Stage 1, grade 1 and pre-menopausal
Comments
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J Natl Cancer Inst. 2012 Mar 21;104(6):441-51. Epub 2012 Mar 6.
CYP2D6 genotype and tamoxifen response in postmenopausal women with endocrine-responsive breast cancer: the breast international group 1-98 trial.
Regan MM, Leyland-Jones B, Bouzyk M, Pagani O, Tang W, Kammler R, Dell'orto P, Biasi MO, Thürlimann B, Lyng MB, Ditzel HJ, Neven P, Debled M, Maibach R, Price KN, Gelber RD, Coates AS, Goldhirsch A, Rae JM, Viale G; Breast International Group (BIG) 1-98 Collaborative Group.Source
IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA 02215, USA. mregan@jimmy.harvard.edu
Abstract
BACKGROUND:
Adjuvant tamoxifen therapy is effective for postmenopausal women with endocrine-responsive breast cancer. Cytochrome P450 2D6 (CYP2D6) enzyme metabolizes tamoxifen to clinically active metabolites, and CYP2D6 polymorphisms may adversely affect tamoxifen efficacy. In this study, we investigated the clinical relevance of CYP2D6 polymorphisms.
METHODS:
We obtained tumor tissues and isolated DNA from 4861 of 8010 postmenopausal women with hormone receptor-positive breast cancer who enrolled in the randomized, phase III double-blind Breast International Group (BIG) 1-98 trial between March 1998 and May 2003 and received tamoxifen and/or letrozole treatment. Extracted DNA was used for genotyping nine CYP2D6 single-nucleotide polymorphisms using polymerase chain reaction-based methods. Genotype combinations were used to categorize CYP2D6 metabolism phenotypes as poor, intermediate, and extensive metabolizers (PM, IM, and EM, respectively; n = 4393 patients). Associations of CYP2D6 metabolism phenotypes with breast cancer-free interval (referred to as recurrence) and treatment-induced hot flushes according to randomized endocrine treatment and previous chemotherapy were assessed. Cox proportional hazards models were used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs). All statistical tests were two-sided.
RESULTS:
No association between CYP2D6 metabolism phenotypes and breast cancer-free interval was observed among patients who received tamoxifen monotherapy without previous chemotherapy (P = .35). PM or IM phenotype had a non-statistically significantly reduced risk of breast cancer recurrence compared with EM phenotype (PM or IM vs EM, HR of recurrence = 0.86, 95% CI = 0.60 to 1.24). CYP2D6 metabolism phenotype was associated with tamoxifen-induced hot flushes (P = .020). Both PM and IM phenotypes had an increased risk of tamoxifen-induced hot flushes compared with EM phenotype (PM vs EM, HR of hot flushes = 1.24, 95% CI = 0.96 to 1.59; IM vs EM, HR of hot flushes = 1.23, 95% CI = 1.05 to 1.43).
CONCLUSIONS:
CYP2D6 phenotypes of reduced enzyme activity were not associated with worse disease control but were associated with increased hot flushes, contrary to the hypothesis. The results of this study do not support using the presence or absence of hot flushes or the pharmacogenetic testing of CYP2D6 to determine whether to treat postmenopausal breast cancer patients with tamoxifen.
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J Natl Cancer Inst. 2012 Mar 21;104(6):452-60. Epub 2012 Mar 6.
CYP2D6 and UGT2B7 genotype and risk of recurrence in tamoxifen-treated breast cancer patients.
Rae JM, Drury S, Hayes DF, Stearns V, Thibert JN, Haynes BP, Salter J, Sestak I, Cuzick J, Dowsett M; ATAC trialists.Source
Department of Internal Medicine, University of Michigan Medical Center, Ann Arbor, MI, USA. jimmyrae@umich.edu
Abstract
BACKGROUND:
Adjuvant tamoxifen therapy substantially decreases the risk of recurrence and mortality in women with hormone (estrogen and/or progesterone) receptor-positive breast cancer. Previous studies have suggested that metabolic conversion of tamoxifen to endoxifen by cytochrome P450 2D6 (CYP2D6) is required for patient benefit from tamoxifen therapy.
METHODS:
Tumor specimens from a subset of postmenopausal patients with hormone receptor-positive early-stage (stages I, II, and IIIA) breast cancer, who were enrolled in the randomized double-blind Arimidex, Tamoxifen, Alone or in Combination (ATAC) clinical trial, were genotyped for variants in CYP2D6 (N = 1203 patients: anastrozole [trade name: Arimidex] group, n = 615 patients; tamoxifen group, n = 588 patients) and UDP-glucuronosyltransferase-2B7 (UGT2B7), whose gene product inactivates endoxifen (N = 1209 patients; anastrozole group, n = 606 patients; tamoxifen group, n = 603 patients). Genotyping was performed using polymerase chain reaction-based TaqMan assays. Based on the genotypes for CYP2D6, patients were classified as poor metabolizer (PM), intermediate metabolizer (IM), or extensive metabolizer (EM) phenotypes. We evaluated the association of CYP2D6 and UGT2B7 genotype with distant recurrence (primary endpoint) and any recurrence (secondary endpoint) by estimating the hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) using Cox proportional hazards models. All statistical tests were two-sided.
RESULTS:
After a median follow-up of 10 years, no statistically significant associations were observed between CYP2D6 genotype and recurrence in tamoxifen-treated patients (PM vs EM: HR for distant recurrence = 1.25, 95% CI = 0.55 to 3.15, P = .64; HR for any recurrence = 0.99, 95% CI = 0.48 to 2.08, P = .99). A near-null association was observed between UGT2B7 genotype and recurrence in tamoxifen-treated patients. No associations were observed between CYP2D6 and UGT2B7 genotypes and recurrence in anastrozole-treated patients.
CONCLUSION:
The results do not support the hypothesis that CYP2D6 genotype predicts clinical benefit of adjuvant tamoxifen treatment among postmenopausal breast cancer patients.
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Breast Cancer Genotype, CYP2D6, Not Predictive of Tamoxifen BenefitBy Anna Azvolinsky, PhD |March 6, 2012
Two studies published in the Journal of the National Cancer Institute today help clarify how to interpret CYP2D6 genetic testing and provide new insight into how different CYP2D6 alleles effect tamoxifen(Drug information on tamoxifen) efficacy in postmenopausal women with breast cancer. The results will likely affect the current trend of CYP2D6 genotyping prior to tamoxifen usage in early-stage estrogen receptor (ER)-positive breast cancer patients.
Adjuvant tamoxifen therapy can decrease the risk of ER-positive breast cancer recurrence and mortality in women with early-stage disease by approximately 30%. The drug is processed by an enzyme, CYP2D6, into 2 active metabolites, derivatives of tamoxifen. One of the metabolites, endoxifen, is thought to be the more important and active derivative. Tamoxifen itself has rather weak activity for the estrogen receptor.
Chemical structure of CYP2D6
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There are genetic variants of CYP2D6 in humans, with a range of enzymatic activity. Depending on the CYP2D6 variant, a breast cancer patient may respond differently to tamoxifen treatment. The working hypothesis, based on laboratory and case-control studies, was that tamoxifen is less effective in those cancer patients who harbor a CYP2D6 allele or 2 copies of the allele that show a poor metabolism activity and lower concentrations.
The Studies
Meredith M. Regan and colleagues at the Dana-Farber Cancer Institute analyzed tumor tissue and assessed the CYP2D6 mutational status among 4,861 postmenopausal women with ER-positive breast cancer, part of a larger phase III tamoxifen trial.
The study found no correlation between CYP2D6 metabolism and breast cancer-free interval in patients treated with tamoxifen monotherapy. Contrary to the current working hypothesis, patients with CYP2D6 alleles associated with a poor or intermediate metabolism of tamoxifen had more hot flashes compared to patients with CYP2D6 alleles with higher tamoxifen metabolism activity. The authors suggest that, based on their results and a previously published study, hot flashes should not be used to gauge the relative tamoxifen metabolism for breast cancer patients.
The authors conclude that patients with CYP2D6 phenotypes associated with reduced enzyme activity did not have worse disease control compared to patients whose CYP2D6 enzymes were associated with higher enzyme activity and should not be used to predict outcome in treatment of ER-positive breast cancer after treatment with tamoxifen.
In the second published study, James M. Rae, department of internal medicine at the University of Michigan Medical Center, and colleagues sequenced the CYP2D6 gene from 1,200 tumor specimens of postmenopausal patients with ER-positive early-stage breast cancer, also enrolled in a clinical trial studying tamoxifen in the United Kingdom. There was no statistically significant association between CYP2D6 metabolism activity, as classified by the CYP2D6 allele, and recurrence in patients treated with tamoxifen. "The results do not support the hypothesis that CYP2D6 genotype predicts clinical benefit of adjuvant tamoxifen," the authors write in their conclusion.
Genotyping CYP2D6 in patients who could potentially benefit from tamoxifen has been recommended and studies have shown that the efficiency of tamoxifen metabolism by CY2D6 is necessary for a breast cancer patients to benefit from tamoxifen treatment. Hot flashes were thought to reflect the efficacy of tamoxifen in patients, showing the phenotype of tamoxifen on the breast tumors in patients.
Is CYP2D6 Genotyping Necessary?
In an editorial assessing both studies, Catherine M. Kelly, department of medical oncology at the Mater Misericordiae University Hospital in Dublin, and Kathleen I. Pritchard, department of medical oncology at the Odette Cancer Centre at Sunnybrook Health Sciences Centre in Toronto, question the utility of CYP2D6 genotyping. Kelly and Pritchard note that the FDA has suggested that the label for tamoxifen include information that patients with poor metabolism of tamoxifen, correlated with specific CYP2D6 alleles, may have an increased risk for breast cancer recurrence.
Both authors would like to see a large, randomized confirmatory study to confirm the current published results, but communicate the substantial evidence of 2 back-to-back studies: "the fact that these two studies confirm each other suggests that this matter has likely been laid to rest," they write.
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BULLETIN-----BULLETIN----BULLETIN
FINALLY GOT AN ANSWER FROM THE IBCSG STATISTICAL CENTER AT HARVARD REGARDING THE SOFT and TEXT TRIALS:
"As you noted, the SOFT
trial successfully completed enrollment of over 3000 premenopausal women in
2011. The women continue to be treated and followed according to the
trial protocol and when there is a median of 5 years of follow-up, then the
first results of the SOFT and TEXT trials will be presented together. We
anticipate that this will be at SABCS in Dec 2013, and so the data collection
period for that report would be through Q3 2013 (treatment and data collection
of course continue beyond that point).
I hope that this is a helpful update of progress of the trial."0 -
Hi guys, I have edited the header, hope it meets with your approval!
Hugs
Annicexx0 -
The Lancet Oncology, Volume 13, Issue 4, Pages 345 - 352, April 2012 <Previous Article|Next Article>doi:10.1016/S1470-2045(11)70373-4
Cite or Link Using DOIPublished Online: 20 January 2012Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial
Original TextNorikazu Masuda MD a, Yasuaki Sagara MD b, Takayuki Kinoshita MD c, Hiroji Iwata MD d, Prof Seigo Nakamura MD e, Yasuhiro Yanagita MD f, Reiki Nishimura MD g, Prof Hirotaka Iwase MD h, Shunji Kamigaki MD i, Hiroyuki Takei MD j, Prof Shinzaburo Noguchi MD k
Summary
Background
Aromatase inhibitors have shown increased efficacy compared with tamoxifen in postmenopausal early breast cancer. We aimed to assess the efficacy and safety of anastrozole versus tamoxifen in premenopausal women receiving goserelin for early breast cancer in the neoadjuvant setting.Methods
In this phase 3, randomised, double-blind, parallel-group, multicentre study, we enrolled premenopausal women with oestrogen receptor (ER)-positive, HER2-negative, operable breast cancer with WHO performance status of 2 or lower. Patients were randomly assigned (1:1) to receive goserelin 3·6 mg/month plus either anastrozole 1 mg per day and tamoxifen placebo or tamoxifen 20 mg per day and anastrozole placebo for 24 weeks before surgery. Patients were randomised sequentially, stratified by centre, with randomisation codes. All study personnel were masked to study treatment. The primary endpoint was best overall tumour response (complete response or partial response), assessed by callipers, during the 24-week neoadjuvant treatment period for the intention-to-treat population. The primary endpoint was analysed for non-inferiority (with non-inferiority defined as the lower limit of the 95% CI for the difference in overall response rates between groups being 10% or less); in the event of non-inferiority, we assessed the superiority of the anastrozole group versus the tamoxifen group. We included all patients who received study medication at least once in the safety analysis set. We report the primary analysis; treatment will also continue in the adjuvant setting for 5 years. This trial is registered with ClinicalTrials.gov, number NCT00605267.Findings
Between Oct 2, 2007, and May 29, 2009, 204 patients were enrolled. 197 patients were randomly assigned to anastrozole (n=98) or tamoxifen (n=99), and 185 patients completed the 24-week neoadjuvant treatment period and had breast surgery (95 in the anastrazole group, 90 in the tamoxifen group). More patients in the anastrozole group had a complete or partial response than did those in the tamoxifen group during 24 weeks of neoadjuvant treatment (anastrozole 70·4% [69 of 98 patients] vs tamoxifen 50·5% [50 of 99 patients]; estimated difference between groups 19·9%, 95% CI 6·5-33·3; p=0·004). Two patients in the anastrozole group had treatment-related grade 3 adverse events (arthralgia and syncope) and so did one patient in the tamoxifen group (depression). One serious adverse event was reported in the anastrozole group (benign neoplasm, not related to treatment), compared with none in the tamoxifen group.Interpretation
Given its favourable risk-benefit profile, the combination of anastrozole plus goserelin could represent an alternative neoadjuvant treatment option for premenopausal women with early-stage breast cancer.Funding
AstraZeneca.0 -
Anice love the updated header!
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annice Thanks for the edit on the header
VR I have not heard anything like this before. Looks like Goserelin combined with an AI for pre-menopausals might be an option? Thanks for sharing.
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Joy... It's not a common combination, but over at the young survivors' website discussion group, I have noticed women choosing that combination. I think physicians are hesitant to do it before doing Tamoxifen first, because some women break through the O/S and that would then make an AI ineffective. I guess if women had to do that combo they would have to be monitored very carefully. That said, the research looks very promising.
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Springfever, I had many of the same symptoms from Tamoxafin that you experienced with Lupron along with feeling agitated all the time. I took it for as long as I could handle it-13mos later I stopped two months ago. I was taking 3000 mg of glucosamine/chondroitin which seemed to help in the beginning. Still having sticking joints, arthretic pain and seeing spots however thankfully the agitation is mostly gone. My Onc thinks I should try Lupron shot monthly along with Arimidex. I saw that there is a group trying to get Lupron taken off the market. I must admit, I have a low tolerance to taking anything without feeling every side effect known to the drug at hand. I fear I won't be able to tolerate the Lupron/arimidex since tamoxfin is the choice drug...I read this somewhere. I'm supposed to see Onc on the 18th to start Lupron, if I so choose. I've been trying to research and see what others reactions are to see if there is anything positive to hang tough on. I fear what side effects I currently suffer are more a permanent damage and I'm considering stopping all treatment. My oncotype was 19-middle bucket and the study had just closed.
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Hi guys. Just to give you an update. I finally decided not to do chemo. I started my tamoxifen yesterday
I'm still devating about ovarian suppression. Haven't had the chance to read all the information here. Too busy packing. We are moving to another city this coming saturday.0 -
Ladies: when making any decision, always remember that you do not have to take the advice of your doctor. Be your own advocate. Do your own research. I did, and am truely glad for the decisions I made with my cancer treatment and I feel that much more healthy and no side effects from drugs.
I did lumpectomy, 6 weeks rads and ovary removal. No tamoxifen, no ovary suppresion drugs, no other hormone treatment. I firmly said no to my onc doc on any hormone treatments. My only side effect is hot flashes but all women get these eventually in their life cycle, it's natural. And, evening primrose, flaxseed and black cohosh are great for hot flashes and night sweats.
AS always, everyone is different and may need the drugs as treatment. I'm not saying no, do not take them, just please do your research on them first.
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Very good advice, Kingir66 !!
I made the same decisions you made 8 years ago EXCEPT that I also refused the rads. I didn't make any lifestyle or diet changes either.
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MarieKelly - I'm doing the diet change. We still get the hormones from the food we eat. I'm going to try changing to organic meat as a start. I've also been counting calories. I can't diet diet, but I can certainly eat less. Throwing in more fruits and vegs and drinking more water to flush everything out. It's a start.
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kingjr66 that is great advice but for everything dealing with BC. My first BS rushed me into surgery and rads. Everything happened so quickly I thought I was really sick and had no time to research so did not ask questions. I learned my lesson and never again will that happen. Before my BMX I interviewed another BS and three PS before I made my decision and my PS could tell I knew what I was talking about and he respects me for the time I have taken to learn.
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Hi ladies - I just wanted to introduce myself. I've been lurking on here for a few weeks having been diagnosed in early April, thinking (hoping) that I would join you in this prognosis/staging. I'm here in new Orleans recovering from a BMX with immediate DIEP recon and am flying home to Michigan tomorrow.
We got the final pathology report today and it was IDC, 2cm, stage 1, grade 1. I'm 39 years old and the pathology you can see below in my signature. I'll get the results of the oncotype test in about two weeks... And I guess I'm hoping that the result is very clear, yes? Nothing borderline! What are the odds of having grade 1 and a intermediate to high oncotype? Low oncotype score is more common, yes?
You all seem to have a wealth of information regarding this prognosis/staging level - so thank you in advance for sharing what you know or find. If you have any recommendations on additional threads or resources that you think might be helpful to me, I would be SO very grateful! Thank you!0 -
Jen...hope you have a quick and uneventful recovery. I am sorry to hear about your diagnosis. Regarding what percentage of women with Grade 1 tumors have high Oncotype DX scores, the answer is not many. 5% of women with Grade 1 tumors will have high scores. Another 5- 10% will have intermediate scores... with most of those intermediate scores occurring in the lower intermediate range.
This discussion thread covers most of the current research for Grade 1, Stage 1. You might like to also do a pubmed.org search. Pubmed is the government's clearinghouse of most published medical research. Also check out the professionals version of the 2012 NCCN breast cancer guidelines. You have to register on their website to access the info,but it's worth it. Read the footnotes too AND especially pages 92-98 which discusses endocrine therapy.0 -
Jen glad to have you here with us although hate that you are having to join us. My oncoscore was a 23 whiched really suprised me. I ended up getting two opinions and both did not recommend chemo because my ki67 was under 10%. I now understand the reason my was so high is because I am barely ER+. I was 48 at diagnosis. When the final studies came out last Dec regarding Zometa in early stage BC my MO put me on that because he thought I was a great candidate for it. I get an infusion every 6 months for three years. Good Luck with your healing from DIEP
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Hi Jen - welcome and also sorry for your diagnosis. I was grade 1 tubular carcinoma and grade 1 dcis. My onco score was 13 and negative for brca. I did not need chemo, 6 wks rads though. No tamoxifen or any other hormones for me. I also removed my ovaries. I am 52 yrs old.
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Thank you so much ladies for sharing your knowledge and personal experiences. I am just home today after being gone for two weeks for my surgery. I'm feeling a little overwhelmed - wanting to educate myself as much as possible on treatment options, but also feeling so emotionally and physically wrought. I know everyone says that it gets better;
I hope and pray that is true for me as well. Much appreciation!0 -
Hi Jen, really hoping for low ocncotype for you. Feeling for you and all the uncertainty that you are going through. We all understand, the waiting for tests and treatment plan is torture. We are here to share our experience if you need us.
I was diagnosed almost a year ago and I still feel its a miracle that my life has returned to normal. I have just had a wonderful holiday in Turkey and enjoyed every single minute, perhaps even more than I would have before! You will get through this difficult time and here's to happy times ahead.
Annice0 -
Good morning! I am 44 and pre-menopausal at diagnosis.
New on this forum. Oncotype results today. Once my incision heals (complication) I will be starting treatment. If treatment is delayed due to me not being healed, I will be asking if I can start the Tamoxifin. I am too much of a "what if" person. If the sides effects are bad with the tamoxifin I will deal with them. However, I were to opt to not take it and then this monster comes back (and it still might if I do take it), I will have a really hard time with dealing with that decision. This is such a hard road to travel. ((Hugs)) to everyone here.
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Forgot to add I am 99% ER/PR+
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Belinda...sorry to hear about your diagnosis and complications. My breast cancer diagnosis came after I had TWO life saving emergency operations, several years apart. What I've learned from my journey is to scratch from my mind those "what if" thoughts. They're too much of a distraction. Now, I try to gather as much information as I can, and then I try to make informed decisions. Afterwards, I revisit those informed decisions as needed. That is, ONLY if I have symptoms or side effects. And believe me, I've had a few! However, I CHOOSE, in my mind, to live a more unfettered life now....keeps me grounded and sane. I wish you well with your protocol decisions. This thread contains a lot of helpful information. Hopefully, by reading it and joining us on the road, it will make your journey a little easier.....
I wish you well. Thoughts and prayers to you!
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Hi Belina sorry you are here but welcome anyway! I started tamoxifen day one of my diagnosis. If you are not having chemo I am not sure there is any need to delay it. I might as well be taking a vitamin tablet, I don't notice any side effects!
VR has shared some wise words here. My work with clinical psychologists in my own practice over the years has taught me about the dangers of catastrophising which is very destructive in any situation. My approach for self preservation is to try as much as possible to live in the moment and to be mindful. And when the negative thoughts start to creep into the front of my mind I register them and then park them away! Acceptance is so important in this disease. The threat of recurrence is oppressive but outcomes for all types and particularly with our stats are much better than many benign diseases!
Good luck with your results and decisions
((((Hugs))))0 -
Belinda - I agree with Annicemd and Voraciousre comments. Live for the moment and think positive. Mind over matter. Please do your research on all treatments available to you and the answers will all be there and will be your choice. You already have one possitive, you are negative on margins and nodes.
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Thanks for such a warm welcome! My Oncotype was 19. Because I am 99% ER/PR receptive my Oncologist feels that number could even be looked at lower. He feels I will benefit highly from the Radiation/Tamoxifen mix. So glad we are not alone in this journey!
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Hi,
I just wanted to add my experience here. I was 43 in 2004 when I was diagnosed Stage l (see details below). My oncologist wanted me to do chemo, but my husband left about a month after the surgery and my daughter was 4. I told him there was no way that I could do chemo and raise her by myself. He put me on goserelin for 3 years, plus 2 more years of tamoxifin. WOW did I have hot flashes!! About 6 months after I finished goserelin I started having random periods again for about 9 months, then I've never had one since.
Just got diagnosed with a local recurrence last month at age 50, 7 1/2 years later. Half the size of the last one (maybe because my ovary, and yes, I only have 1, isn't producing much), but it looks like I'm on anastrazole for a while. Mastectomy in July, with 4 rounds of TC starting in August.
By the way, I am now happily remarried to a wonderful supportive man, and I consider myself very lucky in that regard!
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Wow Shellikind, thats a tough story. You did what you had to do at first diagnosis, I wish you well with your forthcoming surgery and chemox. I assume you did not have the benefit of oncotypeDX or MR in 2004. Local recurrence is not welcome but does not have same significance as distant recurrence so i wish you many more happy and healthy years married to your current lovely supportive partner.
Hugs0 -
Ok, ladies, I just got my oncotype score: 15. Yikes!! I'm not sure how I feel about this! I was really hoping for a 3 or 4 (or 0! Ha!). A 15 means a 10% chance of distant recurrance. Or, as my husband would say: a 90% chance of it NOT recurring!
Not sure what my MOs will say. I meet with one on Friday and another Monday. (Oh, and did I mention I'm 3 weeks post-op from my BMX w/recon, and that I'm undergoing fertility preservation right now? Harvesting my eggs on Saturday! Too much going on!!)
Veraciousreader and Annicemd, and anyone else - I'd love to know your thoughts on my score... Thank you!!0
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