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European Journal of Nuclear Medicine and Molecular Imaging

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29.05.2020 | Original Article

¹⁷⁷Lu-PRRT in advanced gastrointestinal neuroendocrine tumors: 10-year follow-up of the IRST phase II prospective study

verfasst von: Giovanni Paganelli, Maddalena Sansovini, Silvia Nicolini, Ilaria Grassi, Toni Ibrahim, Elena Amadori, Valentina Di Iorio, Manuela Monti, Emanuela Scarpi, Alberto Bongiovanni, Mattia Altini, Luca Urso, Corrado Cittanti, Federica Matteucci, Stefano Severi

Erschienen in: European Journal of Nuclear Medicine and Molecular Imaging | Ausgabe 1/2021

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Abstract

Purpose

In March 2014, we reported the activity and safety of ¹⁷⁷Lu-DOTA-octreotate peptide receptor radionuclide therapy (Lu-PRRT) at two different dosages (18.5 GBq and 27.5 GBq in 5 cycles) in patients with progressive metastatic gastrointestinal neuroendocrine tumors (GI-NETs). Disease control rate (DCR) and toxicity were addressed. Herein, we report the late toxicity, progression-free survival (PFS), and overall survival (OS) in the same cohort after a 10-year follow-up.

Methods

We conducted an open-label, disease-oriented prospective phase II trial. From March 2008 to June 2011, 43 patients received 3.7 GBq or 5.5 GBq of Lu-PRRT every 6 to 8 weeks, each cycle repeated 5 times. All patients showed ⁶⁸Gallium-DOTA-peptide PET/Octreoscan® positivity (score 3–4 Rotterdam scale) in known lesions. Tumor burden was estimated radiologically. Time-to-event data (PFS and OS) were described using Kaplan-Meier curves and compared with the log-rank test.

Results

Forty-three patients (28 males and 15 females) were evaluable and were monitored for a median period of 118 months (range 12.6–139.6). Median PFS in patients receiving 18.5 GBq was 59.8 months (95% confidence interval [95% CI] 14.3–79.6), identical to that of patients treated with 27.5 GBq (59.8 months, 95% CI 23.4–82.0). Median OS was 71.0 months (95% CI 46.1–107.3) in the group who received 18.5 GBq and 97.6 months (95% CI 64.3-not reached) in the group treated with 27.5 GBq (P = 0.22). Patients with progression limited to lymph nodes showed significantly longer median PFS and OS than those with hepatic lesions (P = 0.02 for PFS and P = 0.04 for OS). Age over 65 years at the time of PRRT was also significant for OS. Of note, no late hematological or renal toxicity was observed in either group.

Conclusions

The long-term follow-up of the IRST phase II study shows that Lu-PRRT is a safe and effective therapy for patients with advanced GI-NET, the most important prognostic factor being tumor burden, hepatic lesions, and age. We believe that Lu-PRRT should be offered to patients with early-stage disease.

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Titel: 177Lu-PRRT in advanced gastrointestinal neuroendocrine tumors: 10-year follow-up of the IRST phase II prospective study
verfasst von: Giovanni Paganelli
Maddalena Sansovini
Silvia Nicolini
Ilaria Grassi
Toni Ibrahim
Elena Amadori
Valentina Di Iorio
Manuela Monti
Emanuela Scarpi
Alberto Bongiovanni
Mattia Altini
Luca Urso
Corrado Cittanti
Federica Matteucci
Stefano Severi
Publikationsdatum: 29.05.2020
Verlag: Springer Berlin Heidelberg
Erschienen in: European Journal of Nuclear Medicine and Molecular Imaging / Ausgabe 1/2021
Print ISSN: 1619-7070
Elektronische ISSN: 1619-7089
DOI: https://doi.org/10.1007/s00259-020-04873-0

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¹⁷⁷Lu-PRRT in advanced gastrointestinal neuroendocrine tumors: 10-year follow-up of the IRST phase II prospective study

Abstract

Purpose

Methods

Results

Conclusions

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

Abstract

Purpose

Methods

Results

Conclusions

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