Genentech warns of serious new side effect for Avastin reported in New England Journal of Medicine

Two letters in the March 1, 2005 issue of the New England Journal of Medicine describe a rare neurological syndrome in patients being treated with Avastin ™ (bevacizumab) which the writers believe is due to hypertension and other effects of the drug.

Called reversible posterior leukoencephalopathy syndrome (RPLS), the side effect has been seen with other chemotherapy regimens and treatment for immune system disorders, but has it has not been described before in relation to bevacizumab.

Symptoms include high blood pressure, vision problems, confusion, lethargy, and seizures. Neurological examinations are abnormal, and MRI’s show changes in the brain.

In one patient with kidney cancer, symptoms began about a week after her last treatment with Avastin™.  She went to the emergency room feeling lethargic and had a seizure there. Her blood pressure was high and an MRI showed the RPLS changes.

Another rectal cancer patient began to have difficulty with vision in both eyes, headache, and confusion about 8 hours after her first bevacizumab infusion. She, too, had high blood pressure and changes in her MRI.

Both women recovered when high blood pressure was treated and Avastin™ was discontinued. 

Doctors at the Medical College of Wisconsin, who treated the rectal cancer patient, write to NEJM,

We suggest that RPLES is an important consideration in patients with poorly controlled hypertension who are treated with VEGF inhibitors. Clinicians should be aware of this potential complication and control blood pressure strictly during and after the bevacizumab infusion. Controlling hypertension and discontinuing the offending agent appears to help reverse this complication.

They also warn that a diagnosis of RPLS should be carefully weighed against signs of lack of blood flow to the brain or blood clots in the brain which are also complications of Avastin™ treatment and can lead to permanent vision loss.

In a reply to the physician letters, also published in the New England Journal of Medicine, Genentech agrees that the women’s condition appears to be consistent with RPLS.  They say that they are now reviewing their clinical database for other possible instances of what they call a “rare side effect.”

Writing for Genentech, Hal Barron M.D. says,

We believe it is important for physicians to be cognizant of the signs and symptoms of this rare but reversible syndrome and its association with even moderate hypertension. Hypertension, a known adverse reaction associated with Avastin treatment, has been included in the Avastin package insert since the drug’s approval in 2004. We plan to update the Avastin package insert in the United States to include a description of the syndrome and to recommend discontinuation of Avastin if RPLS is diagnosed.

Posted by Kate Murphy on March 2nd, 2006
Posted in: Research & Treatment News | 2 Comments »

March Message: Colorectal cancer is preventable, treatable, and beatable

Welcome to March — National Colorectal Cancer Awareness Month.

Today we begin spreading the word that colorectal cancer is Preventable, Treatable, and Beatable.

Preventable

• Screening does more than find colon cancer at an early stage when it is most curable — it actually can prevent it from ever occurring by finding and removing the polyps that, left alone, can develop into cancer.  People without special risks should begin screening at age 50. African-Americans should begin screening at age 45.
• People with higher than average risk should be tested with colonoscopies earlier in life and more often.  Higher risk includes a personal or family history of colorectal cancer or polyps, a history of ulcerative colitis or Crohn’s disease, or a family history of inherited colorectal cancer syndrome such as hereditary non-polyposis colon cancer or familial adenomatous polyposis.
• Some lifestyle changes can reduce the risk of colorectal cancer.  Maintaining normal weight, not smoking, exercising, and eating less red meat make colorectal cancer less likely but don’t replace screening. 

Treatable

• Found at an early stage, colorectal cancer is 90% curable with surgery alone. 
• New chemotherapy treatments given after surgery for larger cancers and cancer that has spread to nearby lymph nodes have increased the percentage of patients whose cancer will not return.
• In even the most difficult stage, when cancer has spread far beyond the colon, newly discovered chemotherapy drugs and targeted biologic agents have doubled the time patients can expect to live.  More than half of advanced colorectal cancer patients can now survive more than 2 years. 

Beatable

• A few years ago, there was basically one drug  used to treat colorectal cancer, and it had been in use for more than 50 years.  Today there are four drugs and two targeted biologic agents that can be combined in a variety of standard treatments.  More drugs and more targeted therapies are part of an active and promising research program.
• We are learning volumes about what cancer and pre-cancer looks like deep within cells.  Information about genes and proteins is helping to pinpoint who is a greatest risk for the disease, who will benefit from what treatment, and how treatment can be targeted to help destroy cancer without hurting healthy tissue.
• Although the percentage of people who have had a colorectal cancer screening test is still abysmally low, it is slowly increasing.  Awareness is growing.  Colon cancer, once a unspeakable secret, gets talked about.

We are making progress, but there is a long, long way to go.  The mission of C3 – Colorectal Cancer Coalition is to end suffering and death from colorectal cancer. We do this by speaking up as advocates in the research community, in federal and state agencies, to Congress and the President, and in our own communities.

During National Colorectal Cancer Awareness Month we are joined by 58 NCRCAM partner organizations; thousands of volunteers speaking out in their communities by swinging hockey sticks, rollerskating, walking, running, and raising funds for awareness and research; and over one million survivors of colorectal cancer who are determined that no one should have to suffer or die from this disease.

Join with us and help make a difference this March . . . and throughout the rest of the year.

Posted by Kate Murphy on March 1st, 2006
Posted in: Research & Treatment News | No Comments »