Study identification

PURI

https://redirect.ema.europa.eu/resource/41349

EU PAS number

EUPAS32748

Study ID

41349

Official title and acronym

Impact of cardiovascular comorbidities on the effectiveness of bevacizumab in elderly patients with metastatic colorectal cancer (IRAZU)

DARWIN EU® study

No

Study countries

France

Study description

Colorectal cancer is the third most frequent cancer with a median age at diagnosis of 73 years. About 40% of cases evolve to a metastatic colorectal cancer (mCRC). The arrival of targeted therapies from 2005 in the therapeutic strategy of mCRC has participated to the improvement of overall survival for these patients. However, randomized controlled trials (RCTs) on mCRC suffer from an underrepresentation of elderly patients, while they represent the most part of mCRC patients. Despite this huge gap between the population included in RCTs and the population with mCRC, these RCTs are used to elaborate international guidelines. Owing to the mechanism of action of bevacizumab (angiogenesis inhibitor), cardiovascular adverse events such as heart failure, malignant hypertension, myocardial infarction, and venous and arterial thromboembolism are expected events, and frequently reported in RCTs. Despite the exclusion of patients with cardiovascular comorbidities from RCTs evaluating bevacizumab, the presence of cardiovascular comorbidities does not represent formal contraindications, but only precautions of use. Besides, there are no specific guidelines for the treatment of elderly patients, especially those with cardiovascular comorbidities, which are highly prevalent at mCRC diagnosis. To date, no data related to their impact on mCRC treatment by bevacizumab are available. This study aims to evaluate the impact of the presence of cardiovascular comorbidities on effectiveness and safety in elderly mCRC patients treated with bevacizumab. A cohort of mCRC patients aged ≥65 years at diagnosis, and treated with bevacizumab in first-line treatment will be identified between 2009 and 2015 using the French National Claims Database (SNDS). The primary endpoint will be defined as the occurrence of death from any cause at 36 months, and the secondary endpoints will be the occurrence of serious cardiovascular events during the follow-up.

Study status

Ongoing
Research institutions and networks

Institutions

Bordeaux university hospital Bordeaux, France

Contact details

Amandine Gouverneur

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Ministère des Solidarités et de la Santé - Direction Générale de l'Offre de Soins – PHRC-K 2018
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable