A phase Ib study of pre-operative, locoregional IRX-2 cytokine immunotherapy to prime immune responses in patients with early stage breast cancer.

Publication Title

Clinical cancer research : an official journal of the American Association for Cancer Research

Authors

David B Page, Providence Cancer Center, Earle A. Chiles Research Institute Portland , OR , USAFollow
Joanna Pucilowska, Earle A. Chiles Research Institute, Providence Portland Medical Center, Portland, ORFollow
Katherine G Sanchez, Cancer Research Center, Earle A. Chiles Research Institute, Providence Cancer InstituteFollow
Alison K Conlin
Anupama Acheson, Cancer Research Center, Earle A. Chiles Research Institute, Providence Cancer InstituteFollow
Kelly S Perlewitz, Providence Cancer Institute, Newberg, OR, USA.Follow
James H Imatani, Providence Portland Surgical Specialists, Earle A. Chiles Research Institute, Providence Cancer InstituteFollow
Shagheyegh Aliabadi-Wahle, Earle A. Chiles Research Institute, Portland, OR; Providence Cancer Institute, Portland, ORFollow
Nikki Moxon, Earle A. Chiles Research Institute, Providence Portland Medical Center, Portland, ORFollow
Staci Mellinger, Earle A. Chiles Research Institute, Portland, OR; Providence Cancer Institute, Portland, ORFollow
Amanda Y Seino, Medical Oncology, Earle A. Chiles Research Institute, Providence Cancer InstituteFollow
Maritza Martel, Providence Portland Medical Center, Portland, ORFollow
Yaping Wu, Pathology, Providence Portland Medical CenterFollow
Zhaoyu Sun, Earle A. Chiles Research Institute, Providence Portland Medical CenterFollow
William L. Redmond, Earle A Chiles Research InstituteFollow
Valerie Conrad, Earle A. Chiles Research Institute, Portland, OR; Providence Cancer Institute, Portland, ORFollow
Venkatesh Rajamanickam, Earle A. Chiles Research Institute, Providence Portland Medical Center, Portland, ORFollow
Dottie Waddell, Earle A. Chiles Research Institute, Providence Cancer Institute
Deborah Laxague, Cancer Center, Earle A. Chiles Research Institute, Providence Cancer Institute
Monil Shah
Shu-Ching Chang, Medical Data Research Center, Providence Health & Services, Portland, OR, USAFollow
Walter Urba, Earle A. Chiles Research Institute, Providence Cancer Center, Portland, OR, 97213, USA.Follow

Document Type

Article

Publication Date

12-12-2019

Abstract

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.

Clinical Institute

Cancer

Clinical Institute

Women & Children

Specialty

Oncology

Specialty

Earle A. Chiles Research Institute

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