Phase 1 Radioimmunotherapy Study with Lutetium 177-labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients with Advanced Renal Cell Carcinoma

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Title:	Phase 1 Radioimmunotherapy Study with Lutetium 177-labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients with Advanced Renal Cell Carcinoma
Author(s):	Stillebroer, A.B. ; Boerman, O.C. ; Desar, I.M.E. ; Boers-Sonderen, M.J. ; Herpen, C.M.L. van ; Langenhuijsen, J.F. ; Smith-Jones, P.M.; Oosterwijk, E. ; Oyen, W.J.G. ; Mulders, P.F.A.
Publication year:	2013
Source:	European Urology, vol. 64, iss. 3, (2013), pp. 478-485
ISSN:	0302-2838
DOI:	https://doi.org/10.1016/j.eururo.2012.08.024
Publication type:	Article / Letter to editor
Please use this identifier to cite or link to this item : https://hdl.handle.net/2066/117417
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Subject:	NCMLS 2: Immune Regulation ONCOL 3: Translational research ONCOL 3: Translational research N4i 1: Pathogenesis and modulation of inflammation ONCOL 3: Translational research NCMLS 2: Immune Regulation ONCOL 3: Translational research NCMLS 3: Tissue engineering and pathology ONCOL 4: Quality of Care ONCOL 5: Aetiology, screening and detection ONCOL 5: Aetiology, screening and detection Tijdelijke code tbv inlezen publicaties Radboudumc - Alleen voor gebruik door Radboudumc
Organization:	Nuclear Medicine Medical Oncology Urology
Journal title:	European Urology
Volume:	vol. 64
Issue:	iss. 3
Page start:	p. 478
Page end:	p. 485
Abstract:	BACKGROUND: Patients with metastatic clear cell renal cell carcinoma (ccRCC) have a dismal prognosis. Therefore, new and less toxic treatments are needed. OBJECTIVE: We determined the maximum tolerated dose (MTD) and potential therapeutic efficacy of multiple infusions of lutetium 177 ((177)Lu)-girentuximab (cG250) on various dose levels in a phase 1 trial in patients with progressive metastasized ccRCC. DESIGN, SETTING, AND PARTICIPANTS: In this uncontrolled case series in 23 patients with progressive ccRCC metastases, cG250 accumulation was verified by diagnostic indium 111-cG250 imaging. Patients then received a high-activity dose of (177)Lu-cG250. INTERVENTION: Groups of three patients received (177)Lu-cG250, starting at a dose level of 1110 MBq/m(2)(177)Lu-cG250, with dose increments of 370 MBq/m(2) per group. In the absence of persistent toxicity, progressive disease, and accelerated blood clearance, patients were eligible for retreatment after 3 mo with 75% of the previous activity dose. Patients could receive a total of three treatment cycles. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Determination of the MTD was the primary and therapeutic efficacy was the secondary outcome measurement of the study. RESULTS AND LIMITATIONS: The MTD was 2405 MBq/m(2) because higher doses resulted in dose-limiting myelotoxicity. Some patients received second (13 of 23 [56%]) and third (4 of 23 [17%]) treatment cycles. Most patients (17 of 23 [74%]) demonstrated stable disease 3 mo after the first treatment, and one patient showed a partial response that lasted for 9 mo. Mean growth of target tumor lesions was reduced from 40.4% (95% confidence interval [CI], +/-17.0) during the last 3 mo before study entry to 5.5% (95% CI, +/-5.3; p<0.001) at 3 mo after the first treatment cycle. No major nonhematologic side effects were observed. CONCLUSIONS: (177)Lu-cG250 radioimmunotherapy in metastatic ccRCC patients is well tolerated at an activity dose level as high as 2405 MBq/m(2) (MTD). Radioimmunotherapy with (177)Lu-cG250 may stabilize previously progressive metastatic ccRCC.