Neoadjuvant Nivolumab plus Carboplatin and Paclitaxel in Patients with Locally Advanced Resectable Squamous Cell Carcinoma of the Head and Neck: A Phase II, Single-Arm Trial.
Ralph G Zinner, Eric V Mastrolonardo, Jennifer M Johnson et al.
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In 30 seconds
This single-arm, open-label phase II trial evaluated neoadjuvant nivolumab plus carboplatin and paclitaxel in patients with newly diagnosed, locally advanced, resectable head and neck squamous cell carcinoma, including HPV-negative disease and HPV-positive oropharyngeal disease. Of 34 enrolled patients, 33 underwent surgery. The primary endpoint was pathologic complete response (pCR) at the primary site; 15 patients (45%) achieved pCR, and 24 (73%) had at least a major pathologic response. At 3 years, recurrence-free survival was 74% and overall survival was 83% in an unplanned analysis.
Key findings
- Fifteen patients (45%) achieved a pathologic complete response at the primary site; 24 (73%) had at least a major pathologic response.
- In an unplanned 3-year analysis, recurrence-free survival was 74% and overall survival was 83%.
- Fourteen patients (41%) experienced grade 3/4 treatment-related adverse events; 27 (82%) completed all neoadjuvant cycles.
- Thirty-three patients underwent surgery, with R0 resection in 100%.
Why it matters
Pathologic response after neoadjuvant treatment is clinically relevant in resectable head and neck cancer, and this trial reports substantial response rates with a regimen combining chemotherapy and PD-1 inhibition. The findings provide a rationale for confirmatory evaluation, while the single-arm design means they cannot establish comparative benefit over neoadjuvant chemotherapy or other approaches.
What to keep in mind
The phase II trial was single-arm and open-label, so it cannot determine whether adding nivolumab improves outcomes compared with chemotherapy alone. The 3-year survival analysis was unplanned.