@article {Zidan218, author = {Lamiaa Zidan and Amir Iravani and Kira Oleinikov and Simona Ben-Haim and David J. Gross and Amichay Meirovitz and Ophra Maimon and Tim Akhurst and Michael Michael and Rodney J. Hicks and Simona Grozinsky-Glasberg and Grace Kong}, title = {Efficacy and Safety of 177Lu-DOTATATE in Lung Neuroendocrine Tumors: A Bicenter study}, volume = {63}, number = {2}, pages = {218--225}, year = {2022}, doi = {10.2967/jnumed.120.260760}, publisher = {Society of Nuclear Medicine}, abstract = {The purpose of this study was to assess the efficacy and safety of 177Lu-DOTATATE in patients with somatostatin receptor (SSR){\textendash}positive lung neuroendocrine tumors (NETs). Methods: This is a retrospective review of the outcome of patients with typical carcinoid (TC) and atypical carcinoid (AC), treated with 177Lu-DOTATATE at 2 ENETS Centers of Excellence. Morphologic imaging (RECIST 1.1) and 68Ga-DOTATATE PET/CT responses were assessed at 3 mo after completion of 177Lu-DOTATATE. Concordance between 2 response assessment methods was evaluated by κ statistics. Progression-free survival (PFS) and overall survival (OS) were estimated by Kaplan{\textendash}Meier analysis and compared by Log-rank test. Treatment-related adverse events (AEs) were graded based on Common Terminology Criteria for Adverse Events, version 5. Results: Of 48 patients (median age, 63 y; 13 women), 43 (90\%) had AC and 5 (10\%) TC. Almost all patients (47, 98\%) were treated due to progression. Most patients (40, 83\%) received somatostatin analogs, and 10 patients (20\%) had prior everolimus, chemotherapy, or both. All patients had high SSR expression (>= modified Krenning score 3) on pretreatment 68Ga-DOTATATE PET/CT. Patients received a median 4 (range, 1{\textendash}4) cycles of 177Lu-DOTATATE (33\% with concurrent radiosensitizing chemotherapy) to a median cumulative activity of 27 GBq (range, 6{\textendash}43GBq). At a median follow-up of 42 mo, the median PFS and OS were 23 mo (95\% CI, 18{\textendash}28 mo) and 59 mo (95\% CI, 50-not reached [NR]), respectively. Of 40 patients with RECIST-measurable disease and 39 patients with available 68Ga-DOTATATE PET/CT, response categories were partial response, 20\% (95\% CI, 10\%{\textendash}35\%) and 44\% (95\% CI, 30\%{\textendash}59\%); stable disease, 68\% (95\% CI, 52\%{\textendash}80\%) and 44\% (95\% CI, 30\%{\textendash}59\%); and progressive disease, 12\% (95\% CI, 5\%{\textendash}27\%) by both, respectively. There was a moderate concordance between response categories by RECIST and 68Ga-DOTATATE PET/CT, weighted κ of 0.51 (95\% CI, 0.21{\textendash}0.68). Of patients with stable disease by RECIST, those with partial response on 68Ga-DOTATATE PET/CT had a longer OS than those with no response, NR versus 52 mo (95\% CI, 28{\textendash}64), hazard ratio 0.2 (95\% CI, 0.1{\textendash}0.6), P \< 0.001. Most grade 3/4 AEs were reversible and the most common was lymphopenia (14\%) with no incidence of myelodysplasia or leukemia. Conclusion: In patients with advanced progressive lung NET and satisfactory SSR expression, 177Lu-DOTATATE is effective and safe with a high disease control rate and encouraging PFS and OS.}, issn = {0161-5505}, URL = {https://jnm.snmjournals.org/content/63/2/218}, eprint = {https://jnm.snmjournals.org/content/63/2/218.full.pdf}, journal = {Journal of Nuclear Medicine} }