Dataset Information

Treatments and clinical outcomes in stage II colon cancer patients with 12-gene Oncotype DX Colon Recurrence Score® assay-guided therapy: real-world data.

ABSTRACT:

Background

The 12-gene Oncotype DX Colon Recurrence Score® result quantifies the recurrence risk in stage II/III colon cancer (CC). This real-world study investigated stage II CC patients whose treatment decisions incorporated the Recurrence Score® (RS) result.

Materials and methods

This retrospective analysis of a prospectively designed cohort included all stage II, mismatch repair-proficient CC patients who underwent 12-gene testing through Clalit between January 2011 and December 2016 and had available data with a minimum 3-year follow-up.

Results

The analysis included 938 patients {median age 68 [interquartile range (IQR) 60-76] years; 96% T3 tumors}. The median RS was 26 (IQR 19-33) and the three RS categories (0-29, 30-40, 41-100) included 65%, 24%, and 11% of patients, respectively. Chemotherapy (CT) use differed significantly between the three RS categories (14%, 36%, and 60%, respectively; P < 0.001). The CT and observation-only groups were imbalanced with worse clinicopathologic characteristics in the former. Among observation-only patients, Kaplan-Meier (KM) estimates for recurrence-free interval (RFI) and CC-specific survival (CCSS) differed significantly between the three RS categories (P < 0.001). Clinical outcomes by treatment (CT versus observation) within each RS category revealed no differences in RFI and CCSS in the RS 0-29 and 30-40 categories. In contrast, in the RS 41-100 category, the difference in RFI trended toward significance (P = 0.066), and for CCSS, a statistically significant difference was observed, with better outcomes among CT-treated patients (P = 0.035).

Conclusions

RS results are prognostic in stage II CC. Among RS 41-100 patients, outcomes were better in CT-treated versus observation-only patients despite worse clinicopathologic characteristics, suggesting that CT confers clinical benefit in high-risk patients.

SUBMITTER: Brenner B

PROVIDER: S-EPMC11369429 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Publications

Treatments and clinical outcomes in stage II colon cancer patients with 12-gene Oncotype DX Colon Recurrence Score® assay-guided therapy: real-world data.

Brenner B B Shulman K K Hubert A A Man S S Geva R R Ben-Aharon I I Fennig S S Mishaeli M M Yarom N N Bar-Sela G G Brenner R R Shai A A Baehner F L FL Russell C C Soussan-Gutman L L Voet H H Bareket-Samish A A Liebermann N N

ESMO open 20240812 8

<h4>Background</h4>The 12-gene Oncotype DX Colon Recurrence Score® result quantifies the recurrence risk in stage II/III colon cancer (CC). This real-world study investigated stage II CC patients whose treatment decisions incorporated the Recurrence Score® (RS) result.<h4>Materials and methods</h4>This retrospective analysis of a prospectively designed cohort included all stage II, mismatch repair-proficient CC patients who underwent 12-gene testing through Clalit between January 2011 and Decemb ...[more]

PMID: 39137478

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Project description:BackgroundCurrent clinical criteria do not discriminate well between women who will or those who will not develop ipsilateral invasive breast cancer (IBC), or a DCIS recurrence after a ductal carcinoma in situ (DCIS) diagnosis. The 12-gene Oncotype DX® DCIS assay (RT qPCR gene-based scoring system) was established and shown to predict the risk of subsequent ipsilateral IBC or DCIS recurrence. Recent studies have shown that microRNA (miRNA) expression deregulation can contribute to the development of IBC, but very few have evaluated miRNA deregulation in DCIS lesions. In this study, we sought to determine whether specific miRNA expression changes may correlate with Oncotype DX® DCIS scores.MethodsFor this study, we used archived formalin-fixed, paraffin-embedded (FFPE) specimens from 41 women diagnosed with DCIS between 2012 and 2018. The DCIS lesions were stratified into low (n = 26), intermediate (n = 10), and high (n = 5) risk score groups using the Oncotype DX® DCIS assay. Total RNA was extracted from DCIS lesions by macro-dissection of unstained FFPE sections, and next-generation small-RNA sequencing was performed. We evaluated the correlation between miRNA expression data and Oncotype score, as well as patient age. RT-qPCR validations were performed to validate the topmost differentially expressed miRNAs identified between the different risk score groups.ResultsMiRNA sequencing of 32 FFPE DCIS specimens from the three different risk group scores identified a correlation between expression deregulation of 17 miRNAs and Oncotype scores. Our analyses also revealed a correlation between the expression deregulation of 9 miRNAs and the patient's age. Based on these results, a total of 15 miRNAs were selected for RT-qPCR validation. Of these, miR-190b (p = 0.043), miR-135a (p = 0.05), miR-205 (p = 0.00056), miR-30c (p = 0.011), and miR-744 (p = 0.038) showed a decreased expression in the intermediate/high Oncotype group when compared to the low-risk score group. A composite risk score was established using these 5 miRNAs and indicated a significant association between miRNA expression deregulation and the Oncotype DX® DCIS Score (p < 0.0021), between high/intermediate and low risk groups.ConclusionsOur analyses identified a subset of 5 miRNAs able to discriminate between Oncotype DX® DCIS score subgroups. Together, our data suggest that miRNA expression analysis may add value to the predictive and prognostic evaluation of DCIS lesions.

Dataset Information

Treatments and clinical outcomes in stage II colon cancer patients with 12-gene Oncotype DX Colon Recurrence Score® assay-guided therapy: real-world data.

Background

Materials and methods

Results

Conclusions

Publications

Treatments and clinical outcomes in stage II colon cancer patients with 12-gene Oncotype DX Colon Recurrence Score® assay-guided therapy: real-world data.

Similar Datasets

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