N/A
Completed N=213
Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients
Wild-type RAS Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT01732783 ↗
Enrolled (actual)
213
Serious AEs
4.7%
Results posted
Aug 2018
Primary outcomePrimary: Total Number of Panitumumab Infusions — 10.0; 10.0; 8.0 infusions
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Panitumumab Infusions |
10.0; 10.0; 8.0 | — |
| PRIMARY Cumulative Dose of Panitumumab |
4262.5; 4000.0; 3782.5 | — |
| PRIMARY Maximum Dose of Panitumumab |
450.0; 420.0; 507.0 | — |
| PRIMARY Duration of Panitumumab Exposure |
5.339; 6.012; 5.339 | — |
| PRIMARY Mean Interval Between Panitumumab Infusions |
0; 0; 0; 38; 7; 2 | — |
| PRIMARY Percentage of Participants With at Least One Panitumumab Dose Reduction |
36.6; 21.6; 50.0 | — |
| PRIMARY Percentage of Participants With at Least One Panitumumab Dose Delay |
42.7; 21.6; 41.7 | — |
| PRIMARY Reasons for Discontinuation of Panitumumab |
35; 12; 3; 30; 7; 0 | — |
| PRIMARY Duration of Exposure of All Concomitant Chemotherapy |
5.240; 5.092; 3.860 | — |
| PRIMARY Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction |
43.3; 24.3; 58.3 | — |
| PRIMARY Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay |
29.3; 29.7; 33.3 | — |
| SECONDARY Number of Participants With at Least One Hospitalization |
163; 37; 12 | — |
| SECONDARY Types of Hospital Visit |
157; 35; 12; 75; 12; 6 | — |
| SECONDARY Duration of Hospital Stay |
40.0; 28.0; 24.5 | — |
| SECONDARY Reasons for Hospitalization |
144; 30; 10; 88; 16; 9 | — |
| SECONDARY Percentage of Participants With an Overall Response |
47.6; 33.3; 50.0 | — |
| SECONDARY Number of Participants With Resectability |
20; 3; 1; 135; 33; 7 | — |
| SECONDARY Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation |
84; 15; 3 | — |
| SECONDARY Type of Post-Panitumumab Anti-cancer Treatment |
72; 10; 3; 10; 2; 0 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01732783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.