Published: February 23, 2016

FROM THE OREBM COMMITTEEPublications that may change your practice

In this Bulletin article, the Outcomes Research Evidence-Based Medicine (OREBM) Committee shares highlights from a recent key publication in otolaryngology-head and neck surgery. We offer concise summaries of significant findings that may alter current surgical practice.

imagingBy Vikas Mehta, MD, MPH, with input from OREBM Committee Members Neil D. Gross, MD, Samir S. Khariwala, MD, Walter T. Lee, MD, MHS, and Jennifer J. Shin, MD, SM

In this Bulletin article, the Outcomes Research Evidence-Based Medicine (OREBM) Committee shares highlights from a recent key publication in otolaryngology-head and neck surgery. We offer concise summaries of significant findings that may alter current surgical practice.

D’Cruz AK, Vaish R, Kapre N, et al. Elective versus therapeutic neck dissection in node-negative oral cancer. N Engl J Med. 2015 Aug 6;373(6):521-9.

This prospective, randomized-controlled trial compared elective neck dissection (END) to therapeutic neck dissection (TND) in patients with early-stage (T1-2), node-negative oral cavity squamous cell carcinoma (OSCC). Data from prior studies had been conflicting and thus a well-done, adequately powered RCT was warranted. END has shown therapeutic benefit in prior studies and provides pathologic staging, but 70 percent of ENDs are node-negative, prompting proponents of TND to raise concerns that END constitutes “over-treatment.”

Eligible patients were between the ages of 18 and 75 years with stage T1 or T2, lateralized OSCC. Patients’ primary tumor and lymph nodes were assessed using physical examination and ultrasonography (US) of the neck. After randomization, patients underwent excision of the primary tumor with adequate margins (≥5 mm). Patients in the END group underwent an ipsilateral selective neck dissection (levels I-III). In patients with metastatic nodal disease discovered during surgery (operative findings or frozen section), a modified neck dissection was performed with inclusion of levels IV and V. Patients in the TND group underwent the same primary tumor resection and were then monitored, with modified neck dissection (levels I to V) only at the time of nodal relapse. All patients who had positive nodes, a primary-tumor depth of invasion of 10 mm or more, or a positive resection margin received adjuvant radiation.

The findings were reported on the first 500 patients (245 in the END group and 255 in the TND group) who had completed at least nine months of follow-up. There were 50 deaths (20.6 percent) in the END group and 79 (31.2 percent) in the TND group. At three years, the corresponding overall survival rates were 80.0 percent and 67.5 percent, respectively (adjusted hazard ratio, 0.63; 95 percent CI, 0.44 to 0.90). There were 81 recurrences (33.3 percent) in the END group and 146 (57.7 percent) in the TND group. At three years, the corresponding rates of disease-free survival were 69.5 percent and 45.9 percent, respectively (adjusted hazard ratio, 0.44; 95 percent CI, 0.33 to 0.57). Of the 114 patients with cervical-lymph-node relapse in the therapeutic-surgery group, 60 (52.6 percent) died of disease progression. The majority of first events (114 events in 146 patients [78.1 percent]) were nodal relapses in the therapeutic-surgery group. Patients with nodal relapse presented with a more advanced nodal stage (p=0.005) and a higher incidence of extracapsular spread (p<0.001).

The major finding from this study is that END at the time of the primary tumor resection is associated with a significant overall and disease-free survival advantage (37 percent and 66 percent, respectively). Eight patients would need to be treated with END to prevent one death, and four patients would need to be treated to prevent one relapse. The strengths of this study include a prospective, randomized design and a large number of patients. Limitations include the use of ultrasound to detect nodal metastases, which is not as sensitive as other imaging, and the lack of data on treatment morbidity associated with neck dissection. The primary outcome did not focus on the impact of either T1/T2 status or depth of invasion, which were addressed in only subgroup and post-hoc analyses; understanding the impact of these key factors requires ongoing input from head and neck oncological experts and additional study. Although the authors demonstrate a survival advantage in the elective surgery group, the high rate of pathologically negative dissections in this group (70 percent) should not be ignored. Another issue is that the END group received more adjuvant radiation, which may explain the survival benefit. However, the important point is that END properly identified “high-risk” patients requiring more aggressive therapy. In this context, proven techniques such as sentinel-lymph-node biopsy or potential metastatic biomarkers could help identify subgroups requiring neck dissection and reduce patient morbidity while preserving the rate of disease control. Overall, these data help settle this decades-old debate regarding OSCC, and indicate that the neck should be addressed primarily even in early-stage lesions to maximize survival.



More from March 2016 - Vol. 35, No. 02

New task forces focus on education
By Sonya Malekzadeh, MD, AAO-HNSF former Coordinator for Education The AAO-HNS/F has assembled four education task forces to address important issues concerning our Members and the profession. I am honored to be involved in many of these efforts and to serve as chair for two of these groups. The Simulation Task Force was formed in 2011 to define the current state of simulation, to investigate its role and future potential in otolaryngology-head and neck surgery, and to provide educational resources for AAO-HNS Members. Under the leadership of Ellen S. Deutsch, MD, the Simulation Task Force has accomplished: Initiation of Simulation Open Forums, at both the Combined Otolaryngology Spring Meetings (COSM) and the AAO-HNSF Annual Meeting & OTO EXPOSM, has brought together like-minded individuals to discuss interests, challenges, and opportunities in simulation. An active ENTConnect community engages simulation Members in ongoing collaboration and exploration. Launch of the SimTube Project, a national initiative for simulation-based educational research with the immediate goal of assessing the usefulness of a low-cost, low-tech simulator in learning myringotomy and tube placement, and the larger goal of establishing an infrastructure that could support multiprogram collaboration for more complex simulation-based educational research in the future. More than 60 U.S. residency programs now participate in the study. Numerous Annual Meeting Miniseminars highlighting current education efforts and advanced technology in simulation while also demonstrating the value of simulation in quality of care and systems improvement. Recognizing the expanding role of simulation in education, research, and quality, the task force has recently submitted an application to become a Foundation committee. This new designation will permit a formal and permanent structure for furthering Member opportunities and engagement. Dr. Deutsch and Gregory J. Wiet, MD, will chair the committee. The Comprehensive Curriculum Task Force stemmed from the 2013 Board of Directors Strategic Planning meeting where Academy leadership acknowledged the need for a core curriculum in otolaryngology. The Otolaryngology Comprehensive Curriculum will serve as a lifelong, continually expanding learning and assessment tool for otolaryngology professionals. The content and structure will meet the needs of students, residents, allied health colleagues, and all practicing physicians engaged in MOC and lifelong learning. The online format will cover the otolaryngology scope of knowledge, provided in various educational formats, to guide and address cognitive and technical skills. The “living” content will be kept current with frequent updates so users can be assured they are participating in a rich and growing educational program. The task force believes this to be an ideal opportunity to unite the specialties around education, reduce duplicative efforts across societies, and to provide a comprehensive education platform for our specialty. A working group comprised of society representatives is finalizing a list of topics and performing an inventory of all existing education content across the specialties. This information will inform the development of future education programming. The Intraoperative Nerve Monitoring Task Force, in existence since fall 2015, will address key issues relevant to facial nerve monitoring during otologic and neuro-otologic surgery. With representation from the American Neurotology Society (ANS) and the American Otological Society (AOS), the task force will focus on: Determining current practice in training and performance of nerve monitoring among Academy Members and Residency Program Directors. Developing education activities that will provide uniform and standardized training for otolaryngologists to safely and successfully perform the procedure. Clarifying the AAO-HNS/F perspective on intraoperative nerve monitoring within the specialty. AAO-HNS President Sujana S. Chandrasekhar, MD, proposed the latest group, Advanced Practice Professionals (APP) Education Task Force. With the growing presence of mid-level providers in otolaryngology practices, it is imperative that we provide our colleagues with proper education and training in our field. These efforts will improve their contributions to our practices and patients while also educating AAO-HNS Members on the benefits of including APPs in the profession. In collaboration with the APP societies, including SPAO-HNS, the task force will design educational programing and provide resources that will allow advanced practice providers and otolaryngologist-head and neck surgeons to work synergistically to improve patient care. “I have every confidence that this task force will put together a comprehensive ENT APP curriculum, utilizing many Academy resources. Establishing such an educational outline will really help our Members as they seek to incorporate APPs into their practices” said Dr. Chandrasekhar. Karen T. Pitman, MD, and Peter D. Costantino, MD, will serve as chairs of this new task force. Academy task force Members are working hard on topics critical to the Academy and the profession. “These education task forces really complement the work of the education committees by addressing new and innovative education opportunities for our Members,” said Richard V. Smith, MD, coordinator for Education. If you are interested in more information or contributing to any of these projects please email