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- Title
Final results of a phase 2A study for the treatment of metastatic neuroendocrine tumors with a fixed activity of <sup>90</sup>Y-DOTA-D-Phe1-Tyr3 octreotide.
- Authors
Savelli, Giordano; Bertagna, Francesco; Franco, Fabio; Dognini, Ludovica; Bosio, Giovanni; Migliorati, Elena; Rodella, Carlo; Biasiotto, Giorgio; Bettinsoli, Giovanni; Minari, Chiara; Zaniboni, Alberto; Ferrari, Chiara; Tomassetti, Paola; Ferrari, Vittorio; Giubbini, Raffaele
- Abstract
BACKGROUND: The objective of this study was to assess the efficacy of 90Y-DOTA-D-Phe1-Tyr3 octreotide (90Y-DOTATOC) therapy with a fixed activity of 2.56 GigaBequerels bimonthly in patients with advanced stage, well differentiated neuroendocrine carcinomas. METHODS: In total, 38 patients were enrolled in this phase 2A protocol. All patients had gastroenteropancreatic neuroendocrine tumors in sharp clinical and radiologic progression despite previous surgery, chemotherapy, and biotherapy. Their survival rate after therapy with 90Y-DOTATOC was compared with a chronologic control group of patients who had received biotherapy and chemotherapy and with results from a previous similar study. The progression-free survival rate after peptide receptor radionuclide therapy with 90Y-DOTATOC was determined for all patients until they had documented disease progression according to Response Criteria in Solid Tumors, tumor-related death, or censoring. RESULTS: Seventeen patients (43.6%) had a partial response, 10 patients (25.6%) had stable disease, and 11 patients (28.2%) had progressive disease. A statistically significant difference was observed ( P < .001) between the response to 90Y-DOTATOC treatment and the response to biotherapy with somatostatin analogs and chemotherapy and also between the current results and the results from a previous similar study ( P < .05). At the time of the current evaluation with ongoing follow-up for 30 patients, the median progression-free survival was 22.3 months. CONCLUSIONS: The results from this phase 2 study indicated that the treatment of metastatic neuroendocrine tumors with fixed 90Y-DOTATOC activity is useful and safe. Cancer 2011;. © 2011 American Cancer Society.
- Publication
Cancer (0008543X), 2012, Vol 118, Issue 11, p2915
- ISSN
0008-543X
- Publication type
Academic Journal
- DOI
10.1002/cncr.26616