TARGET-EU: Clinical benefit of bevacizumab in metastatic colorectal cancer

11/05/2026
11/05/2026
EU PAS number:
EUPAS1000000996
Study
Ongoing
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Study summary
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Study identification

EU PAS number

EUPAS1000000996

Study ID

1000000996

Official title and acronym

TARGET-EU: Clinical benefit of bevacizumab in metastatic colorectal cancer

DARWIN EU® study

No

Study countries

Netherlands

Study description

This case study is part of the broader TARGET EU project (EUPAS1000000539), which aims to advance the regulatory use of real-world data through the application of target trial emulation and estimand methodologies.

Background: Colorectal cancer (CRC) is the second most commonly diagnosed type of cancer in women and third most commonly diagnosed type in men, with an incidence of 73.5 per 100,000 inhabitants-year in 2022 in the European Union. The mortality in that year was 32.3 per 100,000 inhabitants. In the Netherlands, 23% of the patients with colon cancer and 19% of the patients with rectal cancer presented with metastatic colorectal
cancer (mCRC) at diagnosis. Guidelines recommend fluoropyrimidine-based chemotherapy in combination with oxaliplatin or irinotecan for first-line initially unresectable mCRC. The addition of bevacizumab, an anti-Vascular Endothelial Growth Factor (VEGF) antibody, improved prognosis compared to chemotherapy alone. A randomised clinical trial (RCT) found that addition of bevacizumab had a median overall survival (OS) of 9.4
months compared to 8.0 months for placebo (HR, 0.83; 97.5% CI, 0.72 to 0.95), in combination with oxaliplatin-based chemotherapy.

Objectives: The acceptance of bevacizumab in mCRC treatment landscape varies largely throughout the Netherlands, presumably due to differences in policy and attitude. This study will evaluate the comparative effectiveness of first-line addition of bevacizumab to the capecitabine-oxaliplatin (CapOx) regimen versus the CapOx regimen alone, in initially unresectable mCRC patients.

Methods: We will use the Netherlands Cancer Registry (NCR), a nationwide, population-based, Dutch cancer registry. The primary analysis uses a Cox proportional hazards model, with supplemental analyses using an accelerated failure time model to estimate restricted mean survival time (RMST) at 52 weeks and 104 weeks. Sensitivity analyses will be conducted to assess the impact of censoring assumptions.

Study status

Ongoing
Research institutions and networks

Institutions

Teamit Institute
Spain
First published:
12/03/2024
Institution Other ENCePP partner
Prospective Dutch CRC Cohort

Networks

Contact details

Julia van Dommelen 0009-0004-9553-4247

Primary lead investigator
ORCID number:
0009-0004-9553-4247

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable