If chemotherapy was discontinued permanently because of toxicity, the patient was allowed to continue with bevacizumab therapy. The primary population for all efficacy analyses, full analysis set FAS population, was defined as all patients enrolled into the study who received at least one dose of study medication and had at least one tumor assessment after randomization. In , colorectal cancer was the fifth most common cause of tumor death in men and women, accounting for 5.
Bevacizumab, chemotherapy, first-line treatment, Chinese patients, metastatic colorectal cancer In China, colorectal cancer is the fifth most common malignancy in men and the sixth most common malignancy in women . Tumor assessments using abdominal and pelvic spiral computed tomography CT with chest X-rays or CT scans were performed at baseline and every six weeks for the first 24 weeks and then every 12 weeks.
Duration of response was defined as the time from the first documented complete or partial response to disease progression or death due to any cause. Abstract The efficacy and safety of bevacizumab with modified irinotecan, leucovorin bolus, and 5-fluorouracil intravenous infusion mIFL in the first-line treatment of metastatic colorectal cancer mCRC has not been well evaluated in randomized clinical trials in Chinese patients.
This article has been cited by other articles in PMC. However, as with the randomized phase III trials, these observational studies did not include Chinese patients. Patients were excluded if they had previously received adjuvant irinotecan or anti-vascular endothelial growth factor VEGF therapy or if they had any of the following: This phase III trial—avastin and irinotecon in first-line metastatic colorectal cancer China ARTIST — was performed to evaluate whether the benefits observed in Caucasian patients following the addition of bevacizumab to irinotecan-based chemotherapy in a pivotal phase III trial  and a phase IV trial  could be replicated in Chinese patients with mCRC undergoing first-line therapy with bevacizumab in combination with modified irinotecan, leucovorin bolus, and 5-FU intravenous infusion mIFL compared with mIFL alone.
The safety population was defined as all patients enrolled into the study who received at least one dose of study medication. Duration of response was defined as the time from the first documented complete or partial response to disease progression or death due to any cause. Patients without tumor assessment or survival information at week 24 for any reason were not regarded as progression-free survival at six months. Our results suggested that bevacizumab plus mIFL is effective and well tolerated as first-line treatment for Chinese patients with mCRC.
This phase III trial—avastin and irinotecon in first-line metastatic colorectal cancer China ARTIST — was performed to evaluate whether the benefits observed in Caucasian patients following the addition of bevacizumab to irinotecan-based chemotherapy in a pivotal phase III trial  and a phase IV trial  could be replicated in Chinese patients with mCRC undergoing first-line therapy with bevacizumab in combination with modified irinotecan, leucovorin bolus, and 5-FU intravenous infusion mIFL compared with mIFL alone. Furthermore, combination of bevacizumab with 5-FU—based chemotherapy has been shown to improve PFS compared with 5-FU—based chemotherapy alone in the second-line treatment of patients with mCRC .
Posted by: Vudolkis | on October 2, 2012
Statistical analysis The sample size estimation was based on practical considerations; it had adequate power for detecting the difference in PFS based on the available results from the pivotal global study. Randomized clinical trials have shown that in patients with previously untreated mCRC, bevacizumab improves progression-free survival PFS and overall survival OS in combination with irinotecan-based  or 5-fluorouracil 5-FU —based chemotherapy  and improves PFS in combination with oxaliplatin-based chemotherapy .
In total, patients were enrolled. After disease progression or withdrawal, patients were followed up at least every three months until death.
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