POWER: Real World Data of 1st line panitumumab treatment in combination with chemotherapy in non resectable wild type (WT) RAS metastatic colorectal cancer (mCRC) subjects in Austria, Bulgaria, Croatia, Czech Republic, Hungary, Poland, Slovenia, Romania, Russia, Greece an Observational Ambidirectional Study (20170734)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multicentre, ambidirectional (retrospective-prospective), observational study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01XC08) panitumumab

  panitumumab
• Medical condition to be studied:
  Colorectal cancer metastatic

Population studied

• Short description of the study population:
  The study involved patients aged 18 years or older with non-resectable wild type (WT) RAS metastatic colorectal cancer (mCRC) receiving panitumumab in combination with chemotherapy as first-line treatment identified from European countries, including Austria, Bulgaria, Croatia, Czech Republic, Hungary, Poland, Slovenia, Romania, and Russia.; Inclusion criteria: ; • Subject who received first infusion of panitumumab in combination with chemotherapy as 1st line treatment between 1 and 12 months before enrolment and who continues treatment with panitumumab in combination with chemotherapy at the time of enrolment; • Subject with a record of WT RAS CRC diagnosis as per standard clinical practice; • Subject with metastatic carcinoma of the colon or rectum with at least one metastatic site recorded; • Subject with initially non resectable mCRC at the start of panitumumab plus chemotherapy treatment; • Subject who was diagnosed with a tumour, assessed by CT/MRI etc. prior to panitumumab plus chemotherapy initiation; • Histologically or cytologically confirmed carcinoma of the colon or rectum as the primary site; • Subject ≥ 18 years of age on the date of enrolment; • Subjects whose care will be managed primarily by the enrolling physician and/ or all records will be available from initiation of 1st line panitumumab plus chemotherapy treatment to end of safety follow up; • Subject or subject’s legally acceptable representative has provided informed consent if applicable per local regulations; ; Exclusion criteria:; • Subject with proven brain metastasis; • Subject with mCRC as a secondary malignancy; • Ongoing or planned concurrent participation in any interventional clinical trial
• 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:
  Metastatic colorectal cancer patients
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  To obtain characteristics of subjects with WT RAS non resectable mCRC receiving panitumumab in combination with chemotherapy as a 1 st line treatment, and to describe the patterns of treatment, including 1 st and 2nd line therapies.
• Outcomes:
  The following data will be collected:demographics: age, sex, targeted medical history: type of primary tumour, date of diagnosis, site of primary tumour: rectum vs colon, right vs left colon, surgical procedures, lymph nodes: number and involvement, TNM stage, adjuvant chemotherapy, including regimen, sites, Response to 1st line treatment Safety assessments: ADR reports Prophylaxis treatment for skin toxicity Questionnaire FACT-EGFRI-18 if permitted in a country per local regulations.
• Data analysis plan:
  The baseline data will be summarized using descriptive statistics for subjects with mCRC who received panitumumab in combination with chemotherapy as 1st line treatment according to the type of chemotherapy received. The data will be summarized for the total study population divided by the type of chemotherapy received: FOLFOX, FOLFIRI and others. The data will be summarized for the total study population and per country. Counts and percentages will be provided. Continuous outcomes will be summarized by the number of non-missing values, mean, standard deviation, median, lower and upper quartiles and minimum and maximum values. Time to event data alalysis using Kaplan Meier estimator. The eCRFs will be designed to minimise missing data and to optimise the integrity of collected data. Subjects’ records will not be excluded because of missing data and missing data will not be inputted. For categorical variables, missing responses will be shown as a separate category in the analysis.