Lineberger Comprehensive Cancer Center / Jared M. Weiss*
Abstract
BACKGROUND:
The objective of this study was to demonstrate the feasibility and efficacy of induction chemotherapy, surgery, and pathology-guided adjuvant therapy to treat transorally resectable squamous head and neck cancer.
METHODS:
Patients had squamous head and neck cancer that was resectable by the transoral route and advanced-stage disease (American Joint Committee on Cancer stage III-IV, T3-T4 tumors, and/or positive lymph nodes). They received treatment with weekly carboplatin at an area under the curve of 2, plus paclitaxel 135 mg/m2 , and daily lapatinib 1000mg for 6 weeks followed by surgical resection. Pathology that revealed margins <5 mm, extracapsular extension, N2a of N2b lymph node status, perineural invasion, or lymphovascular space invasion resulted in adjuvant radiotherapy concurrent with weekly cisplatin. Pathology with N2c/N3 lymph node status or positive margins resulted in radiation with bolus cisplatin. The primary endpoint was the clinical response rate to induction chemotherapy, and a key secondary endpoint was feasibility.
RESULTS:
Toxicity was modest, and 37 of 40 patients completed study procedures as planned. The clinical response rate was 93%, the pathologic complete response rate was 36%, and the clinical response did not predict for a pathologic complete response. No patient on study follow-up has recurred or died. Twenty-nine of 39 patients who underwent surgery avoided radiation. Speech and swallowing function were well preserved.
CONCLUSIONS:
The study met both its primary efficacy endpoint and the secondary feasibility endpoint. Neoadjuvant, systemic therapy and surgical resection followed by risk-adapted adjuvant therapy resulted in high response rates and excellent long-term outcomes and should be further studied. Cancer 2018;124:2986-92. © 2018 American Cancer Society.
Author information
Weiss JM1, Grilley-Olson JE1, Deal AM2, Zevallos JP3, Chera BS4, Paul J1, Knowles MF4, Usenko D1, Weissler MC5, Patel S5, Hayes DN6, Hackman T5.
1
Department of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.
2
Lineberger Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.
3
Head and Neck Surgical Oncology, Washington University School of Medicine, St Louis, Missouri.
4
Department of Radiation Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.
5
Division of Head and Neck Surgery, Department of Otolaryngology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.
6
West Cancer Center, Germantown, Tennessee.