Peptide receptor radionuclide therapy with 177Lu-DOTATATE for patients with somatostatin receptor-expressing neuroendocrine tumors: The first US phase 2 experience

Ebrahim S. Delpassand, Amin Samarghandi, Sara Zamanian, Edward M. Wolin, Mohammadali Hamiditabar, Gregory D. Espenan, Jack L. Erion, Thomas M. O'Dorisio, Larry K. Kvols, Jaime Simon, Robert Wolfangel, Arthur Camp, Eric P. Krenning, Alireza Mojtahedi

Research output: Contribution to journalArticle

65 Citations (Scopus)

Abstract

OBJECTIVE: Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs is a novel method of treatment in patients with metastatic neuroendocrine tumors (NETs). For the first time in the United States, we present preliminary results of the treatment with Lutetium 177 ( 177Lu) DOTATATE in patients with progressive NETs. METHODS: Thirty-seven patients with grade 1 and grade 2 disseminated and progressive gastroenteropancreatic NET were enrolled in a nonrandomized, phase 2 clinical trial. Repeated cycles of 200 mCi (7.4 GBq; ±10%) were administered up to the cumulative dose of 800 mCi (29.6 GBq; ±10%). RESULTS: Among 32 evaluable patients, partial response and minimal response to treatment were seen in 28% and 3%, respectively, and stable disease was seen in 41% of patients. A total of 28% had progressive disease. A response to treatment was significantly associated with lower burden of disease in the liver. No significant acute or delayed hematologic or kidney toxicity was observed. An impressive improvement of performance status and quality of life were seen after 177Lu- DOTATATE therapy. CONCLUSIONS: Treatment with multiple cycles of 177Lu-DOTATATE peptide receptor radionuclide therapy is well tolerated. This treatment results in control of the disease in most patients, whereas systemic toxicities are limited and reversible. Quality of life is also improved.

Original languageEnglish (US)
Pages (from-to)518-525
Number of pages8
JournalPancreas
Volume43
Issue number4
DOIs
StatePublished - 2014
Externally publishedYes

Fingerprint

Somatostatin Receptors
Peptide Receptors
Neuroendocrine Tumors
Radioisotopes
Therapeutics
Lutetium
Quality of Life
(177lutetium-DOTA(O)Tyr3)octreotate
Somatostatin
Liver Diseases
Clinical Trials
Kidney

Keywords

  • Neuroendocrine tumors
  • Peptide receptor radionuclide therapy

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Hepatology
  • Endocrinology

Cite this

Peptide receptor radionuclide therapy with 177Lu-DOTATATE for patients with somatostatin receptor-expressing neuroendocrine tumors : The first US phase 2 experience. / Delpassand, Ebrahim S.; Samarghandi, Amin; Zamanian, Sara; Wolin, Edward M.; Hamiditabar, Mohammadali; Espenan, Gregory D.; Erion, Jack L.; O'Dorisio, Thomas M.; Kvols, Larry K.; Simon, Jaime; Wolfangel, Robert; Camp, Arthur; Krenning, Eric P.; Mojtahedi, Alireza.

In: Pancreas, Vol. 43, No. 4, 2014, p. 518-525.

Research output: Contribution to journalArticle

Delpassand, ES, Samarghandi, A, Zamanian, S, Wolin, EM, Hamiditabar, M, Espenan, GD, Erion, JL, O'Dorisio, TM, Kvols, LK, Simon, J, Wolfangel, R, Camp, A, Krenning, EP & Mojtahedi, A 2014, 'Peptide receptor radionuclide therapy with 177Lu-DOTATATE for patients with somatostatin receptor-expressing neuroendocrine tumors: The first US phase 2 experience', Pancreas, vol. 43, no. 4, pp. 518-525. https://doi.org/10.1097/MPA.0000000000000113
Delpassand, Ebrahim S. ; Samarghandi, Amin ; Zamanian, Sara ; Wolin, Edward M. ; Hamiditabar, Mohammadali ; Espenan, Gregory D. ; Erion, Jack L. ; O'Dorisio, Thomas M. ; Kvols, Larry K. ; Simon, Jaime ; Wolfangel, Robert ; Camp, Arthur ; Krenning, Eric P. ; Mojtahedi, Alireza. / Peptide receptor radionuclide therapy with 177Lu-DOTATATE for patients with somatostatin receptor-expressing neuroendocrine tumors : The first US phase 2 experience. In: Pancreas. 2014 ; Vol. 43, No. 4. pp. 518-525.
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abstract = "OBJECTIVE: Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs is a novel method of treatment in patients with metastatic neuroendocrine tumors (NETs). For the first time in the United States, we present preliminary results of the treatment with Lutetium 177 ( 177Lu) DOTATATE in patients with progressive NETs. METHODS: Thirty-seven patients with grade 1 and grade 2 disseminated and progressive gastroenteropancreatic NET were enrolled in a nonrandomized, phase 2 clinical trial. Repeated cycles of 200 mCi (7.4 GBq; ±10{\%}) were administered up to the cumulative dose of 800 mCi (29.6 GBq; ±10{\%}). RESULTS: Among 32 evaluable patients, partial response and minimal response to treatment were seen in 28{\%} and 3{\%}, respectively, and stable disease was seen in 41{\%} of patients. A total of 28{\%} had progressive disease. A response to treatment was significantly associated with lower burden of disease in the liver. No significant acute or delayed hematologic or kidney toxicity was observed. An impressive improvement of performance status and quality of life were seen after 177Lu- DOTATATE therapy. CONCLUSIONS: Treatment with multiple cycles of 177Lu-DOTATATE peptide receptor radionuclide therapy is well tolerated. This treatment results in control of the disease in most patients, whereas systemic toxicities are limited and reversible. Quality of life is also improved.",
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T2 - The first US phase 2 experience

AU - Delpassand, Ebrahim S.

AU - Samarghandi, Amin

AU - Zamanian, Sara

AU - Wolin, Edward M.

AU - Hamiditabar, Mohammadali

AU - Espenan, Gregory D.

AU - Erion, Jack L.

AU - O'Dorisio, Thomas M.

AU - Kvols, Larry K.

AU - Simon, Jaime

AU - Wolfangel, Robert

AU - Camp, Arthur

AU - Krenning, Eric P.

AU - Mojtahedi, Alireza

PY - 2014

Y1 - 2014

N2 - OBJECTIVE: Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs is a novel method of treatment in patients with metastatic neuroendocrine tumors (NETs). For the first time in the United States, we present preliminary results of the treatment with Lutetium 177 ( 177Lu) DOTATATE in patients with progressive NETs. METHODS: Thirty-seven patients with grade 1 and grade 2 disseminated and progressive gastroenteropancreatic NET were enrolled in a nonrandomized, phase 2 clinical trial. Repeated cycles of 200 mCi (7.4 GBq; ±10%) were administered up to the cumulative dose of 800 mCi (29.6 GBq; ±10%). RESULTS: Among 32 evaluable patients, partial response and minimal response to treatment were seen in 28% and 3%, respectively, and stable disease was seen in 41% of patients. A total of 28% had progressive disease. A response to treatment was significantly associated with lower burden of disease in the liver. No significant acute or delayed hematologic or kidney toxicity was observed. An impressive improvement of performance status and quality of life were seen after 177Lu- DOTATATE therapy. CONCLUSIONS: Treatment with multiple cycles of 177Lu-DOTATATE peptide receptor radionuclide therapy is well tolerated. This treatment results in control of the disease in most patients, whereas systemic toxicities are limited and reversible. Quality of life is also improved.

AB - OBJECTIVE: Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs is a novel method of treatment in patients with metastatic neuroendocrine tumors (NETs). For the first time in the United States, we present preliminary results of the treatment with Lutetium 177 ( 177Lu) DOTATATE in patients with progressive NETs. METHODS: Thirty-seven patients with grade 1 and grade 2 disseminated and progressive gastroenteropancreatic NET were enrolled in a nonrandomized, phase 2 clinical trial. Repeated cycles of 200 mCi (7.4 GBq; ±10%) were administered up to the cumulative dose of 800 mCi (29.6 GBq; ±10%). RESULTS: Among 32 evaluable patients, partial response and minimal response to treatment were seen in 28% and 3%, respectively, and stable disease was seen in 41% of patients. A total of 28% had progressive disease. A response to treatment was significantly associated with lower burden of disease in the liver. No significant acute or delayed hematologic or kidney toxicity was observed. An impressive improvement of performance status and quality of life were seen after 177Lu- DOTATATE therapy. CONCLUSIONS: Treatment with multiple cycles of 177Lu-DOTATATE peptide receptor radionuclide therapy is well tolerated. This treatment results in control of the disease in most patients, whereas systemic toxicities are limited and reversible. Quality of life is also improved.

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