It gives me great pride to share a few items which are more personal in nature but very pertinent and of importance to me. I continue my battle against Stage 4 metastatic breast cancer. This is a fight that will not go away but at least it is a fight that can be maintained and treated. My disease is treated with bi-weekly infusions of the drug, Avastin. Yeah…Avastin is that same drug the FDA would like to disprove even though it is one of the few drugs for women with Stage 4 metastatic breast cancer and for individuals like me, literally a lifelong for prolonged life.
The FDA wants to disprove Avastin because it does not prolong life long enough and, to get to the real crunch, because it is not cheap. The annual cost for one woman to receive Avastin is about US$100,000. If Avastin is disproved by the FDA, then insurance companies, Medicare and Medicaid will no longer provide coverage.
I’m not exactly sure from where or how the FDA comes up with its statistics in regards to Avastin not prolonging life long enough. After all, Avastin was only approved by the FDA in 2008 and it is now only 2010. That’s not a long time when it comes to researching and collecting data for medical purposes.
What I do know is that my own oncologist routinely administers a circulating tumor cell (CTC) test which indicates the number of floating cancer cells in the blood. My last CTC test before starting Avastin was five which is a bad result to have. However my last test results after having had several infusions of Avastin are now zero – which is the absolute best result! I now have validation that Avastin is slowing down the growth and spread of my cancer.
Breast Cancer Awareness month begins in October although for me, every day is a cancer awareness month. I have become an outspoken advocate on the importance for awareness and action. I’m not alone. There are many many cancer warriors around the world who feel the same way. I’m a cancer warrior as an active cancer patient. I’m a cancer widow too as my late husband succumbed to a rare and aggressive leukemia. I know first hand what it means to be a care taker and care giver to a loved one with cancer and what it means to face your own fight.
I’m honored that I have been asked by Presbyterian Hospital in Huntersville, North Carolina to be one of their speakers on Sunday, 03 October during Cancer Awareness Day for families. If my message can reach and help out just one person, I am satisfied.
I’m further honored by an article which appeared in today’s local newspaper about me, my doctor and others in the area who are walking in the same shoes as me in their own fight against Metastatic Breast Cancer and the fear that Avastin may be taken away from their grasp. Because the newspaper’s web site is undergoing construction, I’ve provided the article in its entirety below:
by Frank DeLoache
HUNTERSVILLE – For Carol Fleming, Shannon Morgan and a dozen other women they know, Avastin is their best hope for longer life.
They don’t know exactly how long. They each have stage 4-breast cancer, which is inoperable and incurable – but not untreatable.
Avastin represents a new generation of cancer treatment, a new type of immune-based, antibody drugs that target cancer by blocking its blood supply to either stop or drastically slow its growth. Besides attacking cancer in a different way, this new generation of drugs also has fewer side effects than radiation and chemotherapy.
So to Fleming and other women, Avastin represents a last lifeline to hold onto while researchers look for more “targeted” drugs. Avastin represents more months, even years, of life.
They were horrified recently when the independent Oncology Advisory Committee to the U.S. Food and Drug Administration concluded that patient data didn’t show Avastin was proving effective enough against breast cancer. The committee recommended the federal drug agency withdraws its approval of Avastin for breast-cancer patients.
“I don’t know the statistics the FDA has used, and I don’t understand how they can say that extending a woman’s life by 2 1/2 months doesn’t warrant being available,” Fleming, a Huntersville resident, said.
Pat Morgan, Shannon’s husband, has read all he can about Avastin research and e-mailed and called local, state and national officials to keep the drug available to his wife and other stage 4-breast cancer patients. He’s read that Avastin already has helped more than 40,000 women.
“With that drug, you give them life-saving dignity,” Morgan, a South Park resident, said. “Is it worth it? If it is going to give a woman two or three months more of life, who knows what they’ll find in that time?”
A new way of beating cancer
Early this week, Dr. Margaret A. Hamburg, commissioner of the Food and Drug Administration, delayed ruling on the advisory committee’s recommendation and extended until December her agency’s review of Avastin for breast cancer patients.
Dr. John Powderly, a board-certified oncologist who operates Carolina BioOncology Institute, affiliated with Presbyterian Hospital-Huntersville, believes Hamburg, ultimately, will maintain her agency’s endosement of Avastin for breast-cancer patients. Powderly said Hamburg understands the importance of not stealing hope from so many women.
Powderly is treating Fleming, Morgan and about 500 cancer patients at any one time. He is also one of the few Charlotte-area oncologists who has a federal license as a “principle investigator” to test new cancer drugs before they go on the market.
So patients like Fleming and Morgan get access to clinical trials of drugs that could prove personal miracles.
He understands why the Oncology Drug Advisory Committee made its recommendation. The panel of specialists is supposed to evaluate the results of a drug trial, and they said the current trial results don’t provide enough evidence to conclusively say Avastin works for most breast cancer patients. But he’s seen Avastin work for women with stage 4-breast cancer, and he believes those drugs should remain available.
The nature of cancer drugs is changing, along with researchers’ understanding of cancer, Powderly explained. Researchers now understand that each patient’s cancer can be different, depending on the cancer itself and the patient’s own makeup.
For that reason, “cancer medicine is becoming more personalized,” he explained. “We are trying to identify the blueprint of mutation” in each patient’s case.
Simplistically, cancers may fall into two general types, Powderly said. One type grows faster like a snowball, as a solid mass that bigger and needs its own supporting system of blood vessels. The other type grows more slowly like small seeds with roots, which may not need its own system of supporting blood vessels. Since the faster-growing solid tumors depend on their own blood supply for growth, they respond better to Avastin.
Even so, researchers are learning that each cancer is unique, and researchers have not yet found a marker to predict which cancers actually benefit from Avastin.
New cancer drugs like Avastin are designed to target the solid-mass type tumors and cut off their blood supply.
Another targeted, immune-antibody drug called Herceptin has proven “exquisitely effective” for women with a certain type of breast cancer (Her 2 positive), but it can only help about one in four breast cancer patients, Powderly said.
Right now, Avastin is the only other federally approved new-generation drug that blocks a tumor’s system of blood supply, and though it is “phenomenally effective” for some women, researchers still don’t why it helps certain women and not others. That’s one reason the federal advisory committee recommended against continuing its use.
Still, Powderly explained, Avastin has proved very effective in treating other types of cancer, and for that reason, federal officials gave it accelerated approval for breast cancer patients two years ago. Powderly and others don’t think two years is enough time to judge its effectiveness, and given time, researchers will likely discover why it is so effective for certain patients and then better target the drug to women it will help.
And given time, cancer researchers will bring many more drugs on the market that will also “target” particular types of cancers best, providing life-saving therapy to breast-cancer patients. Powderly said he’s aware of at least 900 new cancer drugs in development, “and this is just the beginning, I believe.”
Powderly is proud of Carolina BioOncology Institute, which he opened in 2005 across from the new Presbyterian Hospital in Huntersville, because it gives breast-cancer patients throughout Charlotte access to clinical trials of new drugs. The clinic has a staff of 16, including three Ph.D., tumor biologists who study the new drugs and their effects on cancer cells under very sophisticated microscopes.
His clinic and researchers have equipment that can pluck one cancer cell out of a billion other cells in a sample of blood. Only Duke University has that type of sophisticated equipment in North Carolina – and only 50 clinics in the world. This enables the researchers to actually monitor the growth and strength of cancer cells and the effect of new drugs.
Without Carolina BioOncology Institute, Charlotte-area women would have to drive to Durham or Chapel Hill for treatment at research hospitals at Duke University and the University of North Carolina.
Powderly’s care and Avastin have proved life extending for Shannon Morgan, her husband, Pat, said. Shannon Morgan has been taking the drug about 20 months and her latest tests found no circulating tumor cells in her blood. And scans of his wife’s cancer show no new growth.
Pat Morgan has heard and read the words of other stage 4-breast cancer patients who depend on Avastin. “They say, ‘This has given me new life.’ ‘Please don’t take my life and family away from me,’” he said. “This works for tens of thousands of women. I don’t care if it just represents 5 per cent of all cancer patients.”
Said Powderly: “No woman should die because they can’t get access to these new drugs.”
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