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Translational Medicine / 转化医学KEYNOTE-048 Co-PI & HNSCC Systemic Therapy

Barbara Burtness

芭芭拉·伯特尼斯

MD

🏢Yale School of Medicine / Yale Cancer Center(耶鲁大学医学院/耶鲁癌症中心)🌐USA

Professor of Medicine (Medical Oncology); Co-Leader, Developmental Therapeutics Program, Yale Cancer Center医学(肿瘤内科)教授,耶鲁癌症中心发展治疗学项目联合主任

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Key Papers
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Awards
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Key Contributions

👥Biography 个人简介

Barbara Burtness, MD is Professor of Medicine (Medical Oncology) and Co-Leader of the Developmental Therapeutics Program at Yale Cancer Center. She is one of the leading clinical investigators in head and neck oncology in the United States, recognized particularly as co-principal investigator of KEYNOTE-048—the landmark trial that established pembrolizumab as the new first-line standard for recurrent/metastatic HNSCC. Dr. Burtness has conducted foundational clinical research on EGFR-targeted therapy in HNSCC, including an early landmark Eastern Cooperative Oncology Group (ECOG) trial demonstrating that cetuximab improves outcomes when added to cisplatin in recurrent/metastatic HNSCC, one of the first positive randomized trials in this population. She has been a leader in cooperative group HNSCC trials through ECOG-ACRIN and has designed studies examining EGFR inhibition, immunotherapy combinations, and novel targeted approaches. Dr. Burtness is known for her contributions to the understanding of HNSCC biology, treatment toxicity management (particularly dermatologic toxicity from EGFR inhibitors), and her commitment to mentoring the next generation of head and neck oncologists.

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🧪Research Fields 研究领域

KEYNOTE-048 Co-Principal InvestigatorKEYNOTE-048联合主要研究员
EGFR Inhibition in HNSCCHNSCC中的EGFR抑制
Head and Neck Cancer Systemic Therapy头颈部癌症系统治疗
Novel Therapeutic Combinations in HNSCCHNSCC新型治疗联合方案
Clinical Trial Design in Head and Neck Oncology头颈部肿瘤临床试验设计

🎓Key Contributions 主要贡献

KEYNOTE-048 Co-Principal Investigator

Served as co-PI of KEYNOTE-048, the phase III trial demonstrating pembrolizumab monotherapy (PD-L1 CPS ≥1) and pembrolizumab plus chemotherapy are superior to the EXTREME regimen in first-line recurrent/metastatic HNSCC, earning FDA approval and reshaping the global standard of care.

Cetuximab Plus Cisplatin in R/M HNSCC — ECOG Trial

Led the pivotal ECOG 5397 randomized trial demonstrating that adding cetuximab to cisplatin in recurrent/metastatic HNSCC significantly improved overall response rate, providing early evidence of EGFR-targeted therapy benefit and informing the rationale for the EXTREME regimen.

EGFR Inhibitor Toxicity Management

Developed expert consensus guidance and clinical best-practices for management of EGFR inhibitor-associated dermatologic toxicities in HNSCC, including acneiform rash, paronychia, and xerosis, improving patient quality of life and treatment adherence.

Cooperative Group HNSCC Trial Leadership

Served in ECOG-ACRIN leadership for head and neck cancer, designing and executing cooperative group trials that have enrolled hundreds of HNSCC patients and generated critical evidence for standard-of-care updates across disease settings.

Representative Works 代表性著作

[1]

Phase III Randomized Trial of Cisplatin plus Placebo Compared with Cisplatin plus Cetuximab in Metastatic/Recurrent Head and Neck Cancer: An Eastern Cooperative Oncology Group Study

Journal of Clinical Oncology (2005)

ECOG 5397 randomized trial demonstrating improved response rate for cetuximab plus cisplatin versus cisplatin alone in R/M HNSCC, an early foundation for EGFR-targeted therapy in this disease.

[2]

Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048)

The Lancet (2019)

Co-authored pivotal KEYNOTE-048 trial establishing pembrolizumab ± chemotherapy as new first-line standard of care in R/M HNSCC.

[3]

Management of Dermatologic Toxicities Associated with Epidermal Growth Factor Receptor Inhibition

Journal of Supportive Oncology (2009)

Expert guidance on identification, grading, and management of EGFR inhibitor skin toxicities in patients with HNSCC and other solid tumors.

[4]

Targeting the EGFR Family in Squamous Cell Carcinoma of the Head and Neck

Frontiers in Oncology (2015)

Comprehensive review of EGFR family biology and targeting strategies in HNSCC with analysis of predictive biomarkers and resistance mechanisms.

🏆Awards & Recognition 奖项与荣誉

🏆ECOG-ACRIN Head and Neck Cancer Committee Vice-Chair
🏆Yale Cancer Center Developmental Therapeutics Program Co-Leadership
🏆American Society of Clinical Oncology Young Investigator Award (early career)
🏆ASCO Annual Meeting Head and Neck Symposium Faculty Recognition

📄Data Sources 数据来源

Last updated: 2026-04-06 | All information from publicly available academic sources

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