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Background <p>Pathological complete response (pCR) after neoadjuvant chemoradiotherapy (nCRT) in locally advanced rectal cancer (LARC) is associated with favorable outcomes; however, pre-treatment biomarkers that reliably predict pCR remain limited. We evaluated whether the Tumor Marker Index (TMI; geometric mean of normalized CEA and CA19-9) predicts pCR and examined its relationship with recurrence and survival.</p> Methods <p>This single-center retrospective study included 123 stage III LARC patients treated with nCRT followed by total mesorectal excision (2015–2022). The primary endpoint was pCR (ypT0N0). Secondary endpoints were progression-free survival (PFS) and overall survival (OS). Receiver operating characteristic (ROC) analysis assessed TMI discrimination and identified a cut-off. Predictors of pCR were evaluated by univariable and multivariable logistic regression. Systemic inflammatory markers (NLR, PLR, SII) were also analyzed.</p> Results <p>Median age was 67 years; 61.0% were male. pCR occurred in 18.7% (23/123). Patients with pCR had lower baseline CEA and TMI. TMI predicted pCR (AUC 0.633, 95% CI 0.509–0.756; <i>p</i> = 0.036); the Youden cut-off ≤ 0.79 yielded sensitivity 86.96% and NPV 92.31%. In multivariable analysis (outcome coded as non-pCR), comorbidity (aOR 3.871; <i>p</i> = 0.035), cT3 vs. cT2 (aOR 4.447; <i>p</i> = 0.026) and higher TMI (per unit; aOR 3.343; <i>p</i> = 0.036) independently increased the odds of non-pCR, whereas a longer RT–surgery interval (per week) reduced it (aOR 0.940; <i>p</i> = 0.016). NLR/PLR/SII were not independent predictors. Recurrence was lower in low-TMI patients (20.5% vs. 57.5%, <i>p</i> &lt; 0.001). pCR was associated with longer PFS (91.6 vs. 62.2 months; log-rank <i>p</i> = 0.012) but not OS (81.9 vs. 64.2 months; <i>p</i> = 0.165).</p> Conclusions <p>Pre-treatment TMI is an independent predictor of pCR and correlates with lower recurrence in LARC after nCRT. Given its high sensitivity/NPV at the identified threshold, TMI may support organ-preservation discussions and guide treatment intensification strategies; prospective validation is warranted.</p>

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Predictive value of tumor marker index for pathological complete response following neoadjuvant chemoradiotherapy in locally advanced rectal cancer

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月1日

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  • Selami Bayram,
  • Mustafa Serkan Alemdar,
  • Ali Murat Tatli,
  • Mustafa Ozdogan

摘要

Background

Pathological complete response (pCR) after neoadjuvant chemoradiotherapy (nCRT) in locally advanced rectal cancer (LARC) is associated with favorable outcomes; however, pre-treatment biomarkers that reliably predict pCR remain limited. We evaluated whether the Tumor Marker Index (TMI; geometric mean of normalized CEA and CA19-9) predicts pCR and examined its relationship with recurrence and survival.

Methods

This single-center retrospective study included 123 stage III LARC patients treated with nCRT followed by total mesorectal excision (2015–2022). The primary endpoint was pCR (ypT0N0). Secondary endpoints were progression-free survival (PFS) and overall survival (OS). Receiver operating characteristic (ROC) analysis assessed TMI discrimination and identified a cut-off. Predictors of pCR were evaluated by univariable and multivariable logistic regression. Systemic inflammatory markers (NLR, PLR, SII) were also analyzed.

Results

Median age was 67 years; 61.0% were male. pCR occurred in 18.7% (23/123). Patients with pCR had lower baseline CEA and TMI. TMI predicted pCR (AUC 0.633, 95% CI 0.509–0.756; p = 0.036); the Youden cut-off ≤ 0.79 yielded sensitivity 86.96% and NPV 92.31%. In multivariable analysis (outcome coded as non-pCR), comorbidity (aOR 3.871; p = 0.035), cT3 vs. cT2 (aOR 4.447; p = 0.026) and higher TMI (per unit; aOR 3.343; p = 0.036) independently increased the odds of non-pCR, whereas a longer RT–surgery interval (per week) reduced it (aOR 0.940; p = 0.016). NLR/PLR/SII were not independent predictors. Recurrence was lower in low-TMI patients (20.5% vs. 57.5%, p < 0.001). pCR was associated with longer PFS (91.6 vs. 62.2 months; log-rank p = 0.012) but not OS (81.9 vs. 64.2 months; p = 0.165).

Conclusions

Pre-treatment TMI is an independent predictor of pCR and correlates with lower recurrence in LARC after nCRT. Given its high sensitivity/NPV at the identified threshold, TMI may support organ-preservation discussions and guide treatment intensification strategies; prospective validation is warranted.