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William J. Gradishar, MD, FACP, FASCO


ESMO 2022: Chemotherapy Plus Immunotherapy for Estrogen Receptor–Positive Metastatic Breast Cancer

By: Julia Fiederlein
Posted: Monday, September 12, 2022

Data are limited regarding the safety and efficacy of immune checkpoint inhibitors in patients with estrogen receptor–positive breast cancer. Thus, Jon Amund Kyte, MD, PhD, of Oslo University Hospital, Norway, and colleagues conducted the phase IIB ICON trial to evaluate the concomitant addition of the anti–CTLA-4 monoclonal antibody ipilimumab and the anti–PD-1 monoclonal antibody nivolumab to chemotherapy. Based on their findings, which were presented during the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract 215MO), this combination did not seem to confer clinical benefit in the metastatic setting.

“Patients receiving ipilimumab and nivolumab had more adverse events, but the toxicity was manageable,” the investigators commented. “Biomarker analyses will be important to determine if further studies on selected subgroups are warranted.”

Patients with estrogen receptor–positive, HER2-negative breast cancer who were administered a maximum of one previous line of chemotherapy after metastasis were randomly assigned in a 2:3 ratio to receive chemotherapy with pegylated liposomal doxorubicin plus cyclophosphamide alone (n = 33) or in combination with ipilimumab and nivolumab (n = 49). The incidence rate of serious adverse events was higher with chemotherapy plus immunotherapy than with chemotherapy alone (63% vs. 39%). Hypothyroidism (45%), hyperthyroidism (22%), hypophysitis (10%), and pneumonitis (8%) were the most frequently reported immune-related adverse events with chemotherapy plus immunotherapy.

The median duration of progression-free survival was 5.1 months with chemotherapy plus immunotherapy and 3.7 months with chemotherapy alone (hazard ratio [HR] = 0.94). Chemotherapy plus immunotherapy resulted in a longer median duration of overall survival than chemotherapy alone (20.9 vs. 19.9 months; HR = 1.13). The objective response rate was 32% versus 29% with and without immunotherapy, respectively. The clinical benefit rate was 55% with chemotherapy plus immunotherapy and 48% with chemotherapy alone. Biomarker analyses and assessments of immunologic changes during therapy are ongoing.

Disclosure: For full disclosures of the study authors, visit

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