Wang Lin, Li Zi-Yu, Li Zhong-Wu, Li Yong-Heng, Sun Ying-Shi, Ji Jia-Fu, Gu Jin, Cai Yong
1Department of Colorectal Surgery, Peking University Cancer Hospital, Beijing, People's Republic of China 2Department of Gastrointestinal Surgery, Peking University Cancer Hospital, Beijing, People's Republic of China 3Department of Pathology, Peking University Cancer Hospital, Beijing, People's Republic of China 4Department of Radiation Oncology, Peking University Cancer Hospital, Beijing, People's Republic of China 5Department of Radiology, Peking University Cancer Hospital, Beijing, People's Republic of China.
Dis Colon Rectum. 2015 Feb;58(2):186-92. doi: 10.1097/DCR.0000000000000294.
We previously conducted a prospective phase II clinical trial studying a unique 22-fraction neoadjuvant intensity-modulated radiotherapy with concurrent capecitabine treatment followed by total mesorectal excision for locally advanced rectal cancer.
The objective of this study was to retrospectively review the efficacy, toxicity, and surgical complications following intensity-modulated radiotherapy in patients who have rectal cancer.
This was a retrospective study.
Data were gathered from a surgical database.
This study included patients who underwent intensity-modulated radiotherapy with gross tumor volume/clinical target volume of 50.6/41.8 Gy in 22 fractions with concurrent capecitabine treatment over a period of 30 days, after which the patients underwent surgery for rectal cancer in Peking University Cancer Hospital (2007-2013).
The primary end points were acute toxicity, postoperative complications, and complete response rate.
A total of 260 patients were included in our analysis. The median age was 55 years (range, 21-87 years), and 68.5% of the patients were male. The yield complete response rate was 18.5% (48/260). There were no grade 4 toxicity and perioperative mortality. The grade 3 toxicity rate was 5.8%, which included diarrhea (4.2%), neutropenia (1.2%), and radiation dermatitis (0.4%). The 30-day postoperative and severe complication (≥grade 3) rates were 23.1% and 2.7%. The anastomotic leakage rate was 3.3% (5/152). Perineal wound complications (29.2%, 28/96) represented the most common problem following abdominoperineal resection. The estimated 3-year local recurrence-free survival, cancer-specific survival, and disease-free survival rates were 94.2% (95% CI, 90.1%-98.3%), 92.2% (95% CI, 87.5%-97.0%), and 81.4% (95% CI, 75.4%-87.4%).
The retrospective nature and the single-arm design was the limitation of the study.
The 22-fraction neoadjuvant intensity-modulated radiotherapy regimen used to treat rectal cancer in this study has a high efficacy rate and a low toxicity rate. Further studies are needed to better define the role of intensity-modulated radiotherapy for rectal cancer treatment in a neoadjuvant setting.
我们之前进行了一项前瞻性II期临床试验，研究一种独特的22分次新辅助调强放疗联合卡培他滨同步治疗，随后行全直肠系膜切除术治疗局部晚期直肠癌。
本研究的目的是回顾性分析直肠癌患者接受调强放疗后的疗效、毒性及手术并发症。
这是一项回顾性研究。
数据来自手术数据库。
本研究纳入了北京大学肿瘤医院（2007 - 2013年）接受调强放疗的患者，总肿瘤体积/临床靶体积为50.6/41.8 Gy，分22次，同时接受30天的卡培他滨同步治疗，之后接受直肠癌手术。
主要终点为急性毒性、术后并发症及完全缓解率。
我们的分析共纳入260例患者。中位年龄为55岁（范围21 - 87岁），68.5%的患者为男性。总完全缓解率为18.5%（48/260）。无4级毒性及围手术期死亡。3级毒性率为5.8%，包括腹泻（4.2%）、中性粒细胞减少（1.2%）和放射性皮炎（0.4%）。术后30天及严重并发症（≥3级）发生率分别为23.1%和2.7%。吻合口漏发生率为3.3%（5/152）。会阴伤口并发症（29.2%，28/96）是腹会阴联合切除术后最常见的问题。估计3年局部无复发生存率、癌症特异性生存率和无病生存率分别为94.2%（95%CI，90.1% - 98.3%）、92.2%（95%CI，87.5% - 97.0%）和81.4%（95%CI，75.4% - 87.4%）。
本研究的局限性在于其回顾性性质和单臂设计。
本研究中用于治疗直肠癌的22分次新辅助调强放疗方案疗效高、毒性低。需要进一步研究以更好地明确调强放疗在新辅助治疗直肠癌中的作用。
