Lutetium Lu 177 dotatate (Lutathera) demonstrated meaningful antitumor activity in patients with metastatic bronchopulmonary neuroendocrine tumors (BP-NETs), according to real-world data presented at the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer.
Among 23 patients treated with the peptide receptor radionuclide therapy (PRRT), partial responses occurred in 17% of patients, while 30% achieved stable disease and 23% experienced progressive disease. The findings provide important insights into the clinical utility of this radiopharmaceutical in a challenging patient population.
Real-World Evidence from Mayo Clinic Network
The retrospective analysis evaluated patients with metastatic BP-NETs treated with PRRT at Mayo Clinic sites in Arizona, Florida, and Minnesota between 2014 and 2025. Giuseppe Maiocco, MD, a resident in the Division of Internal Medicine at the Mayo Clinic, and colleagues noted that "in clinical practice, the decision of when to utilize peptide receptor radionuclide therapy varies widely, found here most commonly as a third-line systemic agent."
BP-NETs comprise approximately 20% to 30% of neuroendocrine tumors, and the management of metastatic disease requires substantial tailoring. The study aimed to evaluate real-world use of lutetium Lu 177 dotatate in this specific patient population.
Patient Characteristics and Treatment History
The study population had a median age of 66 years, with 39% being female and 48% having a history of tobacco use. Metastatic sites included liver (78%), bone (61%), pancreas (9%), and contralateral lung (4%). Disease grading showed 26% with grade 1, 39% with grade 2, and 26% with grade 3 tumors per WHO 2017 criteria.
Carcinoid histology was typical in 43% and atypical in 57% of patients. The majority of patients were nonfunctional (70%), had a Krenning scale score of 4 (57%), and an ECOG performance status of 0 (57%). The median number of PRRT treatments was 4.
More than half of patients (52%) received 2 systemic treatments before PRRT. All patients had received somatostatin analogs, while 65% had received chemotherapy, 43% everolimus (Afinitor), and 9% a tyrosine kinase inhibitor. Notably, 43% of patients did not receive systemic treatments following PRRT.
Survival Outcomes Show Promise
The median progression-free survival across all patients was 10.8 months (95% CI, 7.3-15.9). When stratified by histology, patients with typical carcinoid had a median PFS of 11.1 months (95% CI, 2.7-19.3) compared to 8.4 months (95% CI, 6.4-14.7) for those with atypical carcinoid.
Krenning score appeared to be a significant predictor of outcomes. Patients with a Krenning score of 4 achieved a median PFS of 14.7 months (95% CI, 9.1-25.8), while those with a score of 3 or less had a median PFS of 7.3 months (95% CI, 2.7-13.3).
Overall survival data showed a median of 35.6 months (95% CI, 11.9-50.2) across all patients. Patients with typical carcinoid histology had a median OS of 35.5 months (95% CI, 9.2-not reached) versus 19.8 months (95% CI, 8.5-not reached) for atypical carcinoid. The Krenning score stratification showed median OS of 24.4 months for score 4 patients and 16.5 months for those with scores of 3 or less.
Favorable Safety Profile
The treatment demonstrated a favorable safety profile with no grade 3 or higher adverse events reported. The most common treatment-related adverse effects included fatigue (35%), nausea (26%), abdominal pain (22%), and decreased appetite (13%).
"Lutetium Lu 177 dotatate was well tolerated, with no grade 3 or higher adverse events," Maiocco and coauthors concluded in their poster presentation.
Regulatory Context
In April 2024, the FDA approved lutetium Lu 177 dotatate for patients 12 years of age or older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, representing the first FDA approval of a radioactive drug or radiopharmaceutical for this patient population. The current study extends the evidence base to bronchopulmonary neuroendocrine tumors, providing valuable real-world data on this emerging therapeutic approach.
