This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson, including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women. Note: If available, clinical trials should be considered as preferred treatment options for eligible patients.

INITIAL EVALUATION Confirm outside pathology History: ● Chief complaint ● History of present illness and previous treatment Past Medical History: ● Medical illnesses ● Surgeries ● Medication allergies ● Family history ● Social history (including tobacco and alcohol use) ● Medications ● Review of systems Physical Examination: ● Full head and neck exam ● General medical examination Stage T and N (AJCC) Imaging studies: ● High resolution CT with thin cuts and contrast and bone windows ● Chest Imaging as clinically indicated ● Consider PET scan for Stage III or IV

1

Consider Dental Extraction based on results of dental evaluation prior to initiation of primary treatment

PRE-TREATMENT EVALUATION

CONSULTATIONS

Dental oncology1 ● Radiation oncology ● Medical oncology for patients with Stage III or IV ● Speech pathology for patients whose treatment may impact swallowing and/or speech ● Plastic surgery for patients who will require major reconstruction (pharyngeal or bony reconstruction) ● Nutrition ● Smoking cessation for active smokers only 2 ● Pre-Op Internal Medicine Consult ● Audiogram, if receiving chemotherapy ●

Primary Tumor ● T1-T2,N0 Patient information presented at Multidisciplinary Planning Conference

Primary Tumor ● T1-2, N1-3

See page 2

Primary Tumor ● T3-4a, N0-1

Primary Tumor ● T4b, Any N

2

Conditions for pre-op internal medicine consult: Hypertension ● Uncontrolled or newly diagnosed ● Poorly compliant patient ● Multi-drug regimen for control Cardiac Disease ● History of MI or angina ● History of cardiac or vascular surgery ● Cardiac murmur or valvular heart disease ● CHF

Copyright 2015 The University of Texas MD Anderson Cancer Center

Pulmonary Disease ● 20 or more pack per year smoking history ● Moderate to severe COPD with less than 2 flight exercise tolerance ● Reactive airway disease ● Previous lung resection ● Multiple history of pneumonias ● History of TB

CerebrovascularDisease ● Previous CVA ● History of TIA ● Carotid bruit or known stenosis Hepatic Disease ● History of cirrhosis ● Laboratory of hepatic dysfunction

Diabetes ● Type ● Type II

Department of Clinical Effectiveness V5 Approved by the Executive Committee of the Medical Staff on 10/27/2015

This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson, including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women. Note: If available, clinical trials should be considered as preferred treatment options for eligible patients.

CLINICAL EVALUATION Primary Tumor ● T1-T2, N0

PRIMARY TREATMENT Excision of primary tumor or sentinel node biopsy with selective neck dissection if clinically indicated1

Yes

Presence of pathological risk features2?

● ●

Radiation therapy Consider chemoradiation3

No Yes

Primary Tumor ● T1-2, N1-3

No

Initial stage greater than N1?

Glossectomy and neck dissection 4

SURVEILLANCE

ADJUVANT TREATMENT

Consider radiation

Node positive?

Surveillance (See Page 4); 13 Medical Oncology (optional) for chemoprevention trials

No

Yes Primary Tumor ● T3-4a, N0-1

Radiation therapy 3 ● Consider chemoradiation

Glossectomy and neck dissection 4

●

Surgery (preferred for bone invasion)4

Yes Primary Tumor ● T4b, Any N

Primary tumor resectable?

Yes

No

● Chemotherapy/

Radiation ● Consider for clinical trial

Complete response at primary site? No

Copyright 2015 The University of Texas MD Anderson Cancer Center

1

Depth of invasion greater than or equal to 4 mm depth invasion) 2 Pathological Risk Features include: Primary pathology: ● Any T1 or T2 with positive or close (less than 1 mm) margins, perineural Neck dissection invasion, OR lymphovascular invasion Yes (re-excision to clear margins is preferred) Residual ● Any T3 or T4 Neck Nodal Yes Regional pathology: dissection Disease? ● Multiple lymph nodes (any N2, N3) Stage No ● Lymph node(s) with extracapsular extension N3? ● Lymph node(s) in Level IV or V 3 Pathological Risk Factors include: Observe No ● Positive margins (re-excision to clear margins is preferred) Salvage surgery with neck ● Extracapsular extension 4 dissection as clinically indicated Bilateral neck dissection for N2c neck disease. Consider bilateral neck dissection for midline lesion. Department of Clinical Effectiveness V5 Approved by the Executive Committee of the Medical Staff on 10/27/2015

This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson, including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women. Note: If available, clinical trials should be considered as preferred treatment options for eligible patients.

CLINICAL PRESENTATION

RECURRENT TREATMENT ● Consider

Systemic Therapy/Phase I Clinical Trial ● Palliative Care as clinically indicated

Recurrent disease

Restage ● CT of Head and Neck ● CT Chest or PET to evaluate for Metastatic Disease

Yes Previous radiation therapy?

Presence of distant metastatic disease?

Salvage Surgery as clinically indicated, ● Consider postoperative radiation therapy as clinically indicated1 ●

No

Yes No

Consider Salvage Surgery as clinically indicated ● Palliative Care as clinically indicated ●

Yes

Is recurrence resectable?

Surveillance (See Page 4)

Consider re-irradiation if clinically indicated ● Palliative Care ●

No

Yes Previous radiation therapy? No

1

Pathological Risk Factors should be taken into consideration when making concurrent treatment decisions

Copyright 2015 The University of Texas MD Anderson Cancer Center

Consider chemotherapy and radiation therapy

Department of Clinical Effectiveness V5 Approved by the Executive Committee of the Medical Staff on 10/27/2015

This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson, including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women. Note: If available, clinical trials should be considered as preferred treatment options for eligible patients.

ORAL CAVITY CANCER SURVEILLANCE

Total Years for Surveillance Frequency of Surveillance by month

Yr 1

Yr 2

Yr 3

Yr 4

Yr 5

2-3

6

9

12

16

20

24

36

48

60

Head and Neck History and Physical Exam

x

x

x

x

x

x

x

x

x

x

Baseline CT

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

Consider Surveillance CT if clinically indicated Thyroid function, if XRT CXR yearly (CT chest if smoker)

Copyright 2015 The University of Texas MD Anderson Cancer Center

x

x

Department of Clinical Effectiveness V5 Approved by the Executive Committee of the Medical Staff on 10/27/2015

This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson, including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women. Note: If available, clinical trials should be considered as preferred treatment options for eligible patients.

SUGGESTED READINGS

Bernier J, Domenge C, Ozsahin M, et al.(2004). European Organization for Research and Treatment of Cancer Trial 22931. Postoperative Irradiation with or without Concomitant Chemotherapy for Locally Advanced Head and Neck Cancer. N Engl J Med, 350,1945-52. Bernier J, Cooper JS, Pajak TF, et al. (2005). Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the ORTC (#22931) AND RTOG (#9501). Head Neck, 27, 843– 850. Byers RN, Weber RS, Andrews T, et al. (1997). Frequency and therapeutic implications of “skip metastasis” in the neck from squamous carcinoma of the oral tongue. Head Neck, 19(1),14-19. Cooper JS, Pajak TF, Forastiere AA, et al. (2004). Radiation Therapy Oncology Group 9501/Intergroup. Postoperative Concurrent Radiotherapy and Chemotherapy for High-Risk Squamous-Cell Carcinoma of the Head and Neck .N Engl J Med,350,1937-44. Huang DT, Johnson CR, Schmidt-Ullrich R, et al. (1992). Postoperative radiotherapy in head and neck carcinoma with extracapsular lymph node extension and/or positive resection margins: a comparative study. Int J Radiat Oncol Biol Physics, 23,737–742. Myers JN, Greenberg JS, Mo V, et al.(2001). Extracapsular Spread A Significant Predictor of Treatment Failure in Patients with Squamous Cell Carcinoma of the Tongue. Cancer, 92,3030–6. Spiro RH, Huvos AG, Wong GY, et al.(1986). Predictive value of tumor thickness in squamous carcinoma confined to the tongue and floor of mouth. Am J Surgery, 152(4), 345-350. Yuen AP, Lam KY, Wei WI. (2000). A comparison of the prognostic significance of tumor diameter, length, width, thickness, area, volume and clinicopathological features of oral tongue carcinoma. Am J Surg 180(2), 139-143.

Copyright 2015 The University of Texas MD Anderson Cancer Center

Department of Clinical Effectiveness V5 Approved by the Executive Committee of the Medical Staff on 10/27/2015

This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson, including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women. Note: If available, clinical trials should be considered as preferred treatment options for eligible patients.

DEVELOPMENT CREDITS This practice consensus algorithm is based on majority expert opinion of the Head and Neck Center faculty at the University of Texas, MD Anderson Cancer Center. It was developed using a multidisciplinary approach that included input from the following medical, radiation and surgical oncologists:

Beth Beadle, MD, PhD Lauren Byers, MD Gregory Chronowski, MD Gary L Clayman, DMD, MD, FACS Renata Ferrarotto, MD Steven J Frank, MD Clifton Fuller, MD PHD Adam S Garden, MD Paul W Gidley, MD Ann M Gillenwater, MD, FACS Bonnie S Glisson, MD, FACP

Kathryn Gold, MD Neil Gross, MD Brandon Gunn, MD Ehab Y Hanna, MD, FACS Amy C Hessel, MD‡ Waun Ki Hong, MD Merrill S Kies, MD Michael E Kupferman, MD Stephen Y. Lai, MD, PhD Carol Lewis, MD Charles Lu, MD

William H Morrison, MD Jeffrey N Myers, MD, PhD, FACS Vassiliki Papadimitrakopoulou, MD Jack Phan, MD, PHD Kristen B Pytynia, MD David I Rosenthal, MD Shalin Shah, MD Shirley Y. Su, MBBS Erich Madison Sturgis, MD, MPH,FACS Randal S Weber, MD, FACS Mark Zafereo, MD‡

‡Development Lead

Copyright 2015 The University of Texas MD Anderson Cancer Center

Department of Clinical Effectiveness V5 Approved by the Executive Committee of the Medical Staff on 10/27/2015