An Observational Study on Bevacizumab (Avastin) as First-Line Treatment in Colorectal Cancer Participants With Potentially Resectable Liver Metastases

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Bevacizumab

Registration Number: NCT01343901

Lead Sponsor: Hoffmann-La Roche

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 210

Inclusion Criteria

Participants with colorectal cancer with exclusively hepatic or hepatic and pulmonary metastases
First-line treatment with bevacizumab for potentially resectable metastatic disease

Exclusion Criteria

Outright resectable disease
Clearly inoperable disease
Participation in a clinical trial evaluating a cytotoxic anticancer treatment and/or an innovative therapy

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bevacizumab	Bevacizumab	Participants with metastatic colorectal cancer (mCRC) with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases will be observed.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery	Baseline up to 36 months	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).
Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery	Baseline up to 36 months	The percentage of participants with no detectable metastatic disease after a complete response without surgery (missing metastasis) was reported.

Secondary Outcome Measures

Name	Time	Method
Relapse-free Survival (RFS)	Baseline until disease progression or death, whichever occurred first, assessed up to 36 months	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.
Percentage of Participants Who Died	Baseline until death; assessed up to 36 months
Overall Survival (OS)	Baseline until death, assessed up to 36 months	OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.
Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery	Baseline up to 36 months	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%).
Number of Cumulated Cycles of First Line Bevacizumab at Day 0	Day 0
Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0	Day 0
Total Duration of First Line Bevacizumab Treatment at Day 0	Day 0
Percentage of Participants With Unresectability Criteria	Day 0
Percentage of Participants With at Least One Disease and Comorbidity at Day 0	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.
Percentage of Participants With Different Previous Therapies at Day 0	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.
Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period	Baseline up to 36 months
Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period	Baseline up to 36 months
Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment	Baseline up to 36 months	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.
Percentage of Participants With Disease Progression or Death	Baseline until disease progression or death, whichever occurred first, assessed up to 36 months	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.
Progression-free Survival (PFS)	Baseline until disease progression or death, whichever occurred first, assessed up to 36 months	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.
Percentage of Participants With Disease Relapse	Baseline until disease progression or death, whichever occurred first, assessed up to 36 months	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.

Trial Locations

Locations (124): Clinique Esquirol Saint Hilaire
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Agen, France
C.H. Du Pays D'aix En Provence Service du Dr Blanc
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Aix En Provence, France
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
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Aix En Provence, France
Chi D Alencon; Medecine Ambulatoire
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Alencon, France
Ch D Ales; Oncologie
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Ales, France
Hopital Nord; Medecine A
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Amiens, France
Clinique De L Europe; Pmsi
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Amiens, France
Clinique De L Europe; Radiotherapie Chimiotherapie
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Amiens, France
Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero
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Amilly, France
Hotel Dieu; Medecine A
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Angers, France
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Clinique Esquirol Saint Hilaire
🇫🇷Agen, France