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Induction, chemoradiation regimen effective for stage III/IV head and neck cancers
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Induction treatment with cetuximab, paclitaxel and carboplatin, followed by chemoradiation with the same combination, induced high rates of primary site response in patients with stage III or stage IV head and neck squamous cell carcinoma, according to results of a phase 2 study.
The regimen also was associated with promising OS and EFS, researchers wrote.
Harold J. Wanebo
Harold J. Wanebo, MD, director of the department of surgery at Landmark Medical Center in Woonsocket, R.I., and colleagues assessed the regimen in 63 patients with resectable stage III or stage IV head and neck squamous cell carcinoma (HNSCC).
All patients underwent induction therapy with cetuximab (Erbitux; Bristol-Myers Squibb, Eli Lilly), paclitaxel and carboplatin. Primary site restaging biopsies were performed at week 8 in patients who demonstrated clinical complete response and at week 14 among patients with persistent disease.
Chemoradiation with the same three-agent combination began at week 9. Patients whose biopsy at week 14 was negative completed chemoradiation. All other patients underwent resection.
After induction, 41 patients underwent primary site biopsy at week 8. Twenty-four of those patients (59%) had no tumor, equating to pathologic complete response.
Thirty-four patients underwent biopsy at week 14 during chemoradiation; of them, 15 had been classified as positive on week 8 biopsy and 19 had not undergone prior biopsy. Results were negative for 33 of those 34 patients, meaning 90% of eligible patients completed chemoradiation.
Forty-four patients (70%) were alive without surgery or disease progression at 1 year post-treatment. At 3 years, OS was 78% and EFS was 55%.
Twenty-three patients (37%) exhibited disease progression; of them, 10 had local progression only, five had regional progression, two had local and regional progression, and five had distant progression.
Researchers reported no treatment-related deaths. The most common toxicities were hematologic or radiation-related.
Wanebo and colleagues determined response and survival were not dependent on p16 protein expression.
Disclosure: See the study for full list of the researcher’s relevant financial disclosures.
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