Ebrahim S Delpassand1, 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. 1. From the *Excel Diagnostics and Nuclear Oncology Center, Houston, TX; †RadioMedix, Inc, Houston, TX; ‡Samuel Oschin Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA; §Physics Services Inc, Metairie, LA; ∥BioSynthema Inc, St Louis, MO; ¶Department of Internal Medicine, Holden Comprehensive Cancer Center, University of Iowa Health Care, Iowa City, IA; #Department of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center, Tampa, FL; **IsoTherapeutics Group, Angleton, TX; ††Certus International, Inc, St Louis, MO; ‡‡Iso-Tex Diagnostics, Inc, Friendswood, TX; and §§Department of Nuclear Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
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)(Lu) 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 Lu-DOTATATE therapy. CONCLUSIONS: Treatment with multiple cycles of (177)Lu-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.
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)(Lu) 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 Lu-DOTATATE therapy. CONCLUSIONS: Treatment with multiple cycles of (177)Lu-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.
Authors: Mohammadali Hamiditabar; Muzammil Ali; Joseph Roys; Edward M Wolin; Thomas M OʼDorisio; David Ranganathan; Izabela Tworowska; Jonathan R Strosberg; Ebrahim S Delpassand Journal: Clin Nucl Med Date: 2017-06 Impact factor: 7.794
Authors: Jonathan Strosberg; Ghassan El-Haddad; Edward Wolin; Andrew Hendifar; James Yao; Beth Chasen; Erik Mittra; Pamela L Kunz; Matthew H Kulke; Heather Jacene; David Bushnell; Thomas M O'Dorisio; Richard P Baum; Harshad R Kulkarni; Martyn Caplin; Rachida Lebtahi; Timothy Hobday; Ebrahim Delpassand; Eric Van Cutsem; Al Benson; Rajaventhan Srirajaskanthan; Marianne Pavel; Jaime Mora; Jordan Berlin; Enrique Grande; Nicholas Reed; Ettore Seregni; Kjell Öberg; Maribel Lopera Sierra; Paola Santoro; Thomas Thevenet; Jack L Erion; Philippe Ruszniewski; Dik Kwekkeboom; Eric Krenning Journal: N Engl J Med Date: 2017-01-12 Impact factor: 91.245
Authors: Giuseppe Lo Russo; Sara Pusceddu; Natalie Prinzi; Martina Imbimbo; Claudia Proto; Diego Signorelli; Milena Vitali; Monica Ganzinelli; Marco Maccauro; Roberto Buzzoni; Ettore Seregni; Filippo de Braud; Marina Chiara Garassino Journal: Tumour Biol Date: 2016-07-27