Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial
Elizabeth A. Mittendorf
1, 2
,
Biao Lu
3
,
Michelle Melisko
4
,
Julie Price Hiller
5
,
Igor Bondarenko
6
,
A. Murray Brunt
7
,
Grybach Sergii
8
,
KATARINA PETRAKOVA
9
,
George E. Peoples
10
3
3Independent Statistical Contractor, San Ramon, California.
|
6
6Department of Oncology and Medical Radiology, Dnipropetrovsk State Medical Academy, Dnipropetrovsk, Ukraine.
|
8
8Kyiv Regional Oncologic Dispensary, Kyiv, Ukraine.
|
10
10Cancer Insight, San Antonio, Texas.
|
Publication type: Journal Article
Publication date: 2019-07-15
scimago Q1
wos Q1
SJR: 4.800
CiteScore: 19.0
Impact factor: 10.2
ISSN: 10780432, 15573265
PubMed ID:
31036542
Cancer Research
Oncology
Abstract
Purpose:
In phase I/II studies, nelipepimut-S (NP-S) plus GM-CSF vaccine was well tolerated and effectively raised HER2-specific immunity in patients with breast cancer. Results from a prespecified interim analysis of a phase III trial assessing NP-S + GM-CSF are reported.
Patients and Methods:
This multicenter, randomized, double-blind phase III study enrolled females ≥18 years with T1–T3, HER2 low–expressing (IHC 1+/2+), node-positive breast cancer in the adjuvant setting. Patients received 1,000 μg NP-S + 250 μg GM-CSF or placebo + GM-CSF monthly for 6 months, then every 6 months through 36 months. The primary objective was disease-free survival (DFS). Protocol-specified imaging occurred annually. New abnormalities were categorized as recurrence events; biopsy confirmation was not mandated. The interim analysis was conducted as specified in the protocol after 73 DFS events.
Results:
A total of 758 patients (mean age 51.8 years) were randomized. Adverse events were similar between groups; most common were injection-associated: erythema (84.3%), induration (55.8%), and pruritus (54.9%). There was no significant between-arms difference in DFS events at interim analysis at median follow-up (16.8 months). In the NP-S arm, imaging detected 54.1% of recurrence events in asymptomatic patients versus 29.2% in the placebo arm (P = 0.069).
Conclusions:
NP-S was well tolerated. There was no significant difference in DFS events between NP-S and placebo. Use of mandated annual scans and image-detected recurrence events hastened the interim analysis contributing to early trial termination.
Found
Nothing found, try to update filter.
Found
Nothing found, try to update filter.
Top-30
Journals
|
2
4
6
8
10
12
|
|
|
Cancers
11 publications, 6.32%
|
|
|
Vaccines
10 publications, 5.75%
|
|
|
International Journal of Molecular Sciences
8 publications, 4.6%
|
|
|
Frontiers in Immunology
7 publications, 4.02%
|
|
|
Breast Cancer Research and Treatment
5 publications, 2.87%
|
|
|
Journal of Hematology and Oncology
3 publications, 1.72%
|
|
|
Journal of Cancer Research and Clinical Oncology
2 publications, 1.15%
|
|
|
npj Breast Cancer
2 publications, 1.15%
|
|
|
Frontiers in Oncology
2 publications, 1.15%
|
|
|
Journal of Translational Medicine
2 publications, 1.15%
|
|
|
Cancer Cell International
2 publications, 1.15%
|
|
|
Cancer and Metastasis Reviews
2 publications, 1.15%
|
|
|
Pathology Research and Practice
2 publications, 1.15%
|
|
|
Journal of the National Cancer Center
2 publications, 1.15%
|
|
|
Breast Cancer: Targets and Therapy
2 publications, 1.15%
|
|
|
Expert Review of Anticancer Therapy
2 publications, 1.15%
|
|
|
Clinical Cancer Research
2 publications, 1.15%
|
|
|
Journal of Clinical Oncology
2 publications, 1.15%
|
|
|
Pharmaceuticals
2 publications, 1.15%
|
|
|
Molecular Aspects of Medicine
2 publications, 1.15%
|
|
|
Critical Reviews in Oncology/Hematology
2 publications, 1.15%
|
|
|
Endocrine, Metabolic and Immune Disorders - Drug Targets
1 publication, 0.57%
|
|
|
Current Protein and Peptide Science
1 publication, 0.57%
|
|
|
Current Topics in Medicinal Chemistry
1 publication, 0.57%
|
|
|
Oncotarget
1 publication, 0.57%
|
|
|
Breast Care
1 publication, 0.57%
|
|
|
Molecular and Clinical Oncology
1 publication, 0.57%
|
|
|
Cells
1 publication, 0.57%
|
|
|
Current Oncology
1 publication, 0.57%
|
|
|
2
4
6
8
10
12
|
Publishers
|
5
10
15
20
25
30
35
40
45
|
|
|
Springer Nature
45 publications, 25.86%
|
|
|
MDPI
35 publications, 20.11%
|
|
|
Elsevier
30 publications, 17.24%
|
|
|
Taylor & Francis
12 publications, 6.9%
|
|
|
Frontiers Media S.A.
11 publications, 6.32%
|
|
|
Wiley
7 publications, 4.02%
|
|
|
American Chemical Society (ACS)
4 publications, 2.3%
|
|
|
American Association for Cancer Research (AACR)
4 publications, 2.3%
|
|
|
Bentham Science Publishers Ltd.
3 publications, 1.72%
|
|
|
Spandidos Publications
2 publications, 1.15%
|
|
|
American Society of Clinical Oncology (ASCO)
2 publications, 1.15%
|
|
|
Impact Journals
1 publication, 0.57%
|
|
|
S. Karger AG
1 publication, 0.57%
|
|
|
American Scientific Publishers
1 publication, 0.57%
|
|
|
Oxford University Press
1 publication, 0.57%
|
|
|
Open Exploration Publishing
1 publication, 0.57%
|
|
|
Publishing House ABV Press
1 publication, 0.57%
|
|
|
The American Association of Immunologists
1 publication, 0.57%
|
|
|
Higher Education Press
1 publication, 0.57%
|
|
|
Research Square Platform LLC
1 publication, 0.57%
|
|
|
American Association for the Advancement of Science (AAAS)
1 publication, 0.57%
|
|
|
PeerJ
1 publication, 0.57%
|
|
|
BMJ
1 publication, 0.57%
|
|
|
Tomsk Cancer Research Institute
1 publication, 0.57%
|
|
|
AME Publishing Company
1 publication, 0.57%
|
|
|
Ovid Technologies (Wolters Kluwer Health)
1 publication, 0.57%
|
|
|
5
10
15
20
25
30
35
40
45
|
- We do not take into account publications without a DOI.
- Statistics recalculated weekly.
Are you a researcher?
Create a profile to get free access to personal recommendations for colleagues and new articles.
Metrics
174
Total citations:
174
Citations from 2024:
58
(33.33%)
Cite this
GOST |
RIS |
BibTex |
MLA
Cite this
GOST
Copy
Mittendorf E. A. et al. Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial // Clinical Cancer Research. 2019. Vol. 25. No. 14. pp. 4248-4254.
GOST all authors (up to 50)
Copy
Mittendorf E. A., Lu B., Melisko M., Price Hiller J., Bondarenko I., Brunt A. M., Sergii G., PETRAKOVA K., Peoples G. E. Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial // Clinical Cancer Research. 2019. Vol. 25. No. 14. pp. 4248-4254.
Cite this
RIS
Copy
TY - JOUR
DO - 10.1158/1078-0432.ccr-18-2867
UR - https://doi.org/10.1158/1078-0432.ccr-18-2867
TI - Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial
T2 - Clinical Cancer Research
AU - Mittendorf, Elizabeth A.
AU - Lu, Biao
AU - Melisko, Michelle
AU - Price Hiller, Julie
AU - Bondarenko, Igor
AU - Brunt, A. Murray
AU - Sergii, Grybach
AU - PETRAKOVA, KATARINA
AU - Peoples, George E.
PY - 2019
DA - 2019/07/15
PB - American Association for Cancer Research (AACR)
SP - 4248-4254
IS - 14
VL - 25
PMID - 31036542
SN - 1078-0432
SN - 1557-3265
ER -
Cite this
BibTex (up to 50 authors)
Copy
@article{2019_Mittendorf,
author = {Elizabeth A. Mittendorf and Biao Lu and Michelle Melisko and Julie Price Hiller and Igor Bondarenko and A. Murray Brunt and Grybach Sergii and KATARINA PETRAKOVA and George E. Peoples},
title = {Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial},
journal = {Clinical Cancer Research},
year = {2019},
volume = {25},
publisher = {American Association for Cancer Research (AACR)},
month = {jul},
url = {https://doi.org/10.1158/1078-0432.ccr-18-2867},
number = {14},
pages = {4248--4254},
doi = {10.1158/1078-0432.ccr-18-2867}
}
Cite this
MLA
Copy
Mittendorf, Elizabeth A., et al. “Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial.” Clinical Cancer Research, vol. 25, no. 14, Jul. 2019, pp. 4248-4254. https://doi.org/10.1158/1078-0432.ccr-18-2867.