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"Enrollment in Avastin breast cancer study halted"

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Has anyone heard of this? The article further states, "Swiss drug developer Roche said Friday six cases of patients with heart failure symptoms prompted a halt to enrollment in a National Cancer Institute sponsored study of its blockbuster drug Avastin."

Full article: http://seattletimes.nwsource.com/html/businesstechnology/2009944446_apusroc heavastinstudy.html

I just had my first Avastin treatment last week -- not as part of a study. I'm triple-negative with 1 met to the right 8th rib, one met to the upper lobe of the left lung, and 2 small brain mets. I'm an oddball case, so many doctors in the area coferred about my treatment and came up with Abraxane/Avastin/Zometa.

I don't see my doctor until next week, but I'll ask him about this at that time. Meanwhile, any opinions or thoughts?

6 replies

There was a similer caveat about Sutent a couple of years ago. According to a study by MD Anderson cardiologists, any cancer drug can cause potential heart damage, even death, and many doctors do not adequately monitor their patients or manage their care to minimize the health risk.

The study, published in an issue of the journal Circulation, was the first large-scale review that details. Conducted with nine other MD Anderson cardiologists, the study reviewed research on the cardiotoxicity of 29 anti-cancer drugs as well as 30 years of experience at MD Anderson.

Cardiotoxicity can occur in any patient. Generally speaking, patients most at risk are elderly and have other illnesses, such as diabetes and heart disease. Heart problems can occur during treatment or months and even years after treatment.

Toxic effects of these drugs like Avastin, Erbitux, and Rituxin include: hypertension (high blood pressure) or hypotension (low blood pressure). The problems they produce usually involve changes in blood pressure, which can be easily treated if recognized.

The monoclonal antibody Herceptin is less toxic than generally believed, although it can cause chronic heart failure or dysfunction of the left ventricular, the main chamber of the heart that pumps blood to the body.

And the list goes on. Possible solutions include, avoiding certain drugs, lowering drug dosages, administering drugs slower and over a longer period of time, monitoring cardiac health more stringently, avoiding giving some drugs simultaneously, treating cardiac risk factors, use of an echocardiogram during and after cancer treatment, and treating patients with heart failure drugs.

The Anderson researchers found a profile of cardiotoxicity for the most often used anticancer drugs, but it is important to know that every patient has different risk factors that will determine how their hearts handle the treatment. Monitoring and management is key to surviving cancer with a good and lasting heart.

Have they done any sort of base-line screening of you heart so they have something to compare later results to? How much screening of the candidates was done beforehand, especially as this seems to be a known side effect?

I guess this is one of those occasions where the doctors have to weigh up the risks and benefits.

Do you have any history of heart problems and was your heart checked before you started the treatment? It might be worth discussing this with your doctor next week and see if he thinks it is worth doing some sort of heart monitoring. It is a tough one but if the drug is doing you good why stop? The article doesn't indicate when the candidates developed the problem, was it at the beginning, after x number of treatments? I think you need more information about this, does the National Cancer Institute website give any information or have a point of contact? They may be able to give you advice.

Hope you can find more information and feel happy about continuing your treatment (((JillAline))) Vicki xx

JillAline,
Before I started my treatment of Taxol & Avastin in late March 2009, I did some online research of my own and was concerned when it was clearly stated that there is a risk of heart problems when taking Avastin. I had a heart attack in 8/2004 caused by a blocked coronary artery, but had a successful stent placement done there that very night. I have been carefully monitored by my cardioogist these past years and am on nadalol aspirin, and lipitor for high colesterol, which was the culprit. I have good blood pressure and did not suffer heart damage and my cardioogist said it was more important to keep the cancer from spreading and was not overly concerned, since my oncologist would be monitoring me closely and would keep him informed as well. I had to come off of the aspirin therapy during the avastin treatment. I still see the cardiologist every 6 months and just saw him in August, where he gave me a thumbs up on my cardiac health.

I have just finished my 6th round of the taxol & avastin and I have not had any heart or blood pressure effects from this treatment. I even asked both of my doctors if it would be neccessary to monitor my blood pressure at home, and they said it was not. I do get routine blood pressure when I get my bloodwork done the morning of chemo which is 3 weeks on one week off, one day per week. I am getting evaluated after my scans on October 12 to see how long of a break I can have.
Since my 2 previous scans have shown shrinkage in the liver tumors, I have to say I am very happy that the taxol & avastin seems to be working in my case, albeit very slowly. My oncologist explained to me that because my cancer has appreard to be "less agressive" it also takes longer for the chemo to have a greater impact on the tumors. Overall, my side effects have been tolerable, (fatigue, hair loss, some nasal and rectal bleeding and occasional heartburn) so I continue to be patient.

My advice to you would be to make sure to keep track of your blood pressure when they take it. If they dont routinely take it, request it. Read up on warning signs for cardiac distress, angina, etc. so that if you feel any of those sensations, you can notify your Doctor immediately. I think the way avastin works within the blood cells can really help the delay of cancer spreading and is worth a try. Good Luck and keep us informed on how you are doing.

JillAline,
One more thing. The current study you mentioned, is only for early stage breast cancer, where patients are still considered "cureable", so there are different parameters. (could cause permanent heart problems for these people in the long run) Since we are all already stage IV with metastisis, anything to prolong our lives is considered a success. Currently, Avastin is only approved for stage IV breast cancer and usually insurance only approves it in patients receiving chemo for the first time. It is also approved for other cancers, but I can't recall what they are.

Thanks. This is all very helpful. I will run all of it by my onco on Monday, especially the heart monitoring. I was monitoried closely 5 years ago because I was on adriamycin (sp?). My heart held up fine through that. Currently they're monitoring my blood pressure, which is fine, but no mention of a baseline heart evaluation has been mentioned. I will request that! I will also continue to do more research into what's behind this study. Maybe the doctor can print something out for me from one of the medical journals he has paid for. Journalists often summarize to the point that good information is lost.

JillAline,
You also mentioned you will be on zometa. It is a very effective drug for bone mets, but there are serious risks involved, if you dont take proper precautions. It is important that you get a dental checkup. xrays and cleanings before starting zometa. Discuss with your Dentist that you will be on zometa and have him check your teeth thoroughly. If there is a possibility you might need teeth pulled, have them pulled and healed before starting the zometa. I was on zometa monthly infusions for 2yrs 8 months when I had to have two infected teeth pulled. Soon after I developed ONJ (osteonecrosis of the jaw) Not everyone gets it and some get it without getting trauma to the jaw. I dont mean to scare you, but oncologists don't always explain the risks involved with zometa because the rewards outweigh the risks. However, had I been told to get a dental check-up, I could have done so and possibly avoided getting ONJ. Zometa is a bisphosphonate and it stays in your bones for a very long time. Monthly infusions over a long period of time are no longer necessary.
Good luck with everything.

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