ABSTRACT
BACKGROUND: Peptide receptor radionuclide therapy (PRRT) is one of the most promising therapeutic strategies in neuroendocrine neoplasms (NENs). Nevertheless, its role in certain tumor sites remains unclear. This study sought to elucidate the efficacy and safety of [177Lu]Lu-DOTATATE in NENs with different locations and evaluate the effect of the tumor origin, bearing in mind other prognostic variables. Advanced NENs overexpressing somatostatin receptors (SSTRs) on functional imaging, of any grade or location, treated at 24 centers were enrolled. The protocol consisted of four cycles of 177Lu-DOTATATE 7.4 GBq iv every 8 weeks (NCT04949282). RESULTS: The sample comprised 522 subjects with pancreatic (35%), midgut (28%), bronchopulmonary (11%), pheochromocytoma/ paraganglioma (PPGL) (6%), other gastroenteropancreatic (GEP) (11%), and other non-gastroenteropancreatic (NGEP) (9%) NENs. The best RECIST 1.1 responses were complete response, 0.7%; partial response, 33.2%; stable disease, 52.1%; and tumor progression, 14%, with activity conditioned by the tumor subtype, but with benefit in all strata. Median progression-free survival (PFS) was 31.3 months (95% CI, 25.7-not reached [NR]) in midgut, 30.6 months (14.4-NR) in PPGL, 24.3 months (18.0-NR) in other GEP, 20.5 months (11.8-NR) in other NGEP, 19.8 months (16.8-28.1) in pancreatic, and 17.6 months (14.4-33.1) in bronchopulmonary NENs. [177Lu]Lu-DOTATATE exhibited scant severe toxicity. CONCLUSION: This study confirms the efficacy and safety of [177Lu]Lu-DOTATATE in a wide range of SSTR-expressing NENs, regardless of location, with clinical benefit and superimposable survival outcomes between pNENs and other GEP and NGEP tumor subtypes different from midgut NENs.
Subject(s)
Adrenal Gland Neoplasms , Neuroendocrine Tumors , Organometallic Compounds , Paraganglioma , Pheochromocytoma , Humans , Octreotide/adverse effects , Neuroendocrine Tumors/pathology , Prognosis , Receptors, Somatostatin , Organometallic Compounds/adverse effectsABSTRACT
OBJECTIVES: The aim of this study was to create and validate a drawing to help adults establish when to replace a manual toothbrush. METHODS: This cohort study had two phases. Phase I (3 months, 50 subjects) aimed to create a drawing of average wear in a toothbrush based on a wear index (WI) of 68% for the tested toothbrush. This was validated in Phase II (3 months, 30 participants). Pictures of worn brushing surfaces were generated using an image acquisition system. Images in each study phase were superimposed to provide a single reference outline to indicate when a toothbrush should be replaced. Residual plaque index values for identical brushing protocols were recorded using new and worn toothbrushes in Phase I and compared using Student's paired t-test. Student's t-test was used to compare duration of tooth-brushing and WI values in both phases. RESULTS: After brushing according to a uniform protocol, the residual plaque index at baseline was significantly lower than that at the last use of the toothbrush (P < 0.01). The drawings generated in Phases I and II were similar in terms of WI (P = 0.33) and period of use (P = 0.12). CONCLUSIONS: This simple drawing may help adults establish when they should replace a toothbrush.
