A SUSTAINED SURVIVAL BENEFIT SHOWN WITH ZALTRAP® PLUS FOLFIRI CHEMOTHERAPY IN THE VELOUR STUDY

A SUSTAINED SURVIVAL BENEFIT SHOWN WITH ZALTRAP® PLUS FOLFIRI CHEMOTHERAPY IN THE VELOUR STUDY

A SUSTAINED SURVIVAL BENEFIT SHOWN WITH ZALTRAP® PLUS FOLFIRI CHEMOTHERAPY IN THE VELOUR STUDY

This past January Michael Sapienza, our Founder spent a few days in San Francisco for the GI ASCO conference. He met up with Dr. Paul Ruff who has written a follow up for patients about the new CRC drug Zaltrap. 


ZALTRAP® (ziv-aflibercept, also known as aflibercept outside of the United States) is a  protein consisting of parts of the human vascular endothelial growth factor receptor joined to a portion of human immunoglobulin G. ZALTRAP® is designed to effectively block human vascular endothelial growth factor making it an extremely potent inhibitor of angiogenesis (blood vessel growth) in tumors.

The VELOUR Study was a large international study that compared the safety and efficacy of standard FOLFIRI chemotherapy together with either ZALTRAP® or placebo in 1226 patients with advanced colorectal cancer who had previously received one chemotherapy treatment containing the drug oxaliplatin ie. FOLFOX.

 

04/19/2013

The addition of ZALTRAP® to FOLFIRI showed both a statistically and clinically meaningful improvement in overall survival (median of 13.5 months versus 12.06 months, with an 18.3% reduction in risk of dying of cancer), as well as statistically and clinically meaningful improvements in time to progression of the cancer and overall tumor response rate.

The ZALTRAP® treatment effect also continued to improve as time went on in the study. At 18 months, the probability of being alive was 30.9% on the ZALTRAP® arm, a difference of 2.6 months compared to the placebo arm. A probability of being alive of 28.0% was seen with ZALTRAP® at 24 months, versus 19.6 months with placebo.

The improvement in percentage of patients being alive at 24 months was 50% (28.0% for ZALTRAP® versus 18.7% for placebo) and almost double at 30 months (22.3% versus 12.0%).

More common side effects occurred in only a small number of ZALTRAP® containing cycles including severe hypertension (3.6%) and diarrhea (2.8%). The majority of severe side effects occurred in the early treatment cycles (first 3-4 cycles). Most patients also experienced only one episode of a severe side effect with ZALTRAP®. Importantly, none of the side effects in the VELOUR Study impacted on patients’ ability to receive further treatment cycles.

                

Dr. Ruff and Michael Sapienza                                                             Dr. Ruff, Michael Sapienza, and Erika Brown

In conclusion, treatment with ZALTRAP® + FOLFIRI chemotherapy showed an ongoing and consistent improvement in overall survival throughout the study. Although the combined side effects were higher with ZALTRAP® than placebo, these were manageable and occurred early in treatment and in only a small proportion of total cycles administered, with the majority being a single episode in nature.

ZALTRAP® is another important advance in our ongoing fight against advanced colorectal cancer which has seen median overall survivals increase from about 1 year in mid-1990s to nearly 3 years today!

Paul Ruff, MD, director of Medical Oncology at the University of WitwatersrandJohannesburgSouth Africa

Are you at Risk For Colorectal Cancer?

  • 2nd leading cause of cancer deaths for men and women combined
  • Colonoscopies not only discover cancer, but can also stop cancer
  • 50% of Americans still do not get colonoscopy reimbursement
  • Colon cancer research is still vastly under-funded

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