Department of Surgery, Jagiellonian Medical University College, Kraków, Poland.
Department of Surgical Oncology, Medical University, Lublin, Poland.
Radiother Oncol. 2018 Jun;127(3):396-403. doi: 10.1016/j.radonc.2018.04.004. Epub 2018 Apr 18.
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.
术前放疗加局部切除（LE）后局部控制是否可接受尚不确定。尚未建立最佳的术前剂量/分割方案。
在一项 III 期研究中，cT1-2N0M0 或边界 cT2/T3N0M0<4cm 的直肠腺癌患者被随机分为两组，分别接受 5×5 Gy 加 1×4 Gy 推量或放化疗：50.4Gy 分 28 次给予，加 3×1.8Gy 推量，5-氟尿嘧啶加亚叶酸钙冲击。6-8 周后行 LE。ypT0-1R0 疾病患者观察。对反应不佳者（即 ypT1R1/ypT2-3）建议完成全直肠系膜切除术（CTME）。
61 例随机患者中有 10 例被排除，51 例纳入分析；短程组 29 例，放化疗组 22 例。短程组 ypT0-1R0 患者占 66%，放化疗组占 86%，p=0.11。ypT1R1/ypT2-3 患者仅 46%行 CTME。中位随访 8.7 年。短程组和放化疗组的局部复发率和 10 年总生存率分别为 35%比 5%，p=0.036 和 47%比 86%，p=0.009。无 CTME 的 ypT1R1/T2-3 患者 10 年局部复发率为 79%。
本研究表明，在 LE 中，短程放疗后局部复发和生存均较放化疗差。由于存在偏倚风险，需要进行确证性研究。未行 CTME 与局部复发率显著升高相关。
