Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

bevacizumab [Avastin]

Clinical Trials

This observational study will assess the treatment duration, progression-free survival, reason for stopping treatment and patient and tumor characteristics of bevacizumab \[Avastin\] treatment in patients with metastatic colorectal cancer. Data will be collected for approximately 34 months. The target sample size is \>300 patients.

Observational Study of Bevacizumab [Avastin] in Patients With Metastatic Colorectal Cancer (AVASTART)

A Multicenter, Non-interventional, Post-authorization Study to Observe in Daily Clinical Practice the Treatment Duration of Patients Treated With Avastin (Bevacizumab) in 1st Line mCRC in Belgium

Duration of bevacizumab treatment (in months) was defined as: (last treatment date - first treatment date plus \[+\] 1)/30.44. Duration of treatment was estimated using Kaplan-Meier method. Results are reported as per age groups (\<70 years and greater than or equal to \[≥\] 70 years) as well as for overall participants.

PFS (in months) was defined as: (date of progression or censored date - first date of treatment + 1)/30.44. Date of progression was derived from Response Evaluation Criteria in Solid Tumors (RECIST) evaluation or from last available date for participant who withdrew the study for progressive disease without progression according to RECIST evaluation. Progression was defined (as per RECIST) as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier method. Results are reported as per age groups (\<70 years and ≥70 years) as well as for overall participants.

Tumor response was assessed using RECIST. Complete Response (CR): disappearance of all target and non-target lesions; Partial Response (PR): at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Results are reported as per age groups (\<70 years, 70-80 years, and \>80 years) as well as for overall participants.

ECOG performance status measured on a 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, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status. For each time-point, only categories with available data are reported.

Hoffmann-La Roche

All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.

Bevacizumab: Overall

Participants aged less than (\<) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.

Bevacizumab: Age <70 Years

Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.

Bevacizumab: Age 70-80 Years

Participants aged greater than (\>) 80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.

Bevacizumab: Age >80 Years

Total

Reported age data represents age at screening; calculated as: (screening date minus \[-\] birth date) divided by (/) 365.25.

Age, Continuous

Sex: Female, Male

Full analysis population (FAS) included all participants who received bevacizumab in first line mCRC. Baseline characteristics were reported by age groups.

Medical Communications

Participants aged \< 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.

Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged \>80 years, the age groups "70-80 Years" and "\>80 Years" have been pooled in this group.

Bevacizumab: Age ≥70 Years

Duration of Bevacizumab Treatment

Progression-Free Survival (PFS)

Not Evaluable

Participants aged \<70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.

Participants aged \>80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.

FAS. Here, number of participants analyzed = participants with available data for this outcome.

Percentage of Participants With Best Overall Response

Baseline: ECOG 0 (n=108,63,9,180)

Baseline: ECOG 1 (n=108,63,9,180)

Baseline: ECOG 2 (n=108,63,9,180)

Baseline: ECOG 3 (n=108,63,9,180)

Baseline: ECOG 4 (n=108,63,9,180)

Cycle 1: ECOG 0 (n=101,58,9,168)

Cycle 1: ECOG 1 (n=101,58,9,168)

Cycle 1: ECOG 2 (n=101,58,9,168)

Cycle 1: ECOG 3 (n=101,58,9,168)

Cycle 2: ECOG 0 (n=98,54,8,160)

Cycle 2: ECOG 1 (n=98,54,8,160)

Cycle 2: ECOG 2 (n=98,54,8,160)

Cycle 3: ECOG 0 (n=94,48,7,149)

Cycle 3: ECOG 1 (n=94,48,7,149)

Cycle 3: ECOG 2 (n=94,48,7,149)

Cycle 4: ECOG 0 (n=87,45,7,139)

Cycle 4: ECOG 1 (n=87,45,7,139)

Cycle 4: ECOG 2 (n=87,45,7,139)

Cycle 5: ECOG 0 (n=88,36,6,130)

Cycle 5: ECOG 1 (n=88,36,6,130)

Cycle 5: ECOG 2 (n=88,36,6,130)

Cycle 5: ECOG 3 (n=88,36,6,130)

Cycle 6: ECOG 0 (n=75,36,5,116)

Cycle 6: ECOG 1 (n=75,36,5,116)

Cycle 6: ECOG 2 (n=75,36,5,116)

Cycle 7: ECOG 0 (n=67,31,6,104)

Cycle 7: ECOG 1 (n=67,31,6,104)

Cycle 7: ECOG 2 (n=67,31,6,104)

Cycle 8: ECOG 0 (n=63,26,5,94)

Cycle 8: ECOG 1 (n=63,26,5,94)

Cycle 8: ECOG 2 (n=63,26,5,94)

Cycle 9: ECOG 0 (n=62,27,4,93)

Cycle 9: ECOG 1 (n=62,27,4,93)

Cycle 9: ECOG 2 (n=62,27,4,93)

Cycle 10: ECOG 0 (n=53,29,3,85)

Cycle 10: ECOG 1 (n=53,29,3,85)

Cycle 10: ECOG 2 (n=53,29,3,85)

Cycle 11: ECOG 0 (n=54,21,4,79)

Cycle 11: ECOG 1 (n=54,21,4,79)

Cycle 11: ECOG 2 (n=54,21,4,79)

Cycle 12: ECOG 0 (n=48,21,3,72)

Cycle 12: ECOG 1 (n=48,21,3,72)

Cycle 12: ECOG 2 (n=48,21,3,72)

Cycle 13: ECOG 0 (n=39,17,1,57)

Cycle 13: ECOG 1 (n=39,17,1,57)

Cycle 13: ECOG 2 (n=39,17,1,57)

Cycle 14: ECOG 0 (n=34,15,1,50)

Cycle 14: ECOG 1 (n=34,15,1,50)

Cycle 14: ECOG 2 (n=34,15,1,50)

Cycle 15: ECOG 0 (n=30,14,1,45)

Cycle 15: ECOG 1 (n=30,14,1,45)

Cycle 16: ECOG 0 (n=28,13,1,42)

Cycle 16: ECOG 1 (n=28,13,1,42)

Cycle 17: ECOG 0 (n=24,11,1,36)

Cycle 17: ECOG 1 (n=24,11,1,36)

Cycle 18: ECOG 0 (n=18,9,1,28)

Cycle 18: ECOG 1 (n=18,9,1,28)

Cycle 19: ECOG 0 (n=19,10,1,30)

Cycle 19: ECOG 1 (n=19,10,1,30)

Cycle 20: ECOG 0 (n=15,6,0,21)

Cycle 20: ECOG 1 (n=15,6,0,21)

Cycle 21: ECOG 0 (n=15,5,0,20)

Cycle 21: ECOG 1 (n=15,5,0,20)

Cycle 22: ECOG 0 (n=16,5,0,21)

Cycle 22: ECOG 1 (n=16,5,0,21)

Cycle 23: ECOG 0 (n=12,5,0,17)

Cycle 23: ECOG 1 (n=12,5,0,17)

Cycle 24: ECOG 0 (n=10,5,0,15)

Cycle 24: ECOG 1 (n=10,5,0,15)

Cycle 24: ECOG 2 (n=10,5,0,15)

Cycle 25: ECOG 0 (n=9,4,0,13)

Cycle 25: ECOG 1 (n=9,4,0,13)

Cycle 26: ECOG 0 (n=9,4,0,13)

Cycle 26: ECOG 1 (n=9,4,0,13)

Cycle 27: ECOG 0 (n=8,4,0,12)

Cycle 27: ECOG 1 (n=8,4,0,12)

Cycle 28: ECOG 0 (n=5,4,0,9)

Cycle 28: ECOG 1 (n=5,4,0,9)

Cycle 29: ECOG 0 (n=6,4,0,10)

Cycle 29: ECOG 1 (n=6,4,0,10)

Cycle 29: ECOG 2 (n=6,4,0,10)

Cycle 30: ECOG 0 (n=6,4,0,10)

Cycle 30: ECOG 1 (n=6,4,0,10)

Cycle 30: ECOG 2 (n=6,4,0,10)

Cycle 31: ECOG 0 (n=6,3,0,9)

Cycle 31: ECOG 1 (n=6,3,0,9)

Cycle 32: ECOG 0 (n=5,3,0,8)

Cycle 32: ECOG 1 (n=5,3,0,8)

Cycle 33: ECOG 0 (n=6,3,0,9)

Cycle 33: ECOG 1 (n=6,3,0,9)

Cycle 34: ECOG 0 (n=5,3,0,8)

Cycle 34: ECOG 1 (n=5,3,0,8)

Cycle 34: ECOG 2 (n=5,3,0,8)

Cycle 35: ECOG 0 (n=5,2,0,7)

Cycle 35: ECOG 1 (n=5,2,0,7)

Cycle 35: ECOG 2 (n=5,2,0,7)

Cycle 36: ECOG 0 (n=5,2,0,7)

Cycle 36: ECOG 1 (n=5,2,0,7)

Cycle 36: ECOG 2 (n=5,2,0,7)

Cycle 37: ECOG 0 (n=5,1,0,6)

FAS. Here, number of participants analyzed = participants with available data for this outcome and n = participants with available data for specified category, for each arm, respectively. No participants were evaluable for Cycles 48-50; hence, no data reported for these cycles.

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status

All participants with Metastatic Colorectal Cancer (mCRC) for whom the physician decided to prescribe bevacizumab (Avastin) as part of their first line treatment and in line with current Summary of Product Characteristics (SmPC) (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.

Overall Study

Spots Global Cancer Trial Database for Observational Study of Bevacizumab [Avastin] in Patients With Metastatic Colorectal Cancer (AVASTART)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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