Avastin Doesn't Improve Disease-Free Survival in Stage II/III Colon Cancer

Although adding Avastin® (bevacizumab) to FOLFOX chemotherapy showed an effect on reducing recurrences in people with stage II and III colon cancer one year after treatment began, the impact began to fade in the second year, and was completely gone at three years.

There was a transient benefit in the year during which Avastin was given every two weeks, with a 40 percent reduction in the risk of recurrence.  At the end of the first year patients who had been given Avastin had a 94.2 percent chance of being alive and cancer-free compared to 90.7 percent of patients who did get it.

However, at three years disease-free survival was 77.4 percent in the Avastin patients compared to 75.5 percent for those without it, a non-significant difference.

The C-08 clinical trial randomly assigned 2,710 patients with stage II or stage III to either FOLFOX or FOLFOX plus Avastin for six months.  In addition, patients in the Avastin arm received an additional six months of Avastin.

The study found no differences between stage II or stage III disease in the effect that adding Avastin had.  About 25 percent of patients had stage II disease.

Speaking for the National Surgical Adjuvant Breast and Bowel Project (NSABP), Dr. Norman Wolmark concluded,

The addition of bevacizumab to modified FOLFOX did not result in an overall statistically significant prolongation in disease-free survival. There was a transient benefit in DFS during the one-year interval that bevacizumab was utilized. Consideration may be given to clinical trials assessing longer duration of bevacizumab administration.

Dr. Lee Ellis of M.D. Anderson Cancer Center, in discussing the results of the C-08 trial during the ASCO Plenary Session, raised concerns about future clinical trials of Avastin for stage II and III colon cancer.

  • How long does Avastin need to be given to maintain its benefit?
  • Is the real improvement in disease-free survival about 3 to 5 percent?
  • Does this benefit justify the inconvenience to patients of regular IV infusions, cost, and potential side effects?
  • Could long-term anti-VEGF therapy have an adverse effect on the central nervous system?

He pointed out that for some patients receiving Avastin in the C-08 trial there was pain, depression, and dizziness serious enough to interfere with activities of daily living, as well as increased high blood pressure. He urged long-term followup of patients who receive long-term adjuvant treatment with anti-VEGF agents like Avastin including cognitive testing, and tests of both the central nervous  and cardiovascular systems.

Disclosure: C3 has accepted funding for projects and educational programs from Genentech in the form of unrestricted educational grants. C3 has ultimate authority over website content.
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Comments

  1. Sheila Harris says

    If this is true re: avastin what about it’s use in stage 4 Colon Cancer Patients-my daughter is receiving it in conjunction w/ other chemo druugs & is staying stable-should she be looking in to other drugs & discontinue the Avastin?
    Your opinion is appreciated.

  2. Kate Murphy says

    The C-08 trial was done in patients who had either stage II or III colon cancer.

    Other trials in stage IV colorectal cancer have found that adding Avastin to chemotherapy does help increase response to chemo and survival time.

    If your daughter’s cancer is staying stable on her current chemotherapy with Avastin, most doctors would recommend staying on the program she is currently on until there were signs that cancer was progressing (tumors getting larger or tumors in new places)or side effects became too difficult for her.

    We at C3 are not health professionals, so please talk this over with your daughter’s doctor. However, C-08 results do not apply to stage IV colorectal cancer.

  3. Carol Pack Urban says

    I was diagnosed with Stage 3 Colon Cancer in September 2007 at the age of 45. I had a colon resection followed by endoscopic biopsy to diagnose a mass on the head of my pancreas. The biopsy result showed colon cancer in a lymph node which attached to the pancreas. I started on a clinical trial of Xeloda of three pills twice a day (3000mg) for 12 days which landed me in the hospital on the verge of death. After recovering, I started on Folfox with Avastin and was on this treatment for six months. Follow up by PET scan showed this lymph node had shrunk to the point where my surgeon could remove it. Exploratory surgery, possibly doing the Whipple Procedure, was performed where all were surprised that there was no cancer left. Pathology was done on the area of the cancerous lymph node and surrounding area and came back with no evidence of cancer. It was determined to be a pathiological remission. This was July 2008. Followed up with PET scan in January 2009 with no evidence of cancer. PET scan done in July 2009 showed lymph node activity in the chest area down to the vena clava. My CEA level is 0.7 which is well below normal. Both my surgical oncologist and medical oncologist believe my cancer has returned and have scheduled me to return to chemo treatment. At yesterday’s visit with my medical oncologist he stated that all of the colon cancer patients he treated with Folfox and Avastin had their cancers return. If this is the case, and I am very thankful for an extra year of life, is this the best line of defense for me? Is there another treatment option which would work thereby curing the cancer or must I continue to do chemo to prolong my life for the remainder of my life?

  4. Kate Murphy says

    Carol,

    We at C3 are not health professionals, so we can’t give you medical advice.

    However, working with your surgical oncologist and medical oncologist as a team is a good way to go. Keep both involved!

    You might also want to talk about having an interventional radiologist look at the new lymph node to see if radiation might help.

    Chemotherapy usually can’t completely destroy cancer that has spread outside of the colon to other organs or distant lymph nodes. It can prolong life, reduce the size of mets, and — as it did in your case — make curative surgery possible.

    So, keep the whole team involved.

    If the cancer gets worse on FOLFOX and Avastin, there are other chemotherapies that can keep it stable for more time.

    Treatment of advanced colorectal cancer is complex and needs the input of several specialists — medical, surgical, and radiological.

    Good luck with a tough balancing act.

  5. Carol Pack Urban says

    Update to my comment left on July 29, 2009. My chemo regimen was changed from Folfox with Avastin to Folfiri with Avastin due to too many reactions to the Oxaliplatin. I only had one reaction to the Camptosar and that was the first treatment; after that things went smoothly. I had very little diarrhea with the Camptosar which surprised me quite a bit. Follow up PET scan was done on October 23, 2009 which showed no cancer. So, either there was a mistake with the PET scan in July or I keep experiencing miraculous healings. :) Oncologist wanted me to do 8 chemo treatments which I completed on November 30. Next PET scan is sometime in late March or early April 2010. Thanking God for his healing mercies to me.

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