Clinical Oncology (ASCO), 2022
Beschreibung:
<jats:p> 9511 </jats:p><jats:p> Background: The liver is the most common site of metastases in patients (pts) with uveal melanoma (UM). Here, we present results from the prespecified first interim analysis of the SirTac trial, a prospective, single-center, randomized, investigator-initiated, open-label phase 2 study of Selective Internal Radiation Therapy with Yttrium-90-bearing resin microspheres; SIR-Spheres (SIRT) vs Transarterial Chemoembolization with Cisplatin and degradable starch microspheres; EmboCept S (DSM-TACE) in pts with liver-dominant metastatic UM. Methods: Pts with histologically confirmed, liver-dominant metastatic UM and ECOG PS 0-2 were enrolled and randomized 1:1 to SIRT or DSM-TACE. Randomization was stratified by lactate dehydrogenase (<2x vs ≥2x upper limit of normal) and pre-treatment with antiangiogenic agents. Extrahepatic metastases were allowed, if asymptomatic. Primary endpoint was progression-free survival (PFS). A total of 108 pts (54 per arm) were planned to be enrolled. Pts received TACE every 4-6 weeks until tumor devascularization or disease progression or intolerable toxicity was observed, and SIRT either as one whole-liver application or in two sequential sessions for each liver lobe. The primary objective of this prespecified analysis was to assess response by RECIST criteria v1.1 in the per-protocol (PP) population of the first 40 pts (20 pts in each arm). Results: Two patients had been treated with previous liver surgery, whereas all other patients had not received previous treatment for metastatic disease. There were no clinicopathological differences between the groups, except for a difference in age (median age SIRT arm 64 y vs 75 y in the TACE arm, p=0.018). All but 1 pt received treatment as randomized. This pt was excluded and replaced by the next TACE pt for this PP interim analysis. There were no differences in best overall response rates between the groups (no complete response, 1 partial response in both arms, stable disease in 19 (95%) and 17 (85%) pts in the SIRT and TACE arm, respectively, and 2 pts with progressive disease in the TACE arm). At a median follow-up of 13.9 mo from treatment start, median PFS in the PP population was 4.9 mo in the SIRT arm vs 2.2 mo in the TACE arm (p=0.037), with a higher median liver-PFS in the SIRT vs TACE arm (8.3 vs 2.2, p=0.026). Conclusions: In this planned interim analysis treatment in both arms was feasible with no differences in response. The explorativePFS analysis allows no conclusions on the final outcome after completion of the trial. The study continues recruitment. Clinical trial information: NCT02936388. </jats:p>