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MAMMOSITE - I HAD THIS THERAPY
Survivor
Tuesday, November 11, 2008 at 08:50 AM -
MammoSite
Joni
Tuesday, November 11, 2008 at 09:00 AMI had this treatment a little over three years ago. At this point, I am cancer-free. My concern is that, at the time I was given this option, I was not told that it was an experimental treatment. My doctors pushed the convenience factor. I also have very large, dense breasts, and I was told that I would have less burning and irritation as opposed to conventional radiation. That much was true, as my mother and I were diagnosed at approximately the same time, and she had conventional radiation.
re: re: MammoSite
Joni
Tuesday, November 11, 2008 at 09:05 AMre: re: re: MammoSite
sherreeb
Tuesday, November 11, 2008 at 02:47 PMJoni,
Mammosite is far from experimental and has thus far had excellent success rates. We do not have thirty year data because it hasn't been around for thirty years. But, conventional radiation had to start here as well. Everything has to start at the beginning. I don't think you should worry due to the type of radiation. Just continue with your normal surveillance of breast self exam, clinical brest exam and mammogram!
Sherree Bennett, RN, CBEC
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New York Times - Letter to the Editor re: Mammosite
Christine Lessard
Tuesday, November 11, 2008 at 10:07 AMAs the Executive Director for the Arizona Institute for Breast Health, I would like to share the following article. This article was written in response to the October 27th New York Times Article that you are basing your information on.
Letter to the Editor
New York Times
The article "Quickly Vetted, Treatment Is Offered to Patients" unfairly represents the data supporting an important medical advance that provides excellent breast cancer control with a better quality of life for women diagnosed with early stage disease.
As the original pioneer of this new paradigm for breast cancer treatment, leader of the original FDA trial for MammoSite, the Principal Investigator of the National Cancer Institute sponsored and completed phase II trial, and co-Principal Investigator of the current phase III national trial that has already had over 3200 women participate, we are uniquely qualified to evaluate the evidence for or against Accelerated Partial Breast Irradiation (APBI). Dr. Quiet was the lead physician in entering patients onto the MammoSite trial through the American Society of Breast Surgeons, and is the founder of the Arizona Institute for Breast Health.
The focus of Abelson's report is a critique of the FDA fast tract for clearance of MammoSite's clinical use in 2002. Good points are presented and emotional arguments highlighted in favor of patients being protected from untested devices entering the US market. However, the author did not reveal that APBI was developed in 1991, and has undergone impressive medical scrutiny over the past 17 years. The original concept used time-proven brachytherapy (placement of radioactive seeds inside catheters surrounding a tumor site) that has been successfully implemented against cancers of the cervix, uterus, vagina, prostate, head and neck, and soft tissue sarcomas since the 1920s! This method of radiation delivery actually preceded the current use of high-energy x-ray machines, now considered "the gold standard." World-renown biologists carefully and meticulously calculated the dose of radiation needed to sterilize breast cancer cells. Long-term data is available using 5-day brachytherapy from the Ochsner Clinic in New Orleans and William Beaumont Hospital in Royal Oak, Michigan. These published results compare favorably in every clinical outcome with those of mastectomy or lumpectomy followed by whole breast irradiation over 5 to 7 weeks.
True, the MammoSite device was presented to the FDA in 2002. But the dose of radiation to eradicate breast cancer is exactly the same as the original brachytherapy data from New Orleans and Michigan. Only the affected part of the breast was treated, reducing radiation exposure to the underlying lung, heart, and ribs. A Woman's life outside of breast cancer was less intruded upon, and side effects were reduced. When I presented this information to the FDA in 2002, concerns were minimal because we piggybacked on scientific data that was 11 years mature. Now, MammoSite data is being published every month in peer-reviewed medical journals confirming excellent outcomes in large numbers. Just last month, Dr. Peter Beitsch presented the results of 1440 women treated by MammoSite, with an in-breast recurrence rate of only 2.7% at 3 years, comparable to any published studies with "conventional therapy." My original trial for the FDA was published in Annals of Surgery 2007 by Pamela Benitez, MD with long-term follow-up (median 5.5 years), with no local recurrence and 83% good to excellent cosmetic outcomes. Study after study substantiates the concept that we had back in 1991 that select breast cancers could by effectively treated by a 5-day regimen of APBI with fewer side effects and less danger to internal organs.
So, this is one medical device the FDA approved correctly. In their defense, why should the FDA withhold a treatment that delivers the same calculated tumoricidal dose that has been used for 17 years? The MammoSite is a means for delivering the most time-honored and effective treatment against cancer (radiation), not a "highly experimental" device being foisted upon an unsuspecting public.
Robert R. Kuske, MD
Coral A. Quiet, MD
Radiation Oncologists of Central Arizona
8994 E Desert Cove Ave.
Scottsdale, Arizona 85260
602-240-3506re: New York Times - Letter to the Editor re: Mammosite
PJ Hamel
Tuesday, November 11, 2008 at 10:20 AMThanks for this additional information. We need all the facts we can get when trying to make these difficult treatment decisions. And in the end, nothing is guaranteed: we're all participants in the continuing experiment that's cancer treatment. We do the best we can with the information we have, make a decision, and go for it. - PJH
re: New York Times - Letter to the Editor re: Mammosite
sherreeb
Tuesday, November 11, 2008 at 02:45 PMThank you so much for sharing this information as a physician. I am a breast health professional and it is important that women understand all of their options based off of scientific facts and not main stream media hype. Mammosite is far from experimental but rather, a proven benefit to women that saves them time and trouble (and I have no financial tie to the company or any way of making money from it).
Our informatin must be base don facts and not fears.
Thanks
Sherree Bennett, RN, CBEC
re: re: New York Times - Letter to the Editor re: Mammosite
PJ Hamel
Tuesday, November 11, 2008 at 03:07 PMre: re: re: New York Times - Letter to the Editor re: Mammosite
sherreeb
Tuesday, November 11, 2008 at 03:12 PMIn my opinion it does not because no treatment starts with thirty year data. Every single drug, surgery and treatment has to start at ground zero and go from there. Once mammosite reached the FDA for approval, it was based on clinical trials as cited in the second article. Herceptin, which is now standard treatment for Her-2 positive tumors does not have 30 year data either. Breast conserving surgery itself does not quite have 30 year data yet. I believe Dr. Vicini is saying we can't compare 30 year data because it doesn't exist yet, that doesn't mean that the data we have is bad.
Sherree
re: re: re: re: New York Times - Letter to the Editor re: Mammosite
PJ Hamel
Tuesday, November 11, 2008 at 03:40 PMGood point. And I certainly wasn't implying the data on MammoSite was bad. Just that there wasn't as much of it to go on. You're the professional, I'm just speaking as a survivor. I gues your choice depends on whether you're comfortable with new technology, or someone who's more comfortable with the tried-and-true. - PJH
Discussing Mammosite and Patient Education / Literacy
Sarah
Tuesday, November 11, 2008 at 05:05 PMThanks for writing, Sherree. I've enjoyed reading your many insightful posts and comments on this breast cancer support site, and it's great to see you take such a passionate stand on Mammosite as a treatment option for breast cancer patients.
I don't think, however, that discussion about Mammosite, along with how well patients understand their treatment options and the research behind the offerings, can be brushed aside as mainstream media hype.
The author, PJ Hamel, has responded to an important recent news article that deserves a chance for critique and review among breast cancer patients and survivors who have been through the process of making difficult treatment decisions. This is not type of conversation that should exclude or diminish the importance of patient or survivor input, even when medical professionals jump into the fray.
Keep in mind that an entire marketing site for Mammosite exists to promote stories of positive experiences for breast cancer patients. It's called Voices of Mammosite. http://www.voicesofmammosite.com/
I haven't read all the stories on the site, but my guess is that Voices of Mammosite does not emphasize stories of those women who did not have a 100% favorable experience -- or a bad experience -- with the Mammosite treatment.
If you do seek to focus on what other medical professionals have to say, you might want to check out the blog of Dr. Jeffrey Parks, who profiled Mammosite on his blog Buckeye Surgeon, a few weeks before the New York Times article was published.
He writes:
"What is the bottom line?
At this point, although the preliminary evidence for APBI with the Mammosite Balloon is encouraging, we do not yet have definitive, level I evidence to support its use as standard therapy. At this point, it's still an experimental treatment modality that cannot be routinely recommended for all women with early stage breast cancer. The ongoing NSABP B39/RTOG 0413 trial is a randomized controlled trial comparing conventional whole breast irradition with APBI in patients with Stage 0,I,and II breast cancer. Results will be available in the year 2015. In the meantime, I cannot in good conscience recommend APBI until the level I evidence is there to support it."Please read Dr. Parks' entire post on Mammosite to get a full sense of his thinking.
re: Discussing Mammosite and Patient Education / Literacy
sherreeb
Tuesday, November 11, 2008 at 05:29 PMThank you Sarah, I apologize if it seemed dismisive of survivor input. I had no intention of doing so as I am a survivor myself. I simply did not want to see a complete scare because women are afraid they had an experimental treatment that has no science behind it. All patients deserved to make an informed choice about any treatment they receive including radiation of whichever kind. I just wanted to inject that it is scientifically sound and we have good encouraging data and will continue to collect it. There are many more than 25 women involved with great results.
Thanks
re: re: Discussing Mammosite and Patient Education / Literac
PJ Hamel
Tuesday, November 11, 2008 at 10:02 PMSherree, all input is welcome here. Thanks for contributing to the dialogue today - it's been very informative, and I daresay may help women make a good choice about radiation, since they know now - if they didn't before - that there IS a choice: that one method isn't superior to the other. Keep those good posts coming! PJH
re: Discussing Mammosite and Patient Education / Literacy
PJ Hamel
Tuesday, November 11, 2008 at 09:30 PMSarah, I appreciate your citation of another source of information. Only with as much good data as possible can each of us survivors make her own determination as to treatment. Cancer-world can be confusing; with such easy access to SO much information, much of it contradictory, preliminary, or opinion, it's valuable to have sources you can trust. You make this site a source I can trust; thank you. PJ
re: New York Times - Letter to the Editor re: Mammosite
bettye s waller
Wednesday, May 27, 2009 at 06:45 PMI have had this operation and radiation for 5 days twice a day .and am still recuperating. I am interesed in hearing more about it as I was given very little on it b4 operation.Except that it was better because it took less time. The catheter was very heavy and uncomfortable on small and old muscles of breast. I recomend it be used on young women.
re: re: New York Times - Letter to the Editor re: Mammosite
PJ Hamel
Wednesday, May 27, 2009 at 09:20 PMHi - YOu might find this first-person account of MammoSite treatment interesting- PJH
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radiation
steakprincess
Tuesday, November 11, 2008 at 06:31 PMThis is wonderful and informative. I was not offered this back in 2005, even though I knew it existed, because I had implants at the time and the doctors said that I was not a candidate because of the implants.
On the other hand, I did have the conventional radiation 5 times a week for 6 1/2 weeks and my cancer came back in the same breast. No one knows for sure if it was a recurrence or a new cancer, so statistics mean nothing to me. I ended up having a double mastectomy with chemo and that's just the way it went for me.
Let's face it, everything is trial and error and no one knows for sure what the treatments will do or not do. Maybe in the future this MammoSite Radiation will be better than the conventional. To me, it's all the same. "Let's try this and see if it works on this specific person". We have to start somewhere.
Everything happens for a reason.
re: radiation
Anonymous
Wednesday, November 12, 2008 at 09:17 AMI am "Survivor" who had MammoSite almost 3 years ago and am still cancer-free. As other survivors know, when I was diagnosed there was a feeling of urgency - get this out of me! - and I didn't do enough research beforehand. So if I'd known then what I know now, I would have elected for a double mastectomy. Just my personal choice, as my cancer was considered aggressive - the hormone receptors were negative and the HER-2 was positive.
re: re: re: radiation
steakprincess
Wednesday, November 12, 2008 at 01:23 PMthank you PJ.
I do not look back nor do I have regrets. I am grateful for the way things went for me.
Only during the pathology after my mastectomy, did they find an aggressive 2cm tumor which was NEVER seen on MRI, mammogram or PET scan.
I consider myself very lucky.
No tests or treatments are foolproof. This is something everyone should accept and know.
Danielle
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I had MammoSite radiation almost 3 years ago, twice a day for 5 days. As of today, I am cancer-free.