Details

Autor(en) / Beteiligte

• Rugo, Hope S
• Delord, Jean-Pierre
• Im, Seock-Ah
• Ott, Patrick A
• Piha-Paul, Sarina A
• Bedard, Philippe L
• Sachdev, Jasgit
• Le Tourneau, Christophe
• van Brummelen, Emilie M J
• Varga, Andrea
• Salgado, Roberto
• Loi, Sherene
• Saraf, Sanatan
• Pietrangelo, Dina
• Karantza, Vassiliki
• Tan, Antoinette R

Titel

Safety and Antitumor Activity of Pembrolizumab in Patients with Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer

Ist Teil von

• Clinical cancer research, 2018-06, Vol.24 (12), p.2804-2811

Ort / Verlag

United States: American Association for Cancer Research Inc

Erscheinungsjahr

2018

Quelle

MEDLINE

Beschreibungen/Notizen

• We investigated the safety and antitumor activity of the anti-programmed death 1 monoclonal antibody pembrolizumab in patients with estrogen receptor-positive (ER )/human epidermal growth factor receptor 2-negative (HER2 ) advanced breast cancer with programmed death ligand 1-positive (PD-L1-positive) tumors in the phase Ib open-label, multicohort KEYNOTE-028 (NCT02054806) study. Patients with ER /HER2 advanced breast cancer with PD-L1-positive tumors (combined positive score ≥1) received pembrolizumab (10 mg/kg every 2 weeks) up to 2 years or until confirmed progression/intolerable toxicity. Primary endpoints were safety and overall response rate (ORR), based on Response Evaluation Criteria in Solid Tumors, version 1 (RECIST v1.1) as assessed by investigator review. Between April 2014 and January 2015, 25 patients were enrolled. Median number of prior therapies for breast cancer, including endocrine agents, was 9 (range, 3-15). Median follow-up was 9.7 months (range, 0.7-31.8 months). Three patients experienced partial response (PR) and none experienced complete response (CR), resulting in an ORR of 12.0% (95% CI, 2.5%-31.2%); 16% of patients had stable disease (SD) and clinical benefit rate (CR + PR + [SD for ≥24 weeks]) was 20% (95% CI, 7-41). Median duration of response was 12.0 months (range, 7.4-15.9 months). The incidence of treatment-related adverse events was 64%; nausea (20%) and fatigue (12%) were most common and were predominantly grade 1/2. No treatment-related discontinuations or deaths occurred. Pembrolizumab was well tolerated with modest but durable overall response in certain patients with previously treated, advanced, PD-L1-positive, ER /HER2 breast cancer. .