KEY TAKEAWAYS
- The phase II trial aimed to assess the effect of perioperative ICI on disease outcomes in women with residual triple-negative breast cancer after neoadjuvant chemotherapy.
- The primary endpoint is to determine EFS. Secondary endpoints were DFS, DDFS, OS, and safety.
- The tumor and serum samples will be analyzed to study the immune response to perioperative ICI and identify factors that predict response and toxicity.
Cryoablation destroys tumors and releases antigens that can boost the immune system. Preclinical and clinical studies show that cryoablation with immune checkpoint inhibition (ICI) is safe and effective in early-stage breast cancer patients (pts).
Researchers aimed to assess the effect of perioperative ICI on disease outcomes in women with residual triple-negative breast cancer after neoadjuvant chemotherapy, a group at high risk of early recurrence.
The study included women above 18 years old who have low ER and PR levels (<10%), test negative for HER2 according to ASCO/CAP criteria, have a tumor size of at least 1.0 cm, and still have operable residual disease after receiving taxane-based neoadjuvant chemotherapy. Of 16 out of 80 pts have been enrolled and treated with a combination of ipilimumab (ipi), nivolumab (nivo), and cryotherapy followed by breast surgery and adjuvant nivolumab. Pts underwent cryotherapy with image guidance and a research core biopsy 7-10 days before surgery. They also received ipi (1mg/kg IV) and nivo (240mg IV) 1 to 5 days before cryotherapy. After surgery, they received 3 more doses of nivo at 240mg IV every two weeks. To account for the FDA’s approval of pembrolizumab (pembro) for curative purposes in 2021, the protocol has been updated to allow standard-of-care pembro as an alternative ICI option.
Adjuvant treatment with either capecitabine or olaparib is recommended for all pts following their local standard of care. Pts will be stratified based on whether they received platinum-based neoadjuvant chemotherapy, anthracycline-based neoadjuvant chemotherapy, and their clinical nodal status (positive versus negative).
The primary endpoint is to determine the 3-year Event Free Survival (EFS). Secondary endpoints include invasive Disease-Free Survival (IDFS), Distant Disease-Free Survival (DDFS), overall survival (OS), and safety.
The tumor and serum samples will be analyzed to study the immune response to perioperative ICI and identify factors that predict response and toxicity.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.TPS635
Clinical Trial: https://www.clinicaltrials.gov/study/NCT03546686
Heather L. McArthur, Elizabeth Anne Comen, Yolanda Bryce, Stephen Barnett Solomon, Jorge Henrique S. Leal, Christina DiLauro Abaya, Cristal Martinez, Reva K Basho, Philomena McAndrew, Brigid Larkin, David B. Page, Staci L. Mellinger, Nicole Fredrich, Nicole Moxon, Sangeetha M. Reddy, Meredith Carter, Sujata Patil, Basak Dogan, Margaret Elena Gatti-Mays, and Larry Norton. DOI: 10.1200/JCO.2023.41.16_suppl.TPS635 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) TPS635-TPS635.
