Peptide receptor radionuclide therapy with 177Lu-DOTATATE: The IEO phase I-II study

Lisa Bodei, Marta Cremonesi, Chiara M. Grana, Nicola Fazio, Simona Iodice, Silvia M. Baio, Mirco Bartolomei, Dario Lombardo, Mahila E. Ferrari, Maddalena Sansovini, Marco Chinol, Giovanni Paganelli

Research output: Contribution to journalArticlepeer-review


Purpose: Peptide receptor radionuclide therapy (PRRT) is used in tumours expressing type 2 somatostatin receptors (sst 2), mainly neuroendocrine. The aim of this prospective phase I-II study was to evaluate the toxicity and efficacy of 177Lu-DOTATATE in multiple cycles. Methods: Fifty-one consecutive patients with unresectable/metastatic sst 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 177Lu-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. Results: 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 177Lu-DOTATATE was well tolerated up to 29 GBq cumulative activity (up to 7.4 GBq/cycle). The maximum tolerated dose/cycle was not reached. However, considering the individual bone marrow function and the presence of risk factors for kidney toxicity, it seems safer to divide cumulative activities into lower activity cycles.

Original languageEnglish
Pages (from-to)2125-2135
Number of pages11
JournalEuropean Journal of Nuclear Medicine and Molecular Imaging
Issue number12
Publication statusPublished - Dec 2011


  • Neuroendocrine tumours
  • Peptide receptor radionuclide therapy
  • Phase I-II
  • PRRT

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging


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