Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Recurrence

Colorectal Neoplasms

Disease Attributes

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Panitumumab

Antineoplastic Agents, Immunological

Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks

Postmarketing Group Manager

The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.

Specifically, information will be collected on the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders.

The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.

Participants of this surveillance will be patients with unresectable, advanced or recurrent colorectal cancer with the wild-type KRAS gene. The planned sample size is 2,000 patients.

The usual adult dosage is 6 mg/kg of panitumumab given by intravenous drip infusion over a 60-minute period once every 2 weeks. The dosage may also be reduced as needed, depending on the patient's condition.

Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)

Vectibix for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)

The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.

Progression-free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.

Overall survival was defined as the time to death from the start of panitumumab administration was tabulated.

Takeda

Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.

Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks

Concomitant Administration of Panitumumab and Chemotherapy

< 75 years

>= 75 years

Age, Customized

Sex: Female, Male

Asian

Race/Ethnicity, Customized

Japan

Region of Enrollment

Wild type

Non-measurable/non-assessable

Mutant

Not determined

Unknown

KRAS genotype

First-line

Second-line

Third-line or later

Treatment stage (excluding posteroperative adjuvant chemotherapy)

PS:0

PS:1

PS:2

PS:3

PS:4

ECOG-PS is measured on 6-point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work; 2=Ambulatory (\>50% of waking hours), capable of all selfcare, but unable to carry out any work activities; 3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4=Completely disabled, cannot carry on any selfcare, totally confined to bed or chair; 5=Dead.

Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline

Metastatic lesions/sites of relapse

3086 participants completed the survey form (5 participants did not complete it). 3085 participants were included in the safety analysis set after excluding 1 participant due to missing panitumumab treatment and AE data. From that set, 3084 participants were included in the efficacy analysis set after excluding 1 participant with missing data.

The present specified drug-use survey is a one-arm observational study with no control group. Therefore, the observed outcome measures provide exploratory information regarding these endpoints; however, do not constitute verification results.

Medical Director, Clinical Science

Frequency of adverse drug reactions

MedDRA SOC: Skin and subcutaneous tissue disorders

MedDRA SOC: Infections and infestations

MedDRA SOC: Gastrointestinal disorders

MedDRA SOC: Metabolism and nutrition disorders

MedDRA SOC: Cardiac disorders

Of the 3086 participants who completed the survey form, 3085 participants were included in the safety analysis set after excluding 1 participant for whom information regarding panitumumab treatment and adverse events were missing.

Number of Participants With Adverse Drug Reactions

Participants who were included in the efficacy analysis set and received panitumumab monotherapy as a third-line or later therapy.

Progression-free Survival

All participants that received panitumumab monotherapy as a third-line or later therapy.

Overall Survival

Overall Study

Spots Global Cancer Trial Database for Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial