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Journal of Nuclear Medicine Vol. 43 No. 5 610-616
© 2002 by Society of Nuclear Medicine

Clinical Investigations

Tumor Response and Clinical Benefit in Neuroendocrine Tumors After 7.4 GBq 90Y-DOTATOC

Christian Waldherr, MD1, Miklos Pless, MD2, Helmut R. Maecke, PhD3, Tilmann Schumacher, MD1, Armin Crazzolara, MD1, Egbert U. Nitzsche, MD1, Andreas Haldemann, MD4 and Jan Mueller-Brand, MD1

1 PET Center, Institute of Nuclear Medicine, University Hospital, University of Basel, Basel, Switzerland
2 Department of Oncology, University Hospital, University of Basel, Basel, Switzerland
3 Institute of Radiological Chemistry, University Hospital, University of Basel, Basel, Switzerland
4 Oncology Institute of Southern Switzerland, Bellinzona, Switzerland

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/m2 of the radiolabeled somatostatin analog 90Y-1,4,7,10-tetra-azacyclododecan-4,7,10-tricarboxy-methyl-1-yl-acetyl-D-Phe-Tyr3-octreotide (DOTATOC). In addition, we investigated the clinical benefit of 90Y-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/m2 90Y-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/m2 90Y-DOTATOC is a well-tolerated treatment for neuroendocrine tumors, with remarkable clinical benefit and objective response.

Key Words: radionuclide therapy • radiopeptide • somatostatin • octreotide • neuroendocrine tumor • 90Y-DOTATOC




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