Yosuke Ota1, Takeshi Kodaira2, Hirofumi Fujii3, Mototsugu Shimokawa4, Tomoya Yokota5, Torahiko Nakashima6, Nobuya Monden7, Akihiro Homma8, Shinya Ueda9, Tetsuo Akimoto10. 1. Department of Radiation Oncology, Hyogo Cancer Center, 13-70 Kitaouji-cho, Akashi City, Hyogo, 673-8558, Japan. yosukeota@hyogo-cc.jp. 2. Department of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. 3. Department of Clinical Oncology, Jichi Medical University, Shimotsuke, Japan. 4. Department of Biostatistics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan. 5. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto, Japan. 6. Department of Otolaryngology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan. 7. Department of Head and Neck Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan. 8. Department of Otolaryngology-Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan. 9. Department of Gastroenterology-Medical Oncology, Iseikai Hospital, Osaka, Japan. 10. Department of Radiation Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Abstract
BACKGROUND: Radiotherapy plus cetuximab (bioradiotherapy: BRT) is a standard option in the treatment of locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). Published data on its safety and efficacy in real-world settings is limited. Here, we conducted a prospective multi-institutional observational study to evaluate clinical outcomes of BRT in patients with LA-SCCHN. METHODS: We analyzed real-world data of all patients who underwent BRT from 2013 to 2016. The primary endpoint was 1-year progression-free survival (PFS). Secondary endpoints were 1-year locoregional PFS (LPFS), treatment completion rate (TCR), and adverse events (AEs). RESULTS: A total of 171 patients with a minimum 1-year follow-up were analyzed. Median age was 67 (36-85) years, and 37 patients (21.6%) were aged 75 years or older. 1-year PFS and LPFS were 51.5 and 56.1%, respectively. N stage (p = 0.049) was significantly associated with PFS. TCR was 77.2%. Cetuximab was definitively discontinued in 30 patients (17.5%), in 15 cases due to severe mucositis. N stage, T stage, and comorbidity were significantly associated with TCR. Major AEs of grade 3 or higher were pharyngeal mucositis (48.5%), radiation dermatitis (45.6%), and oral mucositis (40.4%). Pneumonitis was observed in 12 patients (7.0%); 6 cases (3.5%) were grades 3-4 and 2 (1.2%) were grade 5. CONCLUSION: As a result of the large number of elderly patients in clinical practice, toxicity reduced TCR. BRT-induced pneumonitis, which is sometimes fatal, was found to be more frequent than with chemotherapy plus cetuximab.
BACKGROUND: Radiotherapy plus cetuximab (bioradiotherapy: BRT) is a standard option in the treatment of locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). Published data on its safety and efficacy in real-world settings is limited. Here, we conducted a prospective multi-institutional observational study to evaluate clinical outcomes of BRT in patients with LA-SCCHN. METHODS: We analyzed real-world data of all patients who underwent BRT from 2013 to 2016. The primary endpoint was 1-year progression-free survival (PFS). Secondary endpoints were 1-year locoregional PFS (LPFS), treatment completion rate (TCR), and adverse events (AEs). RESULTS: A total of 171 patients with a minimum 1-year follow-up were analyzed. Median age was 67 (36-85) years, and 37 patients (21.6%) were aged 75 years or older. 1-year PFS and LPFS were 51.5 and 56.1%, respectively. N stage (p = 0.049) was significantly associated with PFS. TCR was 77.2%. Cetuximab was definitively discontinued in 30 patients (17.5%), in 15 cases due to severe mucositis. N stage, T stage, and comorbidity were significantly associated with TCR. Major AEs of grade 3 or higher were pharyngeal mucositis (48.5%), radiation dermatitis (45.6%), and oral mucositis (40.4%). Pneumonitis was observed in 12 patients (7.0%); 6 cases (3.5%) were grades 3-4 and 2 (1.2%) were grade 5. CONCLUSION: As a result of the large number of elderly patients in clinical practice, toxicity reduced TCR. BRT-induced pneumonitis, which is sometimes fatal, was found to be more frequent than with chemotherapy plus cetuximab.
Authors: David I Pryor; Sandro V Porceddu; Bryan H Burmeister; Alex Guminski; Damien B Thomson; Kristine Shepherdson; Michael Poulsen Journal: Radiother Oncol Date: 2008-10-29 Impact factor: 6.280
Authors: Claire Petit; Benjamin Lacas; Jean-Pierre Pignon; Quynh Thu Le; Vincent Grégoire; Cai Grau; Allan Hackshaw; Björn Zackrisson; Mahesh K B Parmar; Ju-Whei Lee; Maria Grazia Ghi; Giuseppe Sanguineti; Stéphane Temam; Maurice Cheugoua-Zanetsie; Brian O'Sullivan; Marshall R Posner; Everett E Vokes; Juan J Cruz Hernandez; Zbigniew Szutkowski; Eric Lartigau; Volker Budach; Rafal Suwiński; Michael Poulsen; Shaleen Kumar; Sarbani Ghosh Laskar; Jean-Jacques Mazeron; Branislav Jeremic; John Simes; Lai-Ping Zhong; Jens Overgaard; Catherine Fortpied; Pedro Torres-Saavedra; Jean Bourhis; Anne Aupérin; Pierre Blanchard Journal: Lancet Oncol Date: 2021-04-13 Impact factor: 41.316
Authors: Desmond Curran; Jordi Giralt; Paul M Harari; K Kian Ang; Roger B Cohen; Merrill S Kies; Jacek Jassem; José Baselga; Eric K Rowinsky; Nadia Amellal; Sylvie Comte; James A Bonner Journal: J Clin Oncol Date: 2007-06-01 Impact factor: 44.544
Authors: Arlene A Forastiere; Qiang Zhang; Randal S Weber; Moshe H Maor; Helmuth Goepfert; Thomas F Pajak; William Morrison; Bonnie Glisson; Andy Trotti; John A Ridge; Wade Thorstad; Henry Wagner; John F Ensley; Jay S Cooper Journal: J Clin Oncol Date: 2012-11-26 Impact factor: 44.544
Authors: David J Adelstein; Yi Li; George L Adams; Henry Wagner; Julie A Kish; John F Ensley; David E Schuller; Arlene A Forastiere Journal: J Clin Oncol Date: 2003-01-01 Impact factor: 44.544
Authors: Benjamin Lacas; Alexandra Carmel; Cécile Landais; Stuart J Wong; Lisa Licitra; Jeffrey S Tobias; Barbara Burtness; Maria Grazia Ghi; Ezra E W Cohen; Cai Grau; Gregory Wolf; Ricardo Hitt; Renzo Corvò; Volker Budach; Shaleen Kumar; Sarbani Ghosh Laskar; Jean-Jacques Mazeron; Lai-Ping Zhong; Werner Dobrowsky; Pirus Ghadjar; Carlo Fallai; Branko Zakotnik; Atul Sharma; René-Jean Bensadoun; Maria Grazia Ruo Redda; Séverine Racadot; George Fountzilas; David Brizel; Paolo Rovea; Athanassios Argiris; Zoltán Takácsi Nagy; Ju-Whei Lee; Catherine Fortpied; Jonathan Harris; Jean Bourhis; Anne Aupérin; Pierre Blanchard; Jean-Pierre Pignon Journal: Radiother Oncol Date: 2021-01-27 Impact factor: 6.280
Authors: Hisham Mehanna; Max Robinson; Andrew Hartley; Anthony Kong; Bernadette Foran; Tessa Fulton-Lieuw; Matthew Dalby; Pankaj Mistry; Mehmet Sen; Lorcan O'Toole; Hoda Al Booz; Karen Dyker; Rafael Moleron; Stephen Whitaker; Sinead Brennan; Audrey Cook; Matthew Griffin; Eleanor Aynsley; Martin Rolles; Emma De Winton; Andrew Chan; Devraj Srinivasan; Ioanna Nixon; Joanne Grumett; C René Leemans; Jan Buter; Julia Henderson; Kevin Harrington; Christopher McConkey; Alastair Gray; Janet Dunn Journal: Lancet Date: 2018-11-15 Impact factor: 79.321