Pharyngeal Cancer Treatment Protocols 

Pharyngeal Cancer Treatment Protocols 

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Treatment protocols for pharyngeal cancers are provided below, including the following:

Generalized first-line therapy based on stage

Chemoradiation therapy and induction chemotherapy for locally advanced disease

First-, second-, and third-line chemotherapy for metastatic or recurrent disease

See the list below:

Treatment plans for all disease stages should be discussed at a multidisciplinary tumor conference involving ear, nose, throat (ENT) surgeons; radiation oncologists; and medical oncologists

Selected patients with advanced or metastatic disease may receive surgical resection of their primary tumors, depending on their response to first-line therapy

Stages I-II [1, 2] :

Primary treatment for oropharyngeal cancers is surgical resection or definitive radiation therapy

Surgery is the preferred approach, except for some patients who may have early lip, retromolar trigone, and soft palate cancers

Radiation therapy is preferred for patients who may not be able to tolerate surgery

The radiation dose depends on tumor size; however, for early stage disease, doses of 66-74 Gy (2.0 Gy/fraction; daily Monday-Friday in 7wk) may be used with adequate results

Stages III-IVB [1, 2] :

Surgery should be considered for locally advanced disease; however, definitive radiation therapy, concurrent chemoradiation, and induction therapy are alternative options for patients who are not candidates for surgery

Concurrent chemoradiation therapy is the current standard of care for patients with locally advanced squamous cell carcinoma of the head and neck

Chemotherapy is given for the duration of radiation therapy unless otherwise stated; definitive radiation doses used are 66-74 Gy (2.0 Gy/fraction; daily Monday-Friday in 7wk)

Conventional fractionation for concurrent chemoradiation up to 70 Gy (2.0 Gy/fraction)

Postoperative radiation dose is 60-66 Gy (2.0 Gy/fraction); preferred interval between resection and postoperative radiation therapy is 6 wk

The decision to treat the patient with concurrent chemoradiation therapy rather than surgery, radiation, or chemotherapy individually should be made by a multidisciplinary tumor board (including a medical oncologist, a radiation therapist, and an ENT surgeon)

Acceptable chemotherapy regimens for primary systemic therapy with concurrent radiation:

Cisplatin 100 mg/m2 IV on days 1, 22, and 43 [1, 2, 3, 4] or  40-50 mg/m2 IV weekly for 6-7wk [5] or

Cetuximab 400 mg/m2 IV loading dose 1 wk before the start of radiation therapy, then  250 mg/m2 weekly (premedicate with dexamethasone, diphenhydramine, and ranitidine) [6, 7] ; or

Cisplatin 20 mg/m2 IV on day 2 weekly for up to 7 wk plus paclitaxel 30 mg/m2 IV on day 1 weekly for up to 7 wk [8] or

Cisplatin 20 mg/m2/day IV on days 1-4 and 22-25 plus fluorouracil (5-FU) 1000 mg/m2/day by continuous IV infusion on days 1-4 and 22-25 [9, 10, 11] or

5-FU 800 mg/m2 by continuous IV infusion on days 1-5 given on the days of radiation plus hydroxyurea 1 g PO q12 h (11 doses per cycle); chemotherapy and radiation given every other week for a total of 13 wk [8] or

Carboplatin 70 mg/m2/day IV on days 1-4, 22-25, and 43-46 plus  5-FU 600 mg/m2/day by continuous IV infusion on days 1-4, 22-25, and 43-46 [12] or

Carboplatin area under the curve (AUC) 1.5 IV on day 1 weekly plus  paclitaxel 45 mg/m2 IV on day 1 weekly [13] (see also the Carboplatin AUC Dose Calculation [Calvert formula] calculator)

Acceptable chemotherapy regimens for patients receiving postoperative concurrent chemoradiation:

Cisplatin 100 mg/m2 IV on days 1, 22, and 43 [3, 4] or  40-50 mg/m2 IV weekly for 6-7wk [5]

Stages III-IVB:

Induction chemotherapy is typically given to patients with stage III-IVB disease in order to shrink a primary tumor to reduce its bulkiness in preparation for future surgery or radiation therapy

The decision to treat the patient with induction chemotherapy rather than concurrent chemoradiation or surgery, radiation, or chemotherapy alone should be made by a multidisciplinary tumor board (including a medical oncologist, a radiation therapist, and an ENT surgeon) [1, 2]

Acceptable chemotherapy regimens for induction chemotherapy:

Docetaxel 75 mg/m2 IV on day 1 plus  cisplatin 100 mg/m2 IV on day 1 plus  5-FU 100 mg/m2/day by continuous IV infusion on days 1-4 every 3 wk for 3 cycles; then  3-8 wk later, carboplatin AUC 1.5 IV weekly for up to 7wk during radiation therapy; then  6-12 wk later, pursue surgery, if applicable [14, 15] ; or

Docetaxel 75 mg/m2 IV on day 1 plus  cisplatin 75 mg/m2 IV on day 1 plus  5-FU 750 mg/m2/day by continuous IV infusion on days 1-4 every 3wk for 4 cycles; then  4-7wk later, radiation; surgical resection can be pursued before or after chemotherapy [16]

Paclitaxel 175 mg/m2 IV on day 1 plus  cisplatin 100 mg/m2 IV on day 2 plus  5-FU 500 mg/m2/day by continuous IV infusion on days 2-6 every 3 wk for 3 cycles; then  radiation with cisplatin 100 mg/m2 IV on days 1, 22, and 43 [17]

Stage IVC:

Treatment recommendations include the use of single-agent or combination chemotherapy

Platinum-based chemotherapy regimens are preferred if the patient can tolerate these agents; if not, single agents have been used in this setting [1, 2]

Below are first-line chemotherapy options for metastatic disease or recurrent squamous head and neck cancers (after surgery and/or radiation)

Acceptable chemotherapy regimens in patients with metastatic (incurable) head and neck cancers (unless otherwise stated, goal is to complete at least six cycles):

Cisplatin 100 mg/m2 IV on day 1 every 3 wk for six cycles plus  5-FU 1000 mg/m2/day by continuous IV infusion on days 1-4 every 3 wk for six cycles plus  cetuximab 400 mg/m2 IV loading dose on day 1, then  250 mg/m2 IV weekly until disease progression (premedicate with dexamethasone, diphenhydramine, and ranitidine) [18] ; or

Carboplatin AUC 5 IV on day 1 every 3 wk for six cycles plus  5-FU 1000 mg/m2/day by continuous IV infusion on days 1-4 every 3 wk for six cycles plus  cetuximab 400 mg/m2 IV loading dose on day 1, then  250 mg/m2 IV weekly until disease progression (premedicate with dexamethasone, diphenhydramine, and ranitidine) [18] ; or

Cisplatin 75 mg/m2 IV on day 1 plus  docetaxel 75 mg/m2 IV on day 1 every 3 wk [19, 20] or

Cisplatin 75 mg/m2 IV on day 1 plus  paclitaxel 175 mg/m2 IV on day 1 every 3 wk [21, 22] or

Carboplatin AUC 6 IV on day 1 plus  docetaxel 65 mg/m2 IV on day 1 every 3 wk [23] or

Carboplatin AUC 6 IV on day 1 plus  paclitaxel 200 mg/m2 IV on day 1 every 3 wk [24] or

Cisplatin 75-100 mg/m2 IV on day 1 every 3-4 wk plus  cetuximab 400 mg/m2 IV loading dose on day 1, then  250 mg/m2 IV weekly (premedicate with dexamethasone, diphenhydramine, and ranitidine) [25, 26, 27] ; or

Cisplatin 100 mg/m2 IV on day 1 plus  5-FU 1000 mg/m2/day by continuous IV infusion on days 1-4 every 3 wk [11, 22, 28, 29, 30] or

Methotrexate 40 mg/m2 IV weekly (3 wk equals one cycle) [11, 28] or

Paclitaxel 200 mg/m2 IV every 3 wk [31, 32] or

Docetaxel 75 mg/m2 IV every 3 wk [33, 34, 35] or

Cetuximab 400 mg/m2 IV loading dose on day 1, then  250 mg/m2 IV weekly until disease progression (premedicate with dexamethasone, diphenhydramine, and ranitidine) [36]

Stage IVC:

Second-line chemotherapy is given after disease progression or recurrence following completion of first-line therapy

Third-line therapies are given after disease progression or recurrence following completion of first-line and second-line therapies

Second- and third-line regimens are similar to regimens used as first-line therapy but usually offer lower response rates and survival benefits

Patients should be treated with platinum-based chemotherapy regimens if they have not previously received a platinum-based drug

Acceptable chemotherapy regimens in patients with recurrent head and neck cancers (unless otherwise stated, goal is to complete at least six cycles):

Cisplatin 100 mg/m2 IV on day 1 every 3 wk for six cycles plus  5-FU 1000 mg/m2/day by continuous IV infusion on days 1-4 every 3 wk for six cycles plus  cetuximab 400 mg/m2 IV loading dose on day 1, then  250 mg/m2 IV weekly until disease progression (premedicate with dexamethasone, diphenhydramine, and ranitidine) [18] ; or

Carboplatin AUC 5 IV on day 1 every 3 wk for six cycles plus  5-FU 1000 mg/m2/day by continuous IV infusion on days 1-4 every 3wk for six cycles plus  cetuximab 400 mg/m2 IV loading dose on day 1, then  250 mg/m2 IV weekly until disease progression (premedicate with dexamethasone, diphenhydramine, and ranitidine) [19] ; or

Cisplatin 75 mg/m2 IV on day 1 plus  docetaxel 75 mg/m2 IV on day 1 every 3 wk [19] or

Cisplatin 75 mg/m2 IV on day 1 plus  paclitaxel 175 mg/m2 IV on day 1 every 3 wk [21, 22] or

Carboplatin AUC 6 IV on day 1 plus  docetaxel 65 mg/m2 IV on day 1 every 3 wk [23] or

Carboplatin AUC 6 IV on day 1 plus  paclitaxel 200 mg/m2 IV on day 1 every 3 wk [24] or

Cisplatin 75-100 mg/m2 IV on day 1 every 3-4 wk plus  cetuximab 400 mg/m2 IV loading dose on day 1, then  250 mg/m2 IV weekly (premedicate with dexamethasone, diphenhydramine, and ranitidine) [25, 26, 27] ; or

Cisplatin 100 mg/m2 IV on day 1 plus  5-FU 1000 mg/m2/day by continuous IV infusion on days 1-4 every 3wk [11, 22, 28, 29, 30] or

Methotrexate 40 mg/m2 IV weekly (3 wk equals one cycle) [11, 28] or

Paclitaxel 200 mg/m2 IV every 3 wk [2, 32] or

Docetaxel 75 mg/m2 IV every 3 wk [33, 34, 35] or

Cetuximab 400 mg/m2 IV loading dose on day 1, then  250 mg/m2 IV weekly until disease progression (premedicate with dexamethasone, diphenhydramine, and ranitidine) [36]

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A phase III randomised trial of cisplatinum, methotrextate, cisplatinum + methotrexate and cisplatinum + 5-FU in end stage squamous carcinoma of the head and neck. Liverpool Head and Neck Oncology Group. Br J Cancer. 1990 Feb. 61(2):311-5. [Medline]. [Full Text].

Calais G, Alfonsi M, Bardet E, Sire C, Germain T, Bergerot P, et al. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst. 1999 Dec 15. 91(24):2081-6. [Medline].

Haddad R, Sonis S, Posner M, Wirth L, Costello R, Braschayko P, et al. Randomized phase 2 study of concomitant chemoradiotherapy using weekly carboplatin/paclitaxel with or without daily subcutaneous amifostine in patients with locally advanced head and neck cancer. Cancer. 2009 Oct 1. 115(19):4514-23. [Medline].

Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, et al. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25. 357(17):1705-15. [Medline].

Lorch JH, Goloubeva O, Haddad RI, Cullen K, Sarlis N, Tishler R, et al. Induction chemotherapy with cisplatin and fluorouracil alone or in combination with docetaxel in locally advanced squamous-cell cancer of the head and neck: long-term results of the TAX 324 randomised phase 3 trial. Lancet Oncol. 2011 Feb. 12(2):153-9. [Medline].

Vermorken JB, Remenar E, van Herpen C, et al. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007;357:1695-704:

Hitt R, López-Pousa A, Martínez-Trufero J, et al. Phase III study comparing cisplatin plus fluorouracil to paclitaxel, cisplatin, and fluorouracil induction chemotherapy followed by chemoradiotherapy in locally advanced head and neck cancer. J Clin Oncol. 2005 Dec 1. 23(34):8636-45. [Medline].

Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11. 359(11):1116-27. [Medline].

Glisson BS, Murphy BA, Frenette G, Khuri FR, Forastiere AA. Phase II Trial of docetaxel and cisplatin combination chemotherapy in patients with squamous cell carcinoma of the head and neck. J Clin Oncol. 2002 Mar 15. 20(6):1593-9. [Medline].

Baur M, Kienzer HR, Schweiger J, DeSantis M, Gerber E, Pont J, et al. Docetaxel/cisplatin as first-line chemotherapy in patients with head and neck carcinoma: a phase II trial. Cancer. 2002 Jun 1. 94(11):2953-8. [Medline].

Forastiere AA, Leong T, Rowinsky E, Murphy BA, Vlock DR, DeConti RC, et al. Phase III comparison of high-dose paclitaxel + cisplatin + granulocyte colony-stimulating factor versus low-dose paclitaxel + cisplatin in advanced head and neck cancer: Eastern Cooperative Oncology Group Study E1393. J Clin Oncol. 2001 Feb 15. 19(4):1088-95. [Medline].

Gibson MK, Li Y, Murphy B, Hussain MH, DeConti RC, Ensley J, et al. Randomized phase III evaluation of cisplatin plus fluorouracil versus cisplatin plus paclitaxel in advanced head and neck cancer (E1395): an intergroup trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2005 May 20. 23(15):3562-7. [Medline].

Samlowski WE, Moon J, Kuebler JP, Nichols CR, Gandara DR, Ozer H, et al. Evaluation of the combination of docetaxel/carboplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN): a Southwest Oncology Group Phase II study. Cancer Invest. 2007 Apr-May. 25(3):182-8. [Medline].

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Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1. 23(34):8646-54. [Medline].

Baselga J, Trigo JM, Bourhis J, Tortochaux J, Cortés-Funes H, Hitt R, et al. Phase II multicenter study of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum-refractory metastatic and/or recurrent squamous cell carcinoma of the head and neck. J Clin Oncol. 2005 Aug 20. 23(24):5568-77. [Medline].

Herbst RS, Arquette M, Shin DM, Dicke K, Vokes EE, Azarnia N, et al. Phase II multicenter study of the epidermal growth factor receptor antibody cetuximab and cisplatin for recurrent and refractory squamous cell carcinoma of the head and neck. J Clin Oncol. 2005 Aug 20. 23(24):5578-87. [Medline].

Forastiere AA, Metch B, Schuller DE, Ensley JF, Hutchins LF, Triozzi P, et al. Randomized comparison of cisplatin plus fluorouracil and carboplatin plus fluorouracil versus methotrexate in advanced squamous-cell carcinoma of the head and neck: a Southwest Oncology Group study. J Clin Oncol. 1992 Aug. 10(8):1245-51. [Medline].

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Clavel M, Vermorken JB, Cognetti F, Cappelaere P, de Mulder PH, Schornagel JH, et al. Randomized comparison of cisplatin, methotrexate, bleomycin and vincristine (CABO) versus cisplatin and 5-fluorouracil (CF) versus cisplatin (C) in recurrent or metastatic squamous cell carcinoma of the head and neck. A phase III study of the EORTC Head and Neck Cancer Cooperative Group. Ann Oncol. 1994 Jul. 5(6):521-6. [Medline].

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Forastiere AA, Shank D, Neuberg D, Taylor SG 4th, DeConti RC, Adams G. Final report of a phase II evaluation of paclitaxel in patients with advanced squamous cell carcinoma of the head and neck: an Eastern Cooperative Oncology Group trial (PA390). Cancer. 1998 Jun 1. 82(11):2270-4. [Medline].

Catimel G, Verweij J, Mattijssen V, Hanauske A, Piccart M, Wanders J, et al. Docetaxel (Taxotere): an active drug for the treatment of patients with advanced squamous cell carcinoma of the head and neck. EORTC Early Clinical Trials Group. Ann Oncol. 1994 Jul. 5(6):533-7. [Medline].

Dreyfuss AI, Clark JR, Norris CM, Rossi RM, Lucarini JW, Busse PM, et al. Docetaxel: an active drug for squamous cell carcinoma of the head and neck. J Clin Oncol. 1996 May. 14(5):1672-8. [Medline].

Couteau C, Chouaki N, Leyvraz S, Oulid-Aissa D, Lebecq A, Domenge C, et al. A phase II study of docetaxel in patients with metastatic squamous cell carcinoma of the head and neck. Br J Cancer. 1999 Oct. 81(3):457-62. [Medline]. [Full Text].

Vermorken JB, Trigo J, Hitt R, Koralewski P, Diaz-Rubio E, Rolland F, et al. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol. 2007 Jun 1. 25(16):2171-7. [Medline].

Marvaretta M Stevenson, MD Assistant Professor, Division of Medical Oncology, Duke University Medical Center

Disclosure: Nothing to disclose.

Jasmeet Anand, PharmD, RPh Adjunct Instructor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Nothing to disclose.

Christopher D Braden, DO Hematologist/Oncologist, Chancellor Center for Oncology at Deaconess Hospital; Medical Director, Deaconess Hospital Outpatient Infusion Centers; Chairman, Deaconess Hospital Cancer Committee

Christopher D Braden, DO is a member of the following medical societies: American Society of Clinical Oncology, American Society of Hematology

Disclosure: Nothing to disclose.

Guy J Petruzzelli, MD, PhD, MBA, FACS Physician-in-Chief and Vice President of Oncology Programs, Curtis and Elizabeth Anderson Cancer Institute at Memorial University Medical Center; Professor of Surgery-Head, Neck, and Endocrine Surgery, Mercer University School of Medicine-Savannah Campus

Guy J Petruzzelli, MD, PhD, MBA, FACS is a member of the following medical societies: American Academy of Otolaryngology-Head and Neck Surgery, American Association for the Advancement of Science, American Association of Clinical Anatomists, American College of Surgeons, American Head and Neck Society, American Medical Association, American Society of Clinical Oncology, Chicago Medical Society, Georgia Society of Otolaryngology-Head and Neck Surgery, International Academy of Oral Oncology, International Head and Neck Scientific Group, North American Skull Base Society, Society of Surgical Oncology, Society of University Otolaryngologists-Head and Neck Surgeons, SWOG

Disclosure: Nothing to disclose.

Pharyngeal Cancer Treatment Protocols 

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