A phase III study of receptor-targeted 99mTc-tilmanocept versus blue dye in the evaluation of SLNs in breast cancer and melanoma

Autor: Anne M. Wallace, F. O. Cope, V. K. Sondak
Rok vydání: 2011
Předmět:
Zdroj: Journal of Clinical Oncology. 29:LBA8526-LBA8526
ISSN: 1527-7755
0732-183X
Popis: LBA8526^ Background: Intraoperative lymphatic mapping (ILM) evaluation is widely used for staging clinically node-negative breast CA and melanoma. [99mTc]Tilmanocept (TcT) is a novel CD206 receptor-targeted (intra-nodal CD206+ RE cells) radiopharmaceutical designed for ILM of nodes (LNs) with anatomic nexuses to the tumor bed. We report the results of a Phase III, multicenter trial designed to assess the ILM performance of TcT vs the approved standard, vital blue dye (VBD) in both melanoma and breast CA patients (pts). Methods: 8 centers provided 153 pts w/ 10 melanoma or breast CA (ECOG 0-2; T1-4, N0, M0). TcT (50 µg @ 0.5-1.0mC i 99mTc) and VBD (per label) were injected to each pt; ILM was performed w/ a hand held γ-detector (for TcT) and visual eval (for VBD); all γ+ and blue+ LNs were excised and histologically examined. TcT was injected per study center practice (subareolar and intradermal injection w/ >0.5 hr wait); VBD was injected at surgery. The 10 endpoints were concordance w/ TcT and VBD (% of LNs detected by VBD and identified by TcT) and reverse concordance (% LNs detected by TcT and identified by VBD); path +/- per localization of TcT and VBD were also assessed. Pts were assessed for lab safety and AEs. Results: (Table) VBD pts (standard ILM pt metric) who expressed ≥1 VBD+ LN equate to the intent-to-treat (ITT) group. Conversely, the reverse ITT (RITT) group consisted of pts expressing ≥1 γ+ node. The analyses of the 10 endpoints are estimates of the 95% CIs. The 10 hypothesis is H0: R ≤0.90 vs Ha: R >0.90; R = concordance rate (2-sided, α = 0.05). Additional contrasts include tests for Δ residual disease (path) and effect on pt staging. Conclusions: The receptor targeted ILM agent, TcT, provided clinically superior results compared to label-approved VBD. TcT localization of occult disease was significantly improved vs VBD. The results suggest that receptor targeting of the lymphatic RE cells is a key development in ILM of LN metastasis. [Table: see text]
Databáze: OpenAIRE
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