Session Content References

Guidelines for Oral Cavity

The recent deployment of AJCC v8 guidelines allows for a refresh and reorganization of providers’ approach to oral cavity cancers. It is imperative that the medical professionals involved in the care of oral cavity cancer patients remain current in the expanding knowledge of this cancer. Attendees need to determine when and how the latest AJCC guidelines will affect their day-to-day practice, and thus be able to narrow competency gaps across the management of oral cavity cancer subtypes and stages. This session will focus on how AJCCv8 shapes the guidelines for the management of these patients.

Upon completion of this live activity, attendees should be able to do the following:

• Discuss AJCCv8 guidelines and how they affect patient care.
• Describe the role of multidisciplinary care driven by AJCCv8 in patient management.

References:

• AJCC Cancer Staging Manual.
• Lydiatt, William M., et al. "Head and neck cancers—major changes in the American Joint Committee on cancer eighth edition cancer staging manual." CA: a cancer journal for clinicians 67.2 (2017): 122-137.

Potential Challenges/Barriers to Change:

• Lack of time to read/be informed re AJCCv8 changes.
• Providers may continue to practice along the lines they were trained in lieu of familiarizing themselves with new AJCC guidelines and how they direct patient management.

Surgical Perspectives on Oral Cavity Squamous Cell Carcinoma

Surgery has traditionally been the preferred modality of treatment of oral cavity squamous cell carcinoma. There have been updates in the staging system with ongoing advances in the management of oral cavity squamous cell carcinoma. Given the dynamic nature of treatment options, oncologists must keep up to date on the impact of margins and depth of invasion, options for cervical lymph node management, and indications for adjuvant treatment.

Upon completion of this live activity, attendees should be able to do the following:

• Implement depth of invasion in the management of oral tongue squamous cell carcinoma.
• Discuss the management of clinic N0 neck in oral cavity squamous cell carcinoma.
• Identify the challenges in the concordance of clinical and pathologic margins of resection.

References:

• NCCN Guidelines.
• AJCC 8^th edition.

Radiation Oncology for Oral Cavity Carcinoma

Head and neck cancer is comprised of a variety of individual diagnoses, in which the optimal evaluation methods and treatment paradigms depend on nuances of the patient and the cancer. For cancers of the oral cavity, there are recent changes in staging, evolving treatment algorithms, and emerging recommendations for best treatment. Depending on details of the primary tumor and nodal disease, the patient could be best served with surgery, radiation, or chemotherapy, in various combinations. Understanding the best practice for patients with newly diagnosed cavity cancers is complex with rapidly changing techniques and indications; lack of knowledge about the latest data and opportunities for multidisciplinary care can lead to non-optimal outcomes.

It is crucial that the multidisciplinary treatment team understand the importance and role of radiation therapy, surgery, and chemotherapy in the treatment of patients with oral cavity cancer, and how to use evidence-based medicine to determine the role of radiation therapy in the treatment of these patients. There are recent changes to the staging system, and ongoing clinical trials, which will be highlighted. Navigating complex decisions with different disciplines can be challenging; this session will demonstrate how to have data-driven discussions about patient management so as to ensure each patient is treated with the best available therapy. The challenges in treating patients with oral cavity cancer, and how to mitigate them, will be discussed in terms of practical aspects of daily medical practice.

The role of radiation therapy in oral cavity cancer will be reviewed, highlighting the data that has established its efficacy and dose/target/technique, as well as the impact of AJCC 8^th edition staging. The indications for radiation in oral cavity cancer, as well as the indications for chemoradiation, will be reviewed. After reviewing the evidence-basis of current treatment paradigms, ongoing and upcoming clinical trials for oral cavity cancer will be discussed.

Upon completion of this live activity, attendees should be able to do the following:

• Implement AJCC 8^th edition staging for oral cavity cancers.
• Identify the criteria for use of adjuvant radiation therapy and chemoradiation for patients with oral cavity cancer.
• Identify ongoing clinical trials for which patients with oral cavity cancer would be eligible and explain the goals of these trials.

References:

• Amin, Mahul B., et al. "The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population‐based to a more “personalized” approach to cancer staging." CA: a cancer journal for clinicians 67.2 (2017): 93-99.
• HN006 and RTOG 1216 clinical trial documents: nrgoncology.org

Potential Challenges/Barriers to Change:

• Lack of knowledge/expertise to implement new treatment paradigms.
• Political factors with regard to multidisciplinary management at a given institution.
• Lack of availability of colleagues with knowledge to implement different/advanced care modalities.

Although the current standard treatments for oropharynx cancer are often very effective, they are intensive, and associated with considerable short and long-term toxicity. These standards evolved prior to the recognition that the HPV-associated cancers are biologically, epidemiologically, and clinically distinct from non-HPV-associated disease, and that they have a significantly better prognosis after treatment. The possibility that current treatments might be de-intensified, producing less overall toxicity, without compromising outcome for patients with good prognosis HPV-associated disease has defined clinical investigation for the past decade. Integrating the results of recent approaches to treatment de-intensification into current treatment algorithms is critical for physicians who care for these patients. The recent American Joint Committee 8^th edition now acknowledges HPV-associated oropharynx cancer to be a separate disease, and has redefined disease staging, lending further complexity to treatment decision-making. This educational activity will address this concern and place current de-intensification approaches into appropriate clinical context.

It is imperative that the medical professionals involved in the care of HPV-associated oropharynx cancer patients remain current in the expanding knowledge of this cancer. This meeting provides attendees the opportunity to gain exposure to the latest science and understand its implications. Attendees need to determine when and how the latest science will affect their day-to-day practice, and thus be able to narrow competency gaps in the management of HPV-associated oropharynx cancer.

This session will discuss current treatment standards for the management of HPV-associated oropharynx cancer and assess the impact of current efforts towards treatment deintensification. The implications of the current AJCC 8^th edition staging system will be reviewed, as will the challenges encountered in the clinical investigation of deintensification in radiation and medical oncology. An outline of possible future research initiatives will be presented.

Upon completion of this live activity, attendees should be able to do the following:

• Implement current treatment standards for HPV-associated oropharynx cancer.
• Assess the implications of the AJCC 8th edition on the prognosis and management of this disease.
• Evaluate and integrate the results of recent clinical trials of de-intensification strategies.

References:

• Sher, David J., et al. "Radiation therapy for oropharyngeal squamous cell carcinoma: Executive summary of an ASTRO Evidence-Based Clinical Practice Guideline." Practical radiation oncology 7.4 (2017): 246-253.
• Adelstein, David J., et al. "Role of Treatment Deintensification in the Management of p16+ Oropharyngeal Cancer: ASCO Provisional Clinical Opinion." Journal of Clinical Oncology 37.18 (2019): 1578-1589.

Potential Challenges/Barriers to Change:

• The severity of the toxicities incurred by patients undergoing treatment for HPV-associated oropharynx cancer, coupled with their excellent prognosis after intervention, could encourage unsupported compromises in treatment intensity. Carefully designed and conducted clinical trials, with education and discussion of results and implications can help ensure that optimal treatment choices are made for these patients.
• The AJCC 8^th edition has defined a new staging system for HPV-associated oropharynx cancer which is distinct from staging used in the past. It has undefined treatment implications and is a potential source of significant confusion for physicians. This will be reviewed in detail in the session.
• Promising new treatment modalities and systemic agents have been developed for the management of this disease. As will be discussed in this session, it is important that their role be carefully and systematically evaluated.

The therapeutic options for early stage head and neck cancer have expanded and now there can be several equivalent treatment paradigms. Selection of the “best” treatment option for a particular patient’s cancer diagnosis requires multi-disciplinary discussions and patient engagement. Evidence-based guidelines provide a framework for shared decision making but should not be considered prescriptive. Though histology and clinical stage are the major factors considered when deciding upon a treatment plan, additional factors such as patient preference, biomarkers, co-morbidities, impact on function/QOL, etc. should also be considered.

Attendees need to know the various treatment options for challenging early stage head and neck cancer cases. Attendees must distinguish which treatment options are acceptable alternatives for a particular head and neck cancer case. Attendees should learn how to participate in the shared decision making within a multidisciplinary environment.

This tumor board will cover three challenging early stage head and neck cancer cases. The panelists will consist of a medical oncologist, radiation oncologist, head and neck surgeon, radiologist, and pathologist. The three cases will be: (1) Stage I HPV-associated oropharyngeal squamous cell carcinoma, (2) T1-T2 N0 squamous cell carcinoma of the nasal cavity, and (3) T2 N0 squamous cell carcinoma of the larynx. The case presentations will be structured so that they are controversial with different management options. The moderator will present the cases and the panelists will spend 15 minutes discussing the cases. There will be a 5-minute Q&A mini-session with the audience, where electronic questions and questions at the microphones will be discussed. Audience participation will be prioritized.

Upon completion of this live activity, attendees should be able to do the following:

• Discuss the various treatment options for Stage I HPV-associated oropharyngeal squamous cell carcinoma.
• Reconsider the use of an organ preservation approach for early stage larynx and sinonasal cases.

References:

• www.nccn.org
• Adelstein, David J., et al. "Role of Treatment Deintensification in the Management of p16+ Oropharyngeal Cancer: ASCO Provisional Clinical Opinion." Journal of Clinical Oncology 37.18 (2019): 1578-1589.
• Forastiere, Arlene A., et al. "Use of larynx-preservation strategies in the treatment of laryngeal cancer: American Society of Clinical Oncology clinical practice guideline update." Journal of Clinical Oncology (2017).

Potential Challenges/Barriers to Change:

• It may be difficult for participants to deviate from evidence-based guidelines (i.e. NCCN), because of lack of experience in the management of controversial early stage head and neck cancer.
• Non-standard approaches may be perceived by some as experimental and should only be done on a clinical trial.
• There are occasions where the surgeon and the radiation oncologist are at odds on best management for early stage laryngeal cancer. This can be a delicate issue and requires open communication and honest dialogue with colleagues.

  The therapeutic options for early stage head and neck cancer have expanded and now there can be several equivalent treatment paradigms. Selection of the “best” treatment option for a particular patient’s cancer diagnosis requires multi-disciplinary discussions and patient engagement. Evidence-based guidelines provide a framework for shared decision making but should not be considered prescriptive. Though histology and clinical stage are the major factors considered when deciding upon a treatment plan, additional factors such as patient preference, biomarkers, co-morbidities, impact on function/QOL, etc. should also be considered.

  Attendees need to know the various treatment options for challenging early stage head and neck cancer cases. Attendees must distinguish which treatment options are acceptable alternatives for a particular head and neck cancer case. Attendees should learn how to participate in the shared decision making within a multidisciplinary environment.

  This tumor board will cover three challenging early stage head and neck cancer cases. The panelists will consist of a medical oncologist, radiation oncologist, head and neck surgeon, radiologist, and pathologist. The three cases will be: (1) Stage I HPV-associated oropharyngeal squamous cell carcinoma, (2) T1-T2 N0 squamous cell carcinoma of the nasal cavity, and (3) T2 N0 squamous cell carcinoma of the larynx. The case presentations will be structured so that they are controversial with different management options. The moderator will present the cases and the panelists will spend 15 minutes discussing the cases. There will be a 5-minute Q&A mini-session with the audience, where electronic questions and questions at the microphones will be discussed. Audience participation will be prioritized.

  Upon completion of this live activity, attendees should be able to do the following:

• Discuss the various treatment options for Stage I HPV-associated oropharyngeal squamous cell carcinoma.
• Reconsider the use of an organ preservation approach for early stage larynx and sinonasal cases.

• References:

• www.nccn.org
• Adelstein, David J., et al. "Role of Treatment Deintensification in the Management of p16+ Oropharyngeal Cancer: ASCO Provisional Clinical Opinion." Journal of Clinical Oncology 37.18 (2019): 1578-1589.
• Forastiere, Arlene A., et al. "Use of larynx-preservation strategies in the treatment of laryngeal cancer: American Society of Clinical Oncology clinical practice guideline update." Journal of Clinical Oncology (2017).

• Potential Challenges/Barriers to Change:

• It may be difficult for participants to deviate from evidence-based guidelines (i.e. NCCN), because of lack of experience in the management of controversial early stage head and neck cancer.
• Non-standard approaches may be perceived by some as experimental and should only be done on a clinical trial.
• There are occasions where the surgeon and the radiation oncologist are at odds on best management for early stage laryngeal cancer. This can be a delicate issue and requires open communication and honest dialogue with colleagues.

Data on the utility of immunotherapy in head and neck squamous cell carcinoma (HNSCC) is rapidly emerging, making it difficult for most practitioners to keep pace. Furthermore, the technologies being employed, targets, and combinatorial approaches further complicate the treatment landscape.

This session will discuss current standards of care for immunotherapy in HNSCC and summarize future directions that are likely to influence management. Attendees at this session will gain knowledge on current standards and future directions for immunotherapy in HNSCC.

Upon completion of this live activity, attendees should be able to do the following:

• Discuss the basis for current immunotherapy standards of care in HNSCC.
• Define biomarkers associated with benefit to immunotherapy.
• Determine future approaches that are likely to yield efficacy in HNSCC.

References:

• Cohen, Ezra EW, et al. "The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC)." Journal for immunotherapy of cancer 7.1 (2019): 184.
• Cohen, Ezra EW, et al. "Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study." The Lancet 393.10167 (2019): 156-167.
• Miyauchi, Sayuri, et al. "Immune modulation of head and neck squamous cell carcinoma and the tumor microenvironment by conventional therapeutics." Clinical Cancer Research 25.14 (2019): 4211-4223.

Potential Challenges/Barriers to Change:

• Understanding immunologic response to cancer.
• Finding appropriate patients to treat with immunotherapy.
• Cost.

Surgical Approaches for Early Laryngeal Cancer

There are roughly equivalent rates of disease-free survival and larynx preservation between radiotherapy and endoscopic surgery for early laryngeal cancer. Given the relatively equivalent five-year survival among the two treatment options, larynx preservation and functional outcomes are the new metrics for success in treating patients with glottic cancer. The vocal fold consists of three layers which are responsible for phonation, the epithelium, the lamina propria, and the muscle/ligament. Primary phonomicrosurgery allows for improved laryngeal preservation and is theorized to be associated with improved voice outcomes using the potassium titanyl phosphate laser and photo-ablative techniques by preserving more superficial lamina propria after cancer resection.

It is imperative for the medical professional involved in the treatment of laryngeal cancer to understand the complex physiology of voice production, airway, and deglutition. This discussion should provide an overview of surgical options to be considered for early laryngeal cancer prior to radiotherapy. Attendees will be able to more readily identify ideal candidates for endoscopic surgical techniques and understand options for improving post-treatment function outcomes for this subset of patients.

This presentation is meant to stimulate conversation between radiation oncologists and surgeons regarding the approach for early laryngeal cancer. The algorithm for approaching these tumors has historically favored radiation therapy. Changing paradigms and surgical techniques have made functional preservation realistic without sacrificing oncologic outcome. Cross talk between a laryngeal surgeon and radiation oncologist should be undertaken prior to definitive radiation therapy for these patients.

Upon completion of this live activity, attendees should be able to do the following:

• Identify the types of early laryngeal cancers which would be best served with upfront endoscopic surgery.
• Describe the physiology of phonation and understand while photo-ablative techniques are superior to traditional endoscopic surgical techniques.
• Explain the benefit of an upfront phono-microsurgical approach to treating early laryngeal cancer, with RT reserved for failures only.

References:

• Baird, Brandon Jackson, et al. "Treatment of early-stage laryngeal cancer: A comparison of treatment options." Oral oncology 87 (2018): 8-16.
• Patel, Krupal B., et al. "Treatment of early stage Supraglottic squamous cell carcinoma: meta-analysis comparing primary surgery versus primary radiotherapy." Journal of Otolaryngology-Head & Neck Surgery 47.1 (2018): 19.

Potential Challenges/Barriers to Change:

• Changing treatment paradigms, with advancements in technology.
• Access to laryngeal surgeons/phono-microsurgical centers.
• Changing patient perspectives on the disease, knowledge of surgical outcomes.

Guidelines for Target Delineation

The current literature consistently demonstrates significant heterogeneity in physician delineation of primary larynx and hypopharynx (L/HCa) gross tumor radiotherapy volumes. These inconsistencies are compounded by differences in high- and intermediate-dose target volume expansions generated from the contoured primary tumor. Further, variations in published guidelines for generating L/HCa radiotherapy volumes results in a disjointed literature leaving clinicians with multiple acceptable, but, likely not a best practice approach, for managing their patients on a case by case basis. The overarching clinical impact of these issues is especially important with regard to L/HCa where undertreatment may result in local failures necessitating total laryngectomy or laryngopharyngectomy or overtreatment resulting in life-threatening untoward long-term adverse effects. An understanding of the natural pathologic history of L/HCa growth patterns, pros and cons of available imaging modalities used to create target volumes, and the data supporting published treatment approaches is required to enable clinicians to use the most evidence-based treatment approach in managing their patients with L/HCa.

Radiation oncologists need to understand the growth patterns of L/HCa, the extent of microscopic spread beyond gross disease, the degree of agreement between current imaging modalities and pathologic tumor extent, the current recommendations for treatment volume generation, and dosimetric parameters associated with serious long-term adverse effects. Radiation oncologists need to understand how to create the treatment volumes recommended by published recommendations. Radiation oncologists need to be made aware of expected outcomes of using the different treatment approaches with regard to cure rates, patterns of failures, and expected toxicities.

The program will familiarize the attendees with pathologic data describing the growth patterns and microscopic tumor extent of L/HCa, the concordance of pathologic data with different imaging modalities, the rationale underlying published contouring guidelines, and possible long-term adverse effects of such recommendations. This knowledge set will enable physicians to more accurately manage patients by providing data to ensure maximum tumor coverage while minimizing dose to adjacent organs at risk using imaging modalities and contouring strategies most suited for individual patients.

Upon completion of this live activity, attendees should be able to do the following:

• Utilize current imaging modalities with regard to defining the macroscopic and microscopic extent of disease burden with regard to L/HCa.
• Explain the rationale behind the different published treatment guidelines.
• Accurately contour L/HCa and provide appropriate expansions to ensure maximum tumor coverage while minimizing long-term adverse effects.

References:

• Cooper, Jay S., et al. "An evaluation of the variability of tumor-shape definition derived by experienced observers from CT images of supraglottic carcinomas (ACRIN protocol 6658)." International Journal of Radiation Oncology* Biology* Physics 67.4 (2007): 972-975.
• Eisbruch, Avraham, et al. "Intensity-modulated radiation therapy for head and neck cancer: emphasis on the selection and delineation of the targets." Seminars in radiation oncology. Vol. 12. No. 3. WB Saunders, 2002.
• Target Volumes (CTV-P) in laryngeal, hypopharyngeal, oropharyngeal, and oral cavity squamous cell carcinoma: AIRO, CACA, DAHANCA, EORTC, GEORCC, GORTEC, HKNPCSG, HNCIG, IAG-KHT, LPRHHT, NCIC CTG, NCRI, NRT Oncology, PHNS, SBRT, SOMERA, SRO, SSHNO, TROG consensus guidelines. Radiother. Oncol. 2017
• Lee, Nancy Y., Nadeem Riaz, and Jiade J. Lu, eds. Target volume delineation for conformal and intensity-modulated radiation therapy. Springer, 2014.

Potential Challenges/Barriers to Change:

• Lack of familiarity and comfort with current practices: Provide enough evidence to support adoption of more current recommendations.

Sinonasal Neuroendocrine and Undifferentiated Carcinomas

There is agreement that multimodal therapy is needed for Sinonasal Undifferentiated Carcinoma (SNUC), but the sequence of such treatment is not well defined. Attendees need to understand the sequence of therapy in SNUC.

Upon completion of this live activity, attendees should be able to do the following:

• Identify the optimal treatment sequence for patients with SNUC.
• Explain the role of induction chemotherapy is selecting optimal local therapy.
• Discuss the prognostic significance of response to neoadjuvant therapy.

References:

• Amit, Moran, et al. "Induction chemotherapy response as a guide for treatment optimization in sinonasal undifferentiated carcinoma." Journal of Clinical Oncology 37.6 (2019): 504.

Potential Challenges/Barriers to Change:

• Lack of knowledge about the topic.
• Rarity of this disease.
• Lack of consensus on ideal treatment approach.

This presentation will attempt to address these barriers by providing our experience with this rare disease and discussing the pros and cons of the various treatment strategies providing data to support neoadjuvant therapy.

Intraoperative Molecular Imaging

Nearly 80% of patients with early stage solid tumors undergo surgery at some point during their treatment course. Because oncologic surgeons are often unable to visualize residual cancer at the surgical margins, a major gap in quality of care is represented by the high rate of tumor-positive margins (more than 20%) in surgical resections. In head and neck (HNC) cancer, in particular, tumor-positive margins occur in 25% of cases, a rate that has remained unchanged for the past 20 years. The most likely reason for this unchanged rate is because the technology used by surgical oncologists for sampling and sectioning tumors has also remained unchanged in that same timeframe. Specifically, clinicians depend upon subjective assessment using manual palpation to identify possible close margins. Surgeons also rely on use of frozen section analysis which is a highly inefficient process. Because positive margins directly correlate with local-regional relapse and a 50% reduction in survival rates in head and neck cancer, it is crucial that the surgeon identifies the surgical margin at the time of the operation, in order to prevent local recurrence and/or poor outcome(s) for these patients.

This work has the potential to dramatically improve survival in these patients. Understanding this new technology and how it will be used will be critical for surgeons to understand given that there are over a dozen agents in clinical trial today that are likely to come on to the market over the next several years.

Upon completion of this live activity, attendees should be able to do the following:

• Utilize in vivo and in sity imaging strategies using near infrared fluorescence imaging techniques after systemic administration of a systemic contrast agent specific for cancer.
• Utilize ex vivo imaging strategies using near infrared fluorescence imaging techniques after systemic administration of a systemic contrast agent specific for cancer.

References:

• Baddour Jr, Harry Michael, Kelly R. Magliocca, and Amy Y. Chen. "The importance of margins in head and neck cancer." Journal of surgical oncology 113.3 (2016): 248-255.
• Buchakjian, Marisa R., et al. "Association of main specimen and tumor bed margin status with local recurrence and survival in oral cancer surgery." JAMA Otolaryngology–Head & Neck Surgery 142.12 (2016): 1191-1198.

Potential Challenges/Barriers to Change:

• Limited availability of these drugs of use in the united states
• Understanding of the current process to obtain surgical margins – standard of care process for those who are not surgeons.

FDG-PET Update in Head and Neck Cancer

FDG PET/CT is now widely used in clinical practice for imaging of head and neck cancer for establishing accurate staging as well as for therapy response assessment. Evidence-based utilization of FDG PET/CT in the diagnosis and management of head and neck cancer and understanding the benefits and pitfalls of FDG PET/CT is essential for best patient care and for outcomes.

It is imperative to understand the strengths, pitfalls and benefits of FDG PET/CT in the diagnosis and management of head and neck cancer. It is important to understand the accuracy of PET/CT in staging and therapy response assessment and the appropriate clinical context to practice.

Upon completion of this live activity, attendees should be able to do the following:

• Incorporate into clinical practice evidence-based use of FDG PET/CT in staging and therapy response assessment of head and neck cancer.
• Discuss the limitations and pitfalls of FDG PET/CT in head and neck cancer management.

Potential Theranostic Agents in Head and Neck Cancer

There are already FDA-approved “theranostic” agents that can be used for both imaging and systemic radiopharmaceutical therapy for paragangliomas. In addition, in the near future, this “theranostic” paradigm may be applied for other head and neck cancers such as neuroendocrine cancers and adenoid cystic cancer. The lack of expertise and knowledge about this field may create a practice gap leading to lower quality of care. Clinical head and neck cancer specialists need to have increased awareness of the available PET/SPECT imaging agents and the potential for paired radiopharmaceutical therapy options.

Theranostics agents are paired or combined radioactive drugs that can be used for both imaging and systemic therapy. With multiple recently FDA-approved theranostic agents targeting neuroendocine cancers, this paradigm can already be applied to paragangliomas and potentially other head and neck neuroendocrine cancers. Furthermore, recent imaging and histologic studies in salivary adenoid cystic carcinomas show specific expression of PSMA (prostate specific membrane antigen), providing rationale for clinical trials with PSMA-targeted therapies.

Upon completion of this live activity, attendees should be able to do the following:

• Implement currently available PET/SPECT imaging agents for neuroendocrine head and neck tumors.
• Discuss investigational PET/SPECT imaging agents for other head and neck cancers.
• Describe paradigm of paired theranostic agents for imaging and systemic therapy.

References:

• Janssen, Ingo, et al. "68Ga-DOTATATE PET/CT in the localization of head and neck paragangliomas compared with other functional imaging modalities and CT/MRI." Journal of Nuclear Medicine 57.2 (2016): 186-191.
• Pryma, Daniel A., et al. "Efficacy and Safety of High-Specific-Activity 131I-MIBG Therapy in Patients with Advanced Pheochromocytoma or Paraganglioma." Journal of Nuclear Medicine 60.5 (2019): 623-630.
• Nulent, Thomas JW Klein, et al. "Prostate-specific membrane antigen PET imaging and immunohistochemistry in adenoid cystic carcinoma- a preliminary analysis." European journal of nuclear medicine and molecular imaging 44.10 (2017): 1614-1621.

Potential Challenges/Barriers to Change:

• Lack of expertise to implement imaging or therapy.
• Availability of theranostic agents.
• Currently only applicable to rare head and neck cancers.

Financial Toxicity and Employment in Head and Neck Cancer Patients

Cancer care is associated with direct and indirect costs to the patient and their families. Financial toxicity has an impact on patient outcomes and may increase costs to the health care systems. Social risk factors affect both the patient experience and disease outcomes. Financial hardship is one of the critical social risk factors that has garnered recent attention. Studies have demonstrated that financial hardship is associated with poorer outcomes including increased pain, worsening symptoms, increased distress, poorer adherence to therapy and increased mortality.

This lecture will provide a brief overview of some of the salient issues related to financial toxicity. This presentation will present data on the financial impact of a cancer diagnosis on cancer patients. Included will be a discussion of the types of financial outcomes that may be impacted as well as risk factors for financial toxicity. A separate study assessing the relative impact on African Americans will also be presented.

Upon completion of this live activity, attendees should be able to do the following:

• Discuss the long-term impact of financial toxicity of clinical outcomes.
• Explain the various outcomes measures that assess financial toxicity, particularly “decreased net worth.”
• Explain that patients who are insolvent are more medically frail and likely to have higher rates of hospitalization.
• Describe the impact of the Affordable Care Act on access to care.

References:

• Nikpay, Sayeh S., Margaret G. Tebbs, and Emily H. Castellanos. "Patient Protection and Affordable Care Act Medicaid expansion and gains in health insurance coverage and access among cancer survivors." Cancer 124.12 (2018): 2645-2652.
• Smith, Derek K., Emily H. Castellanos, and Barbara A. Murphy. "Financial and socio-economic factors influencing pre-and post-cancer therapy oral care." Supportive Care in Cancer 26.7 (2018): 2143-2148.

Potential Challenges/Barriers to Change:

• Many of the issues that underpin medical financial toxicity are related to deeply imbedded social inequities.
• Those experiencing financial toxicity are not in a position to rectify the situation due to poor health and limited resources.

Advanced head and neck cancer continues to be a challenge due to morbidity from therapy, high-risk of recurrence and distant metastases and poor outcomes. Optimal management should incorporate patient goals, understanding of prognosis and clinical decision-making from a cohesive multidisciplinary team. Increased knowledge will permit clinicians to appropriately advise patients regarding therapeutic options, relative efficacy and morbidity of each approach. Treatment should incorporate consensus guidelines and novel therapeutic approaches to maximize clinical outcomes.

It is imperative that the medical professionals involved in the care of advanced head and neck cancer patients remain current in the expanding knowledge base of this topic. Attendees need to determine the multifaceted aspects of advanced head and neck cancer care that will affect their day-to-day practice, and thus be able to narrow competency gaps across the management of different advanced stage head and neck cancers.

This session provides attendees the opportunity to gain exposure to the multidisciplinary management of advanced head and neck cancer patients. This session will consist of case presentation of advanced head and neck malignancies in a tumor board format. A multidisciplinary panel of experts will discuss each case and make therapeutic recommendations based on evidence-based guidelines.

Upon completion of this live activity, attendees should be able to do the following:

• Implement current treatment standards for advanced head and neck cancer.
• Explain to treatment options, prognosis and side effects.
• Evaluate and integrate evidence-based treatment guidelines into clinical care.

References:

• https://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf.
• Xiang, Michael, et al. "Survival After Definitive Chemoradiotherapy With Concurrent Cisplatin or Carboplatin for Head and Neck Cancer." Journal of the National Comprehensive Cancer Network 17.9 (2019): 1065-1073.
• Haddad, Robert, et al. "Induction chemotherapy followed by concurrent chemoradiotherapy (sequential chemoradiotherapy) versus concurrent chemoradiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomised phase 3 trial." The lancet oncology 14.3 (2013): 257-264.

Potential Challenges/Barriers to Change:

• Lack of insurance reimbursement for specific therapy.
• Lack of expertise to implement therapy.
• Lack of comprehensive multidisciplinary team.

There are ongoing advances in head and neck cancers in the context of immunology and clinical research into novel immunotherapy developments. Important elements of clinical trial design and recent published or presented data, as well as FDA approvals need to be communicated to practitioners and translational scientists. The use of biomarkers to enrich or select patients for these novel immunotherapies, used alone or in combination with conventional modalities, needs to be disseminated. As treatment options and adverse effects expand, clinicians must increase their knowledge of how to appropriately select/sequence treatments, manage recurrence and late effects, correctly use the immunotherapy in the clinic. Scientists and practitioners must also incorporate translational research into personalization of therapy to maximize cure rates and minimize toxicity. Failure to stay informed and divergence from evidence-based guidelines leads to lower quality of care by practicing clinicians.

It is imperative that the medical professionals involved in the care of head and neck cancer patients remain current in the expanding knowledge of efficacy of various types of immunotherapy, including immune checkpoint inhibitors alone or in combination with chemotherapy, as well as cellular immunotherapy. This meeting provides attendees the opportunity to gain exposure to the latest science of immunotherapy and biomarkers in head and neck cancer. Attendees need to determine when and how the latest results and strategies of immunotherapy will affect their day-to-day practice, and thus be able to narrow competency gaps across the management of different head and neck cancer subtypes and stages.

Upon completion of this live activity, attendees should be able to do the following:

• Explain the role of immunotherapy in the treatment of recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
• Discuss emerging data regarding combination immunotherapy and radiotherapy.
• Describe the role of biomarkers, and cellular therapy in management of HNSCC.

Potential Challenges/Barriers to Change:

• Limited resources for biomarker testing.
• Access to clinical trials, including limited access to combination immunotherapy, and combination immunotherapy with RT.
• Limited overall understanding of the rationale of cellular therapy.

HPV associated head and neck cancer patients have a significantly better prognosis. Current treatment regimens include treatment that was found to be efficacious for HPV negative tumors. Given the significant toxicity noted with current treatment regimens and the improved prognosis for patients with this disease there is a need to deescalate therapy. However, whether de-escalation should include decreasing radiation dose, radiation fields, altering chemotherapy to include induction protocols, targeted agents or transoral surgery followed by decreased adjuvant therapy has not been determined. Also, whether de-escalation would decrease overall survival and toxicity has still to be decided and a number of prospective trials are ongoing, using strategies to reduce radiation dose or extent, dose or type of chemotherapy, as well as reduction in extent of surgery. This debate will provide evidence-based information on whether it is time to deescalate therapy, and if so, how to do so.

It is important that practicing physicians learn how to interpret retrospective data that is currently available and understand results of those prospective trials that are currently underway. Results of some prospective trials have determined that alternative treatment for HPV associated cancers may result in worse outcomes. This debate will discuss results of some of those trials and will focus on a case with an intermediate risk patient with HPV associated head and neck cancer and debate whether the patient would benefit from standard treatment or whether treatment should be de-intensified. Dr. Ferris and Dr. Gillison will debate whether it is time to deescalate therapy for this patient.

Upon completion of this live activity, attendees should be able to do the following:

• Identify when and what appropriate adjuvant therapy is appropriate after transoral resection
• Determine the importance of waiting for results of prospective clinical trials
• Determine the importance of determining differences in treatment for low risk v/s intermediate risk patients and when RT vs chemoRT vs surgery is beneficial to patients.

References:

• Gillison, Maura L., et al. "Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial." The Lancet 393.10166 (2019): 40-50.
• Haughey, Bruce H., and Parul Sinha. "Prognostic factors and survival unique to surgically treated p16+ oropharyngeal cancer." The Laryngoscope 122.S2 (2012): S13-S33.
• Cramer, John D., et al. "Validation of the eighth edition American Joint Committee on Cancer staging system for human papillomavirus‐associated oropharyngeal cancer." Head & neck 40.3 (2018): 457-466.
• Li, Shuli, et al. "E3311 trial of transoral surgery for oropharynx cancer: Implementation of a novel surgeon credentialing and quality assurance process." (2016): 6054-6054.

Potential Challenges/Barriers to Change:

• Lack of resources: may not have a surgeon with the expertise of transoral robotic/laser surgery.
• Lack of knowledge given de-escalation has occurred off protocol and before results of many trials.
• May need to wait for results of prospective trials.

Guidelines for Unknown Primary Management

There are ongoing advances in unknown primary head and neck cancers in the context of tumor staging/pathologic classification, treatment delivery, and clinical research. All elements need to be communicated to and executed by a multidisciplinary team. As treatment options and adverse effects expand, clinicians must increase their knowledge of how to appropriately select/sequence treatments, manage recurrence and late effects, correctly use the updated staging system and incorporate translational research into personalization of therapy to maximize cure rates and minimize toxicity. Failure to stay informed and divergence from evidence-based guidelines leads to lower quality of care by practicing clinicians.

It is imperative that the medical professionals involved in the care of unknown primary head and neck cancer patients remain current in the expanding knowledge of this cancer. This meeting provides attendees the opportunity to gain exposure to the latest guidelines in unknown primary head and neck cancer. Attendees need to determine when and how the latest science will affect their day-to-day practice, and thus be able to narrow competency gaps across the evaluation and management of unknown primary head and neck cancer.

This presentation will review the evaluation of unknown primary cancer of the head and neck, including surgical, pathologic, and radiologic testing. It will also review potential treatment modalities including surgery, chemotherapy, and radiotherapy.

Upon completion of this live activity, attendees should be able to do the following:

• Implement current guidelines for the evaluation and work up of unknown primary head and neck cancer.
• Implement current guidelines for treatment of unknown primary head and neck cancer.

References:

• von der Grün, Jens Müller, et al. "Diagnostic and treatment modalities for patients with cervical lymph node metastases of unknown primary site–current status and challenges." Radiation Oncology 12.1 (2017): 82.
• Farooq, Saadia, et al. "Transoral tongue base mucosectomy for the identification of the primary site in the work-up of cancers of unknown origin: Systematic review and meta-analysis." Oral oncology 91 (2019): 97-106.
• Hu, Kenneth Shung, et al. "Five-year outcomes of an oropharynx-directed treatment approach for unknown primary of the head and neck." Oral oncology 70 (2017): 14-22.

Potential Challenges/Barriers to Change:

• Lack of awareness of unknown primary head and neck cancer evaluation.
• Lack of familiarity with unknown primary head and neck cancer management.

Radiation Oncology for Skin Cancer

There is a wide range of radiation treatment options for cutaneous squamous cell cancer, which are unique to the head and neck given its intricate anatomy and innervation. As such, interpreting the pathological features and patient variables is critical to avoid under- or over-treatment of patients. Given the functional anatomy within the head and neck as well as the challenges of salvaging recurrences, the balance of dose and volume have significant consequences with respect to toxicity and morbidity. It is imperative for clinicians to understand how to appropriately design treatments to maximize the therapeutic ratio. Failure to stay informed leads to lower quality of care by practicing clinicians.

It is essential for practitioners to understand indications for radiation and be able to translate clinical and pathological features into appropriate treatment regimens for cutaneous squamous cell carcinoma. This session will provide attendees with strategies to apply such variables into appropriate treatments to maximize cure and minimize morbidity in a potentially frail patient population. Attendees need to understand how the pathological variables intersect with head and neck anatomy and innervation to narrow competency gaps across the management of cutaneous disease.

While radiation therapy is often used in definitive and adjuvant settings, there are significant therapeutic challenges in treating these malignancies secondary to the complex anatomy of head and neck combined with limited of data and resources to guide therapy. This talk aims to address the key concepts pertinent to treating cutaneous malignancies of the head and neck: patient selection, dose selection, and target volume design.

Upon completion of this live activity, attendees should be able to do the following:

• Identify patients which warrant adjuvant radiation based on clinical and pathological features.
• Design appropriate treatment fields and dose regimens for definitive and adjuvant cutaneous cases.
• Determine which cases require more extensive coverage of cranial nerve pathways for perineural invasion.

References:

• Bakst, Richard L., et al. "Perineural Invasion and Perineural Tumor Spread in Head and Neck Cancer: A Critical Review." International Journal of Radiation Oncology* Biology* Physics (2018).
• Ko, Huaising C., et al. "A contouring guide for head and neck cancers with perineural invasion." Practical radiation oncology 4.6 (2014): e247-e258.
• Jackson, James E., et al. "Radiotherapy for perineural invasion in cutaneous head and neck carcinomas: toward a risk‐adapted treatment approach." Head & Neck: Journal for the Sciences and Specialties of the Head and Neck 31.5 (2009): 604-610.

Potential Challenges/Barriers to Change:

• The range of radiation treatment options for cutaneous squamous cell cancer is wide, which can easily lead to over or under treatment.
• Target volume delineation can be challenging secondary to the complex anatomy and innervation of the head and neck.
• Patients with cutaneous malignancies are often older and with significant co-morbidities and cannot handle protracted radiation courses.