دورية أكاديمية
Evaluation of the SSTR2-targeted Radiopharmaceutical 177Lu-DOTATATE and SSTR2-specific 68Ga-DOTATATE PET as Imaging Biomarker in Patients with Intracranial Meningioma.
| العنوان: | Evaluation of the SSTR2-targeted Radiopharmaceutical 177Lu-DOTATATE and SSTR2-specific 68Ga-DOTATATE PET as Imaging Biomarker in Patients with Intracranial Meningioma. |
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| المؤلفون: | Kurz SC; Department of Neurology & Interdisciplinary Neuro-Oncology, University Hospitals Tübingen, Hertie Institute for Clinical Brain Research, Eberhard Karls University Tübingen, Germany., Zan E; Department of Radiology, Weill Cornell Medicine, New York, New York., Cordova C; Cleveland Clinic Foundation Taussig Cancer Center, Cleveland, Ohio., Troxel AB; Department of Population Health, New York University Grossman School of Medicine, New York, New York., Barbaro M; Brain and Spine Tumor Center, Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York., Silverman JS; Brain and Spine Tumor Center, Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York.; Department of Radiation Oncology, New York University Grossman School of Medicine, New York, New York., Snuderl M; Brain and Spine Tumor Center, Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York.; Department of Pathology, New York University Grossman School of Medicine, New York, New York., Zagzag D; Brain and Spine Tumor Center, Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York.; Department of Pathology, New York University Grossman School of Medicine, New York, New York., Kondziolka D; Brain and Spine Tumor Center, Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York.; Department of Neurosurgery, New York University Grossman School of Medicine, New York, New York., Golfinos JG; Brain and Spine Tumor Center, Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York.; Department of Neurosurgery, New York University Grossman School of Medicine, New York, New York., Chi AS; Alterome Therapeutics, San Diego, California., Sulman EP; Brain and Spine Tumor Center, Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York.; Department of Radiation Oncology, New York University Grossman School of Medicine, New York, New York. |
| المصدر: | Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2024 Feb 16; Vol. 30 (4), pp. 680-686. |
| نوع المنشور: | Multicenter Study; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Denville, NJ : The Association, c1995- |
| مواضيع طبية MeSH: | Meningioma*/diagnostic imaging , Meningioma*/radiotherapy , Meningioma*/drug therapy , Organometallic Compounds*/adverse effects , Meningeal Neoplasms*/diagnostic imaging , Meningeal Neoplasms*/radiotherapy , Meningeal Neoplasms*/drug therapy , Neuroendocrine Tumors*/pathology , Receptors, Somatostatin*, Octreotide/*analogs & derivatives, Adult ; Humans ; Male ; Female ; Middle Aged ; Aged ; Radiopharmaceuticals ; Positron-Emission Tomography/methods ; Biomarkers ; Positron Emission Tomography Computed Tomography |
| مستخلص: | Purpose: There are no effective medical therapies for patients with meningioma who progress beyond surgical and radiotherapeutic interventions. Somatostatin receptor type 2 (SSTR2) represents a promising treatment target in meningiomas. In this multicenter, single-arm phase II clinical study (NCT03971461), the SSTR2-targeting radiopharmaceutical 177Lu-DOTATATE is evaluated for its feasibility, safety, and therapeutic efficacy in these patients. Patients and Methods: Adult patients with progressive intracranial meningiomas received 177Lu-DOTATATE at a dose of 7.4 GBq (200 mCi) every eight weeks for four cycles. 68Ga-DOTATATE PET-MRI was performed before and six months after the start of the treatment. The primary endpoint was progression-free survival (PFS) at 6 months (PFS-6). Secondary endpoints were safety and tolerability, overall survival (OS) at 12 months (OS-12), median PFS, and median OS. Results: Fourteen patients (female = 11, male = 3) with progressive meningiomas (WHO 1 = 3, 2 = 10, 3 = 1) were enrolled. Median age was 63.1 (range 49.7-78) years. All patients previously underwent tumor resection and at least one course of radiation. Treatment with 177Lu-DOTATATE was well tolerated. Seven patients (50%) achieved PFS-6. Best radiographic response by modified Macdonald criteria was stable disease (SD) in all seven patients. A >25% reduction in 68Ga-DOTATATE uptake (PET) was observed in five meningiomas and two patients. In one lesion, this corresponded to >50% reduction in bidirectional tumor measurements (MRI). Conclusions: Treatment with 177Lu-DOTATATE was well tolerated. The predefined PFS-6 threshold was met in this interim analysis, thereby allowing this multicenter clinical trial to continue enrollment. 68Ga-DOTATATE PET may be a useful imaging biomarker to assess therapeutic outcome in patients with meningioma. (©2023 American Association for Cancer Research.) |
| معلومات مُعتمدة: | Novartis (Novartis AG); NIH/NCI P30CA016087 National Cancer Institute (NCI); S10OD01058 and S10OD018338 Office of Research Infrastructure Programs, National Institutes of Health (ORIP) |
| المشرفين على المادة: | AE221IM3BB (lutetium Lu 177 dotatate) 9L17Y0H71P (gallium Ga 68 dotatate) 0 (Radiopharmaceuticals) D73QL0OMU2 (somatostatin receptor 2) 0 (Organometallic Compounds) 0 (Biomarkers) RWM8CCW8GP (Octreotide) 0 (Receptors, Somatostatin) |
| تواريخ الأحداث: | Date Created: 20231204 Date Completed: 20240219 Latest Revision: 20240314 |
| رمز التحديث: | 20240315 |
| DOI: | 10.1158/1078-0432.CCR-23-2533 |
| PMID: | 38048045 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1557-3265 |
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| DOI: | 10.1158/1078-0432.CCR-23-2533 |