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Medical Forum / Diseases and Disorders / Breast Cancer / May 2008MammaPrint or Oncotype DX Test?
What with demoralizing matters like radiation and chemo on the horizon, genetic testing and tailored treatment sure look attractive. Has anyone paid for their own Oncotype DX from Genomic Health, and been able to bargain them down to what insurance companies pay? The $3,600 quoted price tag is rather daunting, but that's hopefully negotiable. Also read about the MammaPrint test for $3,200, but can't see how to get that. Anyone with past experience with either of these tests out there? Les > What with demoralizing matters like radiation and chemo on the > horizon, genetic testing and tailored treatment sure look attractive. [quoted text clipped - 8 lines] > > Les Les, I've seen posts that the company writes off the test: I was also told that they'll do a sliding scale. I'd give them a call. Mine is sent, and I just don't want to know the results, because if it's high, and I decline chemo--because even a 50% risk reduction might translate to a low percent for me, it will make me worry. In medicine, we sometimes talk about incidentalomas--things you find while looking for something else, and are obligated to evaluate. In this case, the recommendation was clear--one needle biopsy showed a question of microvascular invasion--thought to be "crush artifact" while the gross path showed none, but tumor board recommended the oncogene dx. I have to call the office today to check on the status and what I have to do to get insurance on board. Lots of people on breastcancer.org write about it--I'm currently staying off that site because it scares the living daylights out of me... Judy > Has anyone paid for their own Oncotype DX from Genomic Health, and > been able to bargain them down to what insurance companies pay? The > $3,600 quoted price tag is rather daunting, but that's hopefully > negotiable. Genomic called me before they started the test to discuss finances. They did offer to assess my finances to see if I am eligible for a discounted rate. We did a quick approximation, and I was surprised to find out that I would qualify for a partial discount. They work with insurance co. first, including filing appeals if needed. If my insurance doesn't pay (or pays less than my discounted rate) I am responsible, up to the discount. They seemed very helpful (though I haven't gotten the bill yet, so time will tell I suppose). On May 27, 7:13 pm, sar...@rocketmail.com wrote: > > Has anyone paid for their own Oncotype DX from Genomic Health, and > > been able to bargain them down to what insurance companies pay? The [quoted text clipped - 10 lines] > They seemed very helpful (though I haven't gotten the bill yet, so > time will tell I suppose). Thanks Judy and ? (sorry), I will call Genomic Health back and see what they can do for me. In the past it seems like side effects of drugs always hit me hard, so I can just imagine how chemo will be. It would be nice to know if it's really necessary. Judy, you've gotten a lot more information about your tumor than I have on mine. All I know is that both were "infiltrating". Since my biopsies on May 5th, the 1.2 mm tumor is hardly palpable any more, while the .5 mm one is quite a bump. Thanks again for the info; will report in after my appointment with the cancer specialist tomorrow. Les > What with demoralizing matters like radiation and chemo on the > horizon, genetic testing and tailored treatment sure look attractive. [quoted text clipped - 8 lines] > > Les Do these tests show a real provable benefit to patients? I haven't researched them but I've read that this sort of test is of limited benefit in practice. It is one thing to be able to say that theoretically the genetic information should be able to improve the treatment prescription, but has anyone actually done any study of whether the process actually produced improved outcomes (or reduced costs or reduced suffering) for real patients? If it did then surely the insurance companies would want to pay for it, $3,000 is small beer in terms of the cost of a cancer treatment course. Tim Jackson > > What with demoralizing matters like radiation and chemo on the > > horizon, genetic testing and tailored treatment sure look attractive. [quoted text clipped - 20 lines] > > Tim Jackson Tim, I called yesterday to verify that mine was sent, and the administrator I talked to specifically said that low numbers help people decide to forgo expensive chemo. My breast surgeon told me the story of a pre-menopausal attorney who had positive nodes, but no desire for chemo. Oncogene dx is supposed to only be run with negative nodes, as a decision making tool--but they ran it for her, it was a low number, she skipped chemo and is doing well on tamoxifen. I'll bet genomics has some proprietary studies to prove cost- effectiveness. I met with my medical students to say goodbye, and was trying to be vague about why I was out--turns out, one of my students was doing a make-up session at her clinical site--the breast health center--and saw my name on the schedule, and knew the whole story. She did tell me that out of respect, she didn't read my chart.... Privacy?? Judy >> Do these tests show a real provable benefit to patients? > Tim, I called yesterday to verify that mine was sent, and the > administrator I talked to specifically said that low numbers help [quoted text clipped - 4 lines] > they ran it for her, it was a low number, she skipped chemo and is > doing well on tamoxifen. Using anecdotal evidence or testimonials sets my alarm bells ringing. It's only done if there is no statistical evidence. One remission isn't evidence of anything except that they happen, and we knew that. This isn't even that, this is one person who has survived an unspecified time without chemotherapy. The majority can do that: the reason for doing chemo is not wanting to be in the minority that die. I'm sorry but this is non-evidence. Tim > >> Do these tests show a real provable benefit to patients? > > Tim, I called yesterday to verify that mine was sent, and the [quoted text clipped - 17 lines] > > Tim Tim, I didn't critically look at the literature: here is a review from 2007 and states that the genomic testing has not yet been part of a prospective trial: so the evidence isn't really there--see what you think: http://www.ncbi.nlm.nih.gov/pubmed/16455023?ordinalpos=6&itool=EntrezSystem2.PEn trez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum Curr Treat Options Oncol. 2006 Mar;7(2):123-8.Links Gene expression in breast cancer. Kaklamani VG, Gradishar WJ. Department of Medicine, Division of Hematology/Oncology, Feinberg School of Medicine of Northwestern University, 676 North St. Clair Street, Suite 850, Chicago, IL 60611, USA. We now recognize that all breast cancers are not the same. Different characteristics in gene expression profiles result in differential clinical behavior. With the use of gene microarrays, different subtypes of breast cancer have been characterized. The basal subtype is characterized by high expression of keratins 5 and 17, laminin, and fatty acid-binding protein 7. The ERBB2+ subtype is characterized by high expression of genes in the ERBB2 amplicon. The luminal A subtype is characterized by the highest expression of the ER alpha gene. The luminal B and C subtypes have a lower expression of the ER cluster. The importance of these different subtypes lies in the fact that they differ in clinical outcome, with the basal and ERBB2+ subtypes having the worse prognosis and the luminal A group having the best prognosis. Different strategies for evaluating tumors in a clinical setting have been developed. Two such strategies are the 21-gene assay (Oncotype DX; Genomic Health, Redwood City, CA), which is currently in commercial use in the United States, and the 70-gene assay, which has been developed by a group in the Netherlands. These assays have been shown to predict clinical outcome and response to therapy. However, to date these gene assays have not been studied in a prospective manner. Over the next year, prospective clinical trials will be initiated using these predictive tools in the treatment of breast cancer. In the near future, clinical decisions will most likely be dictated by the genetic characteristics of the tumor, with the clinical characteristics becoming less important. Tailoring our treatment based on individual tumor characteristics will help us develop better therapeutic strategies and save many patients from receiving unnecessary toxic therapy. So they do predict response to therapy. In my case, where chemotherapy has a low percentage of increasing disease free survival--as my tumor was small, margins clear, nodes negative and ER+++/PR+++/Her--: the addition of chemo to hormonal therapy is going to give me, if the genetic testing shows a responsive tumor--a relatively low improvement in my odds of disease free survival. Yet, my case is exactly the clinical indication for using the genetic testing. What do you make of this? Judy > > >> Do these tests show a real provable benefit to patients? > > > Tim, I called yesterday to verify that mine was sent, and the [quoted text clipped - 67 lines] > What do you make of this? > Judy Tim: here's the study: from NEJM 2004 http://www.ncbi.nlm.nih.gov/pubmed/15591335?dopt=Abstract N Engl J Med. 2004 Dec 30;351(27):2817-26. Epub 2004 Dec 10. A multigene assay to predict recurrence of tamoxifen-treated, node- negative breast cancer. Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, Baehner FL, Walker MG, Watson D, Park T, Hiller W, Fisher ER, Wickerham DL, Bryant J, Wolmark N. Division of Pathology, Operation Center, and the Biostatistics Center, National Surgical Adjuvant Breast and Bowel Project, Pittsburgh 15212, USA. spaik.nejm@nsabp.org <spaik.nejm@nsabp.org> BACKGROUND: The likelihood of distant recurrence in patients with breast cancer who have no involved lymph nodes and estrogen-receptor- positive tumors is poorly defined by clinical and histopathological measures. METHODS: We tested whether the results of a reverse- transcriptase-polymerase-chain-reaction (RT-PCR) assay of 21 prospectively selected genes in paraffin-embedded tumor tissue would correlate with the likelihood of distant recurrence in patients with node-negative, tamoxifen-treated breast cancer who were enrolled in the National Surgical Adjuvant Breast and Bowel Project clinical trial B-14. The levels of expression of 16 cancer-related genes and 5 reference genes were used in a prospectively defined algorithm to calculate a recurrence score and to determine a risk group (low, intermediate, or high) for each patient. RESULTS: Adequate RT-PCR profiles were obtained in 668 of 675 tumor blocks. The proportions of patients categorized as having a low, intermediate, or high risk by the RT-PCR assay were 51, 22, and 27 percent, respectively. The Kaplan- Meier estimates of the rates of distant recurrence at 10 years in the low-risk, intermediate-risk, and high-risk groups were 6.8 percent (95 percent confidence interval, 4.0 to 9.6), 14.3 percent (95 percent confidence interval, 8.3 to 20.3), and 30.5 percent (95 percent confidence interval, 23.6 to 37.4). The rate in the low-risk group was significantly lower than that in the high-risk group (P<0.001). In a multivariate Cox model, the recurrence score provided significant predictive power that was independent of age and tumor size (P<0.001). The recurrence score was also predictive of overall survival (P<0.001) and could be used as a continuous function to predict distant recurrence in individual patients. CONCLUSIONS: The recurrence score has been validated as quantifying the likelihood of distant recurrence in tamoxifen-treated patients with node-negative, estrogen-receptor- positive breast cancer. Copyright 2004 Massachusetts Medical Society. Publication Types: The pubmed link has a free full text link to NEJM: so there it is-- hoping for a low score. Judy > > > >> Do these tests show a real provable benefit to patients? > > > > Tim, I called yesterday to verify that mine was sent, and the [quoted text clipped - 119 lines] > > Judy Tim, on the genomic health website, apparently the test is now recommended by two concensus groups, but only for node negative, ER + cancer. For Les, they have a gap program specifically to help uninsured patients get the test paid for, there's a number on the website. Judy >>>>> Do these tests show a real provable benefit to patients? >> Tim, I didn't critically look at the literature: here is a review from >> 2007 and states that the genomic testing has not yet been part of a >> prospective trial: so the evidence isn't really there--see what you >> think: It shows that the test predicts recurrence, I would expect that. I wasn't suggesting that it doesn't do what it says on the tin. But that is in the context of the current regime. What is rather harder to show is what effect changes in prescription (eg omitting chemotherapy) would have. That opens a whole other can of worms. We design the regimes on the basis of feedback by comparing outcomes after making small changes. This is talking about making changes to the treatment regime entirely on theoretical prediction. As in "We know this particular group would be at x% risk of recurrence if they took chemo (say 2%), and we know on average chemo reduces risk by a factor of y (say 2), so we project that on skipping chemo their risk would be xy% (ie 4%), which is acceptable to them". But we don't know that there is not some causal mechanism whereby this particular group is achieving exceptional protection through chemo, and so that their risk might be amplified by a much bigger factor. The only way we can be sure is to do trials. And I wonder what happens when the first person goes on to get a recurrence after skipping chemo on the basis of the test (it must happen sooner or later). Would they be able to sue? I'm not knocking the principle, I think it is useful progress, but I think it should be used with care and thought, and I think it is something that is very easy to sell for the wrong reasons, a magnet to the unscrupulous. Tim > >>>>> Do these tests show a real provable benefit to patients? > >> Tim, I didn't critically look at the literature: here is a review from [quoted text clipped - 29 lines] > > Tim Tim, I agree with you, and it brings up the whole problem of applying statistics to the individual: if a hypothetical risk happens to you, then the odds mean nothing, it's 100%. I find the research I did today sobering. They do write a blurb on their website that recurrences occur with low risk results and people with high numbers can live recurrence free for years. (The whole pre and post test predictive probability issue-- still from the study from Pittsburgh in 2004, done on women already on tamoxifen, it did appear to help identify women at risk of recurrence.) So, it's a piece of information, but without prospective trials, just how much weight should it carry? Once again: note to self--DO NOT go on Adjuvant.com and run different scenarios. What's the point of creating fear--and yet I do it. I'm not seeing patients right now, and I'm not used to free time, and this is a huge adjustment. Going in to see my medical students was very positive--the surgeon did email me and tell me that my student was very appropriate but upset when my chart came up. She also told me to focus on the wedding and try to stop worrying-- very difficult. But I do have two dresses--one is beautiful and sleeveless, and the other not so beautiful, but very comfortable with lacy sleeves to the elbow. It will depend on how I feel over the next week. This is a new normal, and it's still evolving. Judy > > >>>>> Do these tests show a real provable benefit to patients? > > >> Tim, I didn't critically look at the literature: here is a review from [quoted text clipped - 60 lines] > > - Show quoted text - Judy & Tim, First, what got me on the subject of Oncotype DX is what I read in the 2005 edition of Susan Love's Breast Book, referring to Genomic Health and Oncotype DX in her chapter about genetic testing: "Scientists selected 21 genetic markers that held promise for prognosis and prediction. They first tested the genes on the tissue from a completed National Surgical Adjuvant Breast and Bowel Project study on women with estrogen-positive, node negative tumors, who were randomized between tamoxifen and placebo. Since this study had already been completed, they knew which women had cancer that recurred within the 10 year follow-up. Their test was able to distinguish a high risk, low risk, and intermediate group. This recurrence score was more predictive than age or tumor size. "By applying their test to women who had received chemotherapy in addition to tamoxifen, they showed that the high risk group benefited significantly from chemotherapy, while the low recurrence score women did not. The benefit from tamoxifen was examined using this test in another study and showed that women with a low recurrence score and high estrogen-receptive score had the biggest benefit from tamoxifen, while the women with a high recurrence score did not." I had my cancer specialist appointment this afternoon. The doctor said that insurance usually pays for Oncotype DX for women who are both hormone-receptive and node-negative, confirming Susan Love's book. Tomorrow I'm getting my breast MRI. I have big hematomas from my biopsies on the 5th which are messing up the situation. The doctor had all my mammograms for the last 10 years, and said they are totally worthless. If what appears on the ultrasounds and biopsies is it, I can still have a lumpectomy plus radiation. Despite having two tumors, my breast is large enough to cut enough out. But she said if there's anything more, it will be mastectomy time. I'm painfully aware of the many false positives of MRIs. I won't know the results till the middle of next week. Meanwhile, my blood pressure has gone up 20 points in two weeks. Les > > >>>>> Do these tests show a real provable benefit to patients? > > >> Tim, I didn't critically look at the literature: here is a review from [quoted text clipped - 58 lines] > This is a new normal, and it's still evolving. > Judy Question..I was encourage to work by my cancer team when undergoing. Their rationale was to keep my life as normal as possible. At the time thought this was cruel, but in hindsight this was a good decision Why did the med students review your chart? This is the big disadvantage of being treated where you are working. Have you thought about a second opinion by doctors who are no emotional connection to you. They can make an objective decision and many may have information before the research is public. Best of luck, Alex > > > >>>>> Do these tests show a real provable benefit to patients? > > > >> Tim, I didn't critically look at the literature: here is a review from [quoted text clipped - 71 lines] > > Best of luck, Alex Alex, Ironically, I teach a small group of first year students, and their semester is over, but my one student was doing a make up day. She didn't get a look at my chart--the surgeon made that very clear--she just knew I was on the surgeon's schedule, and since I had told the group I was out for a few weeks because of surgery, she figured it out. Rhode Island is a tiny state: already the ultrasound tech was a patient, the recovery room nurse also. I am currently not working, but will reserve the right to schedule a few patients in the future if I feel up to it. The problem for me is that my work can be physically and emotionally rough, and I don't want to be there if I'm not up for it. I'm due to retake my boards in August, so this may be a study period for me. I can completely see how maintaining a routine really helps. My teaching schedule is for the students to get the next two months off, so I'm due to start back with them at the end of August. Too much spare time, is not good, I totally agree. Here in Rhode Island, everyone runs to Boston for second opinions. If chemo is considered, I will get an opinion at Dana Farber. If not, I'm comfortable with the radiation oncologist here. I do understand how being treated by people who know you can ruin their objectivity: already the surgeon and I had a difference of opinion re: the initial surgery, and I didn't want to be the "bad" patient by disagreeing with her. My internist was a big help, she backed me up and told me that if the interpersonal stuff got in the way, to write it down. In the end, everyone was in agreement. If I go to work this summer, I'll just be sort of a figure head--see a couple of patients, check in, work on learning the new electronic record. Before this happened, I was putting in 12 hour days, and my husband and I were trying to figure out how to set limits at work--I would leave at 7am and limp home around 8, and eat and go to bed, and we both agreed that wasn't the quality of life we were looking for as empty nesters. So, this forces a much needed re-evaluation of all sorts of priorities. I have a sister who hasn't worked for many years, for sort of unclear reasons, and the lack of structure is very hard on her. The highlight of my week so far was teaching my class. Thanks for the input. Judy |
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