About: Prospective, randomized, single-blinded, multi-center phase II trial of two HER2 peptide vaccines, GP2 and AE37, in breast cancer patients to prevent recurrence

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About: Prospective, randomized, single-blinded, multi-center phase II trial of two HER2 peptide vaccines, GP2 and AE37, in breast cancer patients to prevent recurrence Goto Sponge NotDistinct Permalink

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Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Prospective, randomized, single-blinded, multi-center phase II trial of two HER2 peptide vaccines, GP2 and AE37, in breast cancer patients to prevent recurrence
Creator	James, · Hale, Diane Peace, Kaitlin Vreeland, Timothy Ardavanis, Alexandros Greene, Julia Jackson, Doreen Litton, Jennifer Mittendorf, Elizabeth Papamichail, Michael Peoples, George Perez, Sonia Ponniah, Sathibalan Nathan, · Clifton, · Anastasopoulou, E Baxevanis, N Brown Ii, Tommy Constantin, · Murray, L Myers Iii, John Pistamaltzian, · Shumway, M Symanowski, ·
Source	PMC
abstract	PURPOSE: AE37 and GP2 are HER2 derived peptide vaccines. AE37 primarily elicits a CD4+ response while GP2 elicits a CD8+ response against the HER2 antigen. These peptides were tested in a large randomized trial to assess their ability to prevent recurrence in HER2 expressing breast cancer patients. The primary analyses found no difference in 5-year overall disease-free survival (DFS) but possible benefit in subgroups. Here, we present the final landmark analysis. METHODS: In this 4-arm, prospective, randomized, single-blinded, multi-center phase II trial, disease-free node positive and high-risk node negative breast cancer patients enrolled after standard of care therapy. Six monthly inoculations of vaccine (VG) vs. control (CG) were given as the primary vaccine series with 4 boosters at 6-month intervals. Demographic, safety, immunologic, and DFS data were evaluated. RESULTS: 456 patients were enrolled; 154 patients in the VG and 147 in CG for AE37, 89 patients in the VG and 91 in CG for GP2. The AE37 arm had no difference in DFS as compared to CG, but pre-specified exploratory subgroup analyses showed a trend towards benefit in advanced stage (p = 0.132, HR 0.573 CI 0.275–1.193), HER2 under-expression (p = 0.181, HR 0.756 CI 0.499–1.145), and triple-negative breast cancer (p = 0.266, HR 0.443 CI 0.114–1.717). In patients with both HER2 under-expression and advanced stage, there was significant benefit in the VG (p = 0.039, HR 0.375 CI 0.142–0.988) as compared to CG. The GP2 arm had no significant difference in DFS as compared to CG, but on subgroup analysis, HER2 positive patients had no recurrences with a trend toward improved DFS (p = 0.052) in VG as compared to CG. CONCLUSIONS: This phase II trial reveals that AE37 and GP2 are safe and possibly associated with improved clinical outcomes of DFS in certain subgroups of breast cancer patients. With these findings, further evaluations are warranted of AE37 and GP2 vaccines given in combination and/or separately for specific subsets of breast cancer patients based on their disease biology.
has issue date	2020-04-22(xsd:dateTime)
bibo:doi	10.1007/s10549-020-05638-x
bibo:pmid	32323103
has license	cc-by
sha1sum (hex)	63d19d5429dfc6a26c5eace819547991406c8d4d
schema:url	https://doi.org/10.1007/s10549-020-05638-x
resource representing a document's title	Prospective, randomized, single-blinded, multi-center phase II trial of two HER2 peptide vaccines, GP2 and AE37, in breast cancer patients to prevent recurrence
has PubMed Central identifier	PMC7188712
has PubMed identifier	32323103
schema:publication	Breast Cancer Res Treat
resource representing a document's body	covid:63d19d5429dfc6a26c5eace819547991406c8d4d#body_text
is schema:about of	named entity 'HER2' named entity 'patients' named entity 'evaluated' named entity 'primary' named entity 'response' named entity 'compared' named entity 'based' named entity 'specific' named entity 'improved' named entity 'HER2' named entity 'immunologic' named entity 'prevent' named entity 'breast cancer' named entity 'DFS' named entity 'arm' named entity 'negative' named entity 'analyses' named entity 'vaccine' named entity 'DFS' named entity 'HER2 positive' named entity 'disease' named entity 'biology' named entity 'DFS' named entity 'HER2' named entity 'large' named entity 'group' named entity 'high-risk' named entity 'breast cancer' named entity 'GP2' named entity 'vaccine' named entity 'significant difference' named entity 'HER2' named entity 'disease-free' named entity 'phase II trial' named entity 'HER2' named entity 'CD8+' named entity 'clinical outcomes' named entity 'breast cancer' named entity 'Demographic' named entity 'DFS' named entity 'advanced stage' named entity 'peptide vaccines' named entity 'DFS' named entity 'antigen' named entity 'HER2' named entity 'subgroup analyses' named entity 'GP2' named entity 'randomized trial' named entity 'peptides' named entity 'Vaccine' named entity 'Six' named entity 'HER2' named entity 'advanced stage' named entity 'vaccine' named entity 'GP2' named entity 'breast cancer' named entity 'disease-free survival' named entity 'breast cancer'

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