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We applaud the efforts of the Agency for Health Care Reform and Quality for their efforts in completing an updated review of the evidence for Radiotherapy Treatments for Head and Neck Cancer.  Despite aggressive primary treatment, recurrent disease remains a major clinical challenge.  Below is a list of studies that report on Radiotherapy Treatments for Head and Neck Cancer from the University of Pittsburgh Cancer Institute focusing on Stereotactic Body Radiation Therapy (SBRT) in the recurrent head and neck cancer setting.  Additionally, we have supplied studies germane to the four key questions that the Effective Health Care Program Evidence-based Practice Centers seeks to answer emphasizing the emerging role of SBRT in recurrent head and neck cancer.

Completed Phase II studies at the University of Pittsburgh Cancer Institute for Stereotactic Body Radiotherapy in the treatment of Head and Neck Cancer:

  1. UPCI 06-093 – NCT01104922
    Re-irradiation with Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck

Ongoing Phase II studies at the University of Pittsburgh Cancer Institute for Stereotactic Body Radiotherapy in the treatment of Head and Neck Cancer

  1. UPCI 11-112 ­- NCT02057107
    Stereotactic Body Radiation Therapy (SBRT) With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The above studies constitute all the phase II and above clinical trials examining SBRT in the treatment of Head and Neck Cancer at the University of Pittsburgh Cancer Institute.  Additional citations for lower level of evidence from the University of Pittsburgh Cancer Institute for SBRT in the treatment of Head and Neck Cancer as well as other relevant studies in this regard are listed below in the context of the four key questions.

Key Questions:

1. What is the comparative effectiveness of 3DRT, IMRT, SBRT, and PBRT regarding adverse events and quality of life (QoL)?

a. While to the author’s knowledge no head to head comparisons have been made for SBRT to the other examined modalities in the context of adverse events and QoL, the studies listed below from the SBRT literature may serve as a guide in the task group’s synthesis of the data for comparison.

i. Heron DE, Ferris RL, Karamouzis M, et al. Stereotactic body radiotherapy for recurrent squamous cell carcinoma of the head and neck: results of a phase I dose-escalation trial. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1493-500. PUBMED LINK

ii. Comet B, Kramar A, Faivre-Pierret M, et al. Salvage stereotactic reirradiation with or without cetuximab for locally recurrent head-and-neck cancer: a feasibility study. Int J Radiat Oncol Biol Phys. 2012 Sep 1;84(1):203-9. PUBMED LINK

Vargo JA, Heron DE, Ferris RL, et al. Prospective evaluation of patient-reported quality-of-life outcomes following SBRT ± cetuximab for locally-recurrent, previously-irradiated head and neck cancer. Radiother Oncol. 2012 Jul;104(1):91-5. PUBMED LINK

iii. Yamazaki H, Ogita M, Kodani N, et al. Frequency, outcome and prognostic factors of carotid blowout syndrome after hypofractionated re-irradiation of head and neck cancer using CyberKnife: a multi-institutional study. Radiother Oncol. 2013 Jun;107(3):305-9. PUBMED LINK

v. Yazici G, Sanl TY, Cengiz M, et al. A simple strategy to decrease fatal carotid blowout syndrome after stereotactic body reirradiaton for recurrent head and neck cancers. Radiat Oncol. 2013 Oct 18;8(1):242. OPEN ACCESS PAPER

vi. Vargo JA, Heron DE, Ferris RL, et al. Examining tumor control and toxicity following stereotactic body radiotherapy in locally-recurrent, previously-irradiated head-and-neck cancers: Implications of treatment duration and tumor volume. Head Neck. 2013 Aug 22. [Epub ahead of print]. PUBMED LINK

vii. Yamazaki H, Ogita M, Kodani N,  et al. Frequency, outcome and prognostic factors of carotid blowout syndrome after hypofractionated re-irradiation of head and neck cancer using CyberKnife: a multi-institutional study.  Radiother Oncol 2013;107:305-9. PUBMED LINK
 

2. What is the comparative effectiveness of 3DRT, IMRT, SBRT, and PBRT regarding tumor control and patient survival?

a. While to the author’s knowledge no head to head comparisons have been made for SBRT to the other examined modalities regarding tumor control and patient survival, the studies listed below from the SBRT literature may serve as a guide in the task group’s synthesis of the data for comparison.

i. Lartigau EF, Tresch E, Thariat J, et al.  Multi institutional phase II study of concomitant stereotactic reirradiation and cetuximab for recurrent head and neck cancer.  Radiother Oncol 2013;109:281-5. PUBMED LINK

ii. Rwigema JC, Heron DE, Ferris RL, et al. Fractionated stereotactic body radiation therapy in the treatment of previously-irradiated recurrent head and neck carcinoma: updated report of the University of Pittsburgh experience. Am J Clin Oncol. 2010 Jun;33(3):286-93. PUBMED LINK

iii. Roh KW, Jang JS, Kim MS, et al. Fractionated stereotactic radiotherapy as reirradiation for locally recurrent head and neck cancer. Int J Radiat Oncol Biol Phys. 2009 Aug 1;74(5):1348-55. PUBMED LINK

iv. Siddiqui F, Patel M, Khan M, et al. Stereotactic body radiation therapy for primary, recurrent, and metastatic tumors in the head-and-neck region. Int J Radiat Oncol Biol Phys. 2009 Jul 15;74(4):1047-53. PUBMED LINK

v. Unger KR, Lominska CE, Deeken JF, et al. Fractionated stereotactic radiosurgery for reirradiation of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2010 Aug 1;77(5):1411-9. PUBMED LINK

vi. Kodani N, Yamazaki H, Tsubokura T, et al. Stereotactic body radiation therapy for head and neck tumor: disease control and morbidity outcomes. J Radiat Res 2011;52:24–31. OPEN ACCESS ARTICLE

vii. Cengiz M, Özyiğit G, Yazici G et al. Salvage reirradiaton with stereotactic body radiotherapy for locally recurrent head-and-neck tumors. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):104-9. PUBMED LINK

3. Are there differences in comparative effectiveness of 3DRT, IMRT, SBRT, and PBRT for specific patient and tumor characteristics?

a. A retrospective single-institutional study has compared the effectiveness of SBRT to 3DRT in the specific context of re-irradiation for locally-recurrent nasopharyngeal cancer showing similar cancer specific survival at 2-years (64% vs 47%, p=0.4) and significantly less serious grade 3+ late toxicity as asses with CTCAE v3.0 (21% vs 48%, p=0.04) favoring the use of SBRT over 3DRT.

i. Ozyigit G, Cengiz M, Yazici G, et al. A retrospective comparison of robotic stereotactic body radiotherapy and three-dimensional conformal radiotherapy for the reirradiation of locally recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys 2011;81:e263-8. PUBMED LINK

 

b. Additional non-comparative studies are listed below from the SBRT literature which may serve as a guide in the task group’s synthesis of the data for comparison in the context of specific patient and tumor characteristics.

i. Vargo JA, Wegner RE, Heron DE, et al.  Stereotactic body radiation therapy for locally recurrent, previously irradiated nonsquamous cell cancers of the head and neck.  Head Neck 2012;34:1153-61  PUBMED LINK

ii. Vargo JA, Kubicek G, Ferris RL, et al.   Adjuvant SBRT +/- cetuximab following salvage surgery in previously-irradiated head-and-neck cancer.  Laryngoscope 2013 [Epud ahead of print]. PUBMED LINK

iii. Hasney CP, Swanton RG, Friedlander PL. Cyberknife stereotactic radiosurgery for recurrent squamous cell carcinoma of the head and neck following salvage surgery with close or positive margins.  Laryngoscope 2010;120:S152. PUBMED LINK

iv. Le QT, Tate D, Koong A, et al.  Improved local control with stereotactic radiosurgical boost in patients with nasopharyngeal carcinoma.  Int J Radiat Oncol Biol Phys 2003;56:1046-54 PUBMED LINK

v. Hara W, Loo BW, Goffinet DR, et al.  Excellent local control with stereotactic radiotherapy boost after external beam radiotherapy in patients with nasopharyngeal cancer.   Int J Radiat Oncol Biol Phys 2008;71: 393-400 PUBMED LINK

vi. Chen HH, Tsai ST, Wang MS, et al.   Experience in fractionated stereotactic body radiation therapy boost for newly diagnosed nasopharyngeal carcinoma.   Int J Radiat Oncol Biol Phys 2006;66:1408-1414. PUBMED LINK

vii. Al-Mamgani A, Tans L, Teguh DN, et al.  Stereotactic body radiotherapy: a promising treatment options for the boost of oropharyngeal cancers not suitable for brachytherapy: a single-institutional experience.  Int J Radiat Oncol Biol Phys 2012;82:1494-1500. PUBMED LINK

viii. Kim JH, Kim MS, Yoo SY, et al. Stereotactic body radiotherapy for refractory cervical lymph node recurrence of nonanaplastic thyroid cancer. Otolaryngol Head Neck Surg. 2010 Mar;142(3):338-43. PUBMED LINK

4. Is there variation in comparative effectiveness of 3DRT, IMRT, SBRT, and PBRT because of differences in user experience, treatment planning, treatment delivery, and target volume delineation?

a. While to the author’s knowledge no head to head comparisons have been made for SBRT to the other examined modalities to define if there is variation because of differences in user experience, treatment planning, treatment delivery, and target volume delineation, the studies listed below from the SBRT literature may serve as a guide in the task group’s synthesis of the data for comparison.

i. Wang K, Heron DE, Clump DA, et al. Target delineation in stereotactic body radiation therapy for recurrent head and neck cancer: a retrospective analysis of the impact of margins and automated PET-CT segmentation. Radiother Oncol. 2013 Jan;106(1):90-5. PUBMED LINK

ii. Rwigema JC, Heron DE, Ferris RL, et al. The impact of tumor volume and radiotherapy dose on outcome in previously irradiated recurrent squamous cell carcinoma of the head and neck treated with stereotactic body radiation therapy. Am J Clin Oncol. 2011 Aug;34(4):372-9 PUBMED LINK

iii. Wang K, Heron DE, Flickinger JC, et al. A retrospective, deformable registration analysis of the impact of PET-CT planning on patterns of failure in stereotactic body radiation therapy for recurrent head and neck cancer. Head Neck Oncol. 2012 Apr 19;4:12 PUBMED LINK

iv. Lee DS, Kim YS, Cheon JS, et al.  Long-term outcome and toxicity of hypofractionated stereotactic body radiotherapy as a boost treatment for head and neck cancer: the importance of boost volume assessment.  Radiation Oncology 2012;7:85.  OPEN ACCESS PAPER