This observational study will evaluate the efficacy and safety of bevacizumab as first-line treatment in participants with colorectal cancer and potentially resectable liver metastases.
Study Type
OBSERVATIONAL
Enrollment
210
Participants with mCRC and having exclusively liver or liver and lung metastases who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion will be observed. All concomitant medications as used in routine clinical practice are allowed.
Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery
Secondary resection involves removal of all detectable metastases at surgery including participants with missing metastases left in place. Percentage of participants without detectable metastatic disease after secondary resection removing all detectable metastases at surgery (including participants with disappeared metastases left in place \[missing metastases\]) was reported. Metastases was detected using computed tomography (CT) scan or magnetic resonance imaging (MRI).
Time frame: Baseline up to 36 months
Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery
The percentage of participants with no detectable metastatic disease after a complete response without surgery (missing metastasis) was reported.
Time frame: Baseline up to 36 months
Percentage of Participants With at Least One Disease and Comorbidity at Day 0
Percentage of participants who had any concurrent disease (comorbidity) at Day 0 was reported. Comorbidities included gastrointestinal disease, hypertension, other cardiovascular disease, and other medical history and comorbidities (other than those specified above). Same participant may be counted in more than one category.
Time frame: Day 0
Percentage of Participants With Different Previous Therapies at Day 0
Previous therapies included neoadjuvant treatment (chemotherapy or chemotherapy + radiotherapy) and adjuvant treatment (FOLFOX \[folinic acid+5-fluorouracil+oxaliplatin\], LV5FU2 \[leucovorin+5-Fluorouracil\], capecitabine, or any other adjuvant treatment). Only participants who received neoadjuvant treatment and adjuvant treatment was reported.
Time frame: Day 0
Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period
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Clinique Esquirol Saint Hilaire
Agen, France
C.H. Du Pays D'aix En Provence Service du Dr Blanc
Aix-en-Provence, France
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
Aix-en-Provence, France
Chi D Alencon; Medecine Ambulatoire
Alençon, France
Ch D Ales; Oncologie
Alès, France
Hopital Nord; Medecine A
Amiens, France
Clinique De L Europe; Pmsi
Amiens, France
Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, France
Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero
Amilly, France
Hotel Dieu; Medecine A
Angers, France
...and 116 more locations
Time frame: Baseline up to 36 months
Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period
Time frame: Baseline up to 36 months
Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment
Percentage of participants who had any concurrent disease (comorbidity) was reported. Comorbidities included gastrointestinal disease, other cardiovascular disease, and other medical history and comorbidities (other than those which are specified above). Same participant may be counted in more than one category.
Time frame: Baseline up to 36 months
Percentage of Participants With Disease Progression or Death
Disease progression is defined at least a 20 percent (%) increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 millimeter (mm) or persistence of non-target lesions, or appearance of one or more new lesions.
Time frame: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months
Progression-free Survival (PFS)
Progression-free survival defined as the time elapsed between the Avastin start date and the date of first progressive disease (PD) or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions or appearance of one or more new lesions.
Time frame: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months
Percentage of Participants With Disease Relapse
Relapse was defined as the presence of metastases post last surgery removing all detectable metastases (A1 criterion \[participants without detectable metastatic disease {DMD} after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}\]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.
Time frame: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months
Relapse-free Survival (RFS)
RFS was defined as the time elapsed between the last surgery removing all detectable metastases (A1 criterion \[participants without DMD after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}\]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.
Time frame: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months
Percentage of Participants Who Died
Time frame: Baseline until death; assessed up to 36 months
Overall Survival (OS)
OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.
Time frame: Baseline until death, assessed up to 36 months
Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery
For the non-detectable liver and lung metastases the categorization based on rate of viable cells were as follows (no viable cells =0%, minimum =1 to 49%, maximum =50 to 100%).
Time frame: Baseline up to 36 months
Number of Cumulated Cycles of First Line Bevacizumab at Day 0
Time frame: Day 0
Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0
Time frame: Day 0
Total Duration of First Line Bevacizumab Treatment at Day 0
Time frame: Day 0
Percentage of Participants With Unresectability Criteria
Time frame: Day 0