Breast Cancer, Colorectal Cancer, Gastric Cancer
Conditions
Brief summary
This multi-center observational study will evaluate the use of Xeloda (capecitabine) in patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer and breast cancer in routine clinical practice. Eligible patients receiving treatment with Xeloda according to product label will be followed for up to 10 months.
Interventions
DRUGCapecitabine
Capecitabine will be given according to the label text as monotherapy (1250 mg/m\^2 twice daily) or combination therapy (800 to 1000 mg/m\^2 or 1250 mg/m\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
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
* Patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer who are candidates for receiving Xeloda according to product label
Exclusion criteria
* Contraindications according to label and off-label use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first | Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Dose of Capecitabine | Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first | Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented. |
Countries
Austria
Participant flow
Recruitment details
A total of 563 participants were included from April 2010 to July 2012 at 21 sites in Austria.
Pre-assignment details
Of 563 participants, 220 were treated for adjuvant colon cancer, 200 were treated for metastatic colorectal cancer, 84 were treated for metastatic breast cancer, and 59 were treated for advanced gastric cancer.
Participants by arm
| Arm | Count |
|---|---|
| Capecitabine Participants received capecitabine according to the label text as monotherapy (1250 mg/m\^2 twice daily) or combination therapy (800 to 1000 mg/m\^2 or 1250 mg/m\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days. | 563 |
| Total | 563 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 18 |
| Overall Study | Lost to Follow-up | 99 |
| Overall Study | Other | 49 |
| Overall Study | Withdrawal by Subject | 27 |
Baseline characteristics
| Characteristic | Capecitabine |
|---|---|
| Age, Continuous | 68.0 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | NA Participants |
| Sex: Female, Male Male | NA Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 271 / 563 |
| serious Total, serious adverse events | 34 / 563 |
Outcome results
Primary
Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment
Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.
Time frame: Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
Population: All enrolled participants were considered for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Capecitabine | Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | Adjuvant therapy | 220 Participants |
| Capecitabine | Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | First line therapy | 176 Participants |
| Capecitabine | Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | Second line therapy | 89 Participants |
| Capecitabine | Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | Third line therapy | 78 Participants |
Secondary
Median Dose of Capecitabine
Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.
Time frame: Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
Population: All enrolled participants were considered for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Capecitabine | Median Dose of Capecitabine | Month 7 | 3500 Milligrams |
| Capecitabine | Median Dose of Capecitabine | From Month 8 onwards | 3000 Milligrams |