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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 ● Previous Radiation Therapy – Head and Neck, Thoracic, Breast (for previous primary or benign diagnosis) Physical Examination: ● Full head and neck exam ● Fiberoptic exam ● Videostroboscopy (optional) General medical exam Stage T and N (AJCC) Imaging studies: ● CT scan H&N ● Consider PET scan for Stage III/IV ● Modified Barium Swallow / espophagoscopy ● Chest Imaging as clinically indicated. Copyright 2015 The University of Texas MD Anderson Cancer Center CONSULTATIONS If no biopsy/pathology: consider EUA, DL, Biopsy, esophagoscopy ● Radiation oncology ● Medical oncology for patients with Stage III or IV ● Dental oncology for dentulous patients except those receiving narrow field radiation. ● Speech pathology for all patients and videostroboscopy, if indicated ● Consider esophagoscopy or barium swallow 1 ● IMPAC (for surgical management) ● Plastic surgery for patients who will require major reconstruction (pharyngeal reconstruction) ● Nutritional assessment and follow all patients ● Smoking cessation for active smokers only PRE-TREATMENT EVALUATION ● Glottic Patient information presented at Multidisciplinary Planning Conference Supraglottic ● Node Negative Supraglottic ● Node Positive (based on clinical and/or radiographic imaging) See page 2 See page 3 See page 4 1 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 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 Cerebrovascular Disease Diabetes ● Previous CVA ● Type I ● History of TIA ● Type II ● Carotid bruit or known stenosis Hepatic Disease ● History of cirrhosis ● Laboratory of hepatic dysfunction 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 ADJUVANT TREATMENT PRIMARY TREATMENT Severe dysplasia / carcinoma in situ Endoscopic removal (stripping/laser) Radiation to Primary (greater than or equal to 66 Gy) or ● Endoscopic partial laryngectomy or ● Open partial laryngectomy Is nodal status positive? ● Primary Tumor: Most T1-2, any N Concurrent chemoradiation Glottic Primary Tumor: Most T3, N0-N1 Complete response at primary site? Total laryngectomy1,2 and neck dissection(s), as indicated, and ipsilateral thyroidectomy. ● Consider primary Tracheosophageal Puncture (TEP) Yes No 1 2 Observe Neck dissection(s) No Yes Presence of pathological risk features3? Total laryngectomy and neck dissection(s), as clinically indicated, and ipsilateral thyroidectomy ● Consider primary Tracheosophageal Puncture (TEP) ● No Radiation therapy 4 ● Consider chemoradiation ● 3 No Observe Radiation therapy 4 ● Consider chemoradiation ● Primary tumors requiring total laryngectomy not amenable to partial surgery. Total Laryngectomy to be considered for patients with significant pretreatment laryngopharyngeal dysfunction or are medically unable to tolerate organ preservation therapy. Copyright 2015 The University of Texas MD Anderson Cancer Center Surveillance (See page 6) ● Medical oncology (optional) for chemoprevention trials ● Observe Total laryngectomy and neck dissection(s), as clinically indicated ● Primary Tumor: T4 disease, Any N Radiation therapy or ● Neck dissection(s) ● Yes Yes Residual nodal disease? SURVEILLANCE Pathological Risk Features include: Primary pathology: ● Any T1 or T2 with perineural invasion, OR lymphovascular invasion ● Any T3 or T4 Regional pathology: ● Multiple lymph nodes (any N2, N3) 4 Pathological Risk Factors include: ● Positive margins (re-excision to clear margins is preferred) ● Extracapsular extension 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 ADJUVANT TREATMENT PRIMARY TREATMENT Definitive Radiation Primary Tumor: Most T1-2, N0 Surgery: ● Endoscopic resection with neck dissection(s) or ● Open partial laryngeal surgery with neck dissection(s) Presence of Pathological Risk Features4 ? Complete response at primary site? Concurrent chemoradiation Primary Tumor: ● T3, N0 1 ● Selected T4 , N0 Total laryngectomy2,3 and neck dissection(s), as indicated, and ipsilateral thyroidectomy. ● Consider primary Tracheosophageal Puncture (TEP) Radiation or Chemoradiation Yes Yes No Pathologic N1? No No Yes Residual nodal disease? Yes Supraglottic Node Negative SURVEILLANCE Consider radiation therapy Observe Neck dissection(s) No Observe Laryngectomy, neck dissection(s) as clinically indicated ● Presence of pathological risk features4 ? Yes ● ● Radiation therapy Consider chemoradiation5 Yes No Pathologic N1? No Radiation Therapy Observe 4 Total laryngectomy and neck dissection(s), as indicated, and ipsilateral thyroidectomy. ● Consider primary Tracheosophageal Puncture (TEP) ● Primary Tumor: T4, N0 1 Copyright 2015 The University of Texas MD Anderson Cancer Center See page 4 Surveillance (page 6) Low-volume base-of-tongue involvement Primary tumors requiring total laryngectomy not amenable to partial surgery. 3 Total Laryngectomy to be considered for patients with significant pretreatment laryngopharyngeal dysfunction or are medically unable to tolerate organ preservation therapy. 2 Node Positive Radiation therapy 5 ● Consider chemoradiation ● Surveillance (See page 6) ● Medical oncology (optional) for chemoprevention trials ● Pathological Risk Features include: Primary pathology: ● Any T1 or T2 , with perineural invasion, OR lymphovascular invasion ● Any T3 or T4 Regional pathology: ● Multiple lymph nodes (any N2, N3) 5 Pathological Risk Factors include: ● Positive margins (re-excision to clear margins is preferred) ● Extracapsular extension 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: ● T1-2, N+ and ● Selected T3 (Not requiring Total Laryngectomy) Concurrent chemoradiation Concurrent chemoradiation Copyright 2015 The University of Texas MD Anderson Cancer Center Yes Complete response at primary site? Yes No Total laryngectomy2 and neck dissection(s),79as indicated, and ipsilateral thyroidectomy. ● Consider primary Tracheosophageal Puncture (TEP) Total laryngectomy and neck dissection(s), as indicated and ipsilateral thyroidectomy. ● Consider primary Tracheosophageal Puncture (TEP) N1 (initial stage) Yes Complete response of nodal disease? No Observe Neck dissection N2-3 Salvage surgery as clinically indicated Complete response of nodal disease? Yes Observe No Neck dissection Salvage surgery as clinically indicated ● ● Primary Tumor: T4, N+ Complete response at primary site? No Supraglottic Node Positive Primary Tumor: 1 ● Most T3, N+ or 1 ● Selected T4 SURVEILLANCE TREATMENT Presence of Pathological Risk Features3? Yes No Radiation therapy 4 ● Consider chemoradiation ● Surveillance (See page 6) ● Medical oncology (optional) for chemoprevention trials ● Radiation therapy 3 Pathological Risk Features include: Primary pathology: ● Any T1 or T2 with perineural invasion, OR Surveillance Radiation or lymphovascular invasion (See page 6) chemoradiation ● Any T3 or T4 Regional pathology: ● Multiple lymph nodes (any N2, N3) 4 Pathological Risk Factors include: 1 ● Positive margins (re-excision to clear Low-volume base-of-tongue involvement 2 margins is preferred) Total Laryngectomy to be considered for patients with significant pretreatment laryngopharyngeal ● Extracapsular extension dysfunction or are medically unable to tolerate organ preservation 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. CLINICAL PRESENTATION RECURRENT TREATMENT ● ● Consider Systemic Therapy/Phase I Clinical Trial Palliative Care as clinically indicated Yes Recurrent disease Restage ● CT head and neck ● CT chest or PET to evaluate for distant metastatic disease Consider Salvage Surgery as clinically indicated Presence of distant metastatic disease? Yes Is recurrence resectable? No Yes No ● Primary treatment chemoradiation? ● Consider Systemic Therapy Palliative Care as clinically indicated/clinical trial Surveillance (See page 6) Consider Salvage Surgery as clinically indicated ● Consider postoperative chemotherapy and Radiation Therapy1 ● No Yes Is recurrence resectable? No 1 Consider Chemotherapy and Radiation Therapy Pathological Risk Factors should be taken into consideration when making concurrent treatment decisions 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. LARYNX CANCER SURVEILLANCE Total Years for Surveillance Copyright 2015 The University of Texas MD Anderson Cancer Center Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 Frequency of Surveillance by month 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 CXR (CT chest if smoker) x x x x x x Thyroid function x x x x 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 Bradford C, Wolf GT, Carey TE, et al.(1999). Predictive markers for response to chemotherapy, organ preservation and survival in patients with advanced laryngeal carcinoma. Otolaryngology Head Neck Surg, 121(5),534-538. Forastiere AA, Geopfert H, Maor M, et al. (2003). Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med, 349(22),2091-2098. Fu KK, Pajak TF, Trotti A, et al. (2000). A Radiation Therapy Oncology Group (RTOG) phase III randomized study to compare hyperfractionation and two variants of accelerated fractionation to standard fractionation radiotherapy for head and neck squamous cell carcinomas: first report of RTOG 2003. Int J Radiat Oncol Biol Phys, 48,7-16. Fung K, Lyden TH, Lee J, et al. (2005). Voice and swallowing outcomes of an organ-preservation trial for advanced laryngeal cancer. Int J Rad Onc Bio Phys, 63(5), 1395-1399. Hanna E, Alexiou M, Morgan J, et al. (2004). Intensive chemoradiotherapy as a primary treatment for organ preservation in patients with advanced cancer of the head and neck: efficacy, toxic effects, and limiatations. Arch Otolaryngol Head Neck Surg,130(7),861-867. Hanna E, Sherman A, Cash D, et al. (2004). Quality of life for patients following total laryngectomy vs chemoradiation for laryngeal preservation. Arch Otolaryngol Head Neck Surg, 130(7),875-879. The Department of Veterans Affairs Laryngeal cancer Study Group.(1991). Induction chemotherapy plus radiation compared with surgery plus radiation in patients with advanced laryngeal cancer. N Engl J Med, 324,1685-1690. Weber RS, Berkey BA, Forastiere A, et al. (2003). Outcome of salvage total laryngectomy following organ-preservation therapy: the Radiation Therapy Oncology Group trial 91-11. Arch Otolaryngol Head Neck Surg,129(1), 44-49. 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 Leads 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