Journal

European journal of nuclear medicine and molecular imaging
ISSN: 1619-7089
Titre abrégé: Eur J Nucl Med Mol Imaging
Pays: Germany
ID NLM: 101140988

Informations de publication

Date de publication:
01 2021
Historique:
received: 25 03 2020
accepted: 18 05 2020
pubmed: 31 5 2020
medline: 29 5 2021
entrez: 31 5 2020
Statut: ppublish

Résumé

In March 2014, we reported the activity and safety of 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 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. 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.

Identifiants

pubmed: 32472437
doi: 10.1007/s00259-020-04873-0
pii: 10.1007/s00259-020-04873-0
doi:

Substances chimiques

Radiopharmaceuticals 0
Octreotide RWM8CCW8GP

Types de publication

Clinical Trial, Phase II Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

152-160

Références

Pavel M, O’Toole D, Costa F, Capdevila J, Gross D, Kianmanesh R, et al. ENETS consensus guidelines update for the management of distant metastatic disease of intestinal, pancreatic, bronchial neuroendocrine neoplasms (NEN) and NEN of unknown primary site. Neuroendocrinology. 2016;103(2):172–85. https://doi.org/10.1159/000443167 .
doi: 10.1159/000443167 pubmed: 26731013 pmcid: 26731013
Niederle MB, Hackl M, Kaserer K, Niederle B. Gastroenteropancreatic neuroendocrine tumours: the current incidence and staging based on the WHO and European Neuroendocrine Tumour Society classification: an analysis based on prospectively collected parameters. Endocr Relat Cancer. 2010;17:909–18. https://doi.org/10.1677/ERC-10-0152 .
doi: 10.1677/ERC-10-0152 pubmed: 20702725
Lawrence B, Gustafsson BI, Chan A, Svejda B, Kidd M, Modlin IM. The epidemiology of gastroenteropancreatic neuroendocrine tumors. Endocrinol Metab Clin N Am. 2011;40:1–18, vii. https://doi.org/10.1016/j.ecl.2010.12.005 .
doi: 10.1016/j.ecl.2010.12.005
Yao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, et al. One hundred years after ‘carcinoid’: epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008;26:3063–72. https://doi.org/10.1200/JCO.2007.15.4377 .
doi: 10.1200/JCO.2007.15.4377 pubmed: 18565894
Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, et al. Trends in the incidence, prevalence, and survival outcomes in patients with neuroendocrine tumors in the United States. JAMA Oncol. 2017;3(10):1335–42. https://doi.org/10.1001/jamaoncol.2017.0589 .
doi: 10.1001/jamaoncol.2017.0589 pubmed: 28448665 pmcid: 5824320
Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, et al. NETTER-1 Trial Investigators. Phase 3 trial of
doi: 10.1056/NEJMoa1607427 pubmed: 28076709 pmcid: 5895095
Kwekkeboom DJ, de Herder WW, Kam BL, van Eijck CH, van Essen M, Kooij PP, et al. Treatment with radiolabeled somatostatin analog [
doi: 10.1200/JCO.2007.15.2553 pubmed: 18445841
Severi S, Grassi I, Nicolini S, Sansovini M, Bongiovanni A, Paganelli G. Peptide receptor radionuclide therapy in the management of gastrointestinal neuroendocrine tumors: efficacy profile, safety, and quality of life. Onco Targets Ther. 2017;10:551–7. https://doi.org/10.2147/OTT.S97584 .
doi: 10.2147/OTT.S97584 pubmed: 28203088 pmcid: 5293504
Paganelli G, Sansovini M, Ambrosetti A, Severi S, Monti M, Scarpi E, et al.
doi: 10.1007/s00259-014-2735-5 pubmed: 24615468
Bosman F, Carneiro F, editors. World Health Organization classification of tumours, pathology and genetics of tumours of the digestive system. Lyon: IARC Press; 2010.
Binderup T, Knigge U, Loft A, Federspiel B, Kjaer A. 18F-Fluorodeoxyglucose positron emission tomography predicts survival of patients with neuroendocrine tumors. Clin Cancer Res. 2010;16(3):978–85. https://doi.org/10.1158/1078-0432.CCR-09-1759 .
doi: 10.1158/1078-0432.CCR-09-1759 pubmed: 20103666
Severi S, Nanni O, Bodei L, Sansovini M, Ianniello A, Nicoletti S, et al. Role of 18FDG PET/CT in patients treated with
doi: 10.1007/s00259-013-2369-z pubmed: 23443937
Bahri H, Laurence L, Edeline J, Leghzali H, Devillers A, Raoul JL, et al. High prognostic value of 18F-FDG PET for metastatic gastroenteropancreatic neuroendocrine tumors: a long-term evaluation. J Nucl Med. 2014;55(11):1786–90. https://doi.org/10.2967/jnumed.114.144386 .
doi: 10.2967/jnumed.114.144386 pubmed: 25286923
Bodei L, Cremonesi M, Ferrari M, Pacifici M, Grana CM, Bartolomei M, et al. Long-term evaluation of renal toxicity after peptide receptor radionuclide therapy with 90 Y-DOTATOC and
doi: 10.1007/s00259-008-0778-1 pubmed: 18427807
Bodei L, Cremonesi M, Grana CM, Fazio N, Iodice S, Baio SM, et al. Peptide receptor radionuclide therapy with
doi: 10.1007/s00259-011-1902-1 pubmed: 21892623
Capdevila J, Hernando J, Perez-Hoyos S, Roman-Gonzalez A, Grande E. Meta-analysis of randomized clinical trials comparing active treatment with placebo in metastatic neuroendocrine tumors. Oncologist. 2019;24(12):e1315–20.
doi: 10.1634/theoncologist.2018-0675
Sansovini M, Severi S, Ianniello A, Nicolini S, Fantini L, Mezzenga E, et al. Long-term follow-up and role of FDG PET in advanced pancreatic neuroendocrine patients treated with
doi: 10.1007/s00259-016-3533-z pubmed: 27704193
Ngo H, Tortorella SM, Ververis K, Karagiannis TC. The Warburg effect: molecular aspects and therapeutic possibilities. Mol Biol Rep. 2015;42(4):825–34. https://doi.org/10.1007/s11033-014-3764-7 .
doi: 10.1007/s11033-014-3764-7 pubmed: 25253100
Claringbold PG, Brayshaw PA, Price RA, Turner JH. Phase II study of radiopeptide 177Lu-octreotate and capecitabine therapy of progressive disseminated neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 38(2):302–11. https://doi.org/10.1007/s00259-010-1631-x .
Veenendaal LM, Borel Rinkes IHM, Lips CJM, van Hillegersberg R. Liver metastases of neuroendocrine tumours; early reduction of tumour load to improve life expectancy. World J Surg Oncol. 2006;4:35. https://doi.org/10.1186/1477-7819-4-35 .
doi: 10.1186/1477-7819-4-35 pubmed: 16800893 pmcid: 1524962
Ezziddin S, Attassi M, Yong-Hing CJ, Ahmadzadehfar H, Willinek W, Grünwald F, et al. Predictors of long-term outcome in patients with well-differentiated gastroenteropancreatic neuroendocrine tumors after peptide receptor radionuclide therapy with
doi: 10.2967/jnumed.113.125336 pubmed: 24434296
Panzuto F, Merola E, Pavel ME, Rinke A, Kump P, Partelli S, et al. Stage IV gastro-entero-pancreatic neuroendocrine neoplasms: a risk score to predict clinical outcome. Oncologist. 2017;22(4):409–15. https://doi.org/10.1634/theoncologist.2016-0351 .
doi: 10.1634/theoncologist.2016-0351 pubmed: 28232598 pmcid: 5388376
Bertani E, Fazio N, Radice D, Zardini C, Spinoglio G, Chiappa A, et al. Assessing the role of primary tumour resection in patients with synchronous unresectable liver metastases from pancreatic neuroendocrine tumour of the body and tail. A propensity score survival evaluation. Eur J Surg Oncol. 2017;43(2):372–9. https://doi.org/10.1016/j.ejso.2016.09.011 .
doi: 10.1016/j.ejso.2016.09.011 pubmed: 27742480
Hicks RJ, Kwekkeboom DJ, Krenning E, Bodei L, Grozinsky-Glasberg S, Arnold R, et al. ENETS consensus guidelines for the standards of care in neuroendocrine neoplasia: peptidereceptor radionuclide therapy with radiolabeled somatostatin analogues. Neuroendocrinology. 2017;105(3):295–309. https://doi.org/10.1159/000475526 .
doi: 10.1159/000475526 pubmed: 28402980

Auteurs

Giovanni Paganelli (G)

Nuclear Medicine and Radiometabolic Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli 40, 47014, Meldola, Italy.

Maddalena Sansovini (M)

Nuclear Medicine and Radiometabolic Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli 40, 47014, Meldola, Italy. maddalena.sansovini@irst.emr.it.

Silvia Nicolini (S)

Nuclear Medicine and Radiometabolic Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli 40, 47014, Meldola, Italy.

Ilaria Grassi (I)

Nuclear Medicine and Radiometabolic Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli 40, 47014, Meldola, Italy.

Toni Ibrahim (T)

Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.

Elena Amadori (E)

Radiology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.

Valentina Di Iorio (V)

Oncology Pharmacy, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.

Manuela Monti (M)

Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.

Emanuela Scarpi (E)

Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.

Alberto Bongiovanni (A)

Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.

Mattia Altini (M)

Healthcare Administration, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.

Luca Urso (L)

Nuclear Medicine Unit, University of Ferrara, Ferrara, Italy.

Corrado Cittanti (C)

Nuclear Medicine Unit, University of Ferrara, Ferrara, Italy.

Federica Matteucci (F)

Nuclear Medicine and Radiometabolic Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli 40, 47014, Meldola, Italy.

Stefano Severi (S)

Nuclear Medicine and Radiometabolic Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli 40, 47014, Meldola, Italy.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH