Mays Cancer Center at UT Health San Antonio melanoma expert Monte Shaheen, MD, was part of a team of investigators that conducted a phase II clinical trial funded by the National Cancer Institute (NCI) to determine the efficacy and safety of administering the immunotherapy drug pembrolizumab before and after surgery in high-risk melanoma patients.
Recently published in the New England Journal of Medicine, the results of the clinical trial show participants with stage III and IV melanoma who were given pembrolizumab before and after surgery (neoadjuvant-adjuvant therapy) had significantly lower risks of recurring cancer than participants who received the drug only after surgery (adjuvant-only).
Neoadjuvant therapies are delivered before the main treatment to help reduce the size of a tumor or eradicate cancer cells that have spread. Adjuvant therapies are delivered after the primary treatment to destroy the remaining cancer cells. For this study, patients showed favorable outcomes for the neoadjuvant-adjuvant pembrolizumab in advanced melanoma.
The clinical trial was conducted at several NCI-designated Cancer Centers across the nation. Shaheen, hematology oncologist, professor of oncology and director of the immunotherapy program at Mays Cancer Center at UT Health San Antonio, was one of the principal investigators of the clinical trial.
“These results are significant for patients who are diagnosed with high-risk melanoma and changes the standard of care,” Shaheen said. “It demonstrates pembrolizumab is best administered before and after surgery. At Mays Cancer Center, our multidisciplinary team provides high-quality comprehensive care for our patients with melanoma. We continue to work to bring novel immunotherapy options to the San Antonio community and South Texas.”
Investigators enrolled 345 participants with stage III or stage IV melanoma. Participants aged 18 to 90 randomly received either 200 mg of pembrolizumab every three weeks following surgery (adjuvant-only) for a total of 18 doses, or 200 mg of pembrolizumab every three weeks for three doses leading up to surgery (neoadjuvant-adjuvant), then an additional 15 doses following surgery.
Among the participants with stage III or stage IV melanoma, event-free survival was significantly longer for those who started with the neoadjuvant-adjuvant therapy. No new toxic effects were identified. Event-free survival is defined as the time after treatment when a group of clinical trial participants did not have recurring cancer or conditions.
For more information about the Mays Cancer Center, visit cancer.uthscsa.edu or call (210) 450-1000.