NANETS2022 15th Annual Multidisciplinary NET Medical Symposium NANETS 2022 Clinical – Nuclear Medicine/Interventional Radiology/Imaging (16 abstracts)
Effectiveness and Safety of Re-Treatment With 177Lu-DOTATATE in Patients With Progressive NETs in the US: a Retrospective Real-World Study
Ebrahim Delpassand 1 , Soheil Mohammadi Yazdi 1 , Shashank Ghantoji 2 , Antonio Reis Nakasato 2 , Corinne Denise Strickland 2 , Rodolfo Nunez 1 , Afshin Shafie 1 , Susan Cork 1 , Clare Byrne 3 , Jackson Tang 3 , Kyle Runeckles 3 & Jeetvan Patel 2
1Excel Diagnostics and Nuclear Oncology Center, Houston, TX; 2Novartis Pharmaceuticals Corporation, East Hanover, NJ; 3Asclepius Analytics, New York, NY.
Background: Advanced neuroendocrine tumors (NETs) are associated with poor prognoses. A 4-dose regimen of lutetium Lu 177 (177Lu)-DOTATATE has been shown to improve progression-free survival (PFS) and overall survival (OS) in patients with advanced NETs. This is the first United States (US) study to evaluate the effectiveness and safety of additional doses in patients with progressive NETs.
Methods: This was a retrospective chart review of 31 adults with advanced NETs who underwent initial treatment with ≤4 doses of 177Lu-DOTATATE and who, following disease progression and a period of ≥6 months since the end of initial treatment, were re-treated with ≥1 additional dose at a single US center (2010–2020). Patient characteristics, treatment patterns, and clinical outcomes were evaluated descriptively. Response was evaluated per RECIST 1.1; toxicity was defined using CTCAE 5.0 criteria. Kaplan–Meier plots were used to evaluate PFS and OS.
Results: Of the 31 patients who received 177Lu-DOTATATE re-treatment, 19 (61%) were male and 29 (94%) were white. Overall, patients received a median of 6 doses (4 initial and 2 re-treatment doses). Mean±sd administered activity was 41.9±4.4 GBq. Two patients received additional re-treatment (1 and 2 doses, respectively) following a second period of ≥6 months and progression after re-treatment. Best responses of partial response and stable disease were observed in 11 (35%) and 20 (65%) patients after initial treatment and 7 (23%) and 14 (45%) patients after re-treatment (Table). Median PFS was 20.2 and 9.6 months after initial and re-treatment, respectively; median OS was 42.6 and 12.6 months. Hematological parameters decreased significantly during both initial and re-treatment but recovered, with no significant difference between the values, prior to initial treatment and re-treatment. Clinically significant hematotoxicity occurred in 1 and 3 patients following initial and re-treatment, respectively. No grade 3/4 nephrotoxicity (based on creatinine levels) was observed.
| Outcome | Initial Treatment (n=31) | Re-treatment (n=31) |
| Response, n (%) | ||
| Complete response | 0 | 0 |
| Partial response | 11 (35%) | 7 (23%) |
| Stable disease | 20 (65%) | 14 (45%) |
| Progressive disease | 0 | 3 (10%) |
| Unknown | 0 | 7 (23%) |
| Median PFS, months (95% CI) | 20.2 (13.5–25.8) | 9.6 (5.5–16.2) |
| Median OS, months (95% CI) | 42.6 (31.2–53.8) | 12.6 (9.6–18.9) |
| Grade 3/4 hematotoxicity (Including leukopenia, neutropenia, and thrombocytopenia), n (%) | 1 (3%) | 3 (10%) |
Conclusions: Re-treatment with 177Lu-DOTATATE after progression appeared to be well tolerated and offered disease control in patients with progressive NETs following initial 177Lu-DOTATATE treatment.
Abstract ID 21354
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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