Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Colorectal Surgery, Peking University Cancer Hospital & Institute, Beijing, China.
Dis Colon Rectum. 2013 Apr;56(4):422-32. doi: 10.1097/DCR.0b013e31828576c6.
In China, standard neoadjuvant chemoradiation therapy has not been well accepted, not only because of financial constraints but also because of the poorly-tolerated long duration of the regimen.
The current study aimed to evaluate the impact of a modified neoadjuvant radiation regimen on the prognosis of rectal cancer patients in China.
This was a nonrandomized cohort study evaluating outcomes of patients who chose to undergo preoperative radiotherapy compared with those who chose not to undergo preoperative radiotherapy (controls).
The study was carried out in Peking University Cancer Hospital, a tertiary care cancer center in China.
Records of patients with locally advanced, mid-to-low rectal cancer who underwent total mesorectal excision at Peking University Cancer Hospital from 2001 through 2005 were analyzed in this study.
Patients who chose preoperative radiotherapy received a total dose of 30 Gy delivered in 10 once-daily fractions of 3.0 Gy each, with at least a 14-day delay of surgery after delivery of the last fraction.
Tumor downstaging was evaluated. Local recurrence, distant metastases, and disease-free and overall survival were analyzed with the Kaplan-Meier method.
A total of 101 patients accepted and 162 patients declined the modified preoperative radiotherapy regimen. Of the 101 patients receiving preoperative radiotherapy, 5 (5%) had a complete response, and 50 (50%) achieved TNM downstaging. The local recurrence rate was 5% with preoperative radiotherapy and 18% in the control groups (p = 0.02). Within the preoperative radiotherapy group, 5-year disease-free survival and overall survival rates were significantly higher in patients with T-, N-, or TNM-downstaging than in patients without downstaging. Evaluation of literature reports indicated that clinical safety and effectiveness of the modified protocol are comparable to results of standard neoadjuvant procedures.
The allocation to study groups was not randomized, and patient self-selection may have introduced bias, particularly because patients with greater financial means were more likely to choose to undergo the preoperative radiotherapy regimen.
Compared with surgery alone, this modified preoperative radiotherapy regimen is associated with significantly reduced local recurrence and complication rates, with improved survival in patients who show downstaging. The modified protocol offers a clinical outcome equivalent to standard preoperative radiotherapy regimens while offering an alternative for increasing the flexibility of preoperative radiation regimens in China.
在中国，标准的新辅助放化疗并未得到广泛接受，这不仅是由于经济限制，还因为该方案的治疗时间长，患者耐受性差。
本研究旨在评估改良新辅助放疗方案对中国直肠癌患者预后的影响。
这是一项非随机队列研究，评估了选择术前放疗的患者与选择不进行术前放疗的患者（对照组）的结局。
本研究在北京肿瘤医院进行，这是一家中国的三级癌症治疗中心。
本研究分析了 2001 年至 2005 年在北京肿瘤医院接受全直肠系膜切除术的局部进展期中低位直肠癌患者的病历。
选择术前放疗的患者接受总剂量 30 Gy，分 10 次给予，每次 3.0 Gy，每次剂量后至少间隔 14 天再行手术。
评估肿瘤降期情况。采用 Kaplan-Meier 法分析局部复发、远处转移、无病生存和总生存情况。
共 101 例患者接受了改良术前放疗方案，162 例患者拒绝该方案。在接受术前放疗的 101 例患者中，5 例（5%）达到完全缓解，50 例（50%）达到 TNM 降期。术前放疗组的局部复发率为 5%，对照组为 18%（p=0.02）。在术前放疗组中，肿瘤降期患者的 5 年无病生存率和总生存率明显高于未降期患者。对文献报告的评估表明，改良方案的临床安全性和有效性与标准新辅助治疗方案相当。
研究分组未采用随机分配，患者的自我选择可能会引入偏倚，特别是因为经济条件较好的患者更有可能选择接受术前放疗方案。
与单纯手术相比，改良的术前放疗方案可显著降低局部复发率和并发症发生率，并提高降期患者的生存率。改良方案提供了与标准术前放疗方案相当的临床疗效，同时为增加中国术前放疗方案的灵活性提供了一种替代方案。
