Clinical results of radionuclide therapy of neuroendocrine tumours with 90Y-DOTATATE and tandem 90Y/177Lu-DOTATATE: which is a better therapy option?

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Abstract

Purpose

Peptide receptor radionuclide therapy (PRRT) using radiolabelled somatostatin analogues is a treatment option for patients with disseminated neuroendocrine tumours (NET). A combination treatment using the high-energy ⁹⁰Y beta emitter for larger lesions and the lower energy ¹⁷⁷Lu for smaller lesions has been postulated in the literature.The aim of the study was to evaluate combined ⁹⁰Y/ ¹⁷⁷Lu-DOTATATE therapy in comparison to ⁹⁰Y-DOTATATE alone.

Methods

Fifty patients with disseminated NET were included in the study prospectively and divided into two groups: group A ( n = 25) was treated with ⁹⁰Y-DOTATATE, whereas group B ( n = 25) received the 1:1 ⁹⁰Y/ ¹⁷⁷Lu-DOTATATE. The administered activity was based on 3.7 GBq/m ² body surface area in three to five cycles, with amino acid infusion for nephroprotection.

Results

The median overall survival time in group A was 26.2 months while in group B median survival was not reached. Overall survival was significantly higher in group B ( p = 0.027). Median event-free survival time in group A was 21.4 months and in group B 29.4 months ( p > 0.1). At the 12-month follow-up, comparison of group A vs group B showed stable disease (SD) in 13 vs 16 patients, disease regression (RD) in 5 vs 3 patients and disease progression (PD) in 3 vs 4 patients; 4 and 2 patients died, respectively. The 24-month follow-up results were SD in nine vs ten patients, RD in one patient vs none and PD in four patients in both groups; three and four patients died, respectively. Side effects were rare and mild.

Conclusion

The results indicate that therapy with tandem radioisotopes ( ⁹⁰Y/ ¹⁷⁷Lu-DOTATATE) provides longer overall survival than with a single radioisotope ( ⁹⁰Y-DOTATATE) and the safety of both methods is comparable.

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Most cited references 25

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Treatment with the radiolabeled somatostatin analog [177 Lu-DOTA 0,Tyr3]octreotate: toxicity, efficacy, and survival.

Dik Kwekkeboom, Wouter de Herder, Boen L r Kam … (2008)

Despite the fact that most gastroenteropancreatic neuroendocrine tumors (GEPNETs) are slow-growing, median overall survival (OS) in patients with liver metastases is 2 to 4 years. In metastatic disease, cytoreductive therapeutic options are limited. A relatively new therapy is peptide receptor radionuclide therapy with the radiolabeled somatostatin analog [(177)Lu-DOTA(0),Tyr(3)]octreotate. Here we report on the toxicity and efficacy of this treatment, performed in over 500 patients. Patients were treated up to a cumulative dose of 750 to 800 mCi (27.8-29.6 GBq), usually in four treatment cycles, with treatment intervals of 6 to 10 weeks. Toxicity analysis was done in 504 patients, and efficacy analysis in 310 patients. Any hematologic toxicity grade 3 or 4 occurred after 3.6% of administrations. Serious adverse events that were likely attributable to the treatment were myelodysplastic syndrome in three patients, and temporary, nonfatal, liver toxicity in two patients. Complete and partial tumor remissions occurred in 2% and 28% of 310 GEPNET patients, respectively. Minor tumor response (decrease in size > 25% and < 50%) occurred in 16%. Median time to progression was 40 months. Median OS from start of treatment was 46 months, median OS from diagnosis was 128 months. Compared with historical controls, there was a survival benefit of 40 to 72 months from diagnosis. Treatment with [(177)Lu-DOTA(0),Tyr(3)]octreotate has few adverse effects. Tumor response rates and progression-free survival compare favorably to the limited number of alternative treatment modalities. Compared with historical controls, there is a benefit in OS from time of diagnosis of several years.

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Nonparametric estimation of incomplete observations

EL Kaplan, P Meier, M. Meier-Cillien … (1958)

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Safe and effective inhibition of renal uptake of radiolabelled octreotide by a combination of lysine and arginine.

Roelf Valkema, Edgar Rolleman, E Krenning … (2002)

As scintigraphy with [(111)In-DTPA(0)]octreotide has become a standard technique in analysing somatostatin receptor-receptor positive lesions such as neuroendocrine tumours, a logical next step is peptide receptor radionuclide therapy (PRRT). Initial studies on PRRT were performed with high doses of [(111)In-DTPA(0)]octreotide, and recently other radionuclides coupled to other somatostatin analogues have been used for this purpose. However, the dose delivered to the kidney is a major dose-limiting factor. Amino acid solutions have previously been used to reduce renal uptake of radioactivity, but these solutions have some disadvantages, i.e. their hyperosmolarity and their propensity to cause vomiting and metabolic changes. In this study we tested various amino acid solutions in patients receiving [(111)In-DTPA(0)]octreotide PRRT in order to assess their safety and their capacity to inhibit the renal uptake of radioactivity. Patients served as their own non-infused control. Renal radioactivity at 24 h following the injection of [(111)In-DTPA(0)]octreotide was inhibited by (1) a commercially available amino acid solution (AA) (21%+/-14%, P<0.02), (2) by 25 g (17%+/-9%, P<0.04), 50 g (15%+/-13%, P<0.04) or 75 g of lysine (44%+/-11%, P<0.001) and (3) by a combination of 25 g of lysine plus 25 g of arginine (LysArg) (33%+/-23%, P<0.01). Fluid infusion alone (500, 1,000 or 2,000 ml of saline/glucose) did not change renal uptake of radioactivity. In patients studied with 75 g of lysine (Lys75) and LysArg, serum potassium levels rose significantly. Maximal potassium levels were within the toxic range (6.3, 6.7 and 6.8 mmol/l) in three out of six patients infused with Lys75, whereas with LysArg the highest concentration measured was 6.0 mmol/l. Electrocardiographic analysis did not reveal significant changes in any of the patients. Vomiting occurred in 50% of patients infused with AA, but in only 6% of patients receiving no amino acid infusion (controls) and 9% of patients receiving LysArg. We conclude that co-infusion of Lys75 or LysArg results in a significant inhibition of renal radioactivity in PRRT, allowing higher treatment doses and thus resulting in higher tumour radiation doses. Because Lys75 produced serious hyperkalaemia, it is not suitable for clinical use. LysArg, however, is effective in offering renal protection in PRRT and is safe.

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Author and article information

Contributors

: +48-22-5992270 , +48-22-5991170 , jolanta.kunikowska@wum.edu.pl

Journal

Journal ID (nlm-ta): Eur J Nucl Med Mol Imaging

Title: European Journal of Nuclear Medicine and Molecular Imaging

Publisher: Springer-Verlag (Berlin/Heidelberg )

ISSN (Print): 1619-7070

ISSN (Electronic): 1619-7089

Publication date (Electronic): 7 May 2011

Publication date PMC-release: 7 May 2011

Publication date (Print): October 2011

Volume: 38

Issue: 10

Pages: 1788-1797

Affiliations

[1 ]Nuclear Medicine Department, Medical University of Warsaw, ul. Banacha 1 a, 02-097 Warsaw, Poland

[2 ]Collegium Medicum Cracow, Cracow, Poland

[3 ]Institute of Atomic Energy POLATOM, Świerk-Otwock, Poland

Article

Publisher ID: 1833

DOI: 10.1007/s00259-011-1833-x

PMC ID: 3168754

PubMed ID: 21553086

SO-VID: f946c40b-8b06-455a-9131-7b11cf7a385f

History

Date received : 7 January 2011

Date accepted : 14 April 2011

Custom metadata

ScienceOpen disciplines: Radiology & Imaging

Keywords: peptide receptor radionuclide therapy,177lu-dotatate,somatostatin receptor,90y-dotatate,neuroendocrine tumours

Data availability:

ScienceOpen disciplines: Radiology & Imaging

Keywords: peptide receptor radionuclide therapy, 177lu-dotatate, somatostatin receptor, 90y-dotatate, neuroendocrine tumours