Safety and outcomes of ¹⁷⁷Lu‐DOTATATE for neuroendocrine tumours: experience in New South Wales, Australia

Abstract

Background Peptide receptor radionuclide therapy with 177Lu‐DOTATATE is a promising treatment for inoperable or metastatic neuroendocrine tumours (NET). In 2015, the NSW Ministry of Health provided funding for 177Lu‐DOTATATE treatment of NET under an evaluation framework. Aims To examine the safety and outcomes of NET patients treated with 177Lu‐DOTATATE under the evaluation framework and assess the statewide implementation of the NSW Lutate therapy referral and protocol for neuroendocrine cancer patients. Methods A quality of care clinical audit was conducted on all NET patients treated with 177Lu‐DOTATATE from October 2010 to October 2015 at St George Hospital, and from August 2013 to March 2017 at Royal North Shore Hospital. Percentage of patients who met protocol selection criteria was calculated. Survival was estimated using the Kaplan–Meier method. Adjusted regression analyses assessed associations between key clinical factors and outcomes. Results A total of 279 patients was treated. Statewide protocol implementation led to an increase from 60.5 to 83.8% in patients meeting selection criteria. Estimated median overall survival was significantly longer for patients who met selection criteria compared with those who did not (50.7 vs 34.2 months) (P = 0.018). This was driven by the significantly worse overall survival in patients who failed exclusion criteria (P < 0.001). 177Lu‐DOTATATE was well tolerated with haematological, renal and hepatic treatment‐related serious adverse events experienced by 9.7, 0.4 and 0.4% of patients respectively. Conclusions 177Lu‐DOTATATE is a promising treatment for advanced NET. Superior survival in patients who met selection criteria emphasise the importance of protocol adherence.

Multidisciplinary Management of Neuroendocrine Neoplasia: A Real-World Experience from a Referral Center

“…In accordance with data obtained by pathological data integration/revision, a grading change occurred in 17.9% of patients. It is well known that grading is the most powerful prognostic factor in NENs and may be considered a decision-driving marker when planning treatment [2,3,26,27,28]. Tumor grading needs to be assessed by evaluating the Ki67 proliferation index, and the number of counted cells (recommended 500 to 2000) has to be mentioned [29].…”

Predictive Factors for Resistant Disease with Medical/Radiologic/Liver-Directed Anti-Tumor Treatments in Patients with Advanced Pancreatic Neuroendocrine Neoplasms: Recent Advances and Controversies

“…The estimated PFS at 20 months in patients treated with 177 Lu-DOTATATE was 63%, which was significantly higher than that of patients treated with octreotide (10.8%) [ 58 ]. The efficacy of PRRT was also reported from a pivotal retrospective study involving many panNEN patients, with median PFS and OS of 33 months and 46 months, respectively [ 59 ], as well as in other studies [ 263 ]. Similarly, in a recent systematic analysis of published studies involving 697 patients with advanced panNENs, PRRT treatment was more effective/safe/better tolerated than the use of everolimus [ 61 ].…”

Therapy‐related chronic myeloid leukemia in a patient receiving peptide receptor radionuclide therapy for pancreatic neuroendocrine tumor

“…have been reported after treatment with PRRT with a mean incidence of 2.6%, 8 however, a few cases of TR-CML following PRRT were reported. 8,[13][14][15] Brieau et al 16 This patient was a 61-year-old male with history of prior chemoembolization, and he was Ph + with no additional cytogenetic abnormalities. Our case did not receive any chemotherapy, and he developed TR-CML 60 months after the initiation of PRRT.…”

“…The most serious long‐term toxicity associated with PRRT is irreversible myelotoxicity. Late‐onset myeloid neoplasms have been reported after treatment with PRRT with a mean incidence of 2.6%, 8 however, a few cases of TR‐CML following PRRT were reported 8,13‐15 …”