Each year the AHNS Cancer Prevention Service awards Community Service Awards to individuals, departments, organizations or institutions in support of patient and community-oriented projects targeting head & neck cancer awareness and prevention. Drs. Vlad Sandulache and Diane Chen were recipients of this grant in 2019…

There are approximately 3 million people in the U.S. living with hepatitis C (HCV), with 16,000 new cases diagnosed annually. Because patients with HCV demonstrate an increased risk of hepatocellular carcinoma and other malignancies, and since HCV is now often a curable disease, screening for HCV is a US Preventative Services Task Force recommendation. Head and neck squamous cell carcinoma (HNSCC) remains a deadly malignancy, now manifesting an increased incidence secondary to the human papillomavirus (HPV). HNSCC incidence has been shown to correlate with HCV and dually exposed patients generally demonstrate poor survival overall.

Veterans have a disproportionately higher rate of HCV compared to the general population and also a higher risk of HNSCC in part due to increased tobacco consumption, and in part due to higher rates of HPV- associated HNSCC. Based on these data we instituted a cross-educational and screening program for Veterans with HNSCC and HCV at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas. Over the course of 18 months, we instituted an HCV screening program for Veterans with a new diagnosis of HNSCC; HCV screening was incorporated into our multi-disciplinary pre-treatment staging and counseling process. A total of 210 patients underwent screening as part of this effort. Following the introduction of HCV screening for patients with a new diagnosis of HNSCC, we extended the screening program to patients enrolled in the HNSCC Surveillance Clinic (treatment completion — 5 years post-treatment) and the HNSCC Survivorship Clinic (>5 years post-treatment). Currently, this has resulted in a robust screening program accompanied by counseling and education for Veterans with HNSCC regarding risk factors for HCV, basic pathophysiology of the disease and available treatment options. We are currently analyzing the data from the screening program to calculate the number of previously unknown HCV cases which were detected solely as a result of our screening, in order to determine whether this represents a sustainable, cost-effective activity.

Whereas screening HNSCC patients for HCV proved fairly easy to integrate into the normal work-flow associated with HNSCC care, screening and educational activities targeting HNSCC in the general Veteran population have proven somewhat more challenging. Multiple efforts in several countries and different health care delivery systems have failed to identify effective, cost-efficient HNSCC screening strategies, in large part due to the relatively low frequency of the disease in the general population. Given the relatively higher prevalence of HNSCC in the Veteran population, and particularly the Veteran population with HCV, we have instituted an educational program for both Veterans and PrimeCare providers as a first step toward instituting an in-person screening program for HNSCC. We are currently in the process of implementing an intermediate step in this transition, by leveraging the increased telemedicine capabilities of the institution in order to maximize patient outreach without generating unsustainable levels of clinical effort for the providers.

Together, it is our expectation that the cross-educational and screening activities
implemented over the last 18 months will decrease unnecessary morbidity and mortality associated with undetected HCV and HNSCC in the Veteran population.

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Wenhua (Diane) Chen

Diane Chen MD is a 5th  year resident at Baylor College of Medicine and hails from Dallas, TX. She will be pursuing her fellowship in Head & Neck Surgery at Indiana University School of Medicine starting July 2020.

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• Screening Program for Veterans with HNSCC & HCV – a 2019 AHNS Community Service Award Project - April 30, 2020

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Vlad Sandulache

Vlad C. Sandulache MD PhD is a surgeon-scientist with a clinical practice focused on high-risk squamous cell carcinoma at Baylor College of Medicine and the Michael E. DeBakey Veterans Affairs Medical Center. His laboratory is focused on understanding metabolic reprogramming associated with development of treatment resistance.

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• Screening Program for Veterans with HNSCC & HCV – a 2019 AHNS Community Service Award Project - April 30, 2020

Phase 2 Trial of Neoadjuvant Chemotherapy and Transoral Endoscopic Surgery With Risk-Adapted Adjuvant Therapy for Squamous Cell Carcinoma of the Head and Neck

Weiss JM, Grilley-Olson JE, Deal AM, Zevallos JP, Chera BS, Paul J, Knowles MF, Usenko D, Weissler MC, Patel S, Hayes DN, Hackman T.

From Clinical Trial. Cancer. July 2018; 124(14):2986-2992.

Article Review by Aviram Mizrachi, MD

Background / Hypothesis
In this phase II clinical trial the authors attempt to stratify patients with head and neck squamous cell carcinoma (HNSCC) undergoing trans oral surgery and select them for adjuvant treatment according to the response to neoadjuvant chemotherapy. The main endpoint of this study was response to neoadjuvant chemotherapy that may lead to de-intensification of adjuvant radiation treatment. Other endpoints were feasibility and safety of this protocol. The induction protocol success was set at >75% response rate. Furthermore, the study looked at the percentage of patients, who “avoided” adjuvant radiation, which they were eligible for by having stage III/IV disease at enrolment.

Design
The study included patients with newly diagnosed resectable HNSCC of the oral cavity, oropharynx (HPV+ and HPV-), larynx and hypopharynx. Patients with T1N0 and T2N0 disease were excluded. The neoadjuvant regimen consisted of weekly carboplatin and paclitaxel and daily lapatinib for 6 weeks. Imaging was obtained 2-5 weeks following the completion of neoadjuvant treatment for evaluation of clinical response. Subsequently the patients underwent trans oral surgical resection of the primary tumor and neck dissection. Patients with pN0 and pN1 disease were observed. Adjuvant treatment included concomitant radiation plus cisplatin and was given to patients with adverse features.

(Figure 1).

Summary of Results
A total 40 patients were accrued for the trial and 37 completed the full protocol.
The majority of patients had oropharyngeal cancer (75%) however only 17 had RTOG low-risk HPV+ cancer. The clinical response rate for all patients was 93% with 40% achieving complete clinical response. Pathological complete response was observed in 36% of patients with no correlation between clinical and pathological responses. Overall, 30 patients (77%) successfully avoided adjuvant radiation. At a median follow up of 2.4 years none of the patients had recurred or died.

Toxicity in general was mild with diarrhea being the most common adverse event (lapatinib) and neutropenia being the most severe, accounting for grade 3 and 4 toxicity in 38% of patients. Finally, the functional outcomes reported in the study were excellent in terms of speech and swallowing.

Strengths

• The study demonstrated high clinical and pathological response rates to neoadjuvant
  chemotherapy in patients with advanced stage resectable HNSCC.
• The majority of patients successfully avoided adjuvant radiation therapy.
• None of the patients experienced recurrence or death during follow-up.
• Toxicity profile for this neoadjuvant regimen was relatively modest and well tolerable.
• Functional outcomes were good, probably due to the fact that most patients did not

 Weaknesses

• Small number of participants.
• Heterogeneity of tumor sub-sites and especially the inclusion of HPV+ oropharyngeal
  cancer.
• The majority of patients were RTOG low and medium risk.
• The choice of lapatinib as a neoadjuvant agent while there is not enough evidence to
  support its use in HNSCC.

Key Points

• Neoadjuvant regimens are emerging and may play an important role in the stratification
  and management of patients with HNSCC.
• Specifically, the neoadjuvant regimen of Carboplatin and Paclitaxel achieved excellent
  clinical and pathological response rates.
• The ability to de-intensify treatment by avoiding adjuvant radiation is made possible
  with neoadjuvant therapy followed by surgery, which provides valuable clinical and
  pathological insights.
• De-intensification of adjuvant treatment may result in better functional outcomes and
  improved quality of life without compromising survival.
• Ongoing clinical trials combining immunotherapy in neoadjuvant regimens are showing
  promising preliminary results.

From the Basic Science/Translational Service
Jeffrey C. Liu MD Vice Chair
Richard Wong MD Chair

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Aviram Mizrachi

Dr. Aviram Mizrachi is a surgeon-scientist at the Department of Otolaryngology – Head and Neck Surgery of Rabin Medical Center in Israel. He has an active research laboratory focusing on tumor and radiation biology in head and neck cancer as well as targeted drug delivery. Furthermore, he investigates both radiation and chemotherapy mechanisms of action and their effect on tumor and normal tissue including the utility of novel radio-sensitizing and radio-protective agents. In addition, Dr. Mizrachi conducts clinical research on outcomes in head and neck, skin and thyroid cancers.

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• Cutaneous Malignancies in the Organ Transplant Population - February 8, 2021
• AHNS Basic Science/Translational Newsletter Vol 2 - April 24, 2020

Volume 30 – April, 2020

The AHNS Journal Club reviews the leading head and neck cancer-related journals, sharing with AHNS members some of the most relevant and important manuscripts, and providing summaries and critiques of the work.

The Journal Club members are: Samer Al-Khudari, MD; Daniel Brickman, MD; Nathan Hales, MD FACS; Jason Kass, MD PhD; Luiz Kowalski, MD PhD; Vikas Mehta, MD MPH FACS; Alirio Mijares Brinez, MD; Alvaro Sanabria, PhD; Mark Varvares, MD; Vivian Wu, MD MPH.

CLICK THE ARTICLES BELOW TO ACCESS THE APRIL ISSUE

Postoperative opioid-prescribing practices in otolaryngology: A multiphasic study.
Dang S, Duffy A, Li JC, Gandee Z, Rana T, Gunville B, Zhan T, Curry J, Luginbuhl A, Cottrill E, Cognetti D.
from Laryngyscope, March 2020

Selective neck dissection in the treatment of head and neck squamous cell carcinoma patients with a clinically positive neck
López F, Fernández-Vañes L, García-Cabo P, Grilli G, Álvarez-Marcos C, Llorente JL, Rodrigo JP.
from The Journal of Clinical Oncology, January 2020

Phase II Evaluation of Aggressive Dose De-Escalation for Adjuvant Chemoradiotherapy in Human Papillomavirus–Associated Oropharynx Squamous Cell Carcinoma
Ma DJ, Price KA, Moore EJ, Patel SH, Hinni ML, Garcia JJ, Graner DE, Foster NR, Ginos B, Neben-Wittich M, Garces YI, Chintakuntlawar AV, Price DL, Olsen KD, Van Abel KM, Kasperbauer JL, Janus JR, Waddle M, Miller R, Shiraishi S, Foote RL.
from The Journal of Clinical Oncology, August 2019.

Lymph node yield, depth of invasion, and survival in node-negative oral cavity cancer
Zenga J, Divi V, Stadler M, Massey B, Campbell B, Shukla M, Awan M, Schultz C, Shreenivas A, Wong S, Jackson R, Pipkorn P.
from Oral Oncology, November 2019