Could Opdivo be a New Standard in Esophageal Cancer Therapy?
In a large-scale research study published today in The New England Journal of Medicine (NEJM), Dr. David Ilson reported on the potential of Opdivo (adjuvant nivolumab) as a treatment for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.
According to the study, patients administered with nivolumab have twice the amount of time, from just 11 months to 22 months, without a recurrence of cancer after surgery. This novel cancer therapy recruits the immune system in preventing, or at least, delaying cancer recurrence.
The clinical trial was sponsored by Bristol Myers Squibb and enrolled a total of 794 patients from 29 countries. The qualified patients all had a history of chemotherapy and radiation treatment, and surgery to remove the cancer tumors in their esophagus. The patients were administered either nivolumab or a placebo, randomly.
Adjuvant treatments are often the next course of action due to the high rate of recurrence, especially in cases of Stage II or III esophageal or gastroesophageal junction (GEJ) cancer. With nivolumab, the disease-free survival (DFS) time doubled with no additional adjuvant treatments. More so, this difference from chemotherapy translated to a reduction in disease recurrence or death by 31%.
Before this clinical trial, patients with esophageal cancer were treated with trimodal therapy (chemotherapy, radiotherapy, and surgery), and yet disease recurrence remained to be a great challenge.
Currently, nivolumab is already approved by the U.S. Food and Drug Administration (FDA) as a treatment for advanced-stage cancers, even for those that were classified as unresectable and metastasized or those with tumors that have spread to different parts of the body. Nivolumab is also recommended by the National Comprehensive Cancer Network (NCCN) for use as a category 1 indication in the adjuvant setting for esophageal cancer.
Nivolumab is classified under PD-1 inhibitor drugs that are characterized by their immune approach that enhances the ability of the patient's immune system to identify and get rid of cancer cells or tumors.
Although quite rare compared to other forms of cancer, esophageal cancer claims 15,000 lives each year in the U.S.
Ilson also mentioned that there were no red flags raised in terms of the safety of the treatment, even if there are a few minor side effects such as fatigue, diarrhea, and rash, which affected 10% to 17% of patients. This marked improvement is a "gamechanger" and a "big step forward according to Ilson, an esophageal cancer expert at Memorial Sloan Kettering Cancer Center in New York.