间隔时间延长使病理缓解成为直肠癌预后良好的标志物，但不是其原因：里昂 R90-01 随机试验 17 年随访结果。

Pathologic Response, When Increased by Longer Interval, Is a Marker but Not the Cause of Good Prognosis in Rectal Cancer: 17-year Follow-up of the Lyon R90-01 Randomized Trial.

机构信息

Department of Digestive Surgery, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France; Lyon 1 University, EMR 3738, Lyon-Sud/Charles Mérieux Medical University, Oullins, France.

出版信息

Int J Radiat Oncol Biol Phys. 2016 Mar 1;94(3):544-53. doi: 10.1016/j.ijrobp.2015.10.061. Epub 2015 Nov 4.

DOI:10.1016/j.ijrobp.2015.10.061

PMID:26723110

Abstract

PURPOSE

The Lyon R90-01 randomized trial investigated whether the interval between preoperative radiation therapy and surgery influenced rectal cancer outcome. Long-term results are reported here after a median follow-up of 17 years.

METHODS AND MATERIALS

Between February 1991 and December 1995, 210 patients from 29 French centers were randomly assigned (ratio of 1:1) to groups that waited either 2 weeks (short interval [SI]) or 6 to 8 weeks (long interval [LI]) between neoadjuvant radiation therapy and surgery. The primary endpoint was sphincter-preserving surgery.

RESULTS

LI group showed a better pathologic response (complete response or few residual cells) after radiation therapy than the SI group (26% vs 10.3%, P=.015). A better pathologic response was associated in multivariate analysis with significant improvement of overall survival (pT: P=.0293 and pN: P=.0048) but it was irrespective of the interval duration. The median follow-up was 17.2 years. The 5-, 10-, 15-, and 17-year overall survival rates were, respectively, 66.8%, 48.7%, 40.0%, and 34.0% for the SI group and, respectively, 67.1%, 53.5%, 41.9%, and 34.0% for the LI group. There were no significant differences between groups in terms of survival (P=.7656) or local recurrence rates (SI: 14.4% vs LI: 12.1%, respectively; P=.6202). Of 24 local disease recurrences, 20 (83%) occurred during the first 2 postoperative years, and all but one (96%) occurred during the first 5 postoperative years. The rate of second new malignancies was 9.4% (19 patients).

CONCLUSIONS

The radiation-induced sterilization rate of the preoperative cancer specimen was a marker of good prognosis. The interval duration (the treatment being the same) although it is modifying the sterilization rate has no impact on survival. Radiation therapy did not postpone local recurrence, because the rate of local relapse after 5 years was low. Radiation-induced cancers after radiation therapy were unusual and should not influence treatment decisions in adults.

摘要

目的

里昂 R90-01 随机试验研究了术前放疗与手术之间的间隔是否影响直肠癌的结果。本研究报告了中位随访 17 年后的长期结果。

方法和材料

1991 年 2 月至 1995 年 12 月，来自 29 个法国中心的 210 名患者被随机分配（比例为 1:1）至新辅助放疗和手术之间等待 2 周（短间隔[SI]）或 6-8 周（长间隔[LI]）的两组。主要终点是保留括约肌的手术。

结果

LI 组的放射治疗后病理反应（完全反应或少量残留细胞）优于 SI 组（26%比 10.3%，P=.015）。多变量分析显示，较好的病理反应与总生存的显著改善相关（pT：P=.0293 和 pN：P=.0048），但与间隔时间无关。中位随访时间为 17.2 年。SI 组的 5 年、10 年、15 年和 17 年总生存率分别为 66.8%、48.7%、40.0%和 34.0%，LI 组分别为 67.1%、53.5%、41.9%和 34.0%。两组在生存方面无显著差异（P=.7656）或局部复发率（SI：14.4%比 LI：12.1%，分别；P=.6202）。24 例局部疾病复发中，20 例（83%）发生在术后 2 年内，除 1 例（96%）发生在术后 5 年内。第二新发恶性肿瘤的发生率为 9.4%（19 例）。