Constantijn H J Muselaers1, Marye J Boers-Sonderen2, Tim J van Oostenbrugge3, Otto C Boerman4, Ingrid M E Desar2, Alexander B Stillebroer5, Sasja F Mulder2, Carla M L van Herpen2, Johan F Langenhuijsen5, Egbert Oosterwijk5, Wim J G Oyen4, Peter F A Mulders5. 1. Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands; Department of Radiology and Nuclear Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: stijn.muselaers@radboudumc.nl. 2. Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands. 3. Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands; Department of Radiology and Nuclear Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. 4. Department of Radiology and Nuclear Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. 5. Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands.
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).
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).
Authors: Karim Chamie; Nicholas M Donin; Pia Klöpfer; Paul Bevan; Barbara Fall; Olaf Wilhelm; Stephan Störkel; Jonathan Said; Michael Gambla; Robert E Hawkins; Gustavo Jankilevich; Anil Kapoor; Evgeny Kopyltsov; Michael Staehler; Kimmo Taari; Alberto J A Wainstein; Allan J Pantuck; Arie S Belldegrun Journal: JAMA Oncol Date: 2017-07-01 Impact factor: 31.777
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