Preoperative radiotherapy and local excision of rectal cancer: Long-term results of a randomised study

• Published in: Radiotherapy and oncology Vol. 127; no. 3; pp. 396 - 403
• Main Authors: Wawok, Przemysław, Polkowski, Wojciech, Richter, Piotr, Szczepkowski, Marek, Olędzki, Janusz, Wierzbicki, Ryszard, Gach, Tomasz, Rutkowski, Andrzej, Dziki, Adam, Kołodziejski, Leszek, Sopyło, Rafał, Pietrzak, Lucyna, Kryński, Jacek, Wiśniowska, Katarzyna, Spałek, Mateusz, Pawlewicz, Konrad, Polkowski, Marcin, Kowalska, Teresa, Paprota, Krzysztof, Jankiewicz, Małgorzata, Radkowski, Andrzej, Chalubińska-Fendler, Justyna, Michalski, Wojciech, Bujko, Krzysztof
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier B.V 01-06-2018
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - radiotherapy; Adenocarcinoma - surgery; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Chemoradiotherapy - methods; Combined Modality Therapy; Dose Fractionation, Radiation; Female; Fluorouracil - administration & dosage; Humans; Leucovorin - administration & dosage; Local excision; Male; Middle Aged; Neoplasm Recurrence, Local - radiotherapy; Preoperative Care; Preoperative radiotherapy; Rectal cancer; Rectal Neoplasms - drug therapy; Rectal Neoplasms - radiotherapy; Rectal Neoplasms - surgery; Treatment Outcome; Preoperative radiotherapy; Rectal cancer; Local excision
• ISSN: 0167-8140; 1879-0887
• DOI: 10.1016/j.radonc.2018.04.004

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.
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.
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.
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.