Carolinas HealthCare System
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Breakthrough lung cancer drug holds new promise for patients
with advanced-stage disease, new research suggests
Carolinas HealthCare System published in New England Journal of Medicine for research demonstrating the effectiveness of gene therapy in patients with late-stage lung cancer

April 30, 2015 — Carolinas HealthCare System’s Levine Cancer Institute today was featured in the New England Journal of Medicine for its prominent role in research that advances the treatment of advanced-stage lung cancer. Daniel Haggstrom, MD, is a medical oncologist at the Institute and co-author of the study, which demonstrated the efficacy of a molecular-targeted therapy, AZD9291, in patients with advanced-stage lung cancer.

Non-small cell lung cancer (NSCLC) is the leading cause of cancer mortality in the United States. Historically, treatments were limited to chemotherapy or radiation therapy if surgery cannot be performed. With advances in molecular testing and through clinical trials, oncologists are finding new targeted therapies that work very well for some patients with much less toxicity. The drug, AZD9291, targets a specific gene mutation, which makes the preferred first line therapy for this subset of patients ineffective.

Of the patients enrolled in the study who had developed a resistance to previous medication and were instructed to take the pill, AZD9291, once a day, 80% experienced tumor shrinkage or stability with manageable side effects.

“We are seeing amazing results with this treatment. Patients are living longer, with an improved quality of life compared to traditional chemotherapy, and the side effects of AZD9291 are very manageable,” said Dr. Haggstrom, principal investigator of the study at Levine Cancer Institute. “It is an exciting time in cancer care and, in particular, lung cancer. Through research and clinical trials, we are tailoring our therapies to improve outcomes and limit adverse side effects.”

EGFR, or epidermal growth factor receptor, is a protein that exists on the surface of both cancer cells and normal cells. In some cancer cells this receptor develops a mutation, yielding constant activation of EGFR and uncontrolled cell division and growth of cancer. In lung cancer patients whose tumors possess EGFR mutations (approximately 10-15% of patients in the United States) molecularly targeted oral therapy is a preferred first treatment option.

Unfortunately, these patients with EGFR- driven lung cancer eventually develop resistance to first line treatment, which previously meant revisiting non-targeted therapies, such as chemotherapy and radiation therapy. In nearly half of the patients who develop this resistance, a specific genetic mutation, T790m, is responsible. AZD9291 directly targets this pathway resulting in a reduction in the size and growth of the non-small cell lung cancer, and secondary to its efficacy in this population received “breakthrough” status by the FDA for extending progression-free survival.

“Identifying genetic mutations specific to a patient’s individualized tumor and giving the appropriate treatment is the future,” said Edward Kim, MD, Chair of Solid Tumor Oncology at Levine Cancer Institute.

Dr. Edward Kim, Levine Cancer Institute

Dr. Kim, Chair of Solid Tumor Oncology at Levine Cancer Institute, shares his thoughts about the study and its implications for the future of molecularly-targeted treatment in cancer.

Dr. Daniel Haggstrom, Levine Cancer Institute

Daniel Haggstrom, MD, is a medical oncologist at the Institute and co-author of the study, which demonstrated the efficacy of a molecular-targeted therapy, AZD9291, in patients with advanced-stage lung cancer.

Edwina, AZD9291 Study Participant & Lung Cancer Survivor

Diagnosed with only months to live, Edwina was enrolled in a study that analyzed the genetics of her tumor and then took aim at a specific mutation. A year later Edwina’s cancer is shrinking and she’s literally back on her feet.

About Levine Cancer Institute

Levine Cancer Institute is changing the course of cancer care by removing the barriers that separate patients from access to world-class research and breakthrough treatments. Through the latest advances in technology and by building upon Carolinas HealthCare System’s strong network of affiliated hospitals and providers, the Institute is able to deliver innovative, value-driven protocols when they are needed most – so where a patient lives will not determine how they fight cancer.

About Carolinas HealthCare System

Carolinas HealthCare System (, one of the nation’s leading and most innovative healthcare organizations, provides a full spectrum of healthcare and wellness programs throughout North and South Carolina. Its diverse network of more than 650 care locations includes academic medical centers, hospitals, healthcare pavilions, physician practices, destination centers, surgical and rehabilitation centers, home health agencies, nursing homes, behavioral health centers, and hospice and palliative care. CHS works to improve and enhance the overall health and wellbeing of its communities through high quality patient care, education and research programs, and numerous collaborative partnerships and initiatives.