Results from a new clinical trial suggest that neoadjuvant immunotherapy for oral cavity cancers may elicit tumor regression, which could provide long-term benefit for patients. Findings were presented by Jonathan D. Schoenfeld, MD, MPH, of Dana-Farber/Brigham and Women's Cancer Center, and colleagues at the 2020 Multidisciplinary Head and Neck Cancers Symposium (Abstract 1).
Jonathan D. Schoenfeld, MD, MPH
In the randomized trial, two neoadjuvant doses of nivolumab given with or without ipilimumab led to complete or partial tumor shrinkage in most patients and did not result in the delay of any standard treatment.
“With roughly 3 weeks of treatment, we were able to trigger significant tumor regression. In a couple cases, there were complete pathological responses, and in other cases, there was very little tumor left. Both the single-drug and the two-drug combination led to visible tumor shrinkage, and, albeit with relatively early follow-up, the majority of these patients have no evidence of disease recurrence,” said Dr. Schoenfeld. “Our hope is that even a couple doses of immunotherapy can stimulate an immune response that continues to prevent the cancer from coming back after patients have surgery and other therapy.”
Methods
The trial enrolled 30 adults newly diagnosed with tumors in their tongue, gums, or other part of the mouth; all tumors were stage T2 or higher and over half of the patients' cancers had spread to their lymph nodes. After receiving two doses of the programmed cell death protein 1 inhibitor nivolumab either alone or in combination with a single dose of the CTLA-4 inhibitor ipilimumab over the course of 3 weeks, no patients were delayed from surgery, the first component of standard treatment for this disease.
Responses
Most patients (52%) experienced clinical reduction of their primary tumor after immunotherapy, and four patients (one in the single-drug group, three in the combination group) had more than a 90% pathologic response. While these exploratory results are promising, Dr. Schoenfeld noted that direct comparisons with the current standard of care are needed to determine whether the single-agent or combination therapy can lead to durable responses and improve patient survival. The researchers also want to understand why immunotherapy worked better with some patients than others and identify additional immune targets that could further enhance the treatment.
“Oral cavity cancer is a notoriously difficult cancer with high rates of disease recurrence and death, and the side effects from standard treatment tend to be particularly challenging because the treated area is essential for speaking, swallowing, and breathing. We're excited about moving immunotherapy earlier to treat more of these curative patients and, in the future, possibly reduce how aggressive their other treatments need to be.”— Jonathan D. Schoenfeld, MD, MPH
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Twenty-one of the 30 patients experienced side effects possibly related to treatment, and grade 3–4 toxicities were experienced by 5 patients (33%) in the combination group and 2 patients (14%) in the single-drug group.
While immunotherapy drugs generally are used after other treatments have failed and a patient's cancer has spread, this study adds to a growing body of research on immunotherapy given prior to surgery for patients with newly diagnosed, curable disease, explained the authors. “The preoperative setting is interesting because patients’ immune systems haven't been affected by prior treatment. The tumor is actually in place to serve as a focal point for an immune response, so it may be easier for the body's immune system to recognize and target the tumor,” explained Dr. Schoenfeld.
“Oral cavity cancer is a notoriously difficult cancer with high rates of disease recurrence and death, and the side effects from standard treatment tend to be particularly challenging because the treated area is essential for speaking, swallowing, and breathing,” he continued. “We're excited about moving immunotherapy earlier to treat more of these curative patients and, in the future, possibly reduce how aggressive their other treatments need to be.”
Disclosure: For full disclosures of the study authors, visit astro.confex.com.
