emcc ecco esmo 2011 gi cancerupdates respect phase iib study
DESCRIPTION
EMCC ECCO ESMO 2011 GI CancerUpdates RESPECT Phase IIb Study. Author: J Tabernero et al Reviewed by: Dr. Scott Berry Date posted: October 20, 2011. - PowerPoint PPT PresentationTRANSCRIPT
www.OncologyEducation.com
EMCC ECCO ESMO 2011 GI CancerUpdates
RESPECT Phase IIb Study
Author: J Tabernero et al
Reviewed by: Dr. Scott Berry
Date posted: October 20, 2011
www.OncologyEducation.com
A Phase 2b, Double-Blind, Randomized Study Evaluating the Efficacy and Safety of Sorafenib (SOR) Compared With Placebo (PBO)
When Administered in Combination With Chemotherapy (Modified FOLFOX6) for First-line Treatment (tx) of Patients (Pts) With Metastatic Colorectal Cancer (mCRC). The RESPECT Trial
Author: J Tabernero et al
www.OncologyEducation.com
R
Sorafenib 400 mg po BID+ mFOLFOX6
Placebo+mFOLFOX6
N=200
Primary Outcome:PFS
Study Design
www.OncologyEducation.com
RESULTS
Sorafenib Placebo p-value
Response Rate (%) 46.4 60.4
PFS/TTP (median,
mos) 9.1 8.7 P=0.23
www.OncologyEducation.com
GR 3/4 TOXICITY Sorafenib (%) Placebo (%)
All Systems 82 63
Nervous system
Peripheral Neuropathy
21
16
24
21
GI Disorders
DiarrhoeaNausea
VomitingStomatitis
19
9115
12
5001
Blood and Lymphatic System disorders
Neutropenia Thrombocytopenia
Anaemia
49
4843
24
2242
www.OncologyEducation.com
GR 3/4 TOXICITY
Sorafenib (%) Placebo (%)
Skin Disorders
Hand Foot SyndromeRash
Erythema
25
2032
1
010
Hypertension 4 1
www.OncologyEducation.com
STUDY COMMENTARY
• The excess toxicity seen in the sorafenib arm had a major impact on the delivery of chemo in that arm
• Sorafenib arm – no improvement in PFS, reduced RR and more toxic
www.OncologyEducation.com
BOTTOM LINE FOR
MEDICAL ONCOLOGISTS
• Another VEGF TKI (along with PTK787, sunitininb and cediranib) that has failed to make an impact in the treatment of mCRC