Author(s): Waldherr C, Pless M, Maecke HR, Schumacher T, Crazzolara A,
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Abstract The aim of this prospective phase II study was to evaluate the tumor response of neuroendocrine tumors to high-dose targeted irradiation with 7.4 GBq/m(2) of the radiolabeled somatostatin analog (90)Y-1,4,7,10-tetra-azacyclododecan-4,7,10-tricarboxy-methyl-1-yl-acetyl-D-Phe-Tyr(3)-octreotide (DOTATOC). In addition, we investigated the clinical benefit of (90)Y-DOTATOC regarding the malignant carcinoid syndrome and tumor-associated pain. METHODS: Thirty-nine patients (mean age, 55 y) with progressive neuroendocrine gastroenteropancreatic and bronchial tumors were included. The treatment consisted of 4 equal intravenous injections of a total of 7.4 GBq/m(2) (90)Y-DOTATOC, administered at intervals of 6 wk. After each treatment cycle, a standardized clinical benefit assessment using the National Cancer Institute grading criteria (NCI-CTC) was performed. RESULTS: The objective response rate according to World Health Organization (WHO) criteria was 23\%. For endocrine pancreatic tumors (13 patients), the objective response rate was 38\%. Complete remissions were found in 5\% (2/39), partial remissions in 18\% (7/39), stable disease in 69\% (27/39), and progressive disease in 8\% (3/39). A significant reduction of clinical symptoms could be found in 83\% of patients with diarrhea, in 46\% of patients with flush, in 63\% of patients with wheezing, and in 75\% of patients with pellagra. The overall clinical benefit was 63\%. All responses (both clinical benefit and WHO response) were ongoing for the duration of follow-up (median, 6 mo; range, 2-12 mo). Side effects were grade 3 or 4 (NCI-CTC) lymphocytopenia in 23\%, grade 3 anemia in 3\%, and grade 2 renal insufficiency in 3\%. CONCLUSION: High-dose targeted radiotherapy with 7.4 GBq/m(2) (90)Y-DOTATOC is a well-tolerated treatment for neuroendocrine tumors, with remarkable clinical benefit and objective response.
This article was published in J Nucl Med
and referenced in Journal of Clinical Case Reports