FOCUS ON : RESEARCH
Esophageal Cancer Breakthrough Gets FDA Approval
Dr . Ronan Kelly authors study released in The New England Journal of Medicine on a global phase III clinical trial at 170 sites including Baylor University Medical Center in Dallas .
he results of a study published in April in The New England Journal of Medicine ( NEJM ) found that the immunotherapy drug nivolumab ( Opdivo ® ), if used following chemoradiation therapy and surgical tissue removal for early-stage esophageal or gastroesophageal junction cancers , can significantly prolong disease-free survival and reduce the risk of disease recurrence . The U . S . Food and Drug Administration granted approval for this use in May .
Ronan Kelly , MD , MBA , medical director of Baylor Scott & White Charles A . Sammons Cancer Center and the W . W . Caruth Jr . Chair of Immunology at Baylor University Medical Center in Dallas , was the lead author of the recently released NEJM article . He and the other researchers urgently want to help the 75 % of patients who go through extraordinarily difficult sequences of radiation , chemotherapy and surgery that disfigure the digestive system , only to learn that cancer is still present or has a high likelihood of recurring .
“ The war on cancer is continuing while we fight the COVID-19 pandemic . For the first time ever , we now have a therapeutic option in the postoperative setting to improve disease-free survival for these patients ,” said Dr . Kelly , who served as the study ’ s principal investigator for the last five years .
This breakthrough comes at a time when esophageal and gastric cancers , combined , are the second leading cause of cancer deaths worldwide . The American Cancer Society estimates that in the U . S . there will be 19,260 new esophageal cancer and 26,560 stomach cancer cases diagnosed this year .
“ This novel treatment is the first of its kind to harness the body ’ s own immune system to fight early-stage E / GEJ cancers more effectively , providing patients a chance to prevent disease recurrence ,” Dr . Kelly explained . “ In this trial , we saw a doubling in median disease-free survival compared to placebo , which suggests that Opdivo could become a new standard of care for these patients . This is exciting news , providing renewed hope .” The results of this study have led the therapy to become a potential new standard of care for esophageal and gastroesophageal cancers , which are notoriously difficult to treat and have seen limited advances over the last few decades .
This clinical trial is one of many innovative trials at Baylor University Medical Center , offering patients access to potentially exciting treatment options , many of which are looking to turn on a patient ’ s own cancer fighting cells — their immune cells — to wage a microscopic war on their tumor cells . There are more than
100 active clinical trials enrolling patients with cancer throughout the health system .
JEFF YORK
A Patient Reacts …
Hearing news of the impressive outcomes of the clinical trial that Dr . Kelly led , which resulted in a new therapy for esophageal or gastroesophageal junction cancers , was a moment to remember for Jeff York , a member of the Baylor Scott & White Charles A . Sammons Cancer Center Dallas advisory board and a generous donor who has chosen to help support Hope Lodge .
“ I was quite emotional in the recent board meeting when Dr . Kelly made this announcement because in the recent past , we would not have had this kind of breakthrough in immunotherapy for this type of cancer ,” York recalled of that moment .
York is more than a dedicated board member ; he ’ s also a patient who spends every Wednesday at the Sammons Center for infusions to keep his own esophageal and gastroesophageal junction cancer at bay .
While esophageal and gastroesophageal junction cancers are seeing a significant increase in the U . S . and in other industrialized countries , the breakthroughs in treatment have not kept pace
with the advancement of the disease , York expressed .
“ Dr . Kelly has created a very impactful and powerful advancement in treatment for this cancer ,” he said . “ For the first time in so many years , there is great hope for those battling this disease .
“ Clinical trials in immunotherapy are essential to the future of treatment , and we are grateful for the brilliant doctors and scientists who dedicate their lives to finding a cure .”
Jeff York and Dr . Ronan Kelly
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Opdivo ® is a registered trademark of Bristol Myers Squibb . THE COMPASS / BAYLOR SCOTT & WHITE FOUNDATION NEWS / SUMMER 2021