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Theranostics 2018; 8(12):3308-3316. doi:10.7150/thno.25919 This issue Cite

Research Paper

Response to Single Low-dose ¹⁷⁷Lu-DOTA-EB-TATE Treatment in Patients with Advanced Neuroendocrine Neoplasm: A Prospective Pilot Study

Hao Wang^1,2, Yuejuan Cheng³, Jingjing Zhang^1,2, Jie Zang^1,2, Hui Li^1,2, Qingxing Liu^1,2, Jingnan Wang^1,2, Orit Jacobson⁵, Fang Li^1,2,4, Zhaohui Zhu^1,2,4✉, Xiaoyuan Chen^5✉

1. Department of Nuclear Medicine, Peking Union Medical College (PUMC) Hospital, Chinese Academy of Medical Science and PUMC, Beijing 100730, China.
2. Beijing Key Laboratory of Molecular Targeted Diagnosis and Therapy in Nuclear Medicine, Peking Union Medical College (PUMC) Hospital, Chinese Academy of Medical Science and PUMC, Beijing 100730, China.
3. Division of Medical Oncology, Peking Union Medical College (PUMC) Hospital, Chinese Academy of Medical Science and PUMC, Beijing 100730, China.
4. Key Laboratory of Endocrinology of National Health and Family Planning Commission, Peking Union Medical College (PUMC) Hospital, Chinese Academy of Medical Science and PUMC, Beijing 100730, China.
5. Laboratory of Molecular Imaging and Nanomedicine, National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health (NIH), Bethesda, MD 20892 USA.

✉ Corresponding authors: Zhaohui Zhu (13611093752com); Xiaoyuan Chen (shawn.chengov)

Abstract

Objective: ¹⁷⁷Lu-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 ¹⁷⁷Lu-DOTA-EB-TATE in patients with advanced neuroendocrine neoplasm (NEN).

Methods: With IRB approval and informed consent, 4 NEN patients were enrolled to undergo ¹⁷⁷Lu-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 ¹⁷⁷Lu-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 ⁶⁸Ga-DOTA-TATE PET/CT immediately before and one or three months after the treatment. Maximum SUV (SUV_max) 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 ¹⁷⁷Lu-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 SUV_max 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 SUV_max (ΔSUV = -75.1%--17.1%). There was a significant negative correlation between the baseline SUV_max and the ΔSUV after treatment (r = -0.852, P < 0.001). Compared with the control ¹⁷⁷Lu-DOTA-TATE therapy, the ¹⁷⁷Lu-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 SUV_max from 10.0-35.0.

Conclusion: A single low-dose ¹⁷⁷Lu-DOTA-EB-TATE treatment appears to be safe and effective in the treatment of NENs with high ⁶⁸Ga-DOTA-TATE uptake. This pilot study merits further investigation with increased dose and frequency of ¹⁷⁷Lu-DOTA-EB-TATE administration with potential advantages over ¹⁷⁷Lu-DOTA-TATE.

Keywords: ¹⁷⁷Lu-DOTA-EB-TATE, ⁶⁸Ga-DOTA-TATE, neuroendocrine neoplasm, treatment, PET/CT

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