The Effects of Preoperative Bevacizumab on Perioperative Complications

Study Overview
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Brief Summary
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This is a nationwide multicenter,retrospective,observational real-world study. To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation. To assess the correlation of the interval time between the last dose of bevacizumab and operation and occurrence of perioperative complications. To explore the risk factors of perioperative comlications in patients with tumor received bevacizumab prior to unexpected operation.

Detailed Description
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Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor(VEGF) in in vitro and in vivo assay systems. Bevacizumab was first granted marketing approval in the United States on 26 February 2004 (international birth date) in combination with IV 5-fluorouracil(5-FU) based chemotherapy for the first-line treatment of patients with metastatic carcinoma of the colon or rectum (CRC). At present, bevacizumab is widely used in the treatment of solid tumors such as lung cancer ,colorectal cancer and so on. It has been reported in the literature that bevacizumab may adversely affect wound healing. To prevent postoperative complications, some guidelines state that the interval time between last dose of bevacizumab and operations should be at least 6 weeks, but the optimal time to discontinue bevacizumab before surgery has not been confirmed. This project aims to evaluate the risk of perioperative complications in cancer patients with a history of bevacizumab use within 6 weeks prior to unexpected operation. This is a nationwide multicenter,retrospective,observational real-world study.The study will collect the medical records and prognosis in 30 days following surgery of patients with colorectal cancer and lung cancer who underwent unexpected operation within 6 weeks (including 6 weeks) of bevacizumab discontinuation from 01 Jan 2010 to 31 Dec 2019.All enrolled subjects aged 18-90 years old; Complete clinical data related to important indicators, including preoperative baseline data, surgical information and perioperative prognosis information. The patients who used anti-angiogenic agents other than bevacizumab within 6 weeks prior to surgery would be excluded. Primary Evaluation Measures: To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation:to calculate the total incidence of perioperative complications in patients undergoing unexpected surgery after discontinuation of bevacizumab, including wound healing complications, non-wound-related infections, postoperative bleeding, thrombosis, gastrointestinal perforation, anastomotic leakage, secondary surgery, death and other perioperative adverse events;to calculate the incidence of each perioperative complication in patients undergoing unexpected operation after bevacizumab discontinuation. SAS9.4 statistical analysis software will be used for analysis. Measurement indicators will be statistically described using number of cases, mean, median, standard deviation, minimum and maximum; categorical indicators will be statistically described using frequency and percentage. Unless otherwise specified, all statistical tests will adopt the two-sided test with α = 0.05, and the corresponding OR value and two-sided 95% confidence interval will be provided if applicable.

Official Title
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The Effects of Preoperative Bevacizumab on Perioperative Complications in Patients With Tumor Undergoing Unexpected Operation

Conditions
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Lung Cancer, Colorectal Cancer, Operation Wound; Infection, Bevacizumab

Intervention / Treatment
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* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Patients with colorectal cancer and lung cancer who underwent unexpected operation from 01 Jan 2010 to 31 Dec 2019, and received bevacizumab within 6 weeks (including 6 weeks) before operation; 2.Patients aged 18-90 years old; 3.Complete clinical data related to important indicators, including preoperative baseline data, surgical information and perioperative prognosis information. Exclusion Criteria: Patients who used anti-angiogenic agents other than bevacizumab within 6 weeks prior to unexcepted operation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with CRC or lung cancer was performed unexpected operation<br>This is an observational study; thus, no intervention or treatment is required by the protocol. During the study, enrolled patients may be eligibled if bevacizumab was discontinued within 6 weeks prior to unexpected operation. | Drug: Bevacizumab<br>* Enrolled patients may be eligibled if bevacizumab was discontinued within 6 weeks prior to unexpected operation.<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation. | To calculate the total incidence of perioperative complications in patients undergoing unexpected surgery after discontinuation of bevacizumab, including wound healing complications, non-wound-related infections, postoperative bleeding, thrombosis, gastrointestinal perforation, anastomotic leakage, secondary surgery, death and other perioperative adverse events;To calculate the incidence of each perioperative complication in patients undergoing unexpected operation after bevacizumab discontinuation. | 30 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the correlation of the interval time between the last dose of bevacizumab and operation and occurrence of perioperative complications. | According to the interval between the last dose of preoperative bevacizumab and surgery, the patients were divided into three groups: within 2 weeks (including 2 weeks), 2 weeks to 4 weeks (including 4 weeks), and 4 weeks to 6 weeks (including 6 weeks). If the number of patients actually enrolled in each group was too small to support subsequent analysis, the grouping was adjusted according to the interval between the last dose of preoperative bevacizumab and surgery, such as two groups: within 4 weeks, 4 weeks to 6 weeks, or the possibility of other grouping, depending on the actual enrollment. | 30 days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bevacizumab