6099 Background: New treatments are warranted due to limited systemic treatment options for SGC patients (pts). Gallium [68Ga]Ga prostate-specific membrane antigen (PSMA) PET imaging results in SGC pts have demonstrated PSMA expression of SGC and thus indicated that PSMA radionuclide therapy may be a useful option, especially in the case of adenoid cystic carcinoma (AdCC) and salivary duct carcinoma (SDC) subtypes. Therefore, this study (EudraCT number 2019-003857-27) evaluated the safety and efficacy of PSMA-targeted radionuclide therapy in AdCC and SDC pts. Methods: This was a single-center, single-arm, phase II pilot study. R/M AdCC (n = 10) and SDC (n = 5) pts with sufficient PSMA tracer uptake on [68Ga]Ga-PSMA PET imaging, i.e., ≥1 lesion ≥1.5cm with PSMA expression above mean liver level, were treated with 2-4 cycles of 7.4 GBq [177Lu]Lu-PSMA-I&T, with an interval of 6±1 weeks. Baseline imaging was repeated for evaluation 4 weeks after cycle 2; in case of progressive disease (PD) per RECIST 1.1 the treatment was discontinued; otherwise, pts received the full treatment (4 cycles). All pts received whole body post-therapeutic imaging after 1, 24, 48, 72 h and 7d after each cycle. The primary endpoint was safety. Secondary endpoints include the objective response rate, progression-free survival (PFS), and overall survival (OS). Results: Between 6-2020 and 2-2023, 15 AdCC pts and 10 SDC pts were screened for eligibility. Five AdCC pts and 8 SDC pts were screen failures due to insufficient PSMA expression in 11 pts (AdCC n = 4; SDC n = 7) or due to brain metastases in 2 pts (AdCC n = 1; SDC n = 1). Ten AdCC and 2 SDC pts received at least one cycle of 7.4 GBq [177Lu]Lu-PSMA-I&T. The most observed adverse events (grade 1-2) included: nausea (75%), dry mouth (75%), fatigue (67%), and anemia (58%). Two pts (17%) developed grade 3 toxicity; lymphocytopenia (n = 1) and hyponatremia (n = 1). No grade 4-5 toxicities were observed. Two pts (AdCC n = 1; SDC n = 1) received only 1 treatment cycle due to early PD. The interim-treatment evaluation resulted in the discontinuation of treatment after 2 cycles in an additional 3 AdCC and the second SDC pts due to PD. Six AdCC pts received the full treatment (4 cycles); no responses were observed; 3 pts (75%) showed stable disease of more than 3 months after treatment completion (5, 15 and 21 months); 3 pts showed PD at 3 months after treatment completion. Median PFS in 10 AdCC pts was 6.7 months (95%CI: 0.0-15.1); OS was not reached after a median follow-up of 11.9 months. Conclusions: [177Lu]Lu-PSMA-I&T treatment in SGC pts is well-tolerated. The efficacy in AdCC was limited; only stable disease was achieved in 3 out of 10 pts. In most screened SDC pts, PSMA expression was insufficient to undergo [177Lu]Lu-PSMA-I&T treatment; the 2 SDC pts included showed early PD. Dosimetry analyses will be performed to calculate the delivered radiation doses to organs at risk as well as tumor lesions. Clinical trial information: EUCTR2019-003857-27.
Introduction: Prognosis of patients with brain metastasis (BM) from renal cell carcinoma (RCC) is relevant for treatment decisions and can be estimated with the Renal Graded Prognostic Assessment (GPA). The aim of this study is to validate the updated version of this instrument in a cohort treated with Gamma Knife radiosurgery (GKRS) without prior local intracerebral therapy. Methods: Between 2007 and 2018, 100 RCC patients with BM were treated with GKRS. They were categorized according to the updated Renal GPA. Overall survival (OS), intracranial disease progression and intracranial local failure were estimated using the Kaplan-Meier method and risk factors were identi ed with Cox proportional hazard regressions.Results: Median OS was 10.4 months. Median OS for GPA categories 0.0-1.0 (10%), 1.5-2.0 (13%), 2.5-3.0 (37%) and 3.5-4.0 (31%) was 2.9, 5.5, 8.1 and 20.4 months, respectively. Karnofsky performance status <90, serum hemoglobin ≤12.5 g/dL, age >65 years and time from primary diagnosis to brain metastasis <1 year were signi cantly related with shorter survival, while presence of extracranial disease, the volume and total number of BM had no impact on OS. A total count of >4 BM was the only predictive factor for intracranial disease progression, while none of the investigated factors predicted intracranial local failure.Conclusions: This study con rms the updated Renal GPA in an independent cohort as a valuable instrument to estimate survival in patients with BM from RCC treated with GKRS.
Temporal arteritis is usually caused by giant cell arteritis (GCA). However, inflammation of the temporal artery can also occur secondary to autoimmune diseases or infections.We present a remarkable case of a man in his 70s with biopsy proven temporal arteritis, who was later diagnosed with meningovascular neurosyphilis. The presentation of an acute onset monocular vision loss with inflammation of the temporal artery on biopsy appeared a GCA, misleading the physicians, as it turned out to be a manifestation of neurosyphilis.
Introduction: Prognosis of patients with brain metastasis (BM) from renal cell carcinoma (RCC) is relevant for treatment decisions and can be estimated with the Renal Graded Prognostic Assessment (GPA). The aim of this study is to validate the updated version of this instrument in a cohort treated with Gamma Knife radiosurgery (GKRS) without prior local intracerebral therapy. Methods: Between 2007 and 2018, 100 RCC patients with BM were treated with GKRS. They were categorized according to the updated Renal GPA. Overall survival (OS), intracranial disease progression and intracranial local failure were estimated using the Kaplan-Meier method and risk factors were identified with Cox proportional hazard regressions. Results: Median OS was 10.4 months. Median OS for GPA categories 0.0-1.0 (10%), 1.5-2.0 (13%), 2.5-3.0 (37%) and 3.5-4.0 (31%) was 2.9, 5.5, 8.1 and 20.4 months, respectively. Karnofsky performance status <90, serum hemoglobin ≤12.5 g/dL, age >65 years and time from primary diagnosis to brain metastasis <1 year were significantly related with shorter survival, while presence of extracranial disease, the volume and total number of BM had no impact on OS. A total count of >4 BM was the only predictive factor for intracranial disease progression, while none of the investigated factors predicted intracranial local failure. Conclusions: This study confirms the updated Renal GPA in an independent cohort as a valuable instrument to estimate survival in patients with BM from RCC treated with GKRS.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.