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Surgical Margin Distance in Head and Neck Squamous Cell Carcinoma

Surgical Margin Distance in Head and Neck Squamous Cell Carcinoma

John David Cramer, MD, FACS

Karmanos Cancer Institute, Wayne State Univeristy

09 March 2022

Achieving completed tumor removal is a fundamental tenet of surgical oncology. Surgical margins are the borders of tissue removed in cancer surgery. Surgical margins are carefully measured to determine if complete tumor removal has been achieved. The surgical margin is negative if there are no cancer cells at the edge of tissue on microscopic analysis by a pathologist. The surgical margin is involved if there are cancer cells at the edge of tissue that has been removed. The surgical margin is close if the cancer extends close to the edge of tissue that has been removed. In surgery for head and neck cancers of the mouth and throat various definitions for negative, close and involved margins have been used to help guide decision making and information patients and clinicians about prognosis. One commonly used definition is that if cancer is <1mm from the cut edge the margin is involved, if cancer is 1-5mm from the cut edge then the margin is close and if cancer is 5mm or more from the cut edge then the margin is negative. Another common definition is that surgical margins are negative if there is no cancer at the cut edge and negative if there is cancer at the cut edge. To further complicate matters, others studies support that the definitions for surgical margins should vary based on the primary site in the head and neck. Cancers of the mouth and throat are most commonly caused by a type of cancer called squamous cell carcinoma of the head and neck (SCCHN). Numerous studies have shown that surgical margin distance is critical to determining patients prognosis and their need for additional cancer therapies such as postoperative radiation and/or chemoradiation. However, as the definition of surgical margins has been debated in the literature the indications for additional cancer therapy after surgery can vary from institution to institution and country to country. Much of the existing research on surgical margins has used retrospective data from a single institution which can be less generalizable and there is a need for more investigations using robust prospective data to help make decisions about patient care for this disease. The proposed study seeks to investigate the prognosis of patients negative, close and involved surgical margins who have SCCHN and have undergone surgery. We seek to investigate the investigate the survival with involved (<1mm) and close (1-5mm) margins and to investigate if the risk of cancer recurrence varies based on the site of cancer within the head and neck. We seek to perform a secondary analysis of an existing large randomized controlled trial (NOVARTIS-EGF102988) that collected a robust amount of information on surgical margins of patients with SCCHN who underwent surgery. Our hope is that this study will better clarify the safety of using various definitions of surgical margin distance in different primary cancer sites within the head and neck using a robust prospective cohort of patients to inform optimal decision making about additional postoperative radiation and chemoradiation.

[{ "PostingID": 4204, "Title": "NOVARTIS-EGF102988", "Description": "A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects With Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)" }]

Statistical Analysis Plan