Stivarga Real Life Evidence in Hungary

Effectiveness of Stivarga (Regorafenib) for Patients With Metastatic Colorectal Cancer in the Hungarian Real World Setting

The study aims to evaluate use of regorafenib in clinical practice in Hungary. The study should provide information about clinical characteristics of Hungarian regorafenib patients as well as information about safety and efficacy of regorafenib in Hungarian patients with metastatic colorectal cancer. This much needed data is required by the National Health Insurance Fund in order to accept regorafenib into the regular reimbursement system. This study is proposed to be based on patient data from the Hungarian National Health Insurance Fund's Database. Data to be analyzed includes patient demography and baseline tumor characteristics, overall survival, time to treatment failure, duration of treatment, average dose and dose modifications, and adverse events. Further, treatment costs will be estimated.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Drug: Regorafenib (Stivarga, BAY73-4506)

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be all patients who met the criteria within the SmPC. Using the National Health Insurance Database, patients will be included in this retrospective data analysis if they had at least one dose of regorafenib treatment cycle.

Description

Inclusion Criteria:

• Using the National Health Insurance Database, patients will be included in this retrospective data analysis if they had at least one dose of regorafenib treatment cycle (=28 days).

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort1/Regorafenib; All patients with at least 1 treatment with regorafenib	Drug: Regorafenib (Stivarga, BAY73-4506); Product is used in accordance with SmPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of treatment for each treatment episode	The length of each treatment episode will be calculated based on the duration between the initiation date of a treatment episode and the end date of the same treatment episode	Retrospective analysis of 2 year period
Progression Free Survival (PFS)	PFS will be defined as days between start of the therapy and the date of the medical doctors opinion about progression (confirmed by radiology or clinical assessment)	Retrospective analysis of 2 year period
Overall Survival (OS)		Retrospective analysis of 2 year period
Number of participants with treatment emergent adverse events as a measure of safety and tolerability		Retrospective analysis of 2 year period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resource utilization per patient	Costs per patient for the reimbursed healthcare service e.g. inpatient care, outpatient visit, emergency departement visit, pharmaceutical dispensing	Retrospective analysis of 2 year period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to treatment failure (TTF)	Time to treatment failure is defined as days between the first drug delivery to the health care provider and date of treatment discontinuation due to any reason, including death	Retrospective analysis of 2 year period
Time to progression (TTP)	Time to progression is defined as days between the first drug delivery to the health care provider and the date of progression defined by the medical doctor	Retrospective analysis of 2 year period
Characteristics of patients with better response	Patients with "better response" are defined as receiving more cycles of regorafenib treatment than the median number of cycles (2 cycles). Their distribution is analyzed by KRAS status, by the location of the primary tumour, by age, by prior cancer therapies and by location of metastases.	Retropsective analysis of 2 year period
Time frame between the baseline computed tomography and the first drug delivery	Time frame between the date of the baseline computed tomography (CT) and the date of the first drug delivery to the health care provider	Retrospective analysis of 2 year period

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): February 15, 2017
• Study Completion (Actual): February 15, 2017

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Metastatic colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 18686