Przemysław Wawok1, Wojciech Polkowski2, Piotr Richter1, Marek Szczepkowski3, Janusz Olędzki4, Ryszard Wierzbicki2, Tomasz Gach1, Andrzej Rutkowski5, Adam Dziki6, Leszek Kołodziejski7, Rafał Sopyło8, Lucyna Pietrzak9, Jacek Kryński5, Katarzyna Wiśniowska9, Mateusz Spałek9, Konrad Pawlewicz9, Marcin Polkowski10, Teresa Kowalska11, Krzysztof Paprota12, Małgorzata Jankiewicz12, Andrzej Radkowski13, Justyna Chalubińska-Fendler14, Wojciech Michalski15, Krzysztof Bujko16. 1. Department of Surgery, Jagiellonian Medical University College, Kraków, Poland. 2. Department of Surgical Oncology, Medical University, Lublin, Poland. 3. Department of Rehabilitation, Józef Piłsudski University of Physical Education, Warsaw, Poland; Clinical Department of General and Colorectal Surgery, Bielański Hospital, Warsaw, Poland; Clinical Department of Colorectal, General and Oncological Surgery, Centre of Postgraduate Medical Education, Poland. 4. Department of Colorectal Surgery, Medical University, Warsaw, Poland. 5. Department of Colorectal Cancer, Maria Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland. 6. Department of Colorectal Surgery, Medical University, Łódź, Poland. 7. Department of Surgery, Regional Cancer Centre, Tarnów, Poland. 8. Department of Surgery, Maria Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland. 9. Department of Radiotherapy, Maria Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland. 10. Department of Gastroenterology and Hepatology, Medical Center for Postgraduate Education, Warsaw, Poland. 11. Department of Radiotherapy, Maria Skłodowska-Curie Memorial Cancer Centre, Kraków, Poland. 12. Department of Radiotherapy, St. John's Cancer Center, Lublin, Poland. 13. Department of Radiotherapy, Regional Cancer Centre, Radom, Poland. 14. Department of Radiotherapy, Chair of Oncology, Medical University of Łódź, Poland. 15. Bioinformatics and Biostatistics Unit, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland. 16. Department of Radiotherapy, Maria Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland. Electronic address: bujko@coi.waw.pl.
Abstract
BACKGROUND AND PURPOSE: It is uncertain whether local control is acceptable after preoperative radiotherapy and local excision (LE). An optimal preoperative dose/fractionation schedule has not yet been established. MATERIAL AND METHODS: In a phase III study, patients with cT1-2N0M0 or borderline cT2/T3N0M0 < 4 cm rectal adenocarcinomas were randomised to receive either 5 × 5 Gy plus 1 × 4 Gy boost or chemoradiation: 50.4 Gy in 28 fractions plus 3 × 1.8 Gy boost and 5-fluorouracil with leucovorin bolus. LE was performed 6-8 weeks later. Patients with ypT0-1R0 disease were observed. Completion total mesorectal excision (CTME) was recommended for poor responders, i.e. ypT1R1/ypT2-3. RESULTS:Of 61 randomised patients, 10 were excluded leaving 51 for analysis; 29 in the short-course group and 22 in the chemoradiation group. YpT0-1R0 was observed in 66% of patients in the short-course group and in 86% in the chemoradiation group, p = 0.11. CTME was performed only in 46% of patients with ypT1R1/ypT2-3. The median follow-up was 8.7 years. Local recurrence incidences and overall survival at 10 years were respectively for the short-course group vs. the chemoradiation group 35% vs. 5%, p = 0.036 and 47% vs. 86%, p = 0.009. In total, local recurrence at 10 years was 79% for ypT1R1/T2-3 without CTME. CONCLUSIONS: This trial suggests that in the LE setting, both local recurrence and survival are worse after short-course radiotherapy than after chemoradiation. Because of the risk of bias, a confirmatory study is desirable. Lack of CTME is associated with an unacceptably high local recurrence rate.
RCT Entities:
BACKGROUND AND PURPOSE: It is uncertain whether local control is acceptable after preoperative radiotherapy and local excision (LE). An optimal preoperative dose/fractionation schedule has not yet been established. MATERIAL AND METHODS: In a phase III study, patients with cT1-2N0M0 or borderline cT2/T3N0M0 < 4 cm rectal adenocarcinomas were randomised to receive either 5 × 5 Gy plus 1 × 4 Gy boost or chemoradiation: 50.4 Gy in 28 fractions plus 3 × 1.8 Gy boost and 5-fluorouracil with leucovorin bolus. LE was performed 6-8 weeks later. Patients with ypT0-1R0 disease were observed. Completion total mesorectal excision (CTME) was recommended for poor responders, i.e. ypT1R1/ypT2-3. RESULTS: Of 61 randomised patients, 10 were excluded leaving 51 for analysis; 29 in the short-course group and 22 in the chemoradiation group. YpT0-1R0 was observed in 66% of patients in the short-course group and in 86% in the chemoradiation group, p = 0.11. CTME was performed only in 46% of patients with ypT1R1/ypT2-3. The median follow-up was 8.7 years. Local recurrence incidences and overall survival at 10 years were respectively for the short-course group vs. the chemoradiation group 35% vs. 5%, p = 0.036 and 47% vs. 86%, p = 0.009. In total, local recurrence at 10 years was 79% for ypT1R1/T2-3 without CTME. CONCLUSIONS: This trial suggests that in the LE setting, both local recurrence and survival are worse after short-course radiotherapy than after chemoradiation. Because of the risk of bias, a confirmatory study is desirable. Lack of CTME is associated with an unacceptably high local recurrence rate.