Skip to content

CENTRALISED ONLINE REGISTRY FOR PATIENT WITH METASTATIC COLORECTAL CANCER TREATED WITH REGORAFENIB (submitted in 2019)

Pdf

PDF Icon

European Statement

Clinical Pharmacy Services

Author(s)

Vanesa Alonso Castro, Beatriz López Centeno, Daniele Alioto, Angela Gil Martin, Ignacio Martin Casasempere, Maria Segura Bedmar, Ainhoa Aranguren Oyarzábal, Maria Jose Calvo Alcántara

Why was it done?

The European Society for Medical Oncology (ESMO) has developed the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) to assess the magnitude of clinical benefit for cancer medicines. In the CORRECT trial, regorafenib has an ESMO-MCBS score of 1 (questionable benefit). It is necessary to assess the effectiveness and safety of regorafenib treatment in real clinical practice.

What was done?

To describe the implementation of a centralised registry (CR) for all patients with metastatic colorectal cancer (mCRC) being treated with regorafenib in a Regional Health Service (RHS).

How was it done?

A working team including oncologists, hospital pharmacists and RHS professionals developed the CR for patients with mCRC starting treatment with regorafenib in 2019. The variables selected were: age, sex, ECOG, primary tumour location, number of metastatic sites, presence of liver or brain metastases, RAS-mutation status, BRAF-mutation status, previous lines, follow-up variables (dose, type of response and adverse events), date and reason for withdrawal.

What has been achieved?

The CR is available for all professionals in the RHS in April 2019 and it is compulsory to include all patients starting treatment in 2019. Forty-nine patients were included (59.2% males). The median age was 68 years. The baseline characteristics of the patients were: − 36.7% and 63.3% of patients had ECOG 0 and 1 respectively; − 79.4% had the primary tumour in the left colon; − 36.7% had 3 or more metastatic sites; −71.4% and 2.0% had liver and brain metastases respectively; − RAS gene was mutated in 57.1% of patients and undetermined in 2.0%; − BRAF gene was mutated in 4.1% of the patients and undetermined in 34.7%; −in 65.3% of patients regorafenib was the fourth line or later therapy. With median treatment duration of 2.5 months, 42.9% of patients had discontinued treatment: 30.6% had progressive disease, 8.2% had adverse events and 4.1% had died.

What next?

The experience obtained with this registry has allowed us to know the use profile of this drug in all hospitals of RHS. A comprehensive assessment of the collected data and a longer follow-up period are necessary to assess the effectiveness and safety of regorafenib treatment in real clinical practice.

×

EAHP Forum

All the EAHP team is working on providing a Forum that can help connect all the members in Conversations and Groups to talk about important matters for the European Hospital Pharmacist.

The Forum will be accessible for all the EAHP members, you don’t have to create a new account to browse and participate.

Conversations and groups

The Conversations will be moderated by our team to provide documents and relevant topics for the community.

The Groups will connect all members that share a category. Members who work on the same assocation, on the same hospital, that have the same role, etc.

Stay tuned for the realase of the forum. Soon on EAHP.