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Background and purpose <p>Short-course radiotherapy (SCRT) and long-course radiotherapy (LCRT) are the primary neoadjuvant radiotherapy schedules for locally advanced rectal cancer. Recent research has questioned the efficacy of&#xa0;SCRT. This study presents an updated analysis of our previous research, extending the follow-up to evaluate 5-year outcomes by comparing the long-term results of these two strategies.</p> Materials and methods <p>This randomized controlled trial compared SCRT and LCRT in locally advanced middle or high rectal adenocarcinoma. The SCRT group received 25&#xa0;Gy/5 fractions over 1&#xa0;week plus CAPOX, while the LCRT group received 50–50.4&#xa0;Gy/25–28 fractions over 5–5.5&#xa0;weeks plus capecitabine. All patients received consolidation chemotherapy&#xa0;and&#xa0;then underwent delayed surgery after 8&#xa0;weeks or more post-radiotherapy. The endpoints of this updated analysis include overall survival (OS),disease-free survival (DFS), locoregional recurrence (LR) and distant metastasis (DM).</p> Results <p>Ninety-nine cases (45 LCRT, 54 SCRT) were followed for a median of 4.7&#xa0;years. Five-year OS rates were 77.3% for LCRT vs. 65.6% for SCRT group (<i>P</i> = 0.4). The 5-year DFS rates were 69.6% for LCRT vs. 54.9% for SCRT (<i>P</i> = 0.07). Cox regression indicated no prominent difference between the two groups regarding OS, LR,&#xa0;or DM. Subgroup analysis demonstrated a significantly better DFS with LCRT compared to SCRT in&#xa0;male patients ([HR] = 2.48, 95%CI: 1.04–5.93, <i>P</i> = 0.03), patients under the age of 60 (HR = 3.19, 95%CI: 1.03–9.92, <i>P</i> = 0.04), and cT4 patients (HR not calculated: no events in LCRT group, <i>P</i> = 0.004).</p> Conclusion <p>DFS showed a trend in favor of the LCRT group, with LCRT being significantly superior among men, patients under 60, and cT4 stage. Despite being intensified, SCRT failed to achieve long-term outcomes comparable to LCRT. Further research is needed to compare these two approaches in the context of total neoadjuvant treatment.</p> Trial registration data <p>IRCT2017110424266N3 (Registration date: 2017–11-12).&#xa0;<a href="https://irct.behdasht.gov.ir/trial/20526">https://irct.behdasht.gov.ir/trial/20526</a>.</p>

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Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: long-term results of a randomized controlled trial

  • 期刊论文

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  • 发表日期：

    2025年5月14日

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  • Mahdi Aghili,
  • Mohammad-Mahdi Aghaei,
  • Romina Abyaneh,
  • Mohammad Babaei,
  • Farshid Farhan,
  • Marzieh Lashkari,
  • Borna Farazmand,
  • Kasra Kolahdouzan,
  • Guglielmo Niccolò Piozzi,
  • Felipe Counago,
  • Reza Ghalehtaki

摘要

Background and purpose

Short-course radiotherapy (SCRT) and long-course radiotherapy (LCRT) are the primary neoadjuvant radiotherapy schedules for locally advanced rectal cancer. Recent research has questioned the efficacy of SCRT. This study presents an updated analysis of our previous research, extending the follow-up to evaluate 5-year outcomes by comparing the long-term results of these two strategies.

Materials and methods

This randomized controlled trial compared SCRT and LCRT in locally advanced middle or high rectal adenocarcinoma. The SCRT group received 25 Gy/5 fractions over 1 week plus CAPOX, while the LCRT group received 50–50.4 Gy/25–28 fractions over 5–5.5 weeks plus capecitabine. All patients received consolidation chemotherapy and then underwent delayed surgery after 8 weeks or more post-radiotherapy. The endpoints of this updated analysis include overall survival (OS),disease-free survival (DFS), locoregional recurrence (LR) and distant metastasis (DM).

Results

Ninety-nine cases (45 LCRT, 54 SCRT) were followed for a median of 4.7 years. Five-year OS rates were 77.3% for LCRT vs. 65.6% for SCRT group (P = 0.4). The 5-year DFS rates were 69.6% for LCRT vs. 54.9% for SCRT (P = 0.07). Cox regression indicated no prominent difference between the two groups regarding OS, LR, or DM. Subgroup analysis demonstrated a significantly better DFS with LCRT compared to SCRT in male patients ([HR] = 2.48, 95%CI: 1.04–5.93, P = 0.03), patients under the age of 60 (HR = 3.19, 95%CI: 1.03–9.92, P = 0.04), and cT4 patients (HR not calculated: no events in LCRT group, P = 0.004).

Conclusion

DFS showed a trend in favor of the LCRT group, with LCRT being significantly superior among men, patients under 60, and cT4 stage. Despite being intensified, SCRT failed to achieve long-term outcomes comparable to LCRT. Further research is needed to compare these two approaches in the context of total neoadjuvant treatment.

Trial registration data

IRCT2017110424266N3 (Registration date: 2017–11-12). https://irct.behdasht.gov.ir/trial/20526.