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Background: Bevacizumab BV as approved in February 2010 in China ith indication of combined ith 5-FU for metastatic colorectal cancer mCRC . Post-marketing surveillance of patients Pts ho received BV as required because of limited clinical data, especially safety profile in China. In order to understand practical use of BV and guide clinical practice in China, e have studied safety and efficacy of BV combined ith chemotherapy CT in 1st- or 2nd-line treatment for Pts ith mCRC. Methods: The current study is a prospective observational study conducted in 24 Chinese cancer centers. Pts ere treated ith BV plus CT for mCRC as 1st- or 2nd-line therapy. The primary objective as to investigate the safety profile of these treatments. Results: 606 Pts median age 56.6 years 2281 ; ECOG PS 0-1: 76.7 percent ere treated ith BV plus CT as 1st- line n = 453 or 2nd- line n = 153 therapy.The median cycles on BV treatment ere 5 3.0 8.0 cycles. The incidence of any AEs grade 3 as 16.8 percent. In hich grade 3 AEs related to BV ere reported in 10.9 percent of Pts. AE of special interest grade 3 included hypertension 1.8 percent , proteinuria 0.8 percent , GI perforation 0.5 percent , bleeding 3.3 percent , arterial TE 0.3 percent , venous TE 1.0 percent , fistula formation 0.8 percent and ound healing complications 0.2 percent . The safety profile as similar beteen 1st- and 2nd-line therapies. The ORR and median PFS ere 18.3 percent 95 percent CI, 15.3 percent21.6 percent and 9.1 months 95 percent CI, 8.19.8 , respectively. The one-year PFS rate and one-year survival rate ere 33.1 percent and 68.8 percent, respectively. The ORR in KRAS ild-type and mutant Pts ere 15.9 percent 95 percent CI, 9.025.2 and 9.5 percent 95 percent CI, 4.716.8 , respectively. The median PFS as 9.8 months 95 percent CI, 6.712.3 in KRAS ild-type Pts and 8.6 months 95 percent CI, 6.29.9 in KRAS mutant Pts. Conclusions: The safety profile of BV containing regimen in China seemed comparable ith those reported from other pivotal studies or Chinese registration study ARTIST . BV combined ith standard CT is effective as observed in our registry. Hoever, due to the short treatment cycles, the ORR in this observational study is not good as previous studies. Clinical trial information: lta href=http:clinicaltrials.govshoNCT01319877 NCT01319877,J Clin Oncol 34, 2016 suppl; abstr e15012 ,NCT01319877Publication Only Gastrointestinal Colorectal Cancer
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