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Thread: regorafenib Phase III trial Results

  1. #1

    regorafenib Phase III trial Results

    New Drug For Advanced Colorectal Cancer Shows Promise In Trial
    18 Jan 2012

    An experimental drug for advanced colorectal cancer that available approved treatments have failed to halt has shown promise in a clinical trial, says Bayer HealthCare, the company that makes it. The results of the phase III trial show that compared to placebo, regorafenib slowed tumor growth and extended survival.

    In a statement released yesterday, Bayer announced that the Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial "met its primary endpoint, showing statistically significant improvement in overall survival ... in patients with metastatic colorectal cancer (mCRC) whose disease had progressed after approved standard therapies".

    The statement goes on to add that the trial also shows that regorafenib showed statistically significant improvement in progression-free survival and improvement in disease control rate in the patients who received the drug compared to those who received placebo.

    The trial results show that more of the side effects commonly or occasionally seen with chemotherapy occurred with the drug than with placebo, including fatigue, hand-foot skin reaction, diarrhea, anorexia, high blood pressure, oral mucositis (inflammation of the lining of the mouth) and rash/skin peeling.

    The trial was "unblinded" late in 2011 after an independent data monitoring committee said the drug was showing significant improvement in overall survival and patients receiving placebo should be offered the option to take it.

    It was conducted in North America, Europe, China, Japan and Australia and enrolled 760 patients.

    Bayer said they will be seeking Food and Drug Administration (FDA) approval for regorafenib within the next 12 months. If approved, it will be the first new treatment for colorectal cancer in over five years.

    Dr Axel Grothey, MD, Professor of Oncology at the Mayo Clinic is a co-principal investigator on the trial.

    About half of patients diagnosed with the disease have the advanced form (metastases, usually to the liver), either at the time of diagnosis or due to recurrent disease.

    Written by Catharine Paddock PhD

    Article URL: http://www.medicalnewstoday.com/articles/240428.php

  2. #2
    good to know thanks Lance
    MOMS Journey
    April06- Emergencysurgery,exploratory,10units blood,largetumor and 10inches of colon removed,temp.colostomy.diagnosed stage IV colon.
    Oct06-radiation,surgery,several lymphs,cervix,1 ovary,fallopian,40% remaining colon,large tumor to adipose tissue,appendix,gallbladder removed.permant colostomy/iliostomy
    April 07-xeloda-overdose
    surgery-1/3liver,partial diaphra, removed clipped and questionable spots oblated.
    port-port rejection-port removed 1week.
    picc line,5fu,oxyplatin,camptosar.
    Oct-08-surgery-remaining ovary engulfed in tumor,partial bone scrape.
    transfusion central line TPN 1 month.
    oct-09-surgery tumor ,colon and jejuneum removed.
    xeloda reduced. severe dehydration,heart attack.
    mar-11 return to original site-oxyplatin,5fu
    dec-28-blood transfusion
    dec-30-back to chemo erbitux camtosar
    Jan-16 injections neulasta and aranesp
    feb 21-Tumor found stomach,liver, and liver "hot spots" inflamed lymph in rt ureter in kidney causing obstruction-surgery schedualed Mar 16.
    march 16/12-no more kidney obstruction not lymph ...dehydration is causing blockage, two litters blood for anemia, stomach liver tumor small-med,abalation, 1 hidden tumor deep in muscle mass on side flank(hid from scans) -gone!
    june/15/12-blood transfusion
    starting a regimine of celebrex
    aug/16/12-blood transfusion
    aug/30-12 discontinued celebrex -failure one kidney. needed to see urologist
    sept/10-12-good urologist report one kidney functioning well for now.
    oct/23/12-chemo pill Stivarga(regorafenib)
    Nov/22/12-blood transfusion
    dec/18/12-blood transfusion chemo pill dosage cut back to 1 pill.
    Feb/21/13 neulasta injection
    Feb/22/13-blood transfusion. still taking stivarga.
    mar/20/13-arenespt injection rehydration and magnesium IV
    mar/21/13-acute renal failure-kidney infection
    april/1/13.-recovery from 4 day coma infection cleared/4 units blood/ off stivarga/starting rehab therapy,
    swollen hand no apparent reason black spots in vision off and on. both cleared up.
    may/22/13-home oxycodone for pain shoulder neck arm
    june/1/13 pain subsided off oxy onto aleve
    june/09/13-pain back off aleve on vicodin
    june 10/13-cancer in back/neck- starting radiation for arm neck and shoulder pain.
    june24/13-last day of radiation-on steroids
    july1/13-swollen legs and feet-lasix off steroids still on vicodin and xanax
    july 23/13 vicodin cut in half blood transfusion.
    sept/6/13-off all pain meds since late aug
    scan results fracture in spine mid back
    sept/12/13-spine healing on its own,weaning off steroids, no visible tumors.
    nov/7/13-edema both legs and one arm on lasix since oct.
    nov/21/13- leg edema subsiding still alot in one arm- she is talking but keeps her eyes closed. achy but no major pain. nurse and aide to visit once a week schedualed. having trouble standing.
    nov/24/13-sadly but peacefully moms cancer journey is at an end, she will start her new spiritual journey together hand in hand with dad.


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