Metastatic Colorectal Cancer
Conditions
Brief summary
This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate progression free survival (PFS) in a real-life setting in participants with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.
Interventions
OTHERObservational Chemotherapy
No intervention - Observational standard practice chemotherapy
DRUGConcomitant Bevacizumab
No intervention - Observational concomitant bevacizumab
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Having colon or rectal metastatic adenocarcinoma, for which the physician decided during the inclusion visit to start a treatment with bevacizumab combined with a 1st, 2nd or 3rd line chemotherapy * Having received oral and written information about the survey and not objecting to having his/her data computerized
Exclusion criteria
\- Participating in a clinical trial assessing an anticancer treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | within 36 months | Kaplan Meier estimates of median progression-free survival according to the metastatic line of treatment, for a median follow-up of 18, 15 and 13 months, respectively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 36 months | Overall Survival (OS) was defined as the time between the treatment start (date of the first infusion of bevacizumab) and death from any cause. Kaplan Meier estimates of median overall survival were calculated for the metastatic lines of treatment, with a median follow-up of 18, 15 and 13 months, respectively. |
| Quality of Life - Global Health Status | Baseline, 6 and 12 months | Participants rated their quality of life (global health status) on the European Organization for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ C-30), with total scores ranging from 0 (worst) to 100 (best). |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observational Chemotherapy/Bevacizumab Observed patients receiving chemotherapy with concomitant bevacizumab | 737 |
| Total | 737 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Death | 377 |
| Overall Study | Disease Progression | 3 |
| Overall Study | Enrollment in a Clinical Trial | 1 |
| Overall Study | Lost to Follow-up | 20 |
| Overall Study | Moved or Changed Medical Team | 23 |
| Overall Study | Protocol Violation | 28 |
| Overall Study | Unknown reason | 2 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Observational Chemotherapy/Bevacizumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 390 Participants |
| Age, Categorical Between 18 and 65 years | 347 Participants |
| Age, Continuous | 64.5 years STANDARD_DEVIATION 10.9 |
| Gender Female | 293 participants |
| Gender Male | 442 participants |
| Region of Enrollment France | 737 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 353 / 760 |
| serious Total, serious adverse events | 74 / 760 |
Outcome results
Primary
Progression-free Survival
Kaplan Meier estimates of median progression-free survival according to the metastatic line of treatment, for a median follow-up of 18, 15 and 13 months, respectively
Time frame: within 36 months
Population: Efficacy analysis set receiving bevacizumab at inclusion
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab With 1st Line Treatment | Progression-free Survival | 10.4 Months |
| Bevacizumab With 2nd Line Treatment | Progression-free Survival | 8.5 Months |
| Bevacizumab With 3rd Line Treatment | Progression-free Survival | 6.3 Months |
Secondary
Overall Survival
Overall Survival (OS) was defined as the time between the treatment start (date of the first infusion of bevacizumab) and death from any cause. Kaplan Meier estimates of median overall survival were calculated for the metastatic lines of treatment, with a median follow-up of 18, 15 and 13 months, respectively.
Time frame: Up to 36 months
Population: Efficacy analysis set receiving bevacizumab at inclusion
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab With 1st Line Treatment | Overall Survival | 25.3 Months |
| Bevacizumab With 2nd Line Treatment | Overall Survival | 19.1 Months |
| Bevacizumab With 3rd Line Treatment | Overall Survival | 14.9 Months |
Secondary
Quality of Life - Global Health Status
Participants rated their quality of life (global health status) on the European Organization for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ C-30), with total scores ranging from 0 (worst) to 100 (best).
Time frame: Baseline, 6 and 12 months
Population: Participants in the efficacy analysis set who filled out the questionnaire at inclusion
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bevacizumab With 1st Line Treatment | Quality of Life - Global Health Status | at Month 12 (n=173) | 67 units on a scale |
| Bevacizumab With 1st Line Treatment | Quality of Life - Global Health Status | at Inclusion (n=521) | 67 units on a scale |
| Bevacizumab With 1st Line Treatment | Quality of Life - Global Health Status | at Month 6 (n=279) | 67 units on a scale |
| Bevacizumab With 1st Line Treatment | Quality of Life - Global Health Status | at Month 18 (n=134) | 67 units on a scale |