Eighteen-Months Safety and Efficacy Following Intraperitoneal Treatment With 224 Radium-Labeled Microparticles After CRS-HIPEC in Patients With Peritoneal Metastasis From Colorectal Cancer.

Autor: Larsen SG; Department of Oncological Surgery, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway., Graf W; Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.; Department of Surgery, Uppsala Academic Hospital, Uppsala, Sweden., Larsen RH; Sciencons A/S, Oslo, Norway., Revheim ME; Faculty of Medicine, Institute for Clinical Medicine, University of Oslo, Oslo, Norway.; The Intervention Centre, Oslo University Hospital, Oslo, Norway., Mariathasan AM; Department of Oncological Surgery, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway., Sørensen O; Department of Oncological Surgery, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway., Spasojevic M; Department of Oncological Surgery, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway., Rashid G; Department of Radiology, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway., Lundstrøm N; Department of Nuclear Medicine, Uppsala Academic Hospital, Uppsala, Sweden., Gjertsen TJ; Oncoinvent ASA, Oslo, Norway., Aksnes AK; Oncoinvent ASA, Oslo, Norway., Bruland ØS; Faculty of Medicine, Institute for Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Oncology, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
Jazyk: angličtina
Zdroj: Journal of surgical oncology [J Surg Oncol] 2024 Oct 20. Date of Electronic Publication: 2024 Oct 20.
DOI: 10.1002/jso.27897
Abstrakt: Background and Objectives: Peritoneal metastasis from colorectal cancer carries a high risk for relapse after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). A novel alpha-emitting radiopharmaceutical (Radspherin) has been designed to deliver short-range radiation to micrometastases and free-floating tumor cells.
Methods: A Phase 1/2a study evaluated the safety, tolerability, and signal of efficacy of escalating doses of Radspherin injected intraperitoneally after CRS-HIPEC.
Results: Eleven patients received 1-4 MBq (Group 1) whereas 12 patients received 7 MBq; nine patients single dose/three patients split-dose (Group 2). Median age was 66.5 and 61.5 years, and median peritoneal cancer index 6 and 7, respectively. One hundred and seventy-eight adverse events were reported, only seven were deemed related to Radspherin. Thirteen serious adverse events (SAEs) were reported in eight patients and no SAEs were related to Radspherin. At 18-months, none of the 12 patients receiving 7 MBq experienced peritoneal recurrences, however four had non-peritoneal recurrences. Across both groups (n = 22), 41% had recurrent disease, only 14% of them in the peritoneum.
Conclusions: Radspherin was well tolerated. At 18 months, median disease-free survival has not been reached, and none of the patients receiving the recommended dose (7 MBq) had peritoneal recurrences. The results are encouraging and warrant further clinical evaluation.
(© 2024 The Author(s). Journal of Surgical Oncology published by Wiley Periodicals LLC.)
Databáze: MEDLINE
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