Phase 2 Study of Lutetium 177-Labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients with Advanced Renal Cell Carcinoma.
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Embargo End Date
ICR Authors
Authors
Muselaers, CHJ
Boers-Sonderen, MJ
van Oostenbrugge, TJ
Boerman, OC
Desar, IME
Stillebroer, AB
Mulder, SF
van Herpen, CML
Langenhuijsen, JF
Oosterwijk, E
Oyen, WJG
Mulders, PFA
Boers-Sonderen, MJ
van Oostenbrugge, TJ
Boerman, OC
Desar, IME
Stillebroer, AB
Mulder, SF
van Herpen, CML
Langenhuijsen, JF
Oosterwijk, E
Oyen, WJG
Mulders, PFA
Document Type
Journal Article
Date
2016-05
Date Accepted
2015-11-27
Abstract
Unlabelled Despite advances in the treatment of metastatic clear cell renal cell carcinoma (ccRCC), there is still an unmet need in the treatment of this disease. A phase 2 radioimmunotherapy (RIT) trial with lutetium 177 ((177)Lu)-girentuximab was initiated to evaluate the efficacy of this approach. In this nonrandomized single-arm trial, patients with progressive metastatic ccRCC who met the inclusion criteria received 2405 MBq/m(2) of (177)Lu-girentuximab intravenously. In the absence of persistent toxicity and progressive disease, patients were eligible for retreatment after 3 mo with 75% of the previous activity dose. A total of 14 patients were included. After the first therapeutic infusion, eight patients (57%) had stable disease (SD) and one (7%) had a partial regression. The treatment was generally well tolerated but resulted in grade 3-4 myelotoxicity in most patients. After the second cycle, continued SD was observed in five of six patients, but none were eligible for retreatment due to prolonged thrombocytopenia. In conclusion, RIT with (177)Lu-girentuximab resulted in disease stabilization in 9 of 14 patients with progressive metastatic ccRCC, but myelotoxicity prevented retreatment in some patients.Patient summary We investigated the efficacy of lutetium 177-girentuximab radioimmunotherapy in patients with metastatic kidney cancer. The treatment resulted in disease stabilization in 9 of 14 patients. The main toxicity was prolonged low blood cell counts.Trial registration ClinicalTrials.gov identifier: NCT02002312 (https://clinicaltrials.gov/ct2/show/NCT02002312).
Citation
European urology, 2016, 69 (5), pp. 767 - 770
Source Title
Publisher
ISSN
0302-2838
eISSN
1873-7560
Collections
Research Team
Translational Molecular Imaging