ECE2023 Poster Presentations Pituitary and Neuroendocrinology (123 abstracts)
DUONEN multicenter study - personalized PRRT treatment with 177Lu- or 177Lu/90Y-DOTA-TATE in patients with neuroendocrine tumors based on individual dosimetry
Marta Opalinska 1 , Grzegorz Kamiński 2 , Marek Dedecjus 3 , Aldona Kowalska 4 , Maciej Kolodziej 2 , Marek Saracyn 2 , Piotr Garnuszek 5 , Wioletta Lenda-Tracz 6 , Anna Borkowska 6,7 , Danuta Gąsior-Perczak 4 , Anna Budzyńska 8 , Agata Kubik 8 , Krzysztof Kacperski 8 , Patrycja Szubstarska 8 , Wioletta Chalewska 3 , Joanna Długosińska 3 , Joanna Januszkiewicz-Caulier 3 , Alicja Hubalewska-Dydejczyk 1 & Renata Mikolajczak 5
1Jagiellonian University Medical College, Chair and Department of Endocrinology, Krakow, Poland; 2Military Institute of Medicine - National Research Institute, Department of Endocrinology and Isotope Therapy, Warsaw, Poland; 3National Institute of Oncology, Department of Endocrine Oncology and Nuclear Medicine, Warsaw, Poland; 4Collegium Medicum, Jan Kochanowski University in Kielce, Kielce, Poland; 5Radioisotope Center POLATOM, National Centre for Nuclear Research, Otwock, Poland; 6University Hospital in Krakow, Endocrinology, Oncological Endocrinology and Nuclear Medicine Department, Krakow, Poland; 7Jagiellonian University Medical College, Department of Electroradiology, Cracow, Poland; 8Military Institute of Medicine - National Research Institute, Department of Nuclear Medicine, Warsaw, Poland
Introduction: The good expression of somatostatin receptors in neuroendocrine tumor tissue enables effective treatment with peptide receptor radionuclide therapy (PRRT). To date, there is no clear consensus on the optimal PRRT arrangement due to the possibility of the use of different radiopharmaceutical regimens. In theory, the simultaneous use of two radionuclides (90Y and 177Lu) with different energy and radiation ranges should be more effective than monotherapy. The main objectives of DUONEN (a phase III study, EUDRACT No: 2020-006068-99) are: -development of a personalized (dosimetry-based) PRRT algorithm for patients with disseminated NETs -evaluation of the safety and effectiveness of personalized therapy with mixture of [177Lu]Lu- and [90Y] Y-DOTATATE compared to the use of [177Lu]Lu-DOTATATE in standard doses (7400MBq)
Methods: 92 adult patients with advanced, unresectable well-differentiated (G1/G2) NETs, progressing on long-acting SSA are randomized into four arms: - A: treated with [177Lu]Lu -DOTATATE with constant radioactivity of 7400MBq per cycle - B: treated with a mixture of [177Lu]Lu-DOTATATE and [90Y]Y-DOTATATE, initially in a ratio of 3700:1850MBq/MBq, with constant [177Lu]Lu -DOTATATE dose in all cycles, [90Y]Y-DOTATATE dose is adjusted in each cycle based on bone marrow and kidney dosimetry to maintain the highest possible radiation dose in tumor tissue - C: treated with a mixture of [177Lu]Lu-DOTATATE and [90Y]Y-DOTATATE, initially in a ratio of 3700:1850 MBq/MBq, analogously to arm B, except that the dose of [90Y] Yu-DOTATATE is constant and the dose of [177Lu]Lu-DOTATATE will depend on the dosimetry results - D: treated with [177Lu] Lu -DOTATATE initially with a dose of 7400MBq and then with doses based on individual dosimetry results The treatment efficacy will be evaluated on morphological imaging (TK or MR) according to RECIST 1.1 criteria and compared between arms. The safety of individual PRRT schemes will be assessed by biochemical follow-up of the kidney and bone marrow.
Results: 11 patients have already started PRRT (arm A-3, B-4, C-1, D-3 cases). Total reported cycles given 25, including 14 fixed doses (firsts doses or arm A). In 8 of 11 cycles provided for adjustment, the dose of radiopharmaceutical estimated on the basis of personalized dosimetry was increased in 6 and decreased in 2 cases.
Conclusion: Personalized renal and bone marrow dosimetry influences PRRT doses in subsequent treatment cycles, which is likely to affect the results and safety of therapy. Acknowledgments The study is funded by the Medical Research Agency (Project number 2019/ABM/01/00077-00).
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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