Initial safety analysis of a randomized phase II trial of nelipepimut-S + GM-CSF and trastuzumab compared to trastuzumab alone to prevent recurrence in breast cancer patients with HER2 low-expressing tumors
Guy L. Clifton
1
,
Kaitlin M. Peace
1
,
Jarrod P. Holmes
2
,
Timothy J. Vreeland
3
,
Diane F. Hale
1
,
Garth S. Herbert
1
,
Jennifer K. Litton
4
,
Rashmi K. Murthy
4
,
Jason Lukas
5
,
George E. Peoples
6
,
Elizabeth A. Mittendorf
7
1
Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, TX 78234, USA
|
2
Department of Medical Oncology, St. Joseph Health Cancer Center, 3555 Round Barn Circle, Santa Rosa, CA 95403, USA
|
5
Department of Medical Oncology, Providence Regional Cancer Partnership, Everett, WA 98201, USA
|
6
Department of Surgery, Uniformed Services Health University, 4301 Jones Bridge Rd, Bethesda, MD 20814, USA
|
Publication type: Journal Article
Publication date: 2019-04-01
scimago Q2
wos Q2
SJR: 1.279
CiteScore: 7.1
Impact factor: 3.8
ISSN: 15216616, 15217035
PubMed ID:
30817999
Immunology
Immunology and Allergy
Abstract
The development of HER2-targeted therapy has decreased recurrence rates and improved survival, transforming the natural history of HER2-positive breast cancer. However only a minority of breast cancer patients benefit as these agents are not used in patients with tumors expressing low levels of HER2. Preclinical data suggests a synergistic action of HER2-targeted vaccination with trastuzumab. We report the initial safety interim analysis of a phase II trial that enrolled patients with HER2 low-expressing (IHC 1+/2+) breast cancer who were clinically disease-free after standard therapy. Patients were randomized to receive the HER2-peptide vaccine nelipepimut-S + GM-CSF with trastuzumab (vaccine arm) or trastuzumab + GM-CSF (control arm) and were followed for recurrence. A planned analysis that occurred after enrollment of 150 patients showed no significant differences in toxicity between the two arms, including cardiac toxicity. The clinical efficacy of this combination will be reported 6 months after the final patient was enrolled.
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GOST
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Clifton G. L. et al. Initial safety analysis of a randomized phase II trial of nelipepimut-S + GM-CSF and trastuzumab compared to trastuzumab alone to prevent recurrence in breast cancer patients with HER2 low-expressing tumors // Clinical Immunology. 2019. Vol. 201. pp. 48-54.
GOST all authors (up to 50)
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Clifton G. L., Peace K. M., Holmes J. P., Vreeland T. J., Hale D. F., Herbert G. S., Litton J. K., Murthy R. K., Lukas J., Peoples G. E., Mittendorf E. A. Initial safety analysis of a randomized phase II trial of nelipepimut-S + GM-CSF and trastuzumab compared to trastuzumab alone to prevent recurrence in breast cancer patients with HER2 low-expressing tumors // Clinical Immunology. 2019. Vol. 201. pp. 48-54.
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TY - JOUR
DO - 10.1016/j.clim.2019.02.011
UR - https://doi.org/10.1016/j.clim.2019.02.011
TI - Initial safety analysis of a randomized phase II trial of nelipepimut-S + GM-CSF and trastuzumab compared to trastuzumab alone to prevent recurrence in breast cancer patients with HER2 low-expressing tumors
T2 - Clinical Immunology
AU - Clifton, Guy L.
AU - Peace, Kaitlin M.
AU - Holmes, Jarrod P.
AU - Vreeland, Timothy J.
AU - Hale, Diane F.
AU - Herbert, Garth S.
AU - Litton, Jennifer K.
AU - Murthy, Rashmi K.
AU - Lukas, Jason
AU - Peoples, George E.
AU - Mittendorf, Elizabeth A.
PY - 2019
DA - 2019/04/01
PB - Elsevier
SP - 48-54
VL - 201
PMID - 30817999
SN - 1521-6616
SN - 1521-7035
ER -
Cite this
BibTex (up to 50 authors)
Copy
@article{2019_Clifton,
author = {Guy L. Clifton and Kaitlin M. Peace and Jarrod P. Holmes and Timothy J. Vreeland and Diane F. Hale and Garth S. Herbert and Jennifer K. Litton and Rashmi K. Murthy and Jason Lukas and George E. Peoples and Elizabeth A. Mittendorf},
title = {Initial safety analysis of a randomized phase II trial of nelipepimut-S + GM-CSF and trastuzumab compared to trastuzumab alone to prevent recurrence in breast cancer patients with HER2 low-expressing tumors},
journal = {Clinical Immunology},
year = {2019},
volume = {201},
publisher = {Elsevier},
month = {apr},
url = {https://doi.org/10.1016/j.clim.2019.02.011},
pages = {48--54},
doi = {10.1016/j.clim.2019.02.011}
}