Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

Study Overview
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Brief Summary
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The primary objective was to describe the pattern of use of panitumumab (Vectibix®) in combination with chemotherapy in patients with wild-type rat sarcoma viral oncogene homolog (RAS) metastatic colorectal cancer (mCRC): as first-line treatment in combination with FOLFOX or FOLFIRI or second-line treatment in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).

Official Title
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Prospective Observational Cohort Study to Describe the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type RAS Metastatic Colorectal Cancer

Conditions
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Wild-type RAS Metastatic Colorectal Cancer

Intervention / Treatment
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* Other: Panitumumab + Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subject is ≥ 18 years of age at date of enrolment Histologically or cytologically confirmed carcinoma of colon or rectum Subject with metastatic carcinoma of colon or rectum Confirmed wild-type RAS status of tumour Subjects whose care will be managed primarily by the enrolling physician and/ or all records will be available Tumour assessment (ie, computed tomography [CT]/magnetic resonance imaging [MRI]) within 12 weeks (84 days) prior to first Vectibix® infusion. Subjects treated with at least one infusion of Vectibix® in combination with chemotherapy a maximum of 84 days before entering study: first-line in combination with FOLFOX (folinic acid, leucovorin, fluorouracil [5FU], oxaliplatin) or second-line in combination with FOLFIRI (folinic acid, leucovorin, 5FU, irinotecan) in subjects who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) for treatment of wild-type RAS mCRC per approved prescribing information Subject or subject's legally acceptable representative has provided informed consent (for countries where required per local regulations) Subjects treated with Vectibix® in accordance with the current version of the Summary of Product Characteristics (SmPC) Exclusion Criteria Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the European Medicines Agency for any indication Ongoing or planned concurrent participation in any clinical study where the dosing of Vectibix® is determined by the protocol (participation in clinical trials on an approved drug and observational trials are permitted but these cannot mandate how mCRC should be treated)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metastatic Colorectal Cancer<br>Participants with wild-type RAS metastatic colorectal cancer who were receiving panitumumab in combination with chemotherapy. | Other: Panitumumab + Chemotherapy<br>* Participants receiving panitumumab in combination with chemotherapy as prescribed by the treating physician prior to enrollment in this study and according to routine clinical practice for patients with wild-type RAS metastatic colorectal cancer.<br>* Other names: Vectibix®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Panitumumab Infusions |  | 12 months | 
| Cumulative Dose of Panitumumab |  | 12 months | 
| Maximum Dose of Panitumumab |  | 12 months | 
| Duration of Panitumumab Exposure | Duration of exposure is the time from the first to the last panitumumab infusion | 12 months | 
| Mean Interval Between Panitumumab Infusions |  | 12 months | 
| Percentage of Participants With at Least One Panitumumab Dose Reduction |  | 12 months | 
| Percentage of Participants With at Least One Panitumumab Dose Delay |  | 12 months | 
| Reasons for Discontinuation of Panitumumab |  | 12 months | 
| Duration of Exposure of All Concomitant Chemotherapy | Duration of exposure is the time from the first date to the last date of chemotherapy administration. | 12 months | 
| Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction |  | 12 months | 
| Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With at Least One Hospitalization |  | 12 months | 
| Types of Hospital Visit | Participants may have had more than one type of hospital visit. | 12 months | 
| Duration of Hospital Stay |  | 12 months | 
| Reasons for Hospitalization | Participants may have had more than one hospital visit and/or reason for a hospital visit. | 12 months | 
| Percentage of Participants With an Overall Response | Tumor response was assessed by the investigator using standard radiological imaging. Overall response is defined as a best tumor response of complete response or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST). | 12 months | 
| Number of Participants With Resectability | Resectability denotes whether a participant became resectable during the study. | 12 months | 
| Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation |  | 12 months | 
| Type of Post-Panitumumab Anti-cancer Treatment | Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wild-type RAS, Metastatic Colorectal Cancer, Vectibix