Scholarlink

Background <p>The optimal interval between neoadjuvant chemoradiotherapy (nCRT) and total mesorectal excision (TME) in locally advanced rectal cancer (LARC) remains controversial. This randomized controlled trial evaluated whether prolonging the interval between nCRT and surgery improves pathological response and oncological outcomes.</p> Methods <p>Adult patients with histologically confirmed, MRI-staged II–III rectal adenocarcinoma located within 12&#xa0;cm of the anal verge were randomized to undergo surgery at 8&#xa0;weeks or 12&#xa0;weeks after completion of long-course nCRT (50&#xa0;Gy with concurrent 5-fluorouracil). The primary endpoint was pathological complete response (pCR; Dworak grade 4). Secondary endpoints included postoperative complications, surgical quality, disease-free survival (DFS), overall survival (OS), and patterns of recurrence.</p> Results <p>A total of 124 patients were analyzed (61 in the 8-week group and 63 in the 12-week group). Median time to surgery was 72&#xa0;days (10.3&#xa0;weeks) and 93&#xa0;days (13.3&#xa0;weeks), respectively. pCR was achieved in 14.8% vs 14.5% (<i>p</i> = 0.904). There were no significant differences in ypT stage, ypN stage, CRM positivity, or TME quality. Anastomotic leakage was numerically higher in the 12-week group (15.9% vs 4.9%). Three-year OS (76.3% vs 80.0%, <i>p</i> = 0.657) and DFS (62.9% vs 62.2%, <i>p</i> = 0.838) were comparable. Adjuvant chemotherapy was administered more frequently in the 8-week group (61.7% vs 39.7%, <i>p</i> = 0.015).</p> Conclusion <p>Extending the surgical interval from 8 to 12&#xa0;weeks did not improve pathological response or oncological outcomes. These results should be interpreted cautiously in the context of evolving total neoadjuvant therapy (TNT) strategies.</p> Trial registration <p>Clinicaltrialtrials.gov No. NCT03607370.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Effect of prolonged interval between neoadjuvant chemoradiotherapy and surgery on pathological and oncological outcomes in locally advanced rectal cancer: a randomized controlled trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月13日

查看全文
  • Ernestas Sileika,
  • Dovile Cerkauskaite,
  • Augustinas Bausys,
  • Vlada Bernotaite,
  • Rokas Stulpinas,
  • Ugnius Mickys,
  • Laura Zilevice,
  • Kestutis Suziedelis,
  • Andrej Aleinikov,
  • Edgaras Smolskas,
  • Vincas Urbonas,
  • Audrius Dulskas

摘要

Background

The optimal interval between neoadjuvant chemoradiotherapy (nCRT) and total mesorectal excision (TME) in locally advanced rectal cancer (LARC) remains controversial. This randomized controlled trial evaluated whether prolonging the interval between nCRT and surgery improves pathological response and oncological outcomes.

Methods

Adult patients with histologically confirmed, MRI-staged II–III rectal adenocarcinoma located within 12 cm of the anal verge were randomized to undergo surgery at 8 weeks or 12 weeks after completion of long-course nCRT (50 Gy with concurrent 5-fluorouracil). The primary endpoint was pathological complete response (pCR; Dworak grade 4). Secondary endpoints included postoperative complications, surgical quality, disease-free survival (DFS), overall survival (OS), and patterns of recurrence.

Results

A total of 124 patients were analyzed (61 in the 8-week group and 63 in the 12-week group). Median time to surgery was 72 days (10.3 weeks) and 93 days (13.3 weeks), respectively. pCR was achieved in 14.8% vs 14.5% (p = 0.904). There were no significant differences in ypT stage, ypN stage, CRM positivity, or TME quality. Anastomotic leakage was numerically higher in the 12-week group (15.9% vs 4.9%). Three-year OS (76.3% vs 80.0%, p = 0.657) and DFS (62.9% vs 62.2%, p = 0.838) were comparable. Adjuvant chemotherapy was administered more frequently in the 8-week group (61.7% vs 39.7%, p = 0.015).

Conclusion

Extending the surgical interval from 8 to 12 weeks did not improve pathological response or oncological outcomes. These results should be interpreted cautiously in the context of evolving total neoadjuvant therapy (TNT) strategies.

Trial registration

Clinicaltrialtrials.gov No. NCT03607370.