Dosis-Deeskalation der adjuvanten Radiochemotherapie bei HPV-positiven Oropharynxkarzinomen: die MC1273-Phase-II-Studie

go back to reference Ma DJ, Price KA, Moore EJ, Patel SH, Hinni ML, Garcia JJ, Graner DE, Foster NR, Ginos B, Neben-Wittich M, Garces YI, Chintakuntlawar AV, Price DL, Olsen KD, Van Abel KM, Kasperbauer JL, Janus JR, Waddle M, Miller R, Shiraishi S, Foote RL (2019) Phase II evaluation of aggressive dose de-escalation for adjuvant chemoradiotherapy in human papillomavirus-associated oropharynx squamous cell carcinoma. J Clin Oncol 37(22):1909–1918. https://doi.org/10.1200/JCO.19.00463 CrossRefPubMedPubMedCentral Ma DJ, Price KA, Moore EJ, Patel SH, Hinni ML, Garcia JJ, Graner DE, Foster NR, Ginos B, Neben-Wittich M, Garces YI, Chintakuntlawar AV, Price DL, Olsen KD, Van Abel KM, Kasperbauer JL, Janus JR, Waddle M, Miller R, Shiraishi S, Foote RL (2019) Phase II evaluation of aggressive dose de-escalation for adjuvant chemoradiotherapy in human papillomavirus-associated oropharynx squamous cell carcinoma. J Clin Oncol 37(22):1909–1918. https://​doi.​org/​10.​1200/​JCO.​19.​00463 CrossRefPubMedPubMedCentral

go back to reference Marur S, Li S, Cmelak AJ, Gillison ML, Zhao WJ, Ferris RL, Westra WH, Gilbert J, Bauman JE, Wagner LI, Trevarthen DR, Balkrishna J, Murphy BA, Agrawal N, Colevas AD, Chung CH, Burtness B (2017) E1308: phase II trial of induction chemotherapy followed by reduced-dose radiation and weekly cetuximab in patients with HPV-associated resectable squamous cell carcinoma of the oropharynx-ECOG-ACRIN cancer research group. J Clin Oncol 35(5):490–497. https://doi.org/10.1200/JCO.2016.68.3300 CrossRefPubMed Marur S, Li S, Cmelak AJ, Gillison ML, Zhao WJ, Ferris RL, Westra WH, Gilbert J, Bauman JE, Wagner LI, Trevarthen DR, Balkrishna J, Murphy BA, Agrawal N, Colevas AD, Chung CH, Burtness B (2017) E1308: phase II trial of induction chemotherapy followed by reduced-dose radiation and weekly cetuximab in patients with HPV-associated resectable squamous cell carcinoma of the oropharynx-ECOG-ACRIN cancer research group. J Clin Oncol 35(5):490–497. https://​doi.​org/​10.​1200/​JCO.​2016.​68.​3300 CrossRefPubMed

go back to reference Mehanna H, Robinson M, Hartley A, Kong A, Foran B, Fulton-Lieuw T, Dalby M, Mistry P, Sen M, O’Toole L, Al Booz H, Dyker K, Moleron R, Whitaker S, Brennan S, Cook A, Griffin M, Aynsley E, Rolles M, De Winton E, Chan A, Srinivasan D, Nixon I, Grumett J, Leemans CR, Buter J, Henderson J, Harrington K, McConkey C, Gray A, Dunn J, Moleron R, McArdle O, Dyker K, Al Booz H, O’Toole L, Cook A, Husband D, Loo V, Soe W, Aynsley E, Sridhar T, Jankowska P, Joseph M, Geropantas K, Vaidya D, Griffin M, Hartley A, Vijayan R, Hwang D, Harrington K, Pettit L, Whitaker S, De Winton E, Rolles M, Brennan S, Sen M, Mendes R, Forster M, Chan A, Evans M, Buter J, Srinivasan D, Foran B, Nankivell P, Bryant J, Sharma N, Spruce R, Brooks J, Batis N, Roques T, Bidmead M, Yang H, Nutting C, Tyler J, Henderson J, Baines H, Gasnier A, Miles E, Clark C, Evans M (2019) Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV): an open-label randomised controlled phase 3 trial. Lancet 393(10166):51–60. https://doi.org/10.1016/S0140-6736(18)32752-1 CrossRefPubMedPubMedCentral Mehanna H, Robinson M, Hartley A, Kong A, Foran B, Fulton-Lieuw T, Dalby M, Mistry P, Sen M, O’Toole L, Al Booz H, Dyker K, Moleron R, Whitaker S, Brennan S, Cook A, Griffin M, Aynsley E, Rolles M, De Winton E, Chan A, Srinivasan D, Nixon I, Grumett J, Leemans CR, Buter J, Henderson J, Harrington K, McConkey C, Gray A, Dunn J, Moleron R, McArdle O, Dyker K, Al Booz H, O’Toole L, Cook A, Husband D, Loo V, Soe W, Aynsley E, Sridhar T, Jankowska P, Joseph M, Geropantas K, Vaidya D, Griffin M, Hartley A, Vijayan R, Hwang D, Harrington K, Pettit L, Whitaker S, De Winton E, Rolles M, Brennan S, Sen M, Mendes R, Forster M, Chan A, Evans M, Buter J, Srinivasan D, Foran B, Nankivell P, Bryant J, Sharma N, Spruce R, Brooks J, Batis N, Roques T, Bidmead M, Yang H, Nutting C, Tyler J, Henderson J, Baines H, Gasnier A, Miles E, Clark C, Evans M (2019) Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV): an open-label randomised controlled phase 3 trial. Lancet 393(10166):51–60. https://​doi.​org/​10.​1016/​S0140-6736(18)32752-1 CrossRefPubMedPubMedCentral

go back to reference Gillison ML, Trotti AM, Harris J, Eisbruch A, Harari PM, Adelstein DJ, Sturgis EM, Burtness B, Ridge JA, Ringash J, Galvin J, Yao M, Koyfman SA, Blakaj DM, Razaq MA, Colevas AD, Beitler JJ, Jones CU, Dunlap NE, Seaward SA, Spencer S, Galloway TJ, Phan J, Dignam JJ, Le QT (2019) Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial. Lancet 393(10166):40–50. https://doi.org/10.1016/S0140-6736(18)32779-X CrossRefPubMed Gillison ML, Trotti AM, Harris J, Eisbruch A, Harari PM, Adelstein DJ, Sturgis EM, Burtness B, Ridge JA, Ringash J, Galvin J, Yao M, Koyfman SA, Blakaj DM, Razaq MA, Colevas AD, Beitler JJ, Jones CU, Dunlap NE, Seaward SA, Spencer S, Galloway TJ, Phan J, Dignam JJ, Le QT (2019) Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial. Lancet 393(10166):40–50. https://​doi.​org/​10.​1016/​S0140-6736(18)32779-X CrossRefPubMed

go back to reference Harari PM, Harris J, Kies MS, Myers JN, Jordan RC, Gillison ML, Foote RL, Machtay M, Rotman M, Khuntia D, Straube W, Zhang Q, Ang K (2014) Postoperative chemoradiotherapy and cetuximab for high-risk squamous cell carcinoma of the head and neck: Radiation Therapy Oncology Group RTOG-0234. J Clin Oncol 32(23):2486–2495. https://doi.org/10.1200/JCO.2013.53.9163 CrossRefPubMedPubMedCentral Harari PM, Harris J, Kies MS, Myers JN, Jordan RC, Gillison ML, Foote RL, Machtay M, Rotman M, Khuntia D, Straube W, Zhang Q, Ang K (2014) Postoperative chemoradiotherapy and cetuximab for high-risk squamous cell carcinoma of the head and neck: Radiation Therapy Oncology Group RTOG-0234. J Clin Oncol 32(23):2486–2495. https://​doi.​org/​10.​1200/​JCO.​2013.​53.​9163 CrossRefPubMedPubMedCentral

go back to reference Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tân PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML (2010) Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med 363(1):24–35. https://doi.org/10.1056/NEJMoa0912217 CrossRefPubMedPubMedCentral Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tân PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML (2010) Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med 363(1):24–35. https://​doi.​org/​10.​1056/​NEJMoa0912217 CrossRefPubMedPubMedCentral

go back to reference Blanchard P, Bourhis J, Lacas B, Posner MR, Vermorken JB, Cruz Hernandez JJ, Bourredjem A, Calais G, Paccagnella A, Hitt R, Pignon JP (2013) Taxane-cisplatin-fluorouracil as induction chemotherapy in locally advanced head and neck cancers: an individual patient data meta-analysis of the meta-analysis of chemotherapy in head and neck cancer group. J Clin Oncol 31(23):2854–2860. https://doi.org/10.1200/JCO.2012.47.7802 CrossRefPubMed Blanchard P, Bourhis J, Lacas B, Posner MR, Vermorken JB, Cruz Hernandez JJ, Bourredjem A, Calais G, Paccagnella A, Hitt R, Pignon JP (2013) Taxane-cisplatin-fluorouracil as induction chemotherapy in locally advanced head and neck cancers: an individual patient data meta-analysis of the meta-analysis of chemotherapy in head and neck cancer group. J Clin Oncol 31(23):2854–2860. https://​doi.​org/​10.​1200/​JCO.​2012.​47.​7802 CrossRefPubMed

go back to reference Zhang Q, Wu Q, Harari PM, Rosenthal DI (2019) Randomized phase II/III confirmatory treatment selection design with a change of survival end points: statistical design of Radiation Therapy Oncology Group 1216. Head Neck 41(1):37–45. https://doi.org/10.1002/hed.25359 CrossRefPubMed Zhang Q, Wu Q, Harari PM, Rosenthal DI (2019) Randomized phase II/III confirmatory treatment selection design with a change of survival end points: statistical design of Radiation Therapy Oncology Group 1216. Head Neck 41(1):37–45. https://​doi.​org/​10.​1002/​hed.​25359 CrossRefPubMed

go back to reference Huang SH, Perez-Ordonez B, Liu FF, Waldron J, Ringash J, Irish J, Cummings B, Siu LL, Kim J, Weinreb I, Hope A, Gullane P, Brown D, Shi W, O’Sullivan B (2012) Atypical clinical behavior of p16-confirmed HPV-related oropharyngeal squamous cell carcinoma treated with radical radiotherapy. Int J Radiat Oncol Biol Phys 82(1):276–283. https://doi.org/10.1016/j.ijrobp.2010.08.031 CrossRefPubMed Huang SH, Perez-Ordonez B, Liu FF, Waldron J, Ringash J, Irish J, Cummings B, Siu LL, Kim J, Weinreb I, Hope A, Gullane P, Brown D, Shi W, O’Sullivan B (2012) Atypical clinical behavior of p16-confirmed HPV-related oropharyngeal squamous cell carcinoma treated with radical radiotherapy. Int J Radiat Oncol Biol Phys 82(1):276–283. https://​doi.​org/​10.​1016/​j.​ijrobp.​2010.​08.​031 CrossRefPubMed

go back to reference List MA, Rutherford JL, Stracks J, Pauloski BR, Logemann JA, Lundy D, Sullivan P, Goodwin W, Kies M, Vokes EE (2004) Prioritizing treatment outcomes: head and neck cancer patients versus nonpatients. Head Neck 26(2):163–170. https://doi.org/10.1002/hed.10367 CrossRefPubMed List MA, Rutherford JL, Stracks J, Pauloski BR, Logemann JA, Lundy D, Sullivan P, Goodwin W, Kies M, Vokes EE (2004) Prioritizing treatment outcomes: head and neck cancer patients versus nonpatients. Head Neck 26(2):163–170. https://​doi.​org/​10.​1002/​hed.​10367 CrossRefPubMed