Clinical trial NCT03729518 - References

Squamous Cell Carcinoma — TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck

Citation(s)

•   Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML
  Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7.
•   Chen AM, Felix C, Wang PC, Hsu S, Basehart V, Garst J, Beron P, Wong D, Rosove MH, Rao S, Melanson H, Kim E, Palmer D, Qi L, Kelly K, Steinberg ML, Kupelian PA, Daly ME
  Reduced-dose radiotherapy for human papillomavirus-associated squamous-cell carcinoma of the oropharynx: a single-arm, phase 2 study. Lancet Oncol. 2017 Jun;18(6):803-811. doi: 10.1016/S1470-2045(17)30246-2. Epub 2017 Apr 20.
•   ClinicalTrials
  gov. Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS).
•   Cohen MA, Weinstein GS, O'Malley BW Jr, Feldman M, Quon H
  Transoral robotic surgery and human papillomavirus status: Oncologic results. Head Neck. 2011 Apr;33(4):573-80. doi: 10.1002/hed.21500. Epub 2010 Dec 6.
•   Erratum to: Routman DM, Funk RK, Tangsriwong K, et al
  Relapse rates with surgery alone in human papillomavirus-related intermediate- and high-risk group oropharynx squamous cell cancer: A multi-institutional review. Int J Radiat Oncol Biol Phys 2017;99:938-946. Int J Radiat Oncol Biol Phys. 2018 Apr 1;100(5):1304. doi: 10.1016/j.ijrobp.2017.12.286. No abstract available.
•   Expert Panel on Radiation Oncology--Head & Neck Cancer:; Yeung AR, Garg MK, Lawson J, McDonald MW, Quon H, Ridge JA, Saba N, Salama JK, Smith RV, Yom SS, Beitler JJ; American College of Radiology
  ACR Appropriateness Criteria(R) ipsilateral radiation for squamous cell carcinoma of the tonsil. Head Neck. 2012 May;34(5):613-6. doi: 10.1002/hed.21993. Epub 2012 Jan 17.
•   Gamez ME, Halyard MY, Hinni ML, Hayden RE, Nagel TH, Vargas CE, Wong WW, Curtis KK, Zarka MA, Ma D, Patel SH
  Mucosal Sparing Radiation Therapy in Resected Oropharyngeal Cancer. Ann Otol Rhinol Laryngol. 2017 Mar;126(3):185-191. doi: 10.1177/0003489416681580. Epub 2017 Jan 5.
•   H
  B. Musunuru PY, H.C. Ko, T. Kennedy, P.M. Harari, M.E. Witek. Can Elective Neck Radiation Treatment Volumes be Safely Reduced to Diminish Toxicity Profiles for Oropharynx Cancer Patients? International journal of radiation oncology, biology, physics. 2017;99(2 Supplement):E361.
•   Hu KS, Mourad WF, Gamez M, Safdieh J, Lin W, Jacobson AS, Persky MS, Urken ML, Culliney B, Li Z, Tran TN, Schantz SP, Chadha J, Harrison LB
  Low rates of contralateral neck failure in unilaterally treated oropharyngeal squamous cell carcinoma with prospectively defined criteria of lateralization. Head Neck. 2017 Aug;39(8):1647-1654. doi: 10.1002/hed.24806. Epub 2017 May 5.
•   Huang AC, Postow MA, Orlowski RJ, Mick R, Bengsch B, Manne S, Xu W, Harmon S, Giles JR, Wenz B, Adamow M, Kuk D, Panageas KS, Carrera C, Wong P, Quagliarello F, Wubbenhorst B, D'Andrea K, Pauken KE, Herati RS, Staupe RP, Schenkel JM, McGettigan S, Kothari S, George SM, Vonderheide RH, Amaravadi RK, Karakousis GC, Schuchter LM, Xu X, Nathanson KL, Wolchok JD, Gangadhar TC, Wherry EJ
  T-cell invigoration to tumour burden ratio associated with anti-PD-1 response. Nature. 2017 May 4;545(7652):60-65. doi: 10.1038/nature22079. Epub 2017 Apr 10.
•   Huang SH, Waldron J, Bratman SV, Su J, Kim J, Bayley A, Cho J, Giuliani M, Hope A, Ringash J, Hansen A, de Almeida JR, Goldstein D, Perez-Ordonez B, Weinreb I, Tong L, Xu W, O'Sullivan B
  Re-evaluation of Ipsilateral Radiation for T1-T2N0-N2b Tonsil Carcinoma at the Princess Margaret Hospital in the Human Papillomavirus Era, 25 Years Later. Int J Radiat Oncol Biol Phys. 2017 May 1;98(1):159-169. doi: 10.1016/j.ijrobp.2017.01.018. Epub 2017 Jan 9.
•   Ingle CJ, Yip K, Caskie V, Dyson C, Ford A, Scrase CD
  Intensity modulated radiotherapy (IMRT) in the management of locally advanced oropharyngeal squamous cell carcinomata (SCC): disease control and functional outcome using the therapy outcome measure (TOM) score--report from a single U.K. institution. Head Neck Oncol. 2010 Oct 14;2:28. doi: 10.1186/1758-3284-2-28.
•   J
  Gershowitz AD, J.N. Lukens, S.D. Swisher-McClure, G.A. Geiger Jr., A. Lin. Pathologic Risk Factors Associated With Contralateral Neck Disease in Patients with Tonsil Cancer: Implications on Patient Selection for Unilateral Neck Radiation Therapy. International Journal of Radiation Oncology Biology Physics. 2017;99(2):S234.
•   Kaczmar JM, Tan KS, Heitjan DF, Lin A, Ahn PH, Newman JG, Rassekh CH, Chalian AA, O'Malley BW Jr, Cohen RB, Weinstein GS
  HPV-related oropharyngeal cancer: Risk factors for treatment failure in patients managed with primary transoral robotic surgery. Head Neck. 2016 Jan;38(1):59-65. doi: 10.1002/hed.23850. Epub 2015 Apr 6.
•   Kamphorst AO, Pillai RN, Yang S, Nasti TH, Akondy RS, Wieland A, Sica GL, Yu K, Koenig L, Patel NT, Behera M, Wu H, McCausland M, Chen Z, Zhang C, Khuri FR, Owonikoko TK, Ahmed R, Ramalingam SS
  Proliferation of PD-1+ CD8 T cells in peripheral blood after PD-1-targeted therapy in lung cancer patients. Proc Natl Acad Sci U S A. 2017 May 9;114(19):4993-4998. doi: 10.1073/pnas.1705327114. Epub 2017 Apr 26.
•   Lee JY, Garcia-Murillas I, Cutts RJ, De Castro DG, Grove L, Hurley T, Wang F, Nutting C, Newbold K, Harrington K, Turner N, Bhide S
  Predicting response to radical (chemo)radiotherapy with circulating HPV DNA in locally advanced head and neck squamous carcinoma. Br J Cancer. 2017 Sep 5;117(6):876-883. doi: 10.1038/bjc.2017.258. Epub 2017 Aug 15.
•   Liu C, Corry J, Peters L
  Letter to the editor regarding ACR Appropriateness Criteria for ipsilateral radiation for squamous cell carcinoma of the tonsil. Head Neck. 2013 Mar;35(3):464. doi: 10.1002/hed.23207. Epub 2013 Feb 5. No abstract available.
•   Liu C, Dutu G, Peters LJ, Rischin D, Corry J
  Tonsillar cancer: the Peter MacCallum experience with unilateral and bilateral irradiation. Head Neck. 2014 Mar;36(3):317-22. doi: 10.1002/hed.23297. Epub 2013 Jun 1.
•   Lukens JN, Lin A, Gamerman V, Mitra N, Grover S, McMenamin EM, Weinstein GS, O'Malley BW Jr, Cohen RB, Orisamolu A, Ahn PH, Quon H
  Late consequential surgical bed soft tissue necrosis in advanced oropharyngeal squamous cell carcinomas treated with transoral robotic surgery and postoperative radiation therapy. Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):981-988. doi: 10.1016/j.ijrobp.2014.04.024. Epub 2014 Jun 10.
•   Masterson L, Lechner M, Loewenbein S, Mohammed H, Davies-Husband C, Fenton T, Sudhoff H, Jani P, Goon P, Sterling J
  CD8+ T cell response to human papillomavirus 16 E7 is able to predict survival outcome in oropharyngeal cancer. Eur J Cancer. 2016 Nov;67:141-151. doi: 10.1016/j.ejca.2016.08.012. Epub 2016 Sep 24.
•   O'Sullivan B, Huang SH, Siu LL, Waldron J, Zhao H, Perez-Ordonez B, Weinreb I, Kim J, Ringash J, Bayley A, Dawson LA, Hope A, Cho J, Irish J, Gilbert R, Gullane P, Hui A, Liu FF, Chen E, Xu W
  Deintensification candidate subgroups in human papillomavirus-related oropharyngeal cancer according to minimal risk of distant metastasis. J Clin Oncol. 2013 Feb 10;31(5):543-50. doi: 10.1200/JCO.2012.44.0164. Epub 2013 Jan 7.
•   Ojerholm E, Lukens JN, Ahn PH, Geiger G, Swisher-McClure S, Newman J, Chalian A, Weinstein G, O'Malley BW Jr, Cohen R, Lin A
  Benefits of omitting primary site radiation therapy after transoral robotic surgery: Only time will tell. Pract Radiat Oncol. 2017 May-Jun;7(3):e157-e158. doi: 10.1016/j.prro.2016.10.019. Epub 2016 Nov 4. No abstract available.
•   P
  Ahn SS, O. Zhou, J.N. Lukens, A. Lin. A Comparative Quality of Life Cohort of Oropharyngeal Squamous Cell (OPSCC) Patients Treated With Volumetric Modulated Radiation Therapy (VMAT) Versus Proton Pencil Beam Scanning (PBS). International journal of radiation oncology, biology, physics. 2016;93(3 Supp):S71.
•   Parikh F, Duluc D, Imai N, Clark A, Misiukiewicz K, Bonomi M, Gupta V, Patsias A, Parides M, Demicco EG, Zhang DY, Kim-Schulze S, Kao J, Gnjatic S, Oh S, Posner MR, Sikora AG
  Chemoradiotherapy-induced upregulation of PD-1 antagonizes immunity to HPV-related oropharyngeal cancer. Cancer Res. 2014 Dec 15;74(24):7205-16. doi: 10.1158/0008-5472.CAN-14-1913. Epub 2014 Oct 15.
•   Quon H, Cohen MA, Montone KT, Ziober AF, Wang LP, Weinstein GS, O'Malley BW Jr
  Transoral robotic surgery and adjuvant therapy for oropharyngeal carcinomas and the influence of p16 INK4a on treatment outcomes. Laryngoscope. 2013 Mar;123(3):635-40. doi: 10.1002/lary.22172. Epub 2013 Feb 1.
•   Rwigema JM, Langendijk JA, Paul van der Laan H, Lukens JN, Swisher-McClure SD, Lin A
  A Model-Based Approach to Predict Short-Term Toxicity Benefits With Proton Therapy for Oropharyngeal Cancer. Int J Radiat Oncol Biol Phys. 2019 Jul 1;104(3):553-562. doi: 10.1016/j.ijrobp.2018.12.055. Epub 2019 Jan 6.
•   Sikora AG, Toniolo P, DeLacure MD
  The changing demographics of head and neck squamous cell carcinoma in the United States. Laryngoscope. 2004 Nov;114(11):1915-23. doi: 10.1097/01.mlg.0000147920.66486.bc.
•   Sinha P, Lewis JS Jr, Piccirillo JF, Kallogjeri D, Haughey BH
  Extracapsular spread and adjuvant therapy in human papillomavirus-related, p16-positive oropharyngeal carcinoma. Cancer. 2012 Jul 15;118(14):3519-30. doi: 10.1002/cncr.26671. Epub 2011 Nov 15.
•   Society AC
  Cancer Facts and Figures 2011. 2011.
•   Tejeda HA, Green SB, Trimble EL, Ford L, High JL, Ungerleider RS, Friedman MA, Brawley OW
  Representation of African-Americans, Hispanics, and whites in National Cancer Institute cancer treatment trials. J Natl Cancer Inst. 1996 Jun 19;88(12):812-6. doi: 10.1093/jnci/88.12.812.
•   Weinstein GS, O'Malley BW Jr, Cohen MA, Quon H
  Transoral robotic surgery for advanced oropharyngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2010 Nov;136(11):1079-85. doi: 10.1001/archoto.2010.191.
•   Weinstein GS, Quon H, Newman HJ, Chalian JA, Malloy K, Lin A, Desai A, Livolsi VA, Montone KT, Cohen KR, O'Malley BW
  Transoral robotic surgery alone for oropharyngeal cancer: an analysis of local control. Arch Otolaryngol Head Neck Surg. 2012 Jul;138(7):628-34. doi: 10.1001/archoto.2012.1166.
•   Weinstein GS, Quon H, O'Malley BW Jr, Kim GG, Cohen MA
  Selective neck dissection and deintensified postoperative radiation and chemotherapy for oropharyngeal cancer: a subset analysis of the University of Pennsylvania transoral robotic surgery trial. Laryngoscope. 2010 Sep;120(9):1749-55. doi: 10.1002/lary.21021.

A Phase II Study of Volume and Dose De-Intensification Following Transoral Robotic Surgery (TORS) and Neck Dissection for p16+ Oropharyngeal Squamous Cell Carcinoma

Details for clinical trial NCT03729518