e21066 Background: ILM is a key diagnostic component for solid tumor excision. ILM utilizes the injection of a color agent and/or a radiopharmaceutical agent (RPA) which may be tracked intraoperatively w/ a γ-probe. ILM is designed to aid the surgeon in tracing lymph nodes that may have a connection to the tumor bed. ILM in the U.S. employs a non-standard RPA, S-colloid (TcSC). This agent was recently approved by the FDA for breast cancer ILM using a literature review. In contrast, CD206-targeted Tc99m-tilmanocept (TCP) was studied in 2 prospective Ph-3 trials. These trials compared TCP to blue dye, the same dye utilized in the FDA review of TcSC. Methods: For a statistical review and contrast of TCP vs TcSC, we used a meta-analysis and pooled analysis based on the FDA-review of TcSC. We focused on the functional endpoints: 1] Localization rate (% of pts w/ a found hot node) and 2] degree of localization (# of found hot nodes/pt). Both metrics define the potential for agent performance for ILM and nodal metastasis. Results: The contrast of the localization rate/pt for TcSC at 94% was based on TcSC’s reviewed value. The results for the proportion of TCP patients were localization rates of 99.91% by meta-analysis and 98.65% by pooled analysis; p<0.0001 and p<0.008, repsectively (1-sided test, H0 p=/< 0.94). The contrast of the # hot nodes/pt. This value was benchmarked at 1.6 nodes/pt based on TcSC’s review value. The results for the nodes/pt of TCP patients were 2.08 by meta-analysis and 2.16 by pooled analysis; p<0.0001 and p<0.0001, repsectively (1-sided test, H0 p=/< 1.6). Conclusions: TCP provided significantly greater performance in key metrics, node localization/pt, and degree of localization (nodes found/pt) in breast cancer. All values are highly statistically significant for the key clinical performance parameters. These data suggest that receptor targeted TCP may provide improved diagnostic ILM over the currently employed nonspecific RPA lymphatic mapping agent TcSC.
1553 Objectives Primary:The main endpoint for this study was the regional disease recurrence (RC)-free rate, i.e., the absence of RC of the primary malignancy in the proximal lymphatic basin from which the TcTm-identified SLNs were resected. Secondary: Determine the rates of primary tumor site RC, distal RC, and overall RC. Determine the disease-specific mortality and overall survival. Methods All participating Pts were volunteer BC or ME patients (N=109) who were enrolled in a Phase 3 study (N=179) assessing the performance of TcTm; Pts were TIS-T4, N0, M0 at the time of enrollment on the Phase 3 study. Pts were followed for 36 months for evaluation of the primary and secondary metrics. Results 109 Pts were analyzed (64 BCPts, 45 MEPts). Overall, there were 8 cases of tumor RC, 2BC Pts (1pN+ &1 pN0) and 6 MEPts (3 pN+& 3 pN0). 7 Pts died during the follow-up period. Of these, only 4 were related to the primary malignancy (1pN+ BC, 1 pN0 BC, &2pN+ ME). All had distal RC: 3Pts had only distal RC prior to death (2pN+, 1 pN0), and 1Pt (already pN+ ME) had both regional and distal RC prior to death.Pathology-negative (pN0) Pts had a regional RC-free rate of 98.82% (cumulative), whereas pN+ Pts had a regional RC-free rate of 89.47% (cumulative).The mean overall RC-free time was 956.6 days. Mean RC-free time for ME Pts (879.8 days) as shorter than that for BCPts (1010.6 days). Additionally, mean RC-free time was shorter for pN+ Pts (846.0 days) than for pN0 Pts (983.0 days). Conclusions The NPV for 99mTc-Tilmanocept calculated from Study NEO3-04 was 98.61% (95% confidence interval 92.50-99.96%), which was calculated using the 36-month follow-up data. 99mTc-Tilmanocept provided for reliable SLN discrimination and long-term outcome in BC and ME Pts when evaluated as a single agent for SLNB.
Four cases of enterolith obstruction in horses aged from six to 14 years are reported. All four cases had symptoms of persistent low grade abdominal pain and anorexia with an absence of defaecation. Examination revealed reduced gut motility and accumulation of gas, but heart and respiratory rates, rectal temperatures and complete blood counts were all within normal limits. Enteroliths of varying sizes were removed from the region of the transverse colon in all four horses.
