Efficacy and safety of bevacizumab combined with fluoropyrimidine monotherapy in unfit or older metastatic colorectal cancer patients: A systematic review and pooled-analysis.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 705-705
Author(s):  
Lorenzo Antonuzzo ◽  
Giuseppe Aprile ◽  
Sandro Barni ◽  
Evaristo Maiello ◽  
Gianluca Masi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Systematic Review ◽  
Metastatic Colorectal Cancer ◽  
Sampling Error ◽  
Therapeutic Option ◽  
Safety Data ◽  
Pooled Analysis ◽  
Efficacy And Safety ◽  
Phase Ii Trials ◽  
First Line

705 Background: Bevacizumab (BEV) improves progression-free survival (PFS) and overall survival (OS) of metastatic colorectal cancer (mCRC) patients (pts) when added to doublets in first-line setting. Yet, its use in unfit and older mCRC pts remains controversial. This systematic review and pooled-analysis evaluated the efficacy and safety data of BEV combined with first-line fluoropyrimidine monochemotherapy in unfit or elderly mCRC pts. Methods: A literature search to identify studies using first-line fluoropyrimidine monochemotherapy plus BEV in unfit pts was performed in PubMed and EMBASE databases up to May 2015. Unfit pts were selected based on age, comorbities and health status, along with monochemotherapy as the only therapeutic option. The random-effects model was used to combine the effect estimates and the I2 index to quantify the between-study heterogeneity unexplained by sampling error. Results: We screened 1,304 papers and, after a double check, 56 were considered for full text evaluation: 38 were excluded and 10 were deemed not evaluable for lack of data on unfit pts, whereas 8 (3 RCTs, 4 single arm phase II trials and 1 prospective cohort study), including 782 pts, were considered eligible for the meta-analysis. Administered monochemotherapy was capecitabine in 531 (67.9%) pts and 5-fluorouracil (5-FU) in 251 (32.1%); 500 (63.9%) pts also received BEV. Median age was 75 years, 441 (56.4%) pts were male, ECOG performance status was 0-1 in 684 (87.7%) pts. The combination with BEV produced advantages in terms of both OS (HR 0.79; 95% CI: 0.64-0.98, P = 0.03; I2= 0%) and PFS (HR 0.52; 95% CI: 0.43-0.64, P < 0.00001; I2= 0%; pooled effect estimates of RCTs have been previously reported). As expected, higher rates of all grade hypertension (27% vs 4.9%), bleeding (24% vs 6.4%), thromboembolic events (10% vs 5%) and proteinuria (25.6% vs 8.2%) were observed in the BEV combination. Conclusions: Adding BEV to first-line fluoropyrimidine monochemotherapy, either capecitabine or 5-FU, significantly improved PFS and OS in unfit and elderly pts with mCRC, with a manageable safety profile and no unexpected side effects.

Analysis of oxaliplatin-induced sensory neurotoxicity (sNT) in patients receiving FIREFOX, alternating regimen of mFOLFOX-6 and FOLFIRI, with metastatic colorectal cancer (MCRC): Results from combined analysis of KSCC0501 and KSCC0701.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 492-492 ◽  
Author(s):  
T. Kusumoto ◽  
Y. Emi ◽  
Y. Kakeji ◽  
Y. Akagi ◽  
H. Samura ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Study Group ◽  
Efficacy And Safety ◽  
Phase Ii Trials ◽  
First Line ◽  
Duration Of Treatment ◽  
Two Phase ◽  
Combined Analysis ◽  
Kaplan Meier

492 Background: The Kyushu Study Group of Clinical Cancer (KSCC) conducted two phase II trials (KSCC0501 and KSCC0701, Akagi et al. J Clin Oncol. 28:15s, 2010, UMIN ID: 000001342) to evaluate the efficacy and safety of first-line oxaliplatin-based chemotherapy for MCRC. This combined analysis was performed to compare the incidence of oxaliplatin-induced sNT between the two trials. Methods: Patients (pts) were accrued from 2005 to 2007 in KSCC0501 and from 2007 to 2008 in KSCC0701. Sixty pts received FOLFOX-4 in KSCC0501 and 47 pts received FIREFOX(4 cycles of mFOLFOX-6 alternating with 4 cycles of FOLFIRI) in KSCC0701. All pts were reviewed for efficacy and toxicity (NCI-CTCAEv3.0). Kaplan-Meier analysis was performed to assess the incidence of sNT. Results: The incidence of sNT was 71.4% with FOLFOX-4 and 36.2% with FIREFOX (Table). The ORR was 34.5% (95% CI F22.5-48.1%) for FOLFOX4 and 58.7% (43.9-73.5%) for FIREFOX. Median PFS was 7.0 M (5.1-9.8 M) with FOLFOX-4 and 10.3 M (7.5-11.9 M) with FIREFOX. MST and 2-year survival were respectively 31.5 M (18.1-40.1 M) and 58.0% for FOLFOX4, versus not determined and 57.1% for FIREFOX. The median no. of treatment cycles was 9 for FOLFOX-4 and 12 for FIREFOX. After 4, 8, and 12 cumulative treatment cycles, the incidence of grade 2+sNT was respectively 24.0%, 30.7%, and 60.5% with FOLFOX-4 versus 6.5%, 6.5%, and 16.0% with FIREFOX. Conclusions: As first-line oxaliplatin-based chemotherapy for MCRC, FIREFOX caused less oxaliplatin-induced sNT and prolonged the duration of treatment. We have now finished enrollment for study KSCC 0801 (KSCC 0701+bevacizumab) and are following the pts. [Table: see text] [Table: see text]

Bevacizumab in Combination with Capecitabine plus Irinotecan as First-Line Therapy in Metastatic Colorectal Cancer: A Pooled Analysis of 2 Phase II Trials

Onkologie ◽  
2013 ◽  
Vol 36 (6) ◽  
pp. 363-367
Author(s):  
Pilar García Alfonso ◽  
Andrés Muñoz Martin ◽  
Sonsoles Alvarez Suarez ◽  
Monserrat Blanco Codeidido ◽  
Rebeca Mondejar Solis ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Pooled Analysis ◽  
Phase Ii Trials ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

Efficacy and safety of bevacizumab in combination with irinotecan and infusional 5-FU as first-line treatment for patients with metastatic colorectal cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3544-3544 ◽  
Author(s):  
A. Sobrero ◽  
S. Ackland ◽  
R. P. Carrion ◽  
S. Chiara ◽  
S. Clarke ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Safety Data ◽  
Progression Free Survival ◽  
Response Duration ◽  
Primary Objective ◽  
Efficacy And Safety ◽  
First Line ◽  
Open Label ◽  
Chemotherapy Administration

3544 Background: Bevacizumab is a monoclonal antibody that, by inhibiting VEGF, inhibits tumour angiogenesis. It has been proven to improve overall (OS) and progression-free survival (PFS) when administered first-line in combination with the bolus 5-FU-based IFL regimen to patients with metastatic colorectal cancer [Hurwitz et al. NEJM 2004;350:2335–42]. We have conducted a multicentre, open-label trial to further evaluate the efficacy and safety of first-line bevacizumab in combination with regimens combining irinotecan with infusional 5-FU (FOLFIRI). Methods: Eligible patients had: metastatic colorectal cancer; no surgery within 28 days; no prior chemotherapy for metastatic disease; ECOG PS 0/1; adequate organ function; no CNS metastases. Chemotherapy consisted of 6 cycles of irinotecan plus infusional 5-FU and leucovorin, according to the classical FOLFIRI regimen; however, such variations as the simplified FOLFIRI or the weekly regimen were allowed. Bevacizumab 5mg/kg was given on day 1 of chemotherapy, every 2 weeks until disease progression. Safety assessments were made at the time of chemotherapy administration during the first 12 weeks and every 4 weeks thereafter. Tumour assessments were performed every 3 months for the first year and 4-monthly thereafter. The primary objective was PFS; secondary objectives were to evaluate the safety profile of this combination as well as to determine the overall response rate, time to response, duration of response and OS. Results: A total of 209 patients were enrolled at 31 centres in Australia, Canada, Italy, Spain and China between April 2005 and November 2005. 60% of patients were male and median age was 61.9 (range 31–82) years. All patients will be eligible for interim analysis, that will be performed after the last patient enrolled has been followed for a minimum of 12 weeks (6 cycles of chemotherapy), in February 2006. Data on safety and efficacy from this analysis will be presented. Conclusions: This is the largest clinical trial that will report efficacy and safety data for bevacizumab in combination with an irinotecan and infusional 5-FU regimen. [Table: see text]

scholarly journals Treatments after progression to first-line FOLFOXIRI and bevacizumab in metastatic colorectal cancer: a pooled analysis of TRIBE and TRIBE2 studies by GONO

2020 ◽  
Vol 124 (1) ◽  
pp. 183-190
Author(s):  
Daniele Rossini ◽  
Sara Lonardi ◽  
Carlotta Antoniotti ◽  
Daniele Santini ◽  
Gianluca Tomasello ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Pooled Analysis ◽  
First Line
Sign in / Sign up

Export Citation Format

Share Document