Peptide receptor radionuclide therapy with ^sup 177^Lu-DOTATATE: the IEO phase I-II study

• Published in: European journal of nuclear medicine and molecular imaging 2011-12, Vol.38 (12), p.2125
• Main Authors: Bodei, Lisa, Cremonesi, Marta, Grana, Chiara M, Fazio, Nicola, Iodice, Simona, Baio, Silvia M, Bartolomei, Mirco, Lombardo, Dario, Ferrari, Mahila E, Sansovini, Maddalena, Chinol, Marco, Paganelli, Giovanni
• Format: Article
• Language: English
• Subjects: Endocrinology; Kidneys; Peptides; Radiation therapy; Tumors
• ISSN: 1619-7070; 1619-7089
• DOI: 10.1007/s00259-011-1902-1

Peptide receptor radionuclide therapy (PRRT) is used in tumours expressing type 2 somatostatin receptors (sst^sub 2^), mainly neuroendocrine. The aim of this prospective phase I-II study was to evaluate the toxicity and efficacy of ^sup 177^Lu-DOTATATE in multiple cycles. Fifty-one consecutive patients with unresectable/metastatic sst^sub 2^-positive tumours, divided into two groups, received escalating activities (3.7-5.18 GBq/cycle, group 1; 5.18-7.4 GBq/cycle, group 2) of ^sup 177^Lu-DOTATATE. Cumulative activities ranged from 3.7 to 29.2 GBq (median 26.4 GBq in median 6 cycles, group 1, 21 patients) and 5.55 to 28.9 GBq (median 25.2 GBq in 4 cycles, group 2, 30 patients), based on dosimetry. No major acute or delayed renal or haematological toxicity occurred (one grade 3 leukopenia and thrombocytopenia). Cumulative renal absorbed doses were 8-37 Gy (9-41 Gy bioeffective doses). A median decrease of creatinine clearance of 21.7% 6 months after PRRT, 23.9% after 1 year and 27.6% after 2 years was observed. Higher losses (>20%) occurred in patients with risk factors for renal toxicity, particularly hypertension and diabetes. Cumulative bone marrow doses were