Objective: 177 Lu-DOTA-EB-TATE is a theranostic agent based on octreotate that uses an Evans blue structure to bind albumin to improve the pharmacokinetics and pharmacodynamics.This pilot study aims to evaluate the efficacy of a single low-dose treatment using 177 Lu-DOTA-EB-TATE in patients with advanced neuroendocrine neoplasm (NEN).Methods: With IRB approval and informed consent, 4 NEN patients were enrolled to undergo 177 Lu-DOTA-EB-TATE treatment with a single low dose of 0.66 ± 0.06 GBq (17.8 ± 1.7 mCi); 3 other NEN patients were enrolled as controls to undergo 177 Lu-DOTA-TATE treatment with administered activity of 3.98 ± 0.17 GBq (107.6 ± 4.6 mCi).One primary tumor and 62 metastatic lesions in the 7 patients were evaluated by 68 Ga-DOTA-TATE PET/CT immediately before and one or three months after the treatment.Maximum SUV (SUVmax) of the tumors ≥2.0 cm in diameter were measured and percentage of change (ΔSUV) after treatment were calculated.Results: All 4 patients subjected to 177 Lu-DOTA-EB-TATE treatment tolerated the administered activity without significant adverse effects and showed symptomatic remission.Among the patients, 40 tumors were found with diameter ≥2.0 cm, with the baseline SUVmax varied from 1.5-82.9(35.9 ± 21.0) and the ΔSUVs before and three months after the treatment from -75.1-26.3%(-38.9 ± 25.5%).Twenty-nine (72.5%) of the tumors showed >15% decrease of SUVmax (ΔSUV = -75.1%--17.1%).There was a significant negative correlation between the baseline SUVmax and the ΔSUV after treatment (r = -0.852,P < 0.001).Compared with the control 177 Lu-DOTA-TATE therapy, the 177 Lu-DOTA-EB-TATE treatment using approximately 1/6 the dose showed no significant difference in ΔSUV (-7.9 ± 5.4% vs. -5.8± 3.9%, P = 0.189) as demonstrated by the tumors with comparable baseline SUVmax from 10.0-35.0.Conclusion: A single low-dose 177 Lu-DOTA-EB-TATE treatment appears to be safe and effective in the treatment of NENs with high 68 Ga-DOTA-TATE uptake.This pilot study merits further investigation with increased dose and frequency of 177 Lu-DOTA-EB-TATE administration with potential advantages over 177 Lu-DOTA-TATE.
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Wang et al. (2018) studied this question.