Prospective Observational Cohort Study to Describe the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type KRAS Metastatic Colorectal Cancer (20120100)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Healthcare resource utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Colorectal cancer metastatic

Population studied

• Short description of the study population:
  Subjects with wild-type RAS metastatic colorectal cancer CRC treated with Vectibix® according to the SmPC in France and Germany.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Colorectal cancer patients
• Estimated number of subjects:
  740

Study design details

• Main study objective:
  Treatment patterns of Vectibix® and concomitant chemotherapy for mCRC (12mo)
• Outcomes:
  Treatment patterns of Vectibix® and concomitant chemotherapy for mCRC (12mo), Healthcare resource utilization (12mo)Demography of disease population (12mo)Response to Vectibix® (12mo)Planned anti-cancer treatment initiated post Vectibix (12 mo)
• Data analysis plan:
  The analysis of this study will be descriptive in nature. The data will be summarized for patients with metastatic colorectal cancer (mCRC) with tumour expressing wild type (non-mutated) KRAS who received Vectibix® in combination with FOLFOX as first-line treatment and subjects who received Vectibix® in combination with FOLFIRI as second line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). The data will be summarized by country to fulfil local post reimbursement requirements. For continuous outcomes, the mean, standard deviation, median, and range will be provided. For categorical variables, the frequency and percentage, with two-sided 95% CI, will be displayed for the treatment pattern of Vectibix®. Summary tables and analyses will be based on FLFAS and SLFAS and corresponding local tumour response analysis sets. Summary statistics will be reported for the significant covariates.Selected sensitivity analyses may be performed.

Documents

Study results

CICERO_ORSR_abstract_20170816 (002)