David I Rosenthal1, Abdallah S R Mohamed2, Adam S Garden3, William H Morrison3, Adel K El-Naggar4, Mona Kamal5, Randal S Weber6, Clifton D Fuller3, Lester J Peters7. 1. Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: dirosenthal@mdanderson.org. 2. Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas; Department of Clinical Oncology and Nuclear Medicine, Faculty of Medicine, University of Alexandria, Alexandria, Egypt. 3. Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. 4. Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas. 5. Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas; Department of Radiation Oncology, Ain Shams University, Cairo, Egypt. 6. Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas. 7. Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Abstract
PURPOSE: To present the long-term and final report of a phase 3 trial designed to assess dose-response relationship for postoperative radiation therapy (PORT) and pathologic risk groups in head and neck cancer. METHODS AND MATERIALS: Patients who underwent primary surgery for American Joint Committee on Cancer stage III orIV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx and who required PORT were eligible. Patients' primary sites and involved necks were independently assigned to higher- or lower-risk categories based on a cumulative point score representing increasing risk of recurrence. The sites in the lower-risk group were randomized to receive 57.6 or 63 Gy and those in the higher-risk group were randomized to receive 63 or 68.4 Gy, all at 1.8 Gy per fraction. RESULTS:A total of 264 patients were included. The actuarial 5-year locoregional control rate was 67%. A second primary cancer was documented in 27% of patients. The 5- and 10-year freedom-from-distant metastasis rates were 64% and 60%, respectively, whereas the 5- and 10-year overall survival rates were 32% and 20%, respectively. There was no statistically significant difference in tumor control between different dose levels in both the lower- and higher-risk groups. On multivariate analysis, nonwhite race (P=.0003), positive surgical margins (P=.009), extracapsular extension (ECE, P=.01), and treatment package time (TPT) ≥85 days (P=.002) were independent correlates of worse locoregional control, whereas age ≥57 years (P<.0001), positive surgical margins (P=.01), ECE (P=.026), and TPT ≥85 days (P=.003) were independently associated with worse overall survival. CONCLUSIONS: This long-term report of PORT delivered at 1.8 Gy/d to total doses of 57.6 to 68.4 Gy without chemotherapy for head and neck squamous cell carcinoma demonstrated that increasing dose did not significantly improve tumor control. On multivariate analysis, the only significant treatment variable was TPT. The results confirm that positive surgical margins and/or nodal ECE remains the most significant predictive pathologic factors.
RCT Entities:
PURPOSE: To present the long-term and final report of a phase 3 trial designed to assess dose-response relationship for postoperative radiation therapy (PORT) and pathologic risk groups in head and neck cancer. METHODS AND MATERIALS: Patients who underwent primary surgery for American Joint Committee on Cancer stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx and who required PORT were eligible. Patients' primary sites and involved necks were independently assigned to higher- or lower-risk categories based on a cumulative point score representing increasing risk of recurrence. The sites in the lower-risk group were randomized to receive 57.6 or 63 Gy and those in the higher-risk group were randomized to receive 63 or 68.4 Gy, all at 1.8 Gy per fraction. RESULTS: A total of 264 patients were included. The actuarial 5-year locoregional control rate was 67%. A second primary cancer was documented in 27% of patients. The 5- and 10-year freedom-from-distant metastasis rates were 64% and 60%, respectively, whereas the 5- and 10-year overall survival rates were 32% and 20%, respectively. There was no statistically significant difference in tumor control between different dose levels in both the lower- and higher-risk groups. On multivariate analysis, nonwhite race (P=.0003), positive surgical margins (P=.009), extracapsular extension (ECE, P=.01), and treatment package time (TPT) ≥85 days (P=.002) were independent correlates of worse locoregional control, whereas age ≥57 years (P<.0001), positive surgical margins (P=.01), ECE (P=.026), and TPT ≥85 days (P=.003) were independently associated with worse overall survival. CONCLUSIONS: This long-term report of PORT delivered at 1.8 Gy/d to total doses of 57.6 to 68.4 Gy without chemotherapy for head and neck squamous cell carcinoma demonstrated that increasing dose did not significantly improve tumor control. On multivariate analysis, the only significant treatment variable was TPT. The results confirm that positive surgical margins and/or nodal ECE remains the most significant predictive pathologic factors.
Authors: Jay S Cooper; Qiang Zhang; Thomas F Pajak; Arlene A Forastiere; John Jacobs; Scott B Saxman; Julie A Kish; Harold E Kim; Anthony J Cmelak; Marvin Rotman; Robert Lustig; John F Ensley; Wade Thorstad; Christopher J Schultz; Sue S Yom; K Kian Ang Journal: Int J Radiat Oncol Biol Phys Date: 2012-06-30 Impact factor: 7.038
Authors: Giuseppe Sanguineti; Antonella Richetti; Mario Bignardi; Renzo Corvo'; Pietro Gabriele; Maria Pia Sormani; Paolo Antognoni Journal: Int J Radiat Oncol Biol Phys Date: 2005-03-01 Impact factor: 7.038
Authors: Paul M Harari; Jonathan Harris; Merrill S Kies; Jeffrey N Myers; Richard C Jordan; Maura L Gillison; Robert L Foote; Mitchell Machtay; Marvin Rotman; Deepak Khuntia; William Straube; Qiang Zhang; Kian Ang Journal: J Clin Oncol Date: 2014-07-07 Impact factor: 44.544
Authors: H K Awwad; M Lotayef; T Shouman; A C Begg; G Wilson; S M Bentzen; H Abd El-Moneim; S Eissa Journal: Br J Cancer Date: 2002-02-12 Impact factor: 7.640
Authors: Jenny Bertholet; Paul-Henry Mackeprang; Silvan Mueller; Gian Guyer; Hannes A Loebner; Yanick Wyss; Daniel Frei; Werner Volken; Olgun Elicin; Daniel M Aebersold; Michael K Fix; Peter Manser Journal: Radiat Oncol Date: 2022-07-15 Impact factor: 4.309
Authors: Anneke Fryen; Iris Brandes; Jörn Wichmann; Hans Christiansen; Frank Tavassol; Martin Durisin; Roland Merten Journal: In Vivo Date: 2022 May-Jun Impact factor: 2.406
Authors: Anthony C Nichols; Pencilla Lang; Eitan Prisman; Eric Berthelet; Eric Tran; Sarah Hamilton; Jonn Wu; Kevin Fung; John R de Almeida; Andrew Bayley; David P Goldstein; Antoine Eskander; Zain Husain; Houda Bahig; Apostolos Christopoulous; Michael Hier; Khalil Sultanem; Keith Richardson; Alex Mlynarek; Suren Krishnan; Hien Le; John Yoo; S Danielle MacNeil; Adrian Mendez; Eric Winquist; Nancy Read; Varagur Venkatesan; Sara Kuruvilla; Andrew Warner; Sylvia Mitchell; Martin Corsten; Murali Rajaraman; Stephanie Johnson-Obaseki; Libni Eapen; Michael Odell; Shamir Chandarana; Robyn Banerjee; Joseph Dort; T Wayne Matthews; Robert Hart; Paul Kerr; Samuel Dowthwaite; Michael Gupta; Han Zhang; Jim Wright; Christina Parker; Bret Wehrli; Keith Kwan; Julie Theurer; David A Palma Journal: BMC Cancer Date: 2020-02-14 Impact factor: 4.430
Authors: Alexandria Harris; Jinhong Li; Karley Atchison; Christine Harrison; Daniel Hall; Tyler VanderWeele; Jonas T Johnson; Marci L Nilsen Journal: Cancer Med Date: 2022-03-11 Impact factor: 4.711
Authors: Ifigenia Vasiliadou; David Noble; Andrew Hartley; Rafael Moleron; Paul Sanghera; Teresa Guerrero Urbano; Stefano Schipani; Dorothy Gujral; Bernie Foran; Shree Bhide; Anoop Haridass; Kannon Nathan; Andriana Michaelidou; Mehmet Sen; Konstantinos Geropantas; Mano Joseph; Lorcan O'Toole; Matthew Griffin; Laura Pettit; Jonathan Chambers; Petra Jankowska; Emma De Winton; Rebecca Goranova; Niveditha Singh; Ketan Shah; Anthony Kong Conceptualisation Journal: Clin Transl Radiat Oncol Date: 2021-06-30