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

12-gene colon cancer assay Recurrence Score® adjuvant chemotherapy clinical outcomes colon cancer

Journal

ESMO open
ISSN: 2059-7029
Titre abrégé: ESMO Open
Pays: England
ID NLM: 101690685

Informations de publication

Date de publication:
12 Aug 2024
Historique:
received: 31 03 2024
revised: 16 06 2024
accepted: 20 06 2024
medline: 14 8 2024
pubmed: 14 8 2024
entrez: 13 8 2024
Statut: aheadofprint

Résumé

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. 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. 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). 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.

Sections du résumé

BACKGROUND 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 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 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 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.

Identifiants

pubmed: 39137478
pii: S2059-7029(24)01417-0
doi: 10.1016/j.esmoop.2024.103648
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

103648

Informations de copyright

Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.

Auteurs

B Brenner (B)

Davidoff Cancer Center, Rabin Medical Center, Petah Tikva; Faculty of Medicine, Tel Aviv University, Tel Aviv. Electronic address: brennerb@clalit.org.il.

K Shulman (K)

Oncology Department, Lin Medical Center, Haifa; Rappaport Faculty of Medicine, Technion Israeli Institute of Technology, Haifa.

A Hubert (A)

Sharett Institute of Oncology, Hadassah-Hebrew University Hospital, Jerusalem.

S Man (S)

Department of Clinical Oncology and Radiology, Soroka University Medical Center, Beer Sheva.

R Geva (R)

Division of Oncology, Sourasky Medical Center, Tel Aviv.

I Ben-Aharon (I)

Department of Oncology, Rambam Health Care Campus, Haifa.

S Fennig (S)

Institute of Oncology, Kaplan Medical Center, Rehovot.

M Mishaeli (M)

Oncology Department, Meir Medical Center, Kfar Saba.

N Yarom (N)

Oncology Department, Shamir Medical Center, Be'er Ya'akov.

G Bar-Sela (G)

Rappaport Faculty of Medicine, Technion Israeli Institute of Technology, Haifa; Oncology Department, Emek Medical Center, Afula.

R Brenner (R)

Oncology Department, Wolfson Medical Center, Holon.

A Shai (A)

Rappaport Faculty of Medicine, Technion Israeli Institute of Technology, Haifa; Oncology Department, Galilee Medical Center, Nahariya, Israel.

F L Baehner (FL)

Medical Department, Exact Sciences, Redwood City, USA.

C Russell (C)

Medical Department, Exact Sciences, Redwood City, USA.

L Soussan-Gutman (L)

Oncotest, Rhenium, Modi'in.

H Voet (H)

Environmental Economics and Management, Hebrew University of Jerusalem, Rehovot.

A Bareket-Samish (A)

BioInsight, Ltd., Binyamina.

N Liebermann (N)

Community Division, Clalit Health Services, Tel Aviv, Israel.

Classifications MeSH