Subgroup analysis of nelipepimut-S plus GM-CSF combined with trastuzumab versus trastuzumab alone to prevent recurrences in patients with high-risk, HER2 low-expressing breast cancer

被引：31

作者：

Chick, R. Connor ^{[1
]}

Clifton, G. Travis ^{[1
]}

Hale, Diane F. ^{[1
]}

Vreeland, Timothy J. ^{[1
]}

Hickerson, Annelies T. ^{[1
]}

Bohan, Phillip M. Kemp ^{[1
]}

McCarthy, Patrick M. ^{[1
]}

Litton, Jennifer K. ^{[2
]}

Alatrash, Gheath ^{[3
]}

Murthy, Rashmi K. ^{[2
]}

Qiao, Na ^{[4
]}

Philips, Anne ^{[4
]}

Lukas, Jason ^{[5
]}

Holmes, Jarrod P. ^{[6
]}

Mittendorf, Elizabeth A. ^{[7
,8
]}

Peoples, George E. ^{[9
]}

机构：

[1] Brooke Army Med Ctr, Dept Surg, 3551 Roger Brooke Dr, San Antonio, TX 78234 USA

[2] Univ Texas MD Anderson Canc Ctr, Dept Breast Med Oncol, 1515 Holcombe Blvd,Unit 1354,POB 30149, Houston, TX 77230 USA

[3] Univ Texas MD Anderson Canc Ctr, Dept Stem Cell Transplantat & Cellular Therapy, 1515 Holcombe Blvd,Unit 900, Houston, TX 77030 USA

[4] Univ Texas MD Anderson Canc Ctr, Dept Breast Surg Oncol, Unit 1434,POB 301439, Houston, TX 77230 USA

[5] Univ Washington, Div Oncol, Dept Med, 825 Eastlake Ave E, Seattle, WA 98109 USA

[6] St Joseph Hlth Canc Ctr, Dept Med Oncol, 3555 Round Barn Circle,Suite A, Santa Rosa, CA 95403 USA

[7] Brigham & Womens Hosp, Div Breast Surg, Dept Surg, 450 Brookline Ave, Boston, MA 02215 USA

[8] Dana Farber Brigham & Womens Hosp, Breast Oncol Program, 450 Brookline Ave, Boston, MA 02215 USA

[9] Canc Vaccine Dev Program, 1422 E Grayson,3rd Floor, San Antonio, TX 78208 USA

来源：

CLINICAL IMMUNOLOGY | 2021年 / 225卷

关键词：

Breast cancer; Immunotherapy; Cancer vaccine; Personalized medicine; TUMOR-INFILTRATING LYMPHOCYTES; GROUP-STUDY I-01; E75; VACCINE;

D O I：

10.1016/j.clim.2021.108679

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

HER2-targeted therapy has not benefited patients with low levels of HER2 expression; however, combination therapy may be effective. Primary analysis of a phase IIb trial investigating the HER2-derived vaccine nelipepimut-S (NPS) did not benefit the intention-to-treat population, but subset analysis showed a benefit in triple-negative breast cancer (TNBC) patients. The subset analysis of this multicenter, randomized, single-blind, phase IIb trial identified significant improvement in 36-month disease-free survival (DFS) between NPS (n = 55) and placebo (n = 44) in TNBC (HR 0.25, p = 0.01) and those who express HLA-A24 (HR 0.41, p = 0.05). The TNBC cohort demonstrated improved 36-month DFS in those with HER2 1+ expression (HR 0.17, p = 0.01), HLA-A24 positivity (HR 0.08, p < 0.01), or in those who received neoadjuvant chemotherapy (HR 0.21, p < 0.01). NPS vaccination with trastuzumab was associated with improved 36-month DFS among patients with TNBC. The observed benefit to this high-risk subgroup warrants confirmation in a phase III trial.

引用

页数：8

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