scholarly journals Efficacy and safety of bevacizumab plus chemotherapy in Chinese patients with metastatic colorectal cancer: a randomized phase III ARTIST trial

2011 ◽  
Vol 30 (10) ◽  
pp. 682-689 ◽  
Author(s):  
Zhong-Zhen Guan ◽  
Jian-Ming Xu ◽  
Rong-Cheng Luo ◽  
Feng-Yi Feng ◽  
Li-Wei Wang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Iii ◽  
Chinese Patients ◽  
Efficacy And Safety

Safety, efficacy, and time to clinical response with bevacizumab plus FOLFIRI regimen in metastatic colorectal cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15138-e15138
Author(s):  
S. Tomao ◽  
G. Spinelli ◽  
L. Rossi ◽  
G. Pasciuti ◽  
G. Arcangeli ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Clinical Response ◽  
Median Time ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Clinical Activity ◽  
Efficacy And Safety ◽  
First Line ◽  
Ecog Ps

e15138 Background: Bevacizumab (BEV) has shown clinical activity in metastatic colorectal cancer patients (mCRC)and randomised phase III trials have demonstrated that this agent significantly improves overall and/or progression-free survival when added to first-line irinotecan based chemotherapy (CT) regimens. We evaluated the efficacy and safety of BEV plus FOLFIRI (irinotecan, 5- fluorouracil, and leucovorin) as first line treatment in 27 consecutive metastatic colorectal cancer cases, with the primary end point to calculate the median time to clinical response with this chemotherapeutic schedule. Methods: Between October 2007 and January 2008 we collected the data on 27 patients with mCRC treated with first line chemotherapy with BEV plus FOLFIRI. Elegibility criteria had to be: mCRC; no prior CT for metastatic disease; ECOG PS 0/1, adequate organ function; no CNS metastases. The treatment consisted of a minimum of six cycles of irinotecan plus infusional 5-FU/LV according to the classical FOLFIRI schedule; BEV (5mg/kg) was given on day 1 with CT and then every 2 weeks until disease progression. Safety and response were assessed at the time of first CT and every 4 weeks thereafter. Results: 27 pts were evaluable (male 18; median age 61 years (range 45–77), ECOG PS 0: 52%, PS 1: 48%. The sites of metastases were: liver (15 pts), lung (5 pts), liver and lung (5 pts), peritoneal wall (2 pts).Median follow-up was 18 weeks. Two patients had complete response(CR) and 13 pts partial response (PR), with an overall response rate of 57.7%. Five patients had stable disease and 6 patients showed progressive disease. A clinical benefit was demonstrated in 77 % of pts. We observed a median time to clinical response of 11 weeks, evaluated with tumor markers and with CT/NMR/US examinations. A grade 3 or 4 neutropenia was detected in 39% of pts and grade 2 or 3 hypertension in 9%. We did’nt observe cases of thrombosis, bleeding and gastrointestinal perforation, sometimes related to the use of BEV. Conclusions: In this little experience the efficacy and safety of BEV associated with FOLFIRI schedule, a first line therapy in mCRC,is consistent with results from other previous studies, showing moreover a short time to clinical response with this association. No significant financial relationships to disclose.

scholarly journals Efficacy and Safety of Bevacizumab in Chinese Patients with Metastatic Colorectal Cancer

2014 ◽  
Vol 15 (16) ◽  
pp. 6559-6564 ◽  
Author(s):  
Li-Ming Zhu ◽  
Ya-Zhen Zhao ◽  
Hai-Xing Ju ◽  
Lu-Ying Liu ◽  
Lei Chen ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Chinese Patients ◽  
Efficacy And Safety

A randomized, double-blind, placebo-controlled, multi-centered phase 3 trial comparing fruquintinib versus placebo plus best supportive care in Chinese patients with metastatic colorectal cancer (FRESCO).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3508-3508 ◽  
Author(s):  
Jin Li ◽  
Shukui Qin ◽  
Yuxian Bai ◽  
Yanhong Deng ◽  
Lei Yang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Kinase Inhibitor ◽  
Objective Response ◽  
Group Versus ◽  
Phase Iii ◽  
Chinese Patients ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Third Line

3508 Background: Treatment options for third-line metastatic colorectal cancer (mCRC) patients remain limited in China. Fruquintinib, an oral kinase inhibitor selectively targeting vascular endothelial growth factor receptors, in a phase II study was found to significantly improve progression free survival (“PFS”) in patients with mCRC as compared to placebo (ESMO abs#2111). Based on these results, a Phase III registration trial, FRESCO, was carried out to confirm fruquintinib’s efficacy and safety in third-line mCRC patients (clinicaltrials.gov # NCT02314819). Methods: This is a randomized, double-blind, placebo-controlled, multi-center phase III trial. Patients with mCRC who have failed at least 2 lines of systemic chemotherapy were enrolled from 28 centers in China. Patients were stratified based on prior anti-VEGF therapy and K-ras status and randomized to a fruquintinib or placebo arm in a 2:1 ratio. The primary endpoint was overall survival (“OS”) which was analyzed in the intent-to-treat population. Results: Between December 12, 2014 and May 13, 2016, 416 patients were randomized. Protocol predefined number of OS events for final analysis was reached on January 17, 2017. Fruquintinib significantly improved OS comparing to placebo with a hazard ratio of 0.65 (95% CI: 0.51-0.83; two sided p<0.001). Median OS was 9.30 months [95% CI 8.18-10.45] in the fruquintinib group versus 6.57 months [95% CI 5.88-8.11] in the placebo group. Statistically significant benefits were also seen with fruquintinib in all secondary endpoints, such as PFS, objective response rate and disease control rate. The most frequent fruquintinib-related ≥ Grade 3 treatment emerged adverse events included hypertension (21.6%), hand-foot skin reaction (10.8%), proteinuria (3.2%) and diarrhea (3.2%). Conclusion: In this phase III confirmatory trial, fruquintinib demonstrated a statistically significant and clinically meaningful OS benefit as compared with placebo in mCRC patients in China. Fruquintinib was well tolerated with a safety profile that is consistent with what was reported previously. Clinical trial information: NCT02314819.

scholarly journals Efficacy and Safety of Proposed Bevacizumab Biosimilar BE1040V in Patients With Metastatic Colorectal Cancer: A Phase III, Randomized, Double-blind, Noninferiority Clinical Trial

2020 ◽  
Vol 42 (5) ◽  
pp. 848-859
Author(s):  
Hamid Rezvani ◽  
Seyed Mohammadreza Mortazavizadeh ◽  
Abolghasem Allahyari ◽  
Amirabbas Nekuee ◽  
Safa Najjar Najafi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Metastatic Colorectal Cancer ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind

The efficacy and safety of apatinib in patients with metastatic colorectal cancer refractory to standard therapies.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15003-e15003 ◽  
Author(s):  
Wangxia Lv ◽  
Meiqin Yuan ◽  
Yunshan Yang ◽  
Zhong Shi ◽  
Haijun Zhong
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Kinase Inhibitor ◽  
Phase Iii ◽  
Tolerability Profile ◽  
Efficacy And Safety ◽  
Once Daily ◽  
Phase Iii Trial ◽  
Hand Foot Syndrome ◽  
Clinically Significant

e15003 Background: Colorectal cancer is the third most frequent cancer and the fourth most frequent cause of cancer-related death worldwide.25% of patients with colorectal cancer have metastatic disease which leads a clinically significant detrimental effect on prognosis. After failure of standard treatments, regorafinib will be recommended to patients, but it has not been approved in China now. Apatinib is a novel, small-molecule tyrosine kinase inhibitor of VEGFR-2 which has shown a survival benefit in gastric cancer in a Phase III trial. This study is an initial clinical experience about the efficacy and safety of apatinib in patients with metastatic colorectal cancer refractory to standard therapies. Methods: Patients with refractory metastatic colorectal cancer received apatinib 500mg once daily. A treatment cycle was defined as 28 days (4 weeks). Response was assessed using RECIST 1.1 criteria. Toxicity was recorded using CTCAE version 4.0. Results: Between August 2015 to October 2016, seventeen patients were enrolled. One patient had PR (5.9%),twelve patients had SD (70.6%), and four had PD (23.6%). The ORR was 5.9% and DCR was 76.5%. The median PFS was 125 days (4.0months, 95%,CI = 1.1-6.9). The grade3/4 adverse events were hypertension (2/17;11.8%), proteinuria (2/17;11.8%), Hand-foot syndrome (2/17;11.8%), leukopenia(1/17;5.9%), neutropenia(1/17;5.9%), hyperbilirubinemia(1/17;5.9%), and diarrhea(1/17;5.9%),respectively.There were no treatment-related deaths. Conclusions:Apatinib is active for the treatment of refractory metastatic colorectal cancer with a manageable tolerability profile. Further investigations of apatinib in mCRC are needed.

Sign in / Sign up

Export Citation Format

Share Document