Abstract
Background: Sentinel lymph node (SLN) surgery is used worldwide for staging breast cancer patients and helps limit axillary lymph node dissection. [ 99mTc]Tilmanocept is a novel receptor-targeted radiopharmaceutical evaluated in 2 open-label, nonrandomized, within-patient, phase 3 trials designed to assess the lymphatic mapping performance. Methods: A total of 13 centers contributed 148 patients with breast cancer. Each patient received [99mTc]tilmanocept and vital blue dye (VBD). Lymph nodes identified intraoperatively as radioactive and/or blue stained were excised and histologically examined. The primary endpoint, concordance (lower boundary set point at 90 %), was the proportion of nodes detected by VBD and [ 99mTc]tilmanocept. Results: A total of 13 centers contributed 148 patients who were injected with both agents. Intraoperatively, 207 of 209 nodes detected by VBD were also detected by [99mTc]tilmanocept for a concordance rate of 99.04 % (p < 0.0001). [99mTc]tilmanocept detected a total of 320 nodes, of which 207 (64.7 %) were detected by VBD. [99mTc]Tilmanocept detected at least 1 SLN in more patients (146) than did VBD (131, p < 0.0001). In 129 of 131 patients with ≥1 blue node, all blue nodes were radioactive. Of 33 pathology-positive nodes (18.2 % patient pathology rate), [99mTc]tilmanocept detected 31 of 33, whereas VBD detected only 25 of 33 (p = 0.0312). No pathology-positive SLNs were detected exclusively by VBD. No serious adverse events were attributed to [ 99mTc]tilmanocept. Conclusion: [99mTc]Tilmanocept demonstrated success in detecting a SLN while meeting the primary endpoint. Interestingly, [99mTc]tilmanocept was additionally noted to identify more SLNs in more patients. This localization represented a higher number of metastatic breast cancer lymph nodes than that of VBD.
| Original language | English |
|---|---|
| Pages (from-to) | 2590-2599 |
| Number of pages | 10 |
| Journal | Annals of Surgical Oncology |
| Volume | 20 |
| Issue number | 8 |
| DOIs | |
| State | Published - Aug 1 2013 |
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ASJC Scopus subject areas
- Surgery
- Oncology
Cite this
Comparative evaluation of [99mTc]tilmanocept for sentinel lymph node mapping in breast cancer patients : Results of two phase 3 trials. / Wallace, Anne M.; Han, Linda K.; Povoski, Stephen P.; Deck, Kenneth; Schneebaum, Schlomo; Hall, Nathan C.; Hoh, Carl K.; Limmer, Karl K.; Krontiras, Helen; Frazier, Thomas G.; Cox, Charles; Avisar, Eli; Faries, Mark; King, Dennis W.; Christman, Lori; Vera, David R.
In: Annals of Surgical Oncology, Vol. 20, No. 8, 01.08.2013, p. 2590-2599.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Comparative evaluation of [99mTc]tilmanocept for sentinel lymph node mapping in breast cancer patients
T2 - Results of two phase 3 trials
AU - Wallace, Anne M.
AU - Han, Linda K.
AU - Povoski, Stephen P.
AU - Deck, Kenneth
AU - Schneebaum, Schlomo
AU - Hall, Nathan C.
AU - Hoh, Carl K.
AU - Limmer, Karl K.
AU - Krontiras, Helen
AU - Frazier, Thomas G.
AU - Cox, Charles
AU - Avisar, Eli
AU - Faries, Mark
AU - King, Dennis W.
AU - Christman, Lori
AU - Vera, David R.
PY - 2013/8/1
Y1 - 2013/8/1
N2 - Background: Sentinel lymph node (SLN) surgery is used worldwide for staging breast cancer patients and helps limit axillary lymph node dissection. [ 99mTc]Tilmanocept is a novel receptor-targeted radiopharmaceutical evaluated in 2 open-label, nonrandomized, within-patient, phase 3 trials designed to assess the lymphatic mapping performance. Methods: A total of 13 centers contributed 148 patients with breast cancer. Each patient received [99mTc]tilmanocept and vital blue dye (VBD). Lymph nodes identified intraoperatively as radioactive and/or blue stained were excised and histologically examined. The primary endpoint, concordance (lower boundary set point at 90 %), was the proportion of nodes detected by VBD and [ 99mTc]tilmanocept. Results: A total of 13 centers contributed 148 patients who were injected with both agents. Intraoperatively, 207 of 209 nodes detected by VBD were also detected by [99mTc]tilmanocept for a concordance rate of 99.04 % (p < 0.0001). [99mTc]tilmanocept detected a total of 320 nodes, of which 207 (64.7 %) were detected by VBD. [99mTc]Tilmanocept detected at least 1 SLN in more patients (146) than did VBD (131, p < 0.0001). In 129 of 131 patients with ≥1 blue node, all blue nodes were radioactive. Of 33 pathology-positive nodes (18.2 % patient pathology rate), [99mTc]tilmanocept detected 31 of 33, whereas VBD detected only 25 of 33 (p = 0.0312). No pathology-positive SLNs were detected exclusively by VBD. No serious adverse events were attributed to [ 99mTc]tilmanocept. Conclusion: [99mTc]Tilmanocept demonstrated success in detecting a SLN while meeting the primary endpoint. Interestingly, [99mTc]tilmanocept was additionally noted to identify more SLNs in more patients. This localization represented a higher number of metastatic breast cancer lymph nodes than that of VBD.
AB - Background: Sentinel lymph node (SLN) surgery is used worldwide for staging breast cancer patients and helps limit axillary lymph node dissection. [ 99mTc]Tilmanocept is a novel receptor-targeted radiopharmaceutical evaluated in 2 open-label, nonrandomized, within-patient, phase 3 trials designed to assess the lymphatic mapping performance. Methods: A total of 13 centers contributed 148 patients with breast cancer. Each patient received [99mTc]tilmanocept and vital blue dye (VBD). Lymph nodes identified intraoperatively as radioactive and/or blue stained were excised and histologically examined. The primary endpoint, concordance (lower boundary set point at 90 %), was the proportion of nodes detected by VBD and [ 99mTc]tilmanocept. Results: A total of 13 centers contributed 148 patients who were injected with both agents. Intraoperatively, 207 of 209 nodes detected by VBD were also detected by [99mTc]tilmanocept for a concordance rate of 99.04 % (p < 0.0001). [99mTc]tilmanocept detected a total of 320 nodes, of which 207 (64.7 %) were detected by VBD. [99mTc]Tilmanocept detected at least 1 SLN in more patients (146) than did VBD (131, p < 0.0001). In 129 of 131 patients with ≥1 blue node, all blue nodes were radioactive. Of 33 pathology-positive nodes (18.2 % patient pathology rate), [99mTc]tilmanocept detected 31 of 33, whereas VBD detected only 25 of 33 (p = 0.0312). No pathology-positive SLNs were detected exclusively by VBD. No serious adverse events were attributed to [ 99mTc]tilmanocept. Conclusion: [99mTc]Tilmanocept demonstrated success in detecting a SLN while meeting the primary endpoint. Interestingly, [99mTc]tilmanocept was additionally noted to identify more SLNs in more patients. This localization represented a higher number of metastatic breast cancer lymph nodes than that of VBD.
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UR - http://www.scopus.com/inward/citedby.url?scp=84880300454&partnerID=8YFLogxK
U2 - 10.1245/s10434-013-2887-8
DO - 10.1245/s10434-013-2887-8
M3 - Article
VL - 20
SP - 2590
EP - 2599
JO - Annals of Surgical Oncology
JF - Annals of Surgical Oncology
SN - 1068-9265
IS - 8
ER -