San Antonio Breast Cancer Symposium 2012

pegnie- Here is my take on the tables and charts - early tables just show you the composition of the women in the study and how well they complied with treatment.  Figure 4 shows "events" which in this case are bc recurrences which are counted as the sum of local recurrence + contralateral bc + distal recurrence by group (for example women who started out node negative or node positive).  For each group they they compare the number of events seen after  10 years of tamoxifen vs 5 years of tamoxifen.  (I am not looking at the paper right now but I think they look at the "events" that happen by around 15 years out.) They compare what they see with 10 years of tamoxifen treatment vs 5 years of tamoxifen treatment and give an "event rate ratio" by dividing the numbers or percentages at 10 years of tamoxifen to the numbers or percentages at 5 years.  To the right of the event rate ratio is the standard error (just how much variation there is in the data) or a p value.  The p value tells you how statistically significant the event rate ratio is.  The p values should be 0.05 or smaller for good statistical significance.   In other tables further down the "events" they are looking at things like endometrial cancer or stroke in the 10 year tamoxifen vs 5 year tamoxifen groups.  To me the "event rate ratios" and the p values are the important information for the groups being compared.  Not sure if I have done a good job of explaining this and this is just my take on things....

Bessie- I have access to a subscription to the journal.  It also looks like you can pay online  to get access to the full text of the article.  Anyone can go to a medical library (at hospitals or at a university or for those of us in Maryland - the Library of Medicine) and just read the full text of articles when they come out in print.

Drug Combo Extends Breast Cancer Patients' Survival.

Reuters (12/9, Koltrowitz, Copley) reported that Roche announced that a combination of its Perjeta (pertuzumab), Herceptin (trastuzumab) and docetaxel chemotherapy significantly extended the lives of women with previously untreated HER2-positive metastatic breast cancer. The Basel, Switzerland-based pharmaceutical company also presented the updated Phase III clinical trial data on Saturday at the San Antonio Breast Cancer Symposium. Overall, Roche said the Perjeta combination reduced the risk of death by 34 percent compared to the treatment arm that received Herceptin, chemotherapy and a placebo.

Breast Cancer Drug Shows No Advantage Over Capecitabine During Trial.

Bloomberg News (12/8, Matsuyama) reported Tokyo-based Eisai Co.'s breast cancer treatment, Halaven (eribulin), "failed to show an advantage" over Roche's Xeloda (capecitabine) in women with locally advanced or metastatic breast cancer, according to Phase III trial data presented Friday at the San Antonio Breast Cancer Symposium. Peter Kaufman from the "Dartmouth-Hitchcock Norris Cotton Cancer Center in Lebanon, New Hampshire," explained that the women in 1,102-patient trial who were administered Halaven "after at least two prior chemotherapy regimens" of anthracyclines and taxanes "lived a median 15.9 months, compared with 14.5 months for those given the Roche treatment," results that were not "statistically significant."

Trastuzumab May Provide Survival Advantage In HER2-Positive Breast Cancer.

Medscape (12/8, Osterweil) reported, "A decade of data continue to demonstrate that adding trastuzumab ( Herceptin, Genentech) to standard chemotherapy in women with HER2-positive breast cancer improves both overall and disease-free survival." Findings "from the final planned joint analysis of overall survival from the NSABP B-31 and NCCTG N9831 trials" were presented "at the 35th Annual San Antonio Breast Cancer Symposium." Investigators found that, "at a median follow-up of 8.4 years, women randomly assigned to receive doxorubicin and cyclophosphamide (AC) followed by paclitaxel plus trastuzumab had a 37% lower relative risk for death than women who received AC alone." HealthDay (12/8, Dallas) also covered the story.

http://www.medpagetoday.com/MeetingCoverage/SABCS/36328?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&xid=NL_DHE_2012-12-08&eun=g376694d0r&userid=376694&email=jlong@i-review.com&mu_id=5369993

Small Leukemia Risk in Breast Cancer Chemo

As the daughter, wife, and best friend of librarians, I can say that libraries and librarians are some of the most under-utilized resources.  Definitely collateral damage of the internet age, my students don't even realize our online library portal offers databases FREE that cost the school $500,000+ in subscriptions.  So yes, check out the databases, they often have downloadable pdfs free.

That said, I need these boards to help me wade through the studies.  VR is a big influence, Beesie, too and a host of others.  I haven't been at this too long, and I don't always know how to read through the bottom line (like wrapping my head around disease and overall-survival--now I got it).

Thankyou so much for all of this info ladies.

Does anyone know if there is any information yet available on the session : Metformin/Statins used in treating breast cancer.

Er, ok, mods, but I must disagree with BCOs conclusion that

These results are extremely promising and likely to change the hormonal therapy standard of care for women diagnosed with early-stage, estrogen-receptor-positive breast cancer.

I think it is premature to refer to this as the new z'standard of care" for various reasons:

The study may have limited effect on actual medical practice. Compliance levels for Tamoxifen use, already at about 50 percent over the five year period, are likely to go further down if measured over twice that period. 

Another reason why this study may have little practical effect on care standards is because most women get BC either after menopause or close to menopause. As long as chemotherapy continues to be used as widely as it is for breast cancer, many women will also continue to enter into chemopause. Thus, it is likely that oncs will continue to do as they are currently doing: recommend 5 years of TAM, then 5 years of an AI. This study does nothing to change recommendations for AIs.

Finally, amny women may not be swayed by such a statistically modest benefit ratio as that derived in the study - and your commentary needs to honestly characterize the ratio for what it is.

LtotheK: oncotype would not fit because it is not intended to predict risk of recurrence by receptor status. So a person could be advised to forgo chemo based on oncotype results but still be put on Tamoxifen. Sadly, too little is known about TAM for doctors to tell individual women whether they are likely to benefit or not.

Cancer research really has to start approaching the 21st century, It is so yesterday to continue to publish these large clinical trials that take no account of QOL and are intended to showcase the success not of a human life but of a drug.

Modern medicine in many branches, both in the US and the rest of the world, is increasingly measuring clinical success by patient-centered measures such as QOL, adherence and the quality of clinical care. Catch up cancer - there's a reason why we aren't finding cures!

Thank you for helping this addled brain, Athena and VR.

I guess what I'm unclear on is whether the Oncotype score could be used to decide if additional therapy is a benefit.  Without Tamox, I have a 16% recurrence probability according to Oncotype.  With it, I have an 8% chance.  It would seem to me additional Tamox therapy would whittle away at that 8%, but I could have this completely wrong.  If there's a shred of reality in what I'm thinking, the QOL issues vs. overall benefit are really important. 

I am particularly unclear, are these absolute or relative risk numbers?

Finally, they are talking about pre-meno women, because that might be a "no brainer".  But plenty of women can't tolerate AIs and do Tamox.  What are the results for them?

tried to cut and paste a link to the article but it did not work......

Ltothek - Earlier on, you pointed to something that IMO needs more study - whether women could derive the same benefit from Tamoxifen if they took it on an on and off basis. It would be great if they could conduct in-depth studies of how Tamoxifen is metabolized and how long its metabolites or therapeutic effects can remain in the body. It is possible, for example, that women who keep Tamoxifen's benefits longer may benefit from shorter duration therapy and/or lower doses whereas other women would need to take it continuously.

I couldn't agree with you more. I got the slash, refused the burn and only took half of the poision (TAM, refusing chemo).

Many billions thrown at cancer research but, IMO too much promoting drugs intended to provide an answer to those seeking treatment. I am not a Big Pharma conspiracy theorist (although some of the claims are true) - rather, I blame the fear of cancer for the lack of progress. Too many patients and doctors are so insistent on trying this or that treatment that they overlook instances in which less might be more. Clinical studies, in turn, fuel that way of looking at things by merely staging this one-to-one race of drug A versus placebo or drug A versus Drug B. Such studies may tell us which of two contestants in such a race wins; they do NOT tell us what the best cancer treatment is. An analogy to this is, for example, testing whether plastic bag one or plastic bag 2 is more sturdy for carrying groceries, all the time neglecting to think that maybe a linen or cotton bag may be better than any plastic.

We're still comparing plastic to plastic in cancer.

There are so very many things wrong with the way cancer research is going, IMO. And I don't think it's because there are bad people or a conspiracy. The biggest obstacle may simply be fear of the unknown. One might have to step away from the comfort of a plastics factory into scary cotton fields to find that linen solution - that might entail billions of dollars, enormous career risks and a huge probability of failure.

Apologies for crappy mixed metaphor.

Has anyone GOOGLED 'Long term Tamoxifen use'?  There are several articles mentioning negative risks which are not mentioned in these recent press releases promoting 10 year use. The articles are not very old - - -2010. So I wonder why all the contradictions???