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  • [Cancer.] Phase 2 trial of neoadjuvant chemotherapy and transoral endoscopic surgery with risk-adapted adjuvant therapy for squamous cell carcinoma of the head and neck.

    Lineberger Comprehensive Cancer Center / Jared M. Weiss*

  • 출처
    Cancer.
  • 등재일
    2018 Jul 15
  • 저널이슈번호
    124(14):2986-2992. doi: 10.1002/cncr.31526. Epub 2018 May 9.
  • 내용

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    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.

  • 키워드
    induction chemotherapy; lapatinib; neoadjuvant; squamous cell carcinoma of the head and neck; transoral surgery
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