Department of Oncology, Division of Radiation Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada.
Department of Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada.
Radiother Oncol. 2021 Feb;155:237-245. doi: 10.1016/j.radonc.2020.11.008. Epub 2020 Nov 19.
Randomized studies have shown low compliance to adjuvant chemotherapy in rectal cancer patients receiving preoperative chemotherapy and external beam radiation (CT/EBRT) with total mesorectal excision. We hypothesize that giving neoadjuvant CT before local treatment would improve CT compliance.
Between 2010-2017, 180 patients were randomized (2:1) to either Arm A (AA) with FOLFOX x6 cycles prior to high dose rate brachytherapy (HDRBT) and surgery plus adjuvant FOLFOX x6 cycles, or Arm B (AB), with neoadjuvant HDRBT with surgery and adjuvant FOLFOX x12 cycles. The primary endpoint was CT compliance to ≥85% of full-dose CT for the first six cycles. Secondary endpoints were ypT0N0, five-year disease free survival (DFS), local control and overall survival (OS).
Patients were randomized to either AA (n = 120, median age (MA) 62 years) or AB (n = 60, MA 63 years). 175/180 patients completed HDRBT as planned (97.2%). In AA, two patients expired during CT; three patients post-randomization received short course EBRT because of progression under CT (n = 2, AA) or personal preference (n = 1, AB). ypT0N0 was 31% in AA and 28% in AB (p = 0.7). CT Compliance was 80% in AA and 53% in AB (p = 0.0002). Acute G3/G4 toxicity was 35.8% in AA and 27.6% in AB (p = 0.23). With a median follow-up of 48.5 months (IQR 33-72), the five-year DFS was 72.3% with AA and 68.3% with AB (p = 0.74), the five-year OS 83.8% for AA and 82.2% for AB (p = 0.53), and the five-year local recurrence was 6.3% for AA and 5.8% for AB (p = 0.71).
We confirmed improved compliance to neoadjuvant CT in this study. Although there is no statistical difference in ypT0N0 rate, local recurrence, and DFS between the two arms, a trend towards favourable oncological outcomes is observed.
在接受术前化疗和外照射放疗（CT/EBRT）联合全直肠系膜切除术的直肠癌患者中，随机研究显示辅助化疗的依从性较低。我们假设在局部治疗前给予新辅助 CT 会提高 CT 的依从性。
2010 年至 2017 年，180 例患者被随机分为 A 组（AA）和 B 组（AB），每组 120 例和 60 例患者。AA 组接受 FOLFOX 方案 6 个周期后行高剂量率近距离放疗（HDRBT）和手术，术后行 FOLFOX 方案 6 个周期辅助化疗；AB 组接受新辅助 HDRBT 联合手术，术后行 FOLFOX 方案 12 个周期辅助化疗。主要终点是前 6 个周期 CT 完成率≥85%的比例。次要终点是ypT0N0 率、5 年无病生存率（DFS）、局部控制率和总生存率（OS）。
180 例患者被随机分为 AA 组（n=120，中位年龄 62 岁）或 AB 组（n=60，中位年龄 63 岁）。175/180 例患者按计划完成 HDRBT（97.2%）。AA 组中有 2 例患者在 CT 期间死亡；3 例患者在随机分组后因 CT 进展（2 例 AA，1 例 AB）或个人偏好（1 例 AB）接受短程 EBRT。AA 组和 AB 组的 ypT0N0 率分别为 31%和 28%（p=0.7）。AA 组和 AB 组的 CT 依从率分别为 80%和 53%（p=0.0002）。AA 组和 AB 组的急性 3/4 级毒性分别为 35.8%和 27.6%（p=0.23）。中位随访 48.5 个月（IQR 33-72），AA 组的 5 年 DFS 为 72.3%，AB 组为 68.3%（p=0.74）；AA 组和 AB 组的 5 年 OS 分别为 83.8%和 82.2%（p=0.53）；AA 组和 AB 组的 5 年局部复发率分别为 6.3%和 5.8%（p=0.71）。
本研究证实了新辅助 CT 依从性的提高。尽管两组在 ypT0N0 率、局部复发率和 DFS 方面无统计学差异，但观察到有利的肿瘤学结果趋势。
