Sökning: onr:"swepub:oai:DiVA.org:uu-499918" >
First experience wi...
First experience with (224)Radium-labeled microparticles (Radspherin (R)) after CRS-HIPEC for peritoneal metastasis in colorectal cancer (a phase 1 study)
-
- Larsen, Stein Gunnar (författare)
- Oslo Univ Hosp, Norwegian Radium Hosp, Dept Gastroenterol Surg, Sect Surg Oncol, Oslo, Norway.
-
- Graf, Wilhelm (författare)
- Uppsala universitet,Gastrointestinalkirurgi,Uppsala Acad Hosp, Uppsala, Sweden.
-
- Mariathasan, Anthony Burton (författare)
- Oslo Univ Hosp, Norwegian Radium Hosp, Dept Gastroenterol Surg, Sect Surg Oncol, Oslo, Norway.
-
visa fler...
-
- Sørensen, Olaf (författare)
- Oslo Univ Hosp, Norwegian Radium Hosp, Dept Gastroenterol Surg, Sect Surg Oncol, Oslo, Norway.
-
- Spasojevic, Milan (författare)
- Oslo Univ Hosp, Norwegian Radium Hosp, Dept Gastroenterol Surg, Sect Surg Oncol, Oslo, Norway.
-
- Goscinski, Mariusz Adam (författare)
- Oslo Univ Hosp, Norwegian Radium Hosp, Dept Gastroenterol Surg, Sect Surg Oncol, Oslo, Norway.
-
- Selboe, Silje (författare)
- Oslo Univ Hosp, Div Radiol & Nucl Med, Oslo, Norway.
-
- Lundström, Nadja (författare)
- Uppsala Acad Hosp, Uppsala, Sweden.;Dept Nucl Med, Uppsala, Sweden.
-
- Holtermann, Anne (författare)
- Oslo Univ Hosp, Norwegian Radium Hosp, Dept Gastroenterol Surg, Sect Surg Oncol, Oslo, Norway.
-
- Revheim, Mona-Elisabeth (författare)
- Oslo Univ Hosp, Div Radiol & Nucl Med, Oslo, Norway.;Univ Oslo, Inst Clin Med, Fac Med, Oslo, Norway.
-
- Bruland, Øyvind Sverre (författare)
- Univ Oslo, Inst Clin Med, Fac Med, Oslo, Norway.;Oslo Univ Hosp, Dept Oncol, Oslo, Norway.;Oncoinvent AS, Oslo, Norway.
-
visa färre...
-
Oslo Univ Hosp, Norwegian Radium Hosp, Dept Gastroenterol Surg, Sect Surg Oncol, Oslo, Norway Gastrointestinalkirurgi (creator_code:org_t)
- 2023-03-01
- 2023
- Engelska.
-
Ingår i: Frontiers in Medicine. - : Frontiers Media S.A.. - 2296-858X. ; 10
- Relaterad länk:
-
https://doi.org/10.3...
-
visa fler...
-
https://uu.diva-port... (primary) (Raw object)
-
https://urn.kb.se/re...
-
https://doi.org/10.3...
-
visa färre...
Abstract
Ämnesord
Stäng
- Background: Peritoneal metastasis (PM) from colorectal cancer carries a dismal prognosis despite extensive cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). With a median time to recurrence of 11-12 months, there is a need for novel therapies. Radspherin (R) consists of the alpha-emitting radionuclide radium-224 (Ra-224), which has a half-life of 3.6 days and is adsorbed to a suspension of biodegradable calcium carbonate microparticles that are designed to give short-range radiation to the serosal peritoneal surface linings, killing free-floating and/or tumor cell clusters that remain after CRS-HIPEC.Methods: A first-in-human phase 1 study (EudraCT 2018-002803-33) was conducted at two specialized CRS-HIPEC centers. Radspherin (R) was administered intraperitoneally 2 days after CRS-HIPEC. Dose escalation at increasing activity dose levels of 1-2-4-7-MBq, a split-dose repeated injection, and expansion cohorts were used to evaluate the safety and tolerability of Radspherin (R). The aim was to explore the recommended dose and biodistribution using gamma-camera imaging. The results from the planned safety interim analysis after the completion of the dose-limiting toxicity (DLT) period of 30 days are presented.Results: Twenty-three patients were enrolled: 14 in the dose escalation cohort, three in the repeated cohort, and six in the expansion cohort. Of the 23 enrolled patients, seven were men and 16 were women with a median age of 64 years (28-78). Twelve patients had synchronous PM stage IV and 11 patients had metachronous PM [primary stage II; (6) and stage III; (5)], with a disease-free interval of 15 months (3-30). The peritoneal cancer index was median 7 (3-19), operation time was 395 min (194-515), and hospital stay was 12 days (7-37). A total of 68 grade 2 adverse events were reported for 17 patients during the first 30 days; most were considered related to CRS and/or HIPEC. Only six of the TEAEs were evaluated as related to Radspherin (R). One TEAE, anastomotic leakage, was reported as grade 3. Accordion >= 3 grade events occurred in a total of four of the 23 patients: reoperation due to anastomotic leaks (two) and drained abscesses (two). No DLT was documented at the 7 MBq dose level that was then defined as the recommended dose. The biodistribution of Radspherin (R) showed a relatively even peritoneal distribution.Conclusion: All dose levels of Radspherin (R) were well tolerated, and DLT was not reached. No deaths occurred, and no serious adverse events were considered related to Radspherin (R).
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
Nyckelord
- metastatic colorectal cancer
- peritoneal metastasis
- cytoreductive surgery
- hyperthermic intraperitoneal chemotherapy
- Ra-224
- alpha emitter
- targeted alpha particle therapy
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
-
Larsen, Stein Gu ...
-
Graf, Wilhelm
-
Mariathasan, Ant ...
-
Sørensen, Olaf
-
Spasojevic, Mila ...
-
Goscinski, Mariu ...
-
visa fler...
-
Selboe, Silje
-
Lundström, Nadja
-
Holtermann, Anne
-
Revheim, Mona-El ...
-
Bruland, Øyvind ...
-
visa färre...
- Om ämnet
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Kirurgi
- Artiklar i publikationen
-
Frontiers in Med ...
- Av lärosätet
-
Uppsala universitet