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Pembrolizumab inPatients WithAdvancedTriple-NegativeBreast Cancer: PhaseIb KEYNOTE-012 Study Rita NandaLaura Q.M. ChowElizabeth Claire Dees2016 год

Pembrolizumab in Patients With Advanced Triple-Negative Breast Cancer: Phase Ib KEYNOTE-012 Study
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Аннотация: Purpose Immune checkpoint inhibition has been demonstrated to be an effective anticancer strategy. Several lines of evidence support the study of immunotherapy in triple-negative breast cancer (TNBC). We assessed the safety and antitumor activity of the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab in patients with advanced TNBC. Methods KEYNOTE-012 ( ClinicalTrials.gov identifier: NCT01848834) was a multicenter, nonrandomized phase Ib trial of single-agent pembrolizumab given intravenously at 10 mg/kg every 2 weeks to patients with advanced PD-L1–positive (expression in stroma or ≥ 1% of tumor cells by immunohistochemistry) TNBC, gastric cancer, urothelial cancer, and head and neck cancer. This report focuses on the TNBC cohort. Results Among 111 patients with TNBC whose tumor samples were screened for PD-L1 expression, 58.6% had PD-L1–positive tumors. Thirty-two women (median age, 50.5 years; range, 29 to 72 years) were enrolled and assessed for safety and antitumor activity. The median number of doses administered was five (range, 1 to 36 doses). Common toxicities were mild and similar to those observed in other tumor cohorts (eg, arthralgia, fatigue, myalgia, and nausea), and included five (15.6%) patients with grade ≥ 3 toxicity and one treatment-related death. Among the 27 patients who were evaluable for antitumor activity, the overall response rate was 18.5%, the median time to response was 17.9 weeks (range, 7.3 to 32.4 weeks), and the median duration of response was not yet reached (range, 15.0 to ≥ 47.3 weeks). Conclusion This phase Ib study describes preliminary evidence of clinical activity and a potentially acceptable safety profile of pembrolizumab given every 2 weeks to patients with heavily pretreated, advanced TNBC. A single-agent phase II study examining a 200-mg dose given once every 3 weeks ( ClinicalTrials.gov identifier: NCT02447003) is ongoing.
Год издания: 2016
Авторы: Rita Nanda, Laura Q.M. Chow, Elizabeth Claire Dees, Raanan Berger, Shilpa Gupta, Ravit Geva, Lajos Pusztai, Kumudu Pathiraja, Gursel Aktan, Jonathan D. Cheng, Vassiliki Karantza, Laurence Buisseret
Издательство: Lippincott Williams & Wilkins
Источник: Journal of Clinical Oncology
Ключевые слова: Cancer Immunotherapy and Biomarkers, Lung Cancer Treatments and Mutations, CAR-T cell therapy research
Другие ссылки: Journal of Clinical Oncology (HTML)
Europe PMC (PubMed Central) (PDF)
Europe PMC (PubMed Central) (HTML)
PubMed Central (HTML)
PubMed (HTML)