In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 34, No. 4_suppl ( 2016-02-01), p. 436-436
Abstract:
436 Background: Emerging evidence, that 177 Lu-DOTATOC has a particularly favorable therapeutic index compared to other PRRT agents, prompted us to further evaluate efficacy and safety of 177 Lu-DOTATOC. Methods: 56 patients with metastasized and progressive neuroendocrine tumors (NET) (50% gastroenteral, 26.8% pancreatic, 23.2% other primaries) were consecutively treated with 177 Lu-DOTATOC and analyzed retrospectively. Patients received on average 2.1 (range 1 – 4) cycles of 177 Lu-DOTATOC as 7.0 GBq (median) doses at 3-monthly intervals. Efficacy was analyzed based on RECIST and stratified for number of treatment cycles and primary tumor origin. Results: Median progression-free (PFS) and overall survival in the total population (A) were 17.4 and 34.2 months, respectively. Patients treated with 〉 1 cycle had a PFS of 32.0 months for all NET (B), 34.5 months for gastroenteropancreatic NET (GEP-NET) (C), and 11.9 months for other NET (D). Objective response (OR) rates [complete (CR) or partial (PR)], were 34%, 41%, 54%, and 0% for A, B, C, and D, while disease control [CR, PR and stable disease, SD] rates (DCR) were 66%, 94%, 100%, and 75%, resp. CR was found in 16%, 19% and 25% of A, B and C, resp. In 68% of responders initial response occurred within 4 months from the 1 st cycle, whereas in 32% this took 4-8 months. In 47% of all OR it took 〉 8 months to achieve OR. No renal toxicity was found, although 20% of patients had mild renal insufficiency at baseline. No SAE and only a single case of self-limiting grade 3 myelotoxicity was observed. Conclusions: 177 Lu-DOTATOC shows unparalleled potential to induce OR and long lasting DC in progressive NET, even when administered at moderate activity doses. In GEP-NET patients CR was 25%, which is the highest value ever reported. Efficacy was highest when the agent was administered in repetitive cycles. Overall DCR was 94%, compared to 80-85% reported for 177 Lu-DOTATATE. This difference in DCR is mainly accounted for by an approx. 10-fold higher rate of CR with 177 Lu-DOTATOC. This high efficacy together with the observed safety profile suggests a very high therapeutic index, reflecting a uniquely low systemic uptake of 177 Lu-DOTATOC.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2016.34.4_suppl.436
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2016
detail.hit.zdb_id:
2005181-5
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