Previous studies have shown that the addition of bevacizumab to the standard first-line platinum-based combination therapy can improve the objective response rate of patients with advanced non-squamous non-small cell lung cancer by 20% to 28% and improve survival. Data from these published literatures suggest that the improvement in objective response rates is due mainly to patients with stable disease of chemotherapy. It has been reported that 15% of patients achieved objective remission after continuing treatment with the regimen after receiving 2 cycles of platinum-based combination chemotherapy. Therefore, the use of 2 cycles of chemotherapy after stabilization of patients with bevacizumab, hoping to improve the objective response rate of such patients 20%, and may improve survival. For the above reasons, design this study to validate our hypothesis.
Previous studies have shown that the addition of bevacizumab to the standard first-line platinum-based combination therapy can improve the objective response rate of patients with advanced non-squamous non-small cell lung cancer by 20% to 28% and improve survival. Data from these published literatures suggest that the improvement in objective response rates is due mainly to patients with stable disease of chemotherapy. It has been reported that 15% of patients achieved objective remission after continuing treatment with the regimen after receiving 2 cycles of platinum-based combination chemotherapy. Therefore, the use of 2 cycles of chemotherapy after stabilization of patients with bevacizumab, hoping to improve the objective response rate of such patients 20%, and may improve survival. For the above reasons, design this study to validate our hypothesis. So a prospective cohort study has been designed to confirm this hypothesis, patients with advanced pulmonary adenocarcinoma who are stable after two cycles of platinum-based combination chemotherapy are objects of this study, and they can choose to continue the previous treatment regimen according to the guideline or adding bevacizumab to the regimen independently until the progression or intolerance of toxicity, or 4 to 6 cycles of chemotherapy in stable disease. The objective response rate in these two groups who received different treatment is the primary endpoint and the toxicity, quality of life, the progression free survival are the second endpoints.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
159
The patients in conventional group continued the previous chemotherapy,and the patients in experimental group received adding bevacizumab to previous chemotherapy regimen.
Objective Response Rate
The percentage of patients who was assessed as complete response and partial response according RECIST (Response Evaluation In Solid Tumors).
Time frame: Assessment of the response should be done from the written consent to the 3 month after the last patient inrolled in the study, assessed up to 24 months.
Duration of Response Duration of Response
The duration in responsive patients from the first remission to the progression.
Time frame: The start point was the first remission until the date of first documented progression or date of death from any cause, which came first, assessed up to 30 months.
Progression Free Survival.
The time from the day written consent to the first date of objective progression or death from any cause.
Time frame: The progression free survival was start from the written consent to the date of first documented progression or date of death from any cause, which came first,assessed up to 30 months.
Adverse Effects.
The adverse effects of the treatment especially in hematology,cardiovascular system and renal system according the CTCAE 4.0, and the SAE(serious adverse events) in the treatment and follow up.
Time frame: Assessment should be done from the written consent to the date 28 days after the last chemotherapy, assessed up to 24 months.
Quality of Life.
The quality of life should be assessed in the study using FACT-L(Functional Assessment of Cancer Therapy - Lung).
Time frame: Assessment should be done from the written consent to the finish of this study, assessed up to 36 months.
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