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DALLAS – The use of neoadjuvant immunotherapy drugs does not appear to increase the risk of complications after head and neck surgery, according to a study here.

Overall complications within 30 days among patients who underwent head and neck surgery for cancer without upfront checkpoint inhibitors was about 18%, compared with about 16% for patients who did receive neoadjuvant immunotherapy (P=0.55), reported Ramez Philips, MD, of Thomas Jefferson University Hospitals in Philadelphia.

Surgical complications were observed among 14% of the patients who did not have checkpoint inhibitors, and among 10% of those who did (P=0.29), he said at the annual meeting of the American Head and Neck Society. The rates of medical complications were 7% and 10% (P=0.43), respectively.

"There was no difference in the complication rate in patients receiving surgery with or without immune checkpoint inhibitors," Philips said, adding that two patients with primary head and neck squamous cell carcinoma did not undergo definitive surgery related to disease progression after neoadjuvant immune checkpoint inhibition.

Philips did note that patients who received both neoadjuvant immune checkpoint inhibition and chemotherapy appeared to have an increased risk of post-surgical complications. The risk of complication was five times higher than in patients treated with checkpoint inhibition and carboplatin/paclitaxel (P=0.010). A total of 21 of the 83 patients who received checkpoint inhibitors also received chemotherapy, he said.

He added that some of the patients had also received metformin, tadalafil, or other immune agents along with the checkpoint inhibitors but there did not appear to be a relationship between those treatments and the rate of post-surgery complications.

The retrospective study of patients treated between 2017 and 2021 examined outcomes after transoral robotic surgery or free flap reconstruction, with patients stratified by whether they had or had not received immune checkpoint inhibitors. Of the 463 surgery cases, 83 patients were treated with checkpoint inhibitors -- 62 with nivolumab, and 21 with durvalumab.

"Definitive surgery can be conducted safely after neoadjuvant immunotherapy," Philips and his colleagues concluded in their abstract.

Nicole Schmitt, MD, of Emory University in Atlanta, co-chair of the session where the study was presented, told 番茄社区app: "The study appears to show that immunotherapy doesn't affect complications. We are beginning to get information that giving immunotherapy before surgery has better results if immunotherapy is given before the tumor is removed rather than afterwards.

"There are reports that neoadjuvant treatment is effective in treating the cancer, but there have been anecdotal reports that there have been complications after the surgery," she continued. "In his presentation, Dr. Philips said that two of the patients in the study became unresectable after immunotherapy treatment. To me that would be a complication."

The session's other co-chair, Thomas Ow, MD, of Montefiore/Albert Einstein College of Medicine in Bronx, New York, explained: "These immunotherapy drugs are used so close to the time of surgery, that these studies are necessary to make sure that they aren't harming our ability to optimally treat these patients.

"In chemotherapy we look at the amount of the response, but with surgery it is always a complete response unless you can't cut out all the cancer," he told 番茄社区app. "We have to be sure you are doing patients a service with these drugs. There is a lot of data that show this helps."

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