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

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 patie...

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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
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Endocrinology
Kidneys
Peptides
Radiation therapy
Tumors
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container_title European journal of nuclear medicine and molecular imaging
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creator 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
description 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
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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 (&gt;20%) occurred in patients with risk factors for renal toxicity, particularly hypertension and diabetes. Cumulative bone marrow doses were &lt;1.5 Gy. Blood elements showed a progressive mild drop during cycles and recovered during follow-up (median 30 months). Thirty-nine patients were progressive at enrolment. Partial and complete responses occurred in 15 of 46 (32.6%) assessable patients. The median time to progression was 36 months. Overall survival was 68% at 36 months. Non-responders and patients with extensive tumour involvement had lower survival. ^sup 177^Lu-DOTATATE was well tolerated up to 29 GBq cumulative activity (up to 7.4 GBq/cycle). The maximum tolerated dose/cycle was not reached. 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subjects Endocrinology
Kidneys
Peptides
Radiation therapy
Tumors
title Peptide receptor radionuclide therapy with ^sup 177^Lu-DOTATATE: the IEO phase I-II study
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