6083 Background: SGCHN are rare tumors including adenoid cystic carcinoma (ACC) and non-ACC, with no standard systemic treatment for R/M pts. We evaluated N monotherapy in R/M SGCHN pts. Methods: R/M SGCHN pts (ACC or non-ACC) not eligible to local treatment and with centrally confirmed RECIST 1.1 disease progression over the last 6 months were enrolled and received N 3 mg/kg IV, every 2 weeks for a maximum of 12 months (mo). Possibility was given to re-start N in case of progression during the 2-year follow-up phase. Primary endpoint was 6-mo non-progression Rate (NPR6m) as per RECIST 1.1. Secondary endpoints included ORR, PFS, OS, and safety. Considering that N would be uninteresting if NPR6m ≤ 20% and promising if ≥ 40% and using a Fleming’s single-stage design (α: 5% unilateral, power: 90%), at least 14 successes/42 evaluable pts were required for each cohort to be positive. Results: 46 ACC and 52 Non-ACC pts (median age 61 yrs (range 29-81), 43.9% female, 55.1% PS1 and 2.0% PS2) were enrolled and received at least one dose of N. Median treatment duration was 5.5 mo (ACC) and 3.3 (Non-ACC). Median FU was 10.8 mo (ACC) and 8.3 mo (Non-ACC). 95 patients were evaluable for the primary endpoint. NPR6m was 15/45 pts (33.3%, 90%CI :21.8;46.6) and 7/50 pts (14.0%, 90%CI:6.8;24.7) for ACC and non-ACC pts respectively. 4 (8.7%) partial responses (PR) and 26 (56.5%) stable diseases (SD) were observed in ACC cohort while 2 (3.8%) PR and 22 (42.3%) SD were observed in non-ACC. Median PFS was 4.9 mo (95%CI = 3.4;5.6) in ACC pts and 1.8 mo (95%CI = 1.7;3.5) in non-ACC pts. The most common related adverse events (AE) ( > 10% by cohort) were asthenia, hyperthyroidism, diarrhea, rash, pruritus and hypothyroidism. 7/98 pts (7.1%) presented at least one related AE Grade 3-4 (mainly hepatic) and 9 pts (9.2%) prematurely discontinued Nivolumab due to toxicity. Conclusions: Limited efficacy was observed with N in R/M SGCHN pts. N in combination might be of interest and deserves exploration in ACC pts. Clinical trial information: NCT03132038.
AIM:To assess prospectively parameters of computed tomography perfusion (CT p) for evaluation of vascularity of liver metastases from neuroendocrine tumors.
METHODS:This study was approved by the hospital's institutional review board. All 18 patients provided informed consent. There were 30 liver metastases from neuroendocrine tumors. Patients were divided into three groups depending on the appearance of the liver metastases at the arterial phase of morphological CT (hyperdense, hypodense and necrotic). Sequential acquisition of the liver was performed before and for 2 min after intravenous injection of 0.5 mg/kg contrast medium, at 4 mL/s. Data were analyzed using deconvolution analysis to calculate blood flow (BF), blood volume (BV), mean transit time (MTT), hepatic arterial perfusion index (HAPI) and a bi-compartmental analysis was performed to obtain vascular permeability-surface area product (PS). Post-treatment analysis was performed by a radiologist and regions of interest were plotted on the metastases, normal liver, aorta and portal vein.
RESULTS:At the arterial phase of the morphological CT scan, the aspects of liver metastases were hyperdense (n = 21), hypodense (n = 7), and necrotic (n = 2). In cases of necrotic metastases, none of the CT p parameters were changed. Compared to normal liver, a significant difference in all CT p parameters was found in cases of hyperdense metastases, and only for HAPI and MTT in cases of hypodense metastases. No significant difference was found for MTT and HAPI between hypoand hyperdense metastases. A significant decrease of PS, BV and BF was demonstrated in cases of patients with hypodense lesions PS (23 ± 11.6 mL/100 g per minute) compared to patients with hyperdense lesions; PS (13.5 ± 10.4 mL/100 g per minute), BF (93.7 ± 75.4 vs 196.0 ± 115.6 mL/100 g per minute) and BV (9.7 ± 5.9 vs 24.5 ± 10.9 mL/100 g).
CONCLUSION:CT p provides additional information compared to the morphological appearance of liver metastases.
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