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European Journal of Nuclear Medicine and Molecular Imaging

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01.12.2011 | Original Article

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

verfasst von: 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

Erschienen in: European Journal of Nuclear Medicine and Molecular Imaging | Ausgabe 12/2011

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Abstract

Purpose

Peptide receptor radionuclide therapy (PRRT) is used in tumours expressing type 2 somatostatin receptors (sst₂), 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 sst₂-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 <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.

Conclusion

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.

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Titel: Peptide receptor radionuclide therapy with 177Lu-DOTATATE: the IEO phase I-II study
verfasst von: 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
Publikationsdatum: 01.12.2011
Verlag: Springer-Verlag
Erschienen in: European Journal of Nuclear Medicine and Molecular Imaging / Ausgabe 12/2011
Print ISSN: 1619-7070
Elektronische ISSN: 1619-7089
DOI: https://doi.org/10.1007/s00259-011-1902-1

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Springer Medizin

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

Abstract

Purpose

Methods

Results

Conclusion

Live-Webinar: Aktuelle Leitlinien bei Herz-Kreislauf-Erkrankungen

Springer Medizin

Abstract

Purpose

Methods

Results

Conclusion

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