Mawdsley Suzannah, Glynne-Jones Rob, Grainger Juliet, Richman Paul, Makris Andreas, Harrison Mark, Ashford Richard, Harrison Richard A, Osborne Melanie, Livingstone Jeremy I, MacDonald Peter, Mitchell Ian C, Meyrick-Thomas John, Northover John M A, Windsor Alastair, Novell Richard, Wallace Marina
Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom.
Int J Radiat Oncol Biol Phys. 2005 Nov 1;63(3):745-52. doi: 10.1016/j.ijrobp.2005.03.003.
This study set out to determine the impact of a positive circumferential resection margin (CRM) (R1-R2) and pathologic downstaging on local recurrence and survival in patients with borderline resectable or unresectable rectal adenocarcinoma treated with neoadjuvant chemoradiotherapy (CRT).
A total of 150 patients with locally advanced rectal cancer were treated with long-course neoadjuvant CRT using low-dose folinic acid and 5-fluorouracil. CRT was followed 6-12 weeks later by surgical excision. The CRM rate and incidence, site, and pattern of local and systemic recurrences were recorded. The median follow-up was 25 months.
The overall median survival was 37 months, with a 5-year overall survival rate of 34%. Of the 150 patients, 122 underwent curative resection; 12% had a complete pathologic response, and downstaging to pT1-T2 occurred in an additional 16%. A negative CRM (R0) was achieved in 65% overall (98 of 150). Local recurrence occurred in 10% of those with R0 resection and 62% of those with R1-R2 resections. Distant metastases occurred in 29% of those with R0 resections and 75% of those with R1-R2 resections. The 3-year disease-free and 3-year overall survival rate was 9% and 25% and 52% and 64%, respectively, for patients with and without a histologically positive CRM.
After 5-fluorouracil-based CRT, a positive CRM predicted for a high risk of subsequent local recurrence and a 3-year disease-free survival rate of only 9%. For this reason, the CRM should be considered a major prognostic factor and should be validated in future trials as an early alternative clinical endpoint.
本研究旨在确定在接受新辅助放化疗(CRT)的交界可切除或不可切除直肠腺癌患者中,环周切缘阳性(CRM)(R1 - R2)和病理降期对局部复发和生存的影响。
总共150例局部晚期直肠癌患者接受了使用低剂量亚叶酸和5 - 氟尿嘧啶的长疗程新辅助CRT。CRT后6 - 12周进行手术切除。记录CRM率以及局部和全身复发的发生率、部位和模式。中位随访时间为25个月。
总体中位生存期为37个月,5年总生存率为34%。150例患者中,122例行根治性切除;12%有完全病理缓解,另有16%降期至pT1 - T2。总体65%(150例中的98例)实现了阴性CRM(R0)。R0切除患者中10%发生局部复发,R1 - R2切除患者中62%发生局部复发。R0切除患者中29%发生远处转移,R1 - R2切除患者中75%发生远处转移。组织学CRM阳性和阴性患者的3年无病生存率分别为9%和52%,3年总生存率分别为25%和64%。
基于5 - 氟尿嘧啶的CRT后,CRM阳性预示着随后局部复发的高风险,3年无病生存率仅为9%。因此,CRM应被视为一个主要的预后因素,并应在未来试验中作为早期替代临床终点进行验证。