Quick question
 

Does anyone have a link or some info showing ten years on Arimidex is beneficial?? I agreed with my Onc to continue for that time but my friends say they find no evidence in continuing??

Re: Quick question
 

Tricia,
I don't have a link, but I do remember hearing that on the news. They quoted a study, but I don't remember who did it.

My late husband was a pharamacist and he always felt it should be given for ten. I know I wish it would benefit me but I am neg to both estrogen and progesteron.

Sandra

Re: Quick question
 

google showed an ATAC study of 10 years. I couldn't get access but I think one of us her2ers knows how to access.

where's Jackie? she can find anything!

Re: Quick question
 

Results were reported at last year's SABCS on the benefits of 10 years of Tamoxifen. Some have extrapolated from those data. Would like to see studies done on AIs (rather than just extrapolation) but I am not sure they exist as of yet.

Re: Quick question
 

'lizbeth,

Thanks for mentioning me. And thanks to Tricia for asking the question. According to the abstract below, it seems to me only Tamoxifen and Exemestane are recommended for five years:

http://www.ncbi.nlm.nih.gov/pubmed/23835710

Use of Pharmacologic Interventions for Breast Cancer Risk Reduction: American Society of Clinical Oncology Clinical Practice Guideline. Clinical Oncology July 15

Purpose: To update the 2009 American Society of Clinical Oncology guideline on pharmacologic interventions for breast cancer (BC) risk reduction. METHODSA systematic review of randomized controlled trials and meta-analyses published from June 2007 through June 2012 was completed using MEDLINE and Cochrane Collaboration Library. Primary outcome of interest was BC incidence (invasive and noninvasive). Secondary outcomes included BC mortality, adverse events, and net health benefits. Guideline recommendations were revised based on an Update Committee's review of the literature.

Result: tamoxifen, raloxifene, arzoxifene, lasofoxifene, exemestane, and anastrozole. Recommendations: In women at increased risk of BC age ≥ 35 years, tamoxifen (20 mg per day for 5 years) should be discussed as an option to reduce the risk of estrogen receptor (ER) -positive BC. In postmenopausal women, raloxifene (60 mg per day for 5 years) and exemestane (25 mg per day for 5 years) should also be discussed as options for BC risk reduction. Those at increased BC risk are defined as individuals with a 5-year projected absolute risk of BC ≥ 1.66% (based on the National Cancer Institute BC Risk Assessment Tool or an equivalent measure) or women diagnosed with lobular carcinoma in situ. Use of other selective ER modulators or other aromatase inhibitors to lower BC risk is not recommended outside of a clinical trial. Health care providers are encouraged to discuss the option of chemoprevention among women at increased BC risk. The discussion should include the specific risks and benefits associated with each chemopreventive agent.

Re: Quick question
 

Here's an abstract for young women:

J Thorac Dis. 2013 Jun;5(Suppl 1):S36-46. doi: 10.3978/j.issn.2072-1439.2013.05.25.
Hormonal therapies in young breast cancer patients: when, what and for how long?
Christinat A, Di Lascio S, Pagani O.
Source
Institute of Oncology of Southern Switzerland (IOSI) and Breast Unit of Southern Switzerland (CSSI), Bellinzona, Switzerland.
Abstract
Breast cancer in young women (<40 years) is a rare and complex clinical and psychosocial condition, which deserves multidisciplinary and personalized approaches. In young women with hormone-receptor positive disease, 5 years of adjuvant tamoxifen, with or without ovarian suppression/ablation, is considered the standard endocrine therapy. The definitive role of adjuvant aromatase inhibitors has still to be elucidated: the upcoming results of the Tamoxifen and EXemestane Trial (TEXT) and Suppression of Ovarian Function Trial (SOFT) trials will help understanding if we can widen our current endocrine therapeutic options. The optimal duration of adjuvant endocrine therapy in young women also remains an unresolved issue. The recently reported results of the ATLAS and aTToM trials represent the first evidence of a beneficial effect of extended endocrine therapy in premenopausal women and provide an important opportunity in high-risk young patients. In the metastatic setting, endocrine therapy should be the preferred choice for endocrine responsive disease, unless there is evidence of endocrine resistance or need for rapid disease and/or symptom control. Tamoxifen in combination with ovarian suppression/ablation remains the 1st-line endocrine therapy of choice. Aromatase inhibitors in combination with ovarian suppression/ablation can be considered after progression on tamoxifen and ovarian suppression/ablation. Fulvestrant has not yet been studied in pre-menopausal women. Specific age-related treatment side effects (i.e., menopausal symptoms, change in body image and weight gain, cognitive function impairment, fertility damage/preservation, long-term organ dysfunction, sexuality) and the social impact of diagnosis and treatment (i.e., job discrimination, family management) should be carefully addressed when planning long-lasting endocrine therapies in young women with hormone-receptor positive early and advanced breast cancer.

Re: Quick question
 

Here is a link to a thread in the Articles Forum that I posted last year: http://her2support.org/vbulletin/sho...eferrerid=1173

Hopeful

Re: Quick question
 

The study is ongoing. I have a friend in it and she is 8 years in on the Arimidex arm.

Re: Quick question
 

Anastrozole Reduces Recurrence in Early Breast Cancer: 10-Year Results of the ATAC Trial

Summary

Anastrozole (Arimidex®) is better than tamoxifen (Nolvadex®) at preventing a recurrence of breast cancer in postmenopausal women with early-stage hormone receptor-positive tumors, according to 10-year follow-up results from ATAC, a large international clinical trial. However, it does not improve overall survival compared with tamoxifen.
Source

The Lancet Oncology, November 17, 2010 (see the journal abstract).
Background

Postmenopausal women who have been treated for early breast cancer and whose tumors are hormone receptor positive (that is, their tumors grow in response to the hormone estrogen) have been advised to take 5 years of adjuvant treatment with hormone therapy. For years the standard option was the antiestrogen drug tamoxifen. Tamoxifen treatment had been shown to help prevent a relapse and was considered the standard of care for this group of patients.
However, tamoxifen increases the risk of endometrial cancer and blood clotting disorders. It has been suggested that drugs called aromatase inhibitors (AIs), which are a different type of antiestrogen, might be a better alternative.
Like tamoxifen, AIs interfere with cancer cells’ use of hormones. But whereas tamoxifen interferes directly with the cancer cells’ ability to use estrogen to fuel growth, AIs block the action of an enzyme called aromatase, which helps the body to produce estrogen. Another difference is that tamoxifen can be used by both premenopausal and postmenopausal women, whereas AIs block estrogen production only in postmenopausal women.
The Study

The Arimidex, Tamoxifen Alone or in Combination (ATAC) study was a double-blinded phase III clinical trial that was designed to compare the ability of the AI anastrozole, tamoxifen, and the two drugs in combination to prevent breast cancer recurrence in postmenopausal women with hormone receptor-positive tumors.
The study enrolled 9,366 postmenopausal women with localized breast cancer (that is, cancer that hadn’t spread, or metastasized). The women were randomly assigned to receive 5 years of adjuvant treatment with anastrozole alone, tamoxifen alone, or a combination of the two. (The combination treatment group was subsequently discontinued because outcomes for patients in this group were essentially the same as those in the group receiving tamoxifen alone.) Most of the participants (84 percent) had hormone receptor-positive disease.
Results after a median follow-up of 68 months (5.7 years), published in 2005 (see the journal abstract), showed that, compared with tamoxifen, anastrozole prolonged disease-free survival by 13 percent, increased time to relapse by 21 percent, reduced the occurrence of cancer spreading to other organs (distant metastases) by 14 percent, and reduced the occurrence of cancer in the other breast by more than 40 percent. The differences were even greater when the analysis was restricted to women with hormone receptor-positive cancer.
In addition, anastrozole was associated with fewer serious side effects (endometrial cancer, blood clots, vaginal bleeding, and hot flashes) than tamoxifen, although bone fractures and joint pain were more common among patients in the anastrozole group. However, overall survival was similar in the two groups.
In 2006, researchers with the ATAC trial reported data showing that anastrozole was better tolerated than tamoxifen and resulted in fewer serious complications (see the journal abstract). Furthermore, anastrozole had a more favorable overall risk–benefit profile than tamoxifen, and women taking anastrozole had a lower recurrence rate than those taking tamoxifen.
Mainly on the basis of the results published in 2005, treatment with an AI became the standard adjuvant therapy for hormone receptor-positive breast cancer, although tamoxifen is still considered a reasonable alternative. Other trials, involving a total of more than 30,000 women, confirmed that treatment with an AI alone or after tamoxifen was beneficial for patients with hormone-sensitive breast cancer.
The current study reports findings after participants in ATAC had been followed for median of 10 years.
Results

This analysis continued to show a benefit of anastrozole compared with tamoxifen. Among women with hormone receptor-positive tumors, those randomly assigned to receive treatment with anastrozole had a 4.3 percent lower absolute rate of breast cancer recurrence after 10 years, and a 2.6 percent lower absolute rate of distant metastasis, than those randomly assigned to receive treatment with tamoxifen.
The differences between anastrozole and tamoxifen in time to relapse, cancer in the other breast, and disease-free survival were greatest in the first two years of treatment but were maintained throughout the follow-up period, including the period after treatment was completed. However, the authors found that this so-called “carryover effect” – in which benefits extend beyond the treatment period – began to wane after about 8 years.
During treatment, women in the anastrozole group had fewer serious adverse events related to treatment than women in the tamoxifen group. After treatment was completed, however, rates of serious adverse events evened out between the two groups. Patients taking anastrozole reported more fractures during treatment than those taking tamoxifen, but after the completion of treatment fracture rates again became similar in both groups.
Patients taking tamoxifen had higher rates of endometrial cancer and melanoma than those taking anastrozole. There was a slight trend toward more colorectal and lung cancers in patients taking anastrozole compared with those taking tamoxifen. Overall, however, cancers other than breast cancer occurred at similar rates in both groups.
The number of patient deaths, with or without breast cancer recurrence, was similar in the two groups after 10 years of follow-up. Thus, treatment with anastrozole did not improve overall survival compared with tamoxifen.
Comments

In an accompanying editorial, Michael Gnant, M.D., of the Medical University of Vienna in Austria, wrote that he is encouraged by the finding that “the benefit of 5 years’ treatment with anastrozole persists and even seems to increase over time. This so-called carryover effect gives reason for hope because it essentially means that we can intervene early in the course of the disease and affect the rate of recurrence and overall survival.”
It is reassuring, Dr. Gnant added, that “the clinically most important side-effect of aromatase inhibition – an increase in fractures because of reduced serum [estrogen] concentrations – subsides soon after intake of the active drug is stopped.”
Jo Anne Zujewski, M.D., of the National Cancer Institute’s Cancer Therapy Evaluation Program, said: “The 10-year results from ATAC provide strong evidence that anastrozole is both safe and effective in the treatment of postmenopausal women with early-stage breast cancer.”
Dr. Zujewski added, however, that “whether an individual patient should start therapy with an AI or begin therapy with tamoxifen and then change to an AI remains a subject of medical judgment and clinical research. Patients should talk with their doctors about which drug would be best for them given their particular medical condition.”
In August 2010, an ASCO expert committee released an updated Clinical Practice Guideline that recommends that postmenopausal women with hormone receptor-positive breast cancer consider using an AI during adjuvant treatment, either initially or after a course of adjuvant tamoxifen. The committee noted, however, that patients and their physicians should carefully consider side effect profiles when deciding on whether and when to use AI therapy.


http://www.cancer.gov/clinicaltrials.../2004/atac1204

Re: Quick question
 

This is just the results of the trial of Arimidex versus Tamoxifen after 10 years and how the stats hold up. Women on this trial were given 5 years of tamoxifen or 5 years of Arimidex and the AI was better. And the AI was better at these women's ten year mark. But nobody was on an AI ten years. That trial, using all three AIs (Arimidex, Femara and Aromosin) is still ongoing. There are no results yet because the ten year mark isn't here yet.

Re: Quick question
 

Thank you so much everyone and sorry I didn't reply sooner but I've had computer problems for a couple of weeks and just had it repaired.

Thanks Jackie for the links and Becky for the info, I had suspected as much but wasn't sure but will be taking Arimidex for a further three years up to ten.

Thanks also Sandra and I hope it won't be too long before they find something to help hormone negs like yourself too!

Re: Quick question
 

This is what the National Cancer Institute at the NIH is reporting. They do make it sound like the trial is finishing. But this isn't the first time I've heard of NIH doing some premature reporting. I remember reading about Peptide T and that it actually reduced viral loads in AIDs patients, but NIH didn't wait for those results and published a report that squelched the funding.

In the body of the article it does mention that the follow up data was just a little over 5 years, so perhaps they think we recognize it is an interim report.

Becky, since your are familiar with the trial, I hope you will let us know when the final data is available.

Thanks!

Re: Quick question
 

http://her2support.org/vbulletin/sho...145#post297145


ATAC trial: reporting interim results is not helpful

Heather Goodare, chairBreast UK (Breast-cancer Research Ethics and Advocacy Strategy), Horsham, West Sussex RH13 6DF ; Email: hm.goodare@virgin.net




Clare Dimmer, secretaryBreast UK Waterlooville, Hants PO7 6LA ; Email: clare@solvatec.demon.uk




Kathy Page, treasurer

Author information ► Copyright and License information ►

This article has been cited by other articles in PMC.


Editor—We should like to raise some concerns about the ATAC (arimidex, tamoxifen alone or in combination) trial, which was reported on in the Lancet after only half the time stipulated in the protocol (2.5 years instead of 5).1 Ravdin has raised important points: “Early reporting rules can powerfully affect what information can be gleaned from a trial, particularly if they cause a trial to be reported when many of the patients have not completed therapy.”2 In spite of this, the “results” of the trial were reported in the United Kingdom's national lay press.3
However, is arimidex really the best bet? Of course we still don't know as some of the more serious adverse events may not emerge until the five year mark is reached. The problems in patients with endometrial cancer who were taking tamoxifen took many years to become obvious. Why publish results at the halfway mark only? Does this not indicate a lack of respect for the participants?4
Early reporting of the trial was certainly good for AstraZeneca, after losing patent protection for tamoxifen. But was it good for patients? Was it good for science? Publication of interim results can seriously mislead, as in the case of the infamous study of women attending the Bristol Cancer Help Centre.5 As Ravdin says: “It remains to be seen how many of the patients on the two remaining blinded arms will continue to take the therapy that they were randomised to.”

Go to:
References

1. ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists' Group. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet 2002;359: 2131-9. [PubMed]
2. Ravdin P. Aromatase inhibitors for the endocrine adjuvant treatment of breast cancer [commentary]. Lancet 2002;359: 2126. [PubMed]
3. Derbyshire D. New drug prevents breast cancer. Telegraph 2002. June 21.
4. MP. Case study: I was an ATAC guinea pig. What Doctors Don't Tell You 2003;13: 8.
5. Bagenal FS, Easton DF, Harris E, Chilvers CED, McElwain TJ. Survival of patients with breast cancer attending Bristol Cancer Help Centre. Lancet 1990;336: 606-10. [PubMed]

Re: Quick question
 

Thanks 'Lizbeth and I recall reading this after the five year study was up I think, I've been taking it for seven years now and have agreed to another three so it'll be interesting when the final study results are released in two years approx.

Re: Quick question
 

When I finished my five years of femara in January, 2010 (after 4.5 of tamoxifen), my onc asked if I wanted to stay on femara longer. I asked if there were any studies showing benefits of staying on AI's more than 5 years and she said that study was still in progress

That syncs with Becky's input re: 8 years. Of course, I get to go back on AI's for who knows how long again :-(

Re: Quick question - ASCO updates Guidelines on drugs
 

Just received this new update from CancerConnect:

ASCO Updates Guidelines on Interventions for Women at Increased Risk of Breast Cancer

The American Society of Clinical Oncology (ASCO) has released updated guidelines for pharmacologic interventions among women at an increased risk of breast cancer.

This third update of the guidelines, published in the Journal of Clinical Oncology, includes the addition of Aromasin® (exemestane) for the prevention of breast cancer in postmenopausal women at risk for estrogen receptor (ER)-positive disease. Women with a strong family history of breast cancer and women who carry the BRCA1 and BRCA2 genes are at an increased risk of developing breast cancer and may opt to take more aggressive preventive measures, including the use of “chemoprevention”, or drugs that block the effects of estrogen—because estrogen causes some cancers to grow.

There are two types of drugs used to block estrogen. Selective estrogen receptor modulators (SERMs) are drugs that block estrogen receptors within the breast cells, thereby reducing estrogen-stimulated growth. Tamoxifen and Evista® (raloxifene) are examples of SERMs. Aromatase inhibitors suppress the production of estrogen in postmenopausal women. Aromasin is an aromatase inhibitor. Each of these drugs has been shown to reduce the risk of breast cancer in women at high risk of the disease.

The updated recommendation guidelines from ASCO are as follows: For premenopausal women: The use of tamoxifen (20 mg per day orally for 5 years) should be discussed as an option to reduce the risk of invasive, estrogen receptor (ER)-positive breast cancer For postmenopausal women, there are now three options. ASCO strongly recommends that one of the following be considered in order to reduce the risk of invasive, estrogen receptor (ER)-positive breast cancer: Tamoxifen (20 mg per day orally for 5 years) Evista (60 mg per day orally for 5 years) Aromasin (25 mg per day orally for 5 years). (Note: This is a new recommendation, which was based on data from a clinical trial that showed up to a 70 percent reduction in overall and ER-positive invasive breast cancer incidence compared to placebo.)

What’s more, the recommendations state that all three agents should be discussed with women aged 35 or older without a personal history of breast cancer who are at increased risk of developing invasive breast cancer, based on risk factors such as age, race, and medical and reproductive history. Not all women will benefit from the use of these preventive agents. It is important that doctors and women discuss the risks and benefits of each drug in order to determine the best approach.

That said, only a small percentage of eligible women have this discussion with their doctors or even consider these medications. As such, the guidelines also stress the need for ongoing research to determine approaches to increase the use of these drugs in women who will benefit from them.

Reference: Visvanathan K, Hurley P, Bantug E, et al. Use of pharmacologic interventions for breast cancer risk reduction: American Society of Clinical Oncology Clinical Practice Guideline. Journal of Clinical Oncology. Published early online July 8, 2013. doi: 10.1200/JCO.2013.49.3122

Re: Quick question
 

Wow. There seems to be quite a shift in how the medical industry is treating cancer, especially in the last week.

It feels really exciting to me that women can actively have more tools to prevent cancer.

Progress!!!! Yeah!

Wouldn't it be amazing if someday we could all just have a vaccine shot once a year to prevent cancer based on our genetics and risk factors?

Re: Quick question
 

Thank you for the latest info Jackie!

Re: Quick question
 

Saw my onc on Friday for a normal follow up and he said that they are starting a new trial where they will use some women in the current AI study of is 10 years better than 5 years and these 10 year women (at least some of them) will continue to 15 years and see if 15 years is better than 10.

Re: Quick question
 

Thanks Becky, I'm guessing we'll be taking this for life!!!