Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer

Completed

• Conditions: Gastrointestinal Neoplasm

• Registration Number: NCT05172635
• Lead Sponsor: Klinik Favoriten

Brief Summary

We performed a retrospective data analysis of patients with synchronously metastasized colorectal cancer, comparing the histological response on the primary tumour to chemotherapy combined with either vascular endothelial growth factor (VEGF) or epidermal growth factor receptor (EGFR) inhibition.

Detailed Description

We performed a retrospective analysis regarding the response of the primary tumour and the liver metastases of patients with colorectal carcinoma to an induction chemotherapy with antibody therapy, either with a VEGF antibody, or with an EGFR antibody.

We investigated 100 Patients with synchronous metastatic colorectal carcinoma, who underwent hepatic resection in Clinic Landstraße or Clinic Favoriten between 2014 and 2021.

We investigated the tumour response of the primary tumour, using Rödel score, which is a tumour regression score.

We also investigated the tumour response of the liver metastases using Rubbia Brandt tumour regression score.

The pathological response was assessed postoperatively in the surgical specimen. In order to ensure a uniform assessment, the pathologists in our HPB center assessed the histological specimens from both treatment locations prior to this analyses.

The tumour response of the liver metastases was assessed twice: by radiological tumour assessment via computer tomography (CT) of the abdomen or magnetic resonance imaging (MRI) of the liver with RECIST criteria.

Postoperative complications less than 90 days after liver resection were assessed and described according to the classification system by Dindo et al.

Day of tumour recurrence and/or death was assessed.

We also investigated the difference of recurrence free Survival (RFS) and Overall surcical (OS) between the patients, who received EGFR and the patients, who received VEGF antibody treatment.

Study Timeline

• Study Start: 2014-06-01
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-15
• Study First Submitted: 2021-11-28
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-12
• Last Update Submitted: 2021-12-12
• Study First Posted: 2021-12-29
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• older than 18 years
• synchronously hepatic metastasized patients with colorectal carcinoma
• indication of surgical treatment

Exclusion Criteria

• younger than 18 years
• metachronously metastasized patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological response of the primary tumour	Tumour regression was assessed in the surgical specimen 3 to 7 days after surgery.	Investigation of the tumour response of the primary tumor (colorectal carcinoma) using the Rödel Score (tumour regression score)

Secondary Outcome Measures

Name	Time	Method
Pathological response of the liver metastases	Tumour regression was assessed in the surgical specimen 3 to 7 days after surgery. Radiological response was assessed in staging CT abdomen 2 to 4 weeks after induction chemotherapy.	Investigation of the tumour response of the liver metastases using Rubbia Brand score (Tumour regression score) and using radiological assessment
Overall survival	median of 21 months (0 to 80)	Difference of overall survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment
Recurrece free survival	median of 21 months (0-80)	Difference of recurrence free survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment
90 day mortality	90 days	number of patients, who died less than 90 days after liver surgery

Trial Locations

Locations (1)

Clinic Favoriten; 🇦🇹 Vienna, Vienna/Austria, Austria