Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Neoplasm

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Austria
  • Vienna/Austria
    • Vienna, Vienna/Austria, Austria, 1020
      • Clinic Favoriten

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients had synchronously metastasized colorectal cancer and received surgical treatment because of their liver metastases in either Clinic Landstrasse or Clinic Favoriten (HPB center) in Vienna from June 2014 to February 2021..

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients, who received a VEGF antibody; We distinguished between patients who received a VEGF antibody therapy and patients who received a EGFR antibody therapy.
Patients, who received a EGFR antibody; We distinguished between patients who received a VEGF antibody therapy and patients who received a EGFR antibody therapy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological response of the liver metastases	Investigation of the tumour response of the liver metastases using Rubbia Brand score (Tumour regression score) and using radiological assessment	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.
Overall survival	Difference of overall survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment	median of 21 months (0 to 80)
Recurrece free survival	Difference of recurrence free survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment	median of 21 months (0-80)
90 day mortality	number of patients, who died less than 90 days after liver surgery	90 days

Collaborators and Investigators

• Sponsor: Klinik Favoriten
• Investigators: Principal Investigator: Thomas Gruenberger, Prof. Dr. med., Clinic Favoriten (HPB center)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: November 28, 2021
• First Submitted That Met QC Criteria: December 12, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 12, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: colorectal cancer; targeted therapy; synchronous liver metastases; tumour regression grading
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: 0001 (Cancer Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No