177 Lu-Dota-octreotate radionuclide therapy of advanced gastrointestinal neuroendocrine tumors: results from a phase II study
- 940 Downloads
We evaluated the activity and safety profile of 177Lu-Dotatate peptide receptor radionuclide therapy (Lu-PRRT) in patients with advanced, well-differentiated (G1-G2) gastrointestinal neuroendocrine tumors (GI-NETs).
Forty-three patients with radiological tumor progression at baseline and a positive Octreoscan® completed the treatment with Lu-PRRT, resulting in the cumulative activity of 18.5 or 27.8 GBq in five cycles. Total activity was scheduled on the basis of kidney function or bone marrow reserve.
Twenty-five (58 %) patients were treated with a “standard” Lu-PRRT full dosage (FD) of 25.7 GBq (range 22.2-27.8), while the remaining 18 patients (42 %) who, at enrolment, showed a higher probability of developing kidney or bone marrow toxicity received a reduced dosage (RD) of 18.4 GBq (range 14.4-20.4). According to SWOG criteria, the overall response was complete response (CR) in (7 %) cases and stable disease (SD) in 33 (77 %), with a disease control rate (DCR) of 84 %. Median response duration was 25 months (range 7-50). Median progression-free survival (PFS) was 36 months (95 % CI 24-nr), and median overall survival (OS) has not yet been reached. Remarkably, none of the patients, including those at a higher risk of toxicity, showed side-effects after either dosage of Lu-PRRT.
Lu-PRRT was shown to be an effective therapeutic option in our patients with advanced progressive GI-NETs, showing an 84 % DCR (95 % CI 73-95) that lasted for 25 months and a PFS of 36 months. Both activities of 27.8 GBq and 18.5 GBq proved safe and effective in all patients, including those with a higher probability of developing kidney or bone marrow toxicity.
KeywordsPRRT Midgut carcinoids GI NETs 177Lu-DOTATATE
This study was partially supported by grants from the Italian Association for Cancer Research (AIRC) and the Istituto Oncologico Romagnolo (IOR).
Conflict of interest
The authors declare that they have no conflicts of interest.
- 2.Öberg K. Management of neuroendocrine tumours. Annals Oncol. 2004;15(4):293–8.Google Scholar
- 3.Rinke A, Muller H, Schade-Brittinger C, et al. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumour growth in patients with metastatic neuroendocrine midgut tumours: a report from the PROMID study group. J Clin Oncol. 2009;27:4656–63.PubMedCrossRefGoogle Scholar
- 17.Bosman FT, Carniero F, Hruban RH, et al. WHO classification of tumours of the digestive system. 4th ed. Geneva: World Health Organization; 2010.Google Scholar
- 22.Common Terminology Criteria for Adverse Events v3.0 (CTCAE, http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf
- 24.Lawless JS. Statistical models and methods for life-time data. New York, NY: Wiley; 1982.Google Scholar
- 31.A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours (NETTER-1). ClinicalTrials.gov Identifier: NCT01578239.Google Scholar