B Ciseł1, L Pietrzak2, W Michalski3, L Wyrwicz4, A Rutkowski5, E Kosakowska5, A Cencelewicz5, M Spałek2, W Polkowski1, M Jankiewicz6, R Styliński7, M Bębenek8, B Kapturkiewicz8, A Maciejczyk9, J Sadowski10, J Zygulska11, W Zegarski12, M Jankowski12, M Las-Jankowska13, Z Toczko14, U Żelazowska-Omiotek15, L Kępka16, J Socha17, E Wasilewska-Tesluk18, W Markiewicz19, J Kładny20, A Majewski21, W Kapuściński22, R Suwiński23, K Bujko24. 1. Department of Surgical Oncology, Medical University of Lublin, Lublin. 2. II Department of Radiotherapy. 3. Bioinformatics and Biostatistics Unit. 4. Departments of Clinical Oncology. 5. Gastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw. 6. Department of Surgical Oncology, Medical University of Lublin, Lublin; Department of Radiotherapy, St. John's Cancer Center, Lublin. 7. 1st Department of General Surgery, Transplantology and Nutritional Therapy Medical University of Lublin. 8. Departments of Surgery. 9. Radiotherapy, Silesian Oncological Centre, Wrocław. 10. Department of Radiotherapy, Regional Oncological Centre, Kielce. 11. Department of Radiotherapy, Beskid Centre of Oncology, Bielsko-Biala. 12. Departments of Oncological Surgery. 13. Clinical Oncology, Collegium Medicum Nicolaus Copernicus University and Oncology Centre, Bydgoszcz. 14. Department of Surgery, Regional Hospital, Elblag. 15. Department of Radiotherapy, Regional Cancer Centre, Tarnów. 16. Department of Radiotherapy, Military Institute of Medicine, Warsaw. 17. Department of Radiotherapy, Military Institute of Medicine, Warsaw; Department of Radiotherapy, Regional Oncology Center, Czestochowa. 18. Radiotherapy Department, Public Health Care Facility of the Ministry of the Interior and Warmian-Masurian Oncology Centre, Olsztyn; Department of Oncology, University of Warmia and Mazury, Olsztyn. 19. Department of Surgery, Regional Cancer Centre, Białystok. 20. Department of General Surgery and Surgical Oncology First Clinical Hospital of Pomeranian Medical University, Szczecin. 21. Department of Surgery, Regional Hospital, Wałbrzych. 22. Department of Radiotherapy, Regional Cancer Centre, Copernicus Memorial Hospital of Łódź, Łódź. 23. Department of Radiotherapy, M. Skłodowska-Curie Memorial Cancer Centre, Gliwice, Poland. 24. II Department of Radiotherapy. Electronic address: krzysztof.bujko@coi.pl.
Abstract
BACKGROUND: This trial evaluated whether preoperative short-course radiotherapy and consolidation chemotherapy (CCT) were superior to chemoradiation in rectal cancers with clinical (c)T4 or fixed cT3. Previously, we reported early results showing no differences in the radical surgery rate (primary end point). In the short-course/CCT group, we observed lower acute toxicity of preoperative treatment and better overall survival (OS). We updated results to determine whether the benefit in OS was sustained and to evaluate late complications. PATIENTS AND METHODS: Patients with cT4 or fixed cT3 rectal cancer were randomized either to preoperative 5 × 5 Gy and three cycles of FOLFOX4 or to chemoradiation (50.4 Gy with bolus 5-Fu, leucovorin and oxaliplatin). RESULTS:Patients (N = 515) were eligible for analysis, 261 in the short-course/CCT group and 254 in the chemoradiation group. The median follow-up was 7.0 years. The difference in OS was insignificant [hazard ratio (HR) 0.90; 95% confidence interval (CI) 0.70-1.15; P = 0.38). However, the difference in early OS favouring short-course/CCT previously reported was observed again, being 9% at 3 years (95% CI 0.5% to 17%). This difference disappeared later; at 8 years OS was 49% in both groups. There was no difference in disease-free survival (HR 0.95; 95% CI 0.75-1.19; P = 0.65) at 8 years 43% versus 41% in the short-course/CCT group versus the chemoradiation group, respectively. The corresponding values for cumulative incidences of local failure and distant metastases did not differ and were HR = 1.08, 95% CI 0.70-1.23, P = 0.60, 35% versus 32% and HR = 1.10, 95% CI 0.68-1.23, P = 0.54, 36% versus 34%, respectively. The rate of late complications was similar (P = 0.66), grade 3+ being 11% versus 9% in the short-course/CCT group versus the chemoradiation group, respectively. CONCLUSION: The superiority of preoperative short-course/CCT over chemoradiation was not demonstrated. CLINICAL TRIAL NUMBER: The trial is registered as ClinicalTrials.gov number NCT00833131.
RCT Entities:
BACKGROUND: This trial evaluated whether preoperative short-course radiotherapy and consolidation chemotherapy (CCT) were superior to chemoradiation in rectal cancers with clinical (c)T4 or fixed cT3. Previously, we reported early results showing no differences in the radical surgery rate (primary end point). In the short-course/CCT group, we observed lower acute toxicity of preoperative treatment and better overall survival (OS). We updated results to determine whether the benefit in OS was sustained and to evaluate late complications. PATIENTS AND METHODS: Patients with cT4 or fixed cT3 rectal cancer were randomized either to preoperative 5 × 5 Gy and three cycles of FOLFOX4 or to chemoradiation (50.4 Gy with bolus 5-Fu, leucovorin and oxaliplatin). RESULTS:Patients (N = 515) were eligible for analysis, 261 in the short-course/CCT group and 254 in the chemoradiation group. The median follow-up was 7.0 years. The difference in OS was insignificant [hazard ratio (HR) 0.90; 95% confidence interval (CI) 0.70-1.15; P = 0.38). However, the difference in early OS favouring short-course/CCT previously reported was observed again, being 9% at 3 years (95% CI 0.5% to 17%). This difference disappeared later; at 8 years OS was 49% in both groups. There was no difference in disease-free survival (HR 0.95; 95% CI 0.75-1.19; P = 0.65) at 8 years 43% versus 41% in the short-course/CCT group versus the chemoradiation group, respectively. The corresponding values for cumulative incidences of local failure and distant metastases did not differ and were HR = 1.08, 95% CI 0.70-1.23, P = 0.60, 35% versus 32% and HR = 1.10, 95% CI 0.68-1.23, P = 0.54, 36% versus 34%, respectively. The rate of late complications was similar (P = 0.66), grade 3+ being 11% versus 9% in the short-course/CCT group versus the chemoradiation group, respectively. CONCLUSION: The superiority of preoperative short-course/CCT over chemoradiation was not demonstrated. CLINICAL TRIAL NUMBER: The trial is registered as ClinicalTrials.gov number NCT00833131.
Authors: Wang Qiaoli; Huang Yongping; Xiong Wei; Xu Guoqiang; Ju Yunhe; Liu Qiuyan; Li Cheng; Guo Mengling; Li Jiayi; Xiong Wei; Yang Yi Journal: Int J Colorectal Dis Date: 2019-11-19 Impact factor: 2.571
Authors: Nicolette Taku; Y Nancy Yi-Qian; George J Chang; Ethan B Ludmir; Kanwal Pratap Singh Raghav; Miguel A Rodriguez-Bigas; Emma Brey Holliday; Grace L Smith; Bruce D Minsky; Michael J Overman; Craig Messick; David Boyce-Fappiano; Albert C Koong; John Michael Skibber; Eugene Jon Koay; Arvind Dasari; Cullen M Taniguchi; Brian K Bednarski; Van K Morris; Scott Kopetz; Prajnan Das Journal: Clin Colorectal Cancer Date: 2021-10-09 Impact factor: 4.481
Authors: Jun Seok Park; Min Kyu Kang; Seung Ho Song; Gyu-Seog Choi; Soo Yeun Park; Hye Jin Kim; Jong Gwang Kim; Byung Woog Kang; Jin Ho Baek; Dong Won Baek; Jae-Chul Kim; Shin-Hyung Park; Seung Hyun Cho; An Na Seo Journal: Int J Colorectal Dis Date: 2021-02-06 Impact factor: 2.571
Authors: Ebunoluwa E Otegbeye; Jonathan B Mitchem; Haeseong Park; Aadel A Chaudhuri; Hyun Kim; Matthew G Mutch; Matthew A Ciorba Journal: Transl Res Date: 2020-12-08 Impact factor: 7.012
Authors: Ewa Kosakowska; Lucyna Pietrzak; Wojciech Michalski; Lucyna Kepka; Wojciech Polkowski; Malgorzata Jankiewicz; Bogumila Cisel; Jacek Krynski; Jacek Zwolinski; Lucjan Wyrwicz; Andrzej Rutkowski; Roman Stylinski; Grzegorz Nawrocki; Rafal Sopylo; Marek Szczepkowski; Wieslaw Tarnowski; Krzysztof Bujko Journal: Rep Pract Oncol Radiother Date: 2020-08-16
Authors: Agastya Patel; Piotr Spychalski; Giulia Corrao; Barbara A Jereczek-Fossa; Robert Glynne-Jones; Julio Garcia-Aguilar; Jarek Kobiela Journal: Acta Oncol Date: 2021-07-24 Impact factor: 4.311