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RISK OF LYMPH NODE METASTASIS IN T2 COLON CANCER IN THE NETHERLANDS - A NATIONWIDE POPULATION-BASED COHORT STUDY: PUSHING THE BOUNDARIES OF LOCAL TREATMENT?

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RISK OF LYMPH NODE METASTASIS IN T2 COLON CANCER IN THE NETHERLANDS - A NATIONWIDE POPULATION-BASED COHORT STUDY: PUSHING THE BOUNDARIES OF LOCAL TREATMENT?

Julia Hanevelt 1, Richard M. Brohet 1, Leon M.G. Moons 2, Frank P. Vleggaar 2, Erik Van Westreenen 1, Wouter De Vos Tot Nederveen Cappel 1

Affiliations

1 Isala, Zwolle, Netherlands

2 University Medical Center Utrecht, Utrecht, Netherlands

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Abstract

Introduction

The implementation of the national bowel-screening program for colorectal cancer has had a significant impact on detecting early colorectal cancer (pT1 & pT2 carcinomas). In recent decades, there has been a shift towards minimally invasive approaches for treating T1 colon carcinomas (CC), favoring local resection techniques over major surgeries. It is unknown whether risk stratification could establish organ preservation in T2 CC.

Aims & Methods

We aimed to evaluate the incidence of lymph node metastases (LNMs) in patients with pT2 CC in the Netherlands and to develop a prediction model to estimate the risk of LNMs which could be helpful to compare the risk of LNMs against the age-specific adverse events associated with segmental surgery. A retrospective nationwide cohort study was performed including all consecutive patients diagnosed with pT2 CC who underwent (completion) surgery between 2012 and 2020 in the Netherlands. Patients were identified by use of the Dutch ColoRectal Audit (DCRA). Exclusion criteria were: (1) neoadjuvant therapy; (2) synchronous CRC; (3) hereditary predisposition (4) history of IBD; and (5) non-adenocarcinoma. Data obtained from the DCRA were linked to the Dutch Nationwide Pathology Databank (PALGA). A subgroup analysis was conducted on patients up to 70 years old, who were treated between 2018 and 2020, to examine the association between mismatch repair (MMR) status and the presence of LNMs. Predictive factors for LNMs were evaluated with univariate- and multivariate logistic regression. Four machine learning (ML) models were developed and validated to predict LNM, including generalized linear modeling (GLM), GLM-Least Absolute Shrinkage and Selection Operator (GLM-LASSO), random forest (RF), and gradient boosting (XGB).

Results

In total 9,803 patients were included. The overall 30-day complication and mortality rates were 25.2% and 2.2%, respectively. In elderly patients (age ≥ 74), the complication and mortality rates increased to 30%, and 3.5%, respectively. LNMs were found in 1877 out of 9803 patients (19.1%). Younger age (OR 0.98, 95% CI 0.979 ─ 0.990), left-sided CC (OR 1.5, 95% CI 1.4-1.7), poor differentiation (1.7, 95% CI 1.4-2.2), and lymphovascular invasion (LVI) (OR 4.1, 95% CI 3.6-4.7) were independent risk factors for LNMs. In the subgroup analysis, deficient MMR (dMMR) status was found to be associated with a significantly lower risk of LNMs (OR 0.3, 95% CI 0.2-0.5). GLM demonstrated the highest prediction accuracy, achieving AUCs of 0.67 for the full model and 0.68 for the model focusing on patients up to 70 years old. The risk of LNMs in the lower-risk group (age ≥ 74, right-sided CC, LVI absent, good/moderate tumor differentiation) was 10.7%. In the absence of other risk factors, patients with a dMMR carcinoma had a risk of LNMs of 6.1%.

Predicted probability (%) of LNM in patients with T2 colon cancer
		Right sided CC			Left sided CC			dMMR / pMMR
		Age ≥ 74	66 - < 74	Age < 66	Age ≥ 74	66 - < 74	Age < 66	< 71
Good/Moderate differentiation (G1-G2)	LVI -	10.7	12.6	14.1	15.6	18.2	20.2	6.1 / 17.2
Good/Moderate differentiation (G1-G2)	LVI +	33.2	37.5	40.6	43.4	48.1	51.4	19.3 / 43.1
Poor differentiation (G3)	LVI -	16.5	19.3	21.4	23.4	26.9	29.6	27.9 / 55.1
Poor differentiation (G3)	LVI +	45.2	49.9	53.2	56.1	60.6	63.7	58.6 / 81.8

Complication rate		30.1	22.6	18	30.1	22.6	18	19.2
Mortality rate		3.5	1	0.5	3.5	1	0.5	0.7

Conclusion

The predicted probability of LNMs should be balanced against the risks associated with segmental colon surgery. The findings of this study could serve as valuable guidance for clinicians, enabling them to inform patients about these competing risks before making a shared decision.

Event

UEG Week Vienna 2024

Topics

Colorectal Digestive Oncology

Submission format

Abstract

Session

Local treatment for locally advanced colon cancer: How to improve outcome

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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RISANKIZUMAB OUTPERFORMED USTEKINUMAB FOR STEROID-FREE CLINICAL AND BIOCHEMICAL REMISSION IN REAL-WORLD PATIENTS WITH CROHN’S DISEASE AFTER TUMOUR NECROSIS FACTOR ANTAGONIST EXPOSURE: A MULTICENTRE BAYESIAN ANALYSIS - REAL-SEQUENCE (AN IG-IBD STUDY)

Affiliations

1 Humanitas University, Pieve Emanuele, Italy

2 A.O.U. Citta della Salute e della Scienza di Torino, Torino, Italy

3 IRCCS Policlinico Gemelli, Roma, Italy

4 Division of Hepatogastroenterology, University of Campania "Luigi Vanvitelli", Naples, Italy

5 Gastroenterologia Universitaria L'Aquila, L'Aquila, Italy

6 Policlinico Universitario di Monserrato Cagliari, Cagliari, Italy

7 Fondazione IRCCS San Gerardo Dei Tintori, Monza, Italy

8 IRCCS Sacro Cuore Don Calabria Negrar, Negrar di Valpolicella, Italy

9 Ospedale San Bortolo ULSS8 Berica, Vicenza, Italy

10 Ospedale San Paolo ASST Santi Paolo e Carlo, Milano, Italy

11 Ospedale di Rho, Milano, Italy

12 University of Padua, Division of Gastroenterology, Padua, Italy

13 Ospedale Cannizzaro, Catania, Italy

14 Ospedale Manzoni, Milano, Italy

15 Department Of Medicine, University Of Padova, Treviso, Italy

16 Ente Ospedaliero Galliera, Genova, Italy

17 Policlinico di Bari, Bari, Italy

18 Ospedale Valduce, Como, Italy

19 Policlinico San Martino, Genova, Italy

20 Nuovo Ospedale dei Castelli, Ariccia, Italy

21 Osepdale di Taranto, Taranto, Italy

22 Department of Gastroenterology Universita di Ancona, Ancona, Italy

23 UOS Endoscopia Digestiva ASL Toscana Nord Ovest Pontedera, Pontedera, Italy

24 Humanitas Research Hospital, Rozzano, Italy

25 Fondazione Policlinico Universitario "A. Gemelli", IRCCS, Roma, Italy

26 University of Turin, Turin, Italy

27 IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy

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Abstract

Introduction

The SEQUENCE trial showed the superiority of risankizumab (RZB) over ustekinumab (UST) in anti-TNF-experienced patients with Crohn's disease (CD). Whether this advantage translates to real-world practice remains uncertain.

Aims & Methods

We aimed to validate RZB superiority in a large real-world cohort, leveraging a Bayesian framework to integrate prior trial evidence with observational data. We performed a multicentre retrospective cohort study including anti-TNF-experienced CD patients initiating RZB or UST across 23 Italian centres. The primary endpoint was 6-month cumulative probability of steroid-free clinical remission (SFCR), defined as PRO-2 abdominal pain ≤1, stool frequency ≤1.5, and no corticosteroids use within the preceding 3 months. As a secondary endpoint, biochemical SFCR was defined as SFCR plus FCP <250 µg/g or CRP <5 mg/L (FCP prioritised when both available). A Bayesian Cox model was fitted on IPTW-weighted data, incorporating prior evidence from the SEQUENCE trial. The prior distribution for the treatment effect was centered on the clinical remission benefit observed in SEQUENCE (HR~1.5 in favour of RZB), with a conservative variance reflecting the open-label design and the difference in endpoint definition between the trial and the present study. Frequentist IPTW-Cox and a double-robust estimator (IPTW + multivariable Cox) served as sensitivity analyses.

Results

We included 404 patients (UST, n=287, RZB, n=117; Table 1). After IPTW, all covariates were balanced, with standardized mean differences <0.1. The cumulative probability of SFCR at 6 months was 52.5% (95% CI 44.8-59.2) for UST and 71.7% (95% CI 56.8-81.5) for RZB. Bayesian analysis yielded a posterior HR of 1.71 (95% CrI 1.49-1.95), with a posterior probability of RZB superiority >99% (P[superiority]>0.99). Results were robust to prior specification, including under a non-informative prior (HR 1.70, 95% CrI 1.49-1.95). Frequentist IPTW-Cox analysis confirmed these findings (HR 1.77, 95% CI 1.24-2.52, p=0.002), as did the double-robust estimator (aHR 2.08, 95% CI 1.52-2.85, p<0.001). For the biochemical SFCR endpoint, RZB demonstrated an even stronger advantage (Bayesian HR 1.94, 95% CrI 1.64-2.29; P(superiority)>0.99; IPTW-Cox: HR 2.00, 95% CI 1.39-2.89, p=0.0002). Independent predictors of lower SFCR were higher baseline stool frequency (aHR 0.82, 95% CI 0.75-0.90) and baseline steroid use (aHR 0.45, 95% CI 0.26-0.78).

Table 1. Patients’ baseline characteristics

Variable	UST (n=287)	RZB (n=117)	p
Age, years, median (IQR)	50.5 (36–60)	46.0 (34–60)	0.265
Sex, M/F, $n$ (%)	159/128 (55.4%/44.6%)	76/41 (64.7%/35.3%)	0.107
Location: L1/L2/L3, $n$ (%)	115/31/141 (40.2%/10.8%/49.0%)	34/14/69 (29.4%/11.8%/58.8%)	0.117
Behaviour: B1/B2/B3, $n$ (%)	100/131/56 (34.8%/45.5%/19.6%)	48/50/19 (40.8%/42.9%/16.3%)	0.554
Steroids at baseline, $n$ (%)	84 (29.4%)	25 (21.2%)	0.150
Stool frequency, median (IQR)	3.0 (1.0–5.0)	2.0 (0.0–4.0)	<0.001
Abdominal pain score, median (IQR)	1.0 (0–2)	1.0 (0–1)	0.466
CRP, mg/L, median (IQR)	18.0 (7.0–77.0)	28.0 (6.5–84.0)	0.334
FCP, µg/g, median (IQR)	258 (107–654)	380 (141–1000)	0.108

Conclusion

In this large, real-world cohort of anti-TNF-experienced patients with CD, RZB was associated with a significantly higher probability of achieving SFCR at 6 months than UST, corroborating the findings from the SEQUENCE trial and supporting their external validity of randomized evidence in an unselected clinical population. By combining IPTW with a Bayesian framework formally incorporating RCT evidence as prior knowledge, this study provides methodologically rigorous real-world validation, supporting the positioning of RZB over UST in anti-TNF-experienced CD patients in clinical practice.

Disclosure

GP received consultancy fees from Abbvie and Janssen. CB received lecture fees and served as a consultant for Takeda, MSD, Ferring, Abbvie, Galapagos and Janssen.
AA has received consulting and/or advisory board fees from AbbVie, Abivax, Alfa Sigma, Astra Zeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Eli-Lilly, Enthera, Ferring, Galapagos, Gilead, Giuliani, Janssen, Lionhealth, MSD, Nestlé, Pfizer, Protagonist Therapeutics, Roche, Sanofi, Samsung Bioepis, Sandoz, Takeda, Teva Pharmaceuticals, Tillots Pharma; lecture and/or speaker bureau fees from AbbVie, AG Pharma, Alfa Sigma, Biogen, Bristol-Myers Squibb, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, Lionhealth, MSD, Novartis, Pfizer, Roche, Sandoz, Samsung Bioepis, Takeda, Teva Pharmaceuticals; and research grants from MSD, Pfizer, Takeda and Biogen.
The remaining authors declare no competing interests.

Conference

UEG Week Barcelona 2026

Topics

IBD

Submission format

Abstract

Session

Therapeutics in IBD: Real-world experience (II) (Posters)

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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