Neoadjuvant pembrolizumab does not increase surgical complications in oral cavity cancer
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DALLAS — Neoadjuvant pembrolizumab did not increase risk for serious surgical complications among patients with advanced oral cavity cancer, study results presented at American Head & Neck Society Annual Meeting showed.
In addition, neoadjuvant pembrolizumab can potentially reduce perioperative morbidity given immediate tumor response prior to surgical resection.
“A lot of us have been suspicious that perhaps immunotherapy could cause poor wound healing, and this contradicts other data that have already been published,” Alice L. Tang, MD, assistant professor at University of Cincinnati Medical Center, told Healio. “Surgeons in the community and clinicians should be reassured that there is emerging data that tells us more about adverse events after neoadjuvant immunotherapy, and that perhaps we’ll be OK with wound healing in this scenario.”
Background
Surgical complications are common after resection of primary oral cavity cancer.
Pembrolizumab (Keytruda, Merck) — a monoclonal antibody that targets PD-1 — is approved in the United States for treatment of recurrent unresectable or metastatic head and neck squamous cell carcinoma, including squamous cell carcinoma of the oral cavity.
The potential utility of neoadjuvant PD-1 inhibitor therapy as part of primary surgical management of HNSCC — as well as its effect on surgical outcomes — are poorly understood, according to study background.
A multi-institutional clinical trial has been designed to evaluate use of neoadjuvant pembrolizumab for treatment of locally advanced HNSCC. As part of that trial, Tang and colleagues aimed to evaluate surgical complications among patients with treatment-naive primary oral cavity squamous cell carcinoma who received neoadjuvant pembrolizumab prior to surgical resection.
Methods
Tang and colleagues retrospectively reviewed trial data from a cohort of 32 patients (average age, 58 years; standard deviation, ± 3.92; 59% male, 94% white) with primary oral cavity squamous cell carcinoma who received neoadjuvant pembrolizumab prior to surgical resection at a single tertiary medical center.
Most (56%) of the cohort had more than a 10 pack-year smoking history, the majority (85%) had stage IV disease and nearly all (97%) underwent free flap reconstruction.
Researchers captured adverse events that occurred during the trial. They used electronic medical records to identity post-surgical treatment complications, as well as the frequency with which patients returned to the operating room within days of primary surgery.
Investigators compared results from this cohort with controls matched for site, age, sex, race, stage and smoking status.
Key findings
Researchers reported no statistically significant differences between the pembrolizumab group and control group with regard to edema/lymphedema (63% each), flap failure (8.8% vs. 6.3%), fistula (18% vs. 22%), wound dehiscence (12% vs. 22%), wound infection (21% vs. 22%), hematoma (5.9% vs. 3.1%) or return to the operating room within 30 days (21% vs. 22%).
Results showed a statistically significant decrease in trismus in the pembrolizumab group (22% vs. 50%; P = .02).
A prior report from Mays and colleagues showed patients who received preoperative immunotherapy did develop major complications that required surgical treatment.
“Our study differs in that our group is as homogenous as we can get it — advanced-stage, treatment-naive oral cavity cancer,” Tang said. “None of our patients received surgery or radiation prior that might confound the wound healing aspect after surgery.
“We found it interesting that incidence of trismus was lower in the neoadjuvant group,” Tang added. “This suggests potential lower perioperative morbidity with neoadjuvant treatment.”
Tang acknowledged study limitations, including the small sample size and researchers’ ability to only capture certain adverse events.
“We were limited by what was discoverable in our historical matched controls,” Tang said. “We’re not meticulously collecting adverse events during standard of care, whereas in a clinical trial, everything is captured.”
Further studies designed to evaluate larger cohorts of patients receiving neoadjuvant pembrolizumab prior to surgical resection of primary oral cavity squamous cell carcinoma are warranted, Tang said.
“Neoadjuvant immunotherapy is going to be more and more important for head and neck cancers, particularly advanced disease,” she told Healio. “We really need to know much more about the surgical implications and how this can affect outcomes.”
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Tang AL, et al. Abstract AHNS040. Presented at: American Head & Neck Society Annual Meeting at COSM 2022; April 27-28, 2022; Dallas.
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