Adjuvant + Neoadjuvant Pembrolizumab Safe in Patients Undergoing HNSCC Surgery
In patients who undergo surgery for HNSCC, pembrolizumab treatment appears to be well tolerated.
|The following article features coverage from the 2017 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois. Click here to read more of Oncology Nurse Advisor's conference coverage.|
CHICAGO — Neoadjuvant and adjuvant pembrolizumab treatment is safe and well tolerated in patients who undergo surgery for metastatic head and neck squamous cell carcinoma (HNSCC), according to study findings presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.
The study also provides evidence supporting an antitumor effect in these patients with a single dose of pembrolizumab preoperatively, researchers reported.
Ravindra Uppaluri, MD, of Brigham and Women's Hospital (BWH) and Dana-Farber Cancer Institute (DFCI) in Boston, and colleagues presented findings from 24 patients with surgically resectable locally advanced HPV-negative HNSCC, all of whom received 1 dose of pembrolizumab (200 mg) prior to surgery. All patients were treated at Washington University in St Louis, Missouri, by Dr Uppaluri and Douglas Adkins, MD. The trial recently began enrolling patients at BWH and DFCI.
Patients with high-risk pathologic features received postoperative adjuvant (POA) cisplatin and radiation followed by pembrolizumab. The patients had a median age of 59 years, and 84% used tobacco. Clinically staged T2 disease was present in 2 patients and T4 disease was present in 22 patients; cN0/1 and cN2 disease were present in 9 and 15 patients, respectively.
Preliminary analyses revealed no serious study drug-related adverse events or unexpected surgical delays or complications. The investigators observed no locoregional recurrence/distant metastases events in the 14 patients with more than 1 year follow-up after surgery. High-risk pathologic features were found in 42% of patients, and 42% of patients had a pathologic treatment response to neoadjuvant pembrolizumab.
Six patients (25%) experienced a pathologic treatment effect in 50% or more of the resected tumor and/or lymph node tissue area. Baseline tumor biopsies were PD-L1 positive (more than 1% of tumor cells) in 11 (58%) of 19 evaluable samples and in 7 (88%) of 8 evaluable pathologic responders, according to the researchers.
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Reference1. Uppaluri R, Zolkind P, Lin T, et al. Neoadjuvant pembrolizumab in surgically resectable, locally advanced HPV negative head and neck squamous cell carcinoma (HNSCC). Oral presentation at: 2017 American Society of Clinical Oncology Annual Meeting; June 2-6, 2017; Chicago, IL.