Peripheral immune analyses correlate with clinical outcome: A phase II trial of nivolumab, capecitabine, or the combination in patients with triple negative breast cancer

Authors

• NJ Toney
• F Lynce
• C Mainor
• C Isaacs
• J Schlom
• RN Donahue

Abstract

We report on immune correlates from the OXEL study (NCT03487666), a phase II trial in patients with triple negative breast cancer with residual disease following neoadjuvant chemotherapy, treated with post-neoadjuvant nivolumab (Arm A, n=15), capecitabine (Arm B, n=14), or the combination (Arm C, n=13). Peripheral blood mononuclear cells were evaluated at baseline and early after therapy in patients by flow cytometry to identify 158 immune cell subsets. Peripheral immunoscores reflecting enhanced immune cell function were calculated to evaluate changes in the immune profile induced by each therapy, and associations with disease recurrence at baseline. At 6 weeks, an increase in immune cell function was seen in patients on Arms A+C versus Arm B. Additional distinct immune subsets showed statistical changes after therapy that were specific to each arm. At baseline, a higher peripheral immunoscore was associated with no recurrence in patients on Arm A or Arms A+C, but not Arm B. Patients on Arm A or Arms A+C with a peripheral immunoscore above the median had a longer interval of disease-free survival than patients at or below the median, which was not seen in Arm B. Distinct immune subsets at baseline also associated with development of recurrence in each arm. Patients receiving nivolumab, with or without capecitabine, showed enhanced immune cell function. A peripheral immunoscore based on the immune profile at baseline associated with disease recurrence only in patients receiving immunotherapy. These data highlight the importance of assessing peripheral blood to reveal immunologic phenomenon and associations with clinical outcome.

Scientific Focus Area: Cancer Biology

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