CTNI-53. SINGLE ARM, OPEN-LABEL, MULTICENTER PHASE II STUDY OF THE RADIONUCLIDE 177LU-DOTATATE (LUTATHERA) IN ADULTS WITH ADVANCED INTRACRANIAL MENINGIOMA. (9th November 2020)

• Record Type: Journal Article
• Authors: Kurz, Sylvia; Zan, Elcin; Gurewitz, Jasone; Cordova, Christine; Troxel, Andrea B; Sawaged, Zacharia; Sevillano-Torres, Hector; Silverman, Joshua S; Snuderl, Matija; Zagzag, David; Golfinos, John; Kondziolka, Douglas; Sulman, Erik
• Is Part Of: Neuro-oncology. Volume 22(2020)Supplement 2
• Page Start: ii54
• Page End: ii55
• Publication Date: 2020-11-09
• Subjects: Brain Neoplasms -- Periodicals; Brain -- Tumors -- Periodicals; Brain -- Cancer -- Periodicals; Nervous system -- Cancer -- Periodicals; 616.99481
• DOI: 10.1093/neuonc/noaa215.219
• Languages: English
• ISSNs: 1522-8517

Abstract

Abstract: BACKGROUND: Meningiomas are the most common primary intracranial neoplasm. Once surgical and radiotherapeutic options are exhausted, there are no effective medical treatments available. A majority of meningiomas express somatostatin receptor 2 (SSTR2), representing a promising treatment target. 177 Lu-DOTATATE is a SSTR2-targeting radionuclide that has been successful in SSTR2-expressing neuroendocrine tumors. Here we hypothesize that 177 Lu-DOTATATE is effective in treating progressive intracranial meningiomas. METHODS: In this ongoing phase II study (NCT03971461), adults with advanced intracranial meningiomas received 177 Lu-DOTATATE 7.4 GBq (200 mCi) every 8 weeks for 4 doses. 68 Ga-DOTATATE PET-MRI was obtained before and at the end of treatment (EOT). The primary endpoint was progression-free survival at 6 months (PFS-6). Correlative studies evaluated the association of PFS-6, objective response rate, progression-free survival, overall survival with radiographic tumor measurements, 68 Ga-DOTATATE uptake on PET-MRI, SSTR2 expression in tumor, and meningioma methylation subclass. RESULTS: Nine patients (F = 7, M = 2) with progressive meningiomas (WHO I = 2, II = 6, III = 1) have been enrolled. Median age was 63 (range 49–78) years. All patients previously underwent tumor resection and at least one course of radiation. Treatment with 177 Lu-DOTATATE was well tolerated, although CTCAE grade 3/4 electrolyte derangements and cytopenias were observed. Six patients reached PFS-6, three patients experienced progressive disease. Four patients had EOT 68 Ga-DOTATATE PET-MRI evaluations in which anatomic measurements and 68 Ga-DOTATATE standardized uptake values (SUV) pre- and post-treatment were assessed: one patient had reduced SUV measurements in all target lesions indicating altered SSTR2 expression and functional treatment response, one patient had stable disease, one patient had a mixed treatment response, and one patient experienced progressive disease. CONCLUSIONS: SSTR2-targeting 177 Lu-DOTATATE represents a promising treatment option for patients with progressive intracranial meningiomas. Treatment is well tolerated and can lead to functional alteration of tumoral SSTR2 expression by 68 Ga-DOTATATE PET-MR imaging.