A phase Ib study of pre-operative, locoregional IRX-2 cytokine immunotherapy to prime immune responses in patients with early stage breast cancer.
Clinical cancer research : an official journal of the American Association for Cancer Research
PURPOSE: To evaluate the safety and feasibility of pre-operative locoregional cytokine therapy (IRX-2 regimen) in early stage breast cancer, and to evaluate for intratumoral and peripheral immunomodulatory activity.
EXPERIMENTAL DESIGN: Sixteen patients with stage I-III early stage breast cancer (any histology type) indicated for surgical lumpectomy or mastectomy were enrolled to receive pre-operative locoregional immunotherapy with the IRX-2 cytokine biologic (2mL subcutaneous x 10 days to peri-areolar skin). The regimen also included single-dose cyclophosphamide (300mg/m
RESULTS: Pre-operative locoregional cytokine administration was feasible in 100% (n=16/16) of subjects and associated with increases in stromal tumor-infiltrating lymphocytes (p
CONCLUSIONS: IRX-2 is safe in early stage breast cancer. Potentially favorable immunomodulatory changes were observed, supporting further study of IRX-2 in early stage breast cancer and other malignancies.
Women & Children
Earle A. Chiles Research Institute
Page, David B; Pucilowska, Joanna; Sanchez, Katherine G; Conlin, Alison K; Acheson, Anupama; Perlewitz, Kelly S; Imatani, James H; Aliabadi-Wahle, Shagheyegh; Moxon, Nikki; Mellinger, Staci; Seino, Amanda Y; Martel, Maritza; Wu, Yaping; Sun, Zhaoyu; Redmond, William L.; Conrad, Valerie; Rajamanickam, Venkatesh; Waddell, Dottie; Laxague, Deborah; Shah, Monil; Chang, Shu-Ching; and Urba, Walter, "A phase Ib study of pre-operative, locoregional IRX-2 cytokine immunotherapy to prime immune responses in patients with early stage breast cancer." (2019). Articles, Abstracts, and Reports. 2582.