Trial Outcomes & Findings for An Observational Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) And Oxaliplatin in Patients With Colorectal Cancer (NCT NCT01399190)

Results Overview

Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.

Recruitment status

COMPLETED

Target enrollment

68 participants

Primary outcome timeframe

From randomization to progression or death during the study (up to approximately 30 months)

Results posted on

2016-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Bevacizumab Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
Overall Study STARTED	68
Overall Study Included in Final Analysis	63
Overall Study Evaluable for Primary Endpoint Analysis	60
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Bevacizumab Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
Overall Study Not Eligible for Final Analysis	5
Overall Study Adverse Event	8
Overall Study Participant's Request	5
Overall Study Physician Decision	2

Baseline Characteristics

An Observational Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) And Oxaliplatin in Patients With Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab n=63 Participants Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
Age, Continuous	60.08 years STANDARD_DEVIATION 10.38 • n=93 Participants
Sex: Female, Male Female	29 Participants n=93 Participants
Sex: Female, Male Male	34 Participants n=93 Participants

PRIMARY outcome

Timeframe: From randomization to progression or death during the study (up to approximately 30 months)

Population: Includes enrolled participants who were evaluable for the primary endpoint analysis.

Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.

Outcome measures

Outcome measures
Measure	Bevacizumab n=60 Participants Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
Progression-free Survival	7.000 months Interval 5.577 to 8.423

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: Includes enrolled participants who were evaluable for the primary endpoint analysis.

Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR

Outcome measures

Outcome measures
Measure	Bevacizumab n=60 Participants Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
Response Rate (Tumor Assessments According to RECIST) Response Rate	48.4 percentage of participants
Response Rate (Tumor Assessments According to RECIST) Complete remission	6.7 percentage of participants
Response Rate (Tumor Assessments According to RECIST) Partial remission	41.7 percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: Includes enrolled participants eligible for inclusion in the final analysis.

An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Outcome measures
Measure	Bevacizumab n=63 Participants Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
Percentage of Participants With Adverse Events	74.6 percentage of participants

Adverse Events

Bevacizumab

Serious events: 2 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bevacizumab n=63 participants at risk Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
Vascular disorders Hypertensive crisis	1.6% 1/63 • Up to approximately 30 months Includes enrolled participants eligible for inclusion in the final analysis.
Cardiac disorders Atrioventricular block	1.6% 1/63 • Up to approximately 30 months Includes enrolled participants eligible for inclusion in the final analysis.

Other adverse events

Other adverse events
Measure	Bevacizumab n=63 participants at risk Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
Blood and lymphatic system disorders Thrombocytopenia	20.6% 13/63 • Up to approximately 30 months Includes enrolled participants eligible for inclusion in the final analysis.
Blood and lymphatic system disorders Anaemia	6.3% 4/63 • Up to approximately 30 months Includes enrolled participants eligible for inclusion in the final analysis.
Gastrointestinal disorders Diarrhoea	6.3% 4/63 • Up to approximately 30 months Includes enrolled participants eligible for inclusion in the final analysis.
Immune system disorders Allergic reaction	9.5% 6/63 • Up to approximately 30 months Includes enrolled participants eligible for inclusion in the final analysis.
Nervous system disorders Neuropathy peripheral	36.5% 23/63 • Up to approximately 30 months Includes enrolled participants eligible for inclusion in the final analysis.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	6.3% 4/63 • Up to approximately 30 months Includes enrolled participants eligible for inclusion in the final analysis.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER