My Opinion of the Biggest Highlights of SABCS

[Becky]

I will write about the presentations that I believe are the most note worthy and I will continue to repost if I run out of room.

TanDem Trial

This study showed that women in a metastatic setting that were Her2+ and hormone positive who got Arimidex and Herceptin had better response and slower time to progression (2 years) versus women given Arimidex alone. The positive about this trial is that this was a first line therapy so women can have a good quality of life for quite some time before chemotherapy is started. The negative about this trial is when the trial concluded the women on the Arimidex only arm were allowed to crossover but the crossover results were not published. Therefore, could Arimidex be started and when the women progress, add Herceptin, and get an even longer time to progression (for quality of life purposes) before chemotherapy is started.

Effects Trial - in metastatic disease

This is a double blind study between Aromosin and Faslodex. Double blind means that a woman who was assigned to the Aromosin arm wouldn't know it and would get an Aromosin pill and a placebo shot (and if on the Faslodex arm she would get a Faslodex shot and an placebo pill) and even their doctors wouldn't know what they were getting. The jist of this trial is that hormone positive women who progressed on Arimidex (a nonsteroidal aromatase inhibitor) were randomized to either Aromosin (a steroidal aromostase inhibitor) or Faslodex (a "super" Tamoxifen - its action is to degrade the estrogen receptor). The results of this arm were identical in time to progression. Both products work in keeping the cancer under control well after failure on Arimidex. This is not what Astra Zeneca (they sponsored this trial and manufacture Arimidex and Faslodex) wanted but proves that one can stay on another oral drug and get results vs having to go to the onc and get shots.

Role of Abraxane vs Taxotere - randomized phase 2 trial - in metastatic disease

This study was done because of previous studies that show that Abraxane (taxol that is solubilized differently into a nanoparticle) works better than plan old Taxol. Taxotere works slightly better than Taxol so does Abraxane work better than taxotere? Women were randomized to the normal clinical dose of Taxotere every 3 weeks or the equivalent normal dose of Abraxane every 3 weeks or a low dose of Abraxane every week. The every week dose of Abraxane worked superiorly better but another trial must be done because this trial didn't have an endpoint (which is usually time to progression).

[Becky]

Abraxane and Avastin - this was a non randomized trial and the nice thing is that patients enrolled could be on their 2nd, 3rd or even 4th line of therapy for metastatic disease. The women randomized to Abraxane with Avastin did 50% better than Abraxane alone. This proves to oncologists that Avastin can work even in heavily pretreated metastatic women and 50% more time to progression got a huge clap.

17AAG trial for Her2+ metastatic disease.

17AAG is a targeted therapy for metastatic Her2+ bc. 17AAG is a heat shock protein 90 inhibitor. It inhibits Her2 to be able to unfold and go through the chemical reactions it needs to in order to be active (basically shutting down Her2 activity). This molecule, tested in only a few women who were Herceptin resistant, had great activity and is a promising new molecule that works in a different way, in a different pathway, that either Herceptin or Tykerb (thus - more combinations of Targeted therapies that could have syngergies with each other)

Tykerb and Taxol in IBC HER2+ metastatic disease

This trial showed that 80% of women had some response (complete, partial or stable) which is astounding in this aggressive form of Her2.

[Becky]

E75 Vaccine trial

This trial only enrolled Her 2+ women who were NOT stage 4. The women could also be node negative. It is truly trying to prevent metastatic disease.
Women were tested for whether they are HLA 2A+ or negative. Apparently being + has something to do with immunity and could imply a worse prognosis of disease. HLA 2A neg women are the only ones who can receive this vaccine because of how the vaccine is made, therefore, when you are tested, if you are +, you automatically get assigned to the control group.

You are vaccinated once a month for 6 months and get a booster 6 months after that. This study showed that the vaccine could reduce recurrence by 50% but that ended up not being statistical right before SABCS because of a late recurrence in one of the women (because of trial number of patients was small). Also, remember, the women with what is deemed the worst prognosis were the control group (and this fact was well noted and SAID by Eric Winer). So... they really need a large Phase 3 as this study showed the dose needed to get an immune response. Secondly, Dr. Hudis also commented on this study personally to me. He said all this study showed is that a temporary immune response can be shown. His fear is if you truly vaccinate against Her2, will it attack the heart (as Herceptin does) and that is not something you can shut off. He would prefer a target that is unique to bc cells only. We'll see.

I will go over my poster notes and poster abstracts and get some more on the board soon (within a week) but wanted to clue all of you in on the highlights because we went there for you

[Bev]

Thanks Becky for the report. What does HLA 2A stand for? Bev

[Karen t]

Thank you Becky. Am looking forward to learning more about Avastin possibilities.

[heblaj01]

Thanks Becky for these early highlights before having taken time for a break from the long sessions & the return trip.

And happy birthday to you!

[Karen W]

Becky,

Thanks a million!!

Karen

[Chelee]

Becky, Thanks so much for taking the time to give us some details of what was talked about. Your so good at explaining things...makes it easy for all of us to understand. I realize how time consuming it can be to translate all this to us. Its so sweet of you to do. Many, many thanks! (I'm sitting on the edge of my seat waiting for more.) http://www.her2support.org/vbulletin/images/smilies/wink.gif

I can hardly wait. http://www.her2support.org/vbulletin/images/smilies/smile.gif

Chelee

[Christine MH-UK]

You do a brilliant job of keeping us all up to date.

I hope you have a very merry Christmas.

[Becky]

I wanted to add another thing that came up about the TanDem trial (Arimidex vs Arimidex + Herceptin). Dr. Hudis made a statement in regard to the great results of this trial and then (correlated) this to the adjuvant Herceptin trials.


His thoughts? - what are the response rates with or without hormonal therapy. Which hormonal therapy - ie : Tamoxifen, AI - which AIs. His view is that some of the benefit % out of the adjuvant trials comes from combining Herceptin with hormonal therapy and the fact that women who are also hormone positive have less aggressive disease (in theory).

Just another thing to discuss on the board.

[Andi]

Thanks, Becky! You do such a great job of explaining things so that us "lay people" can understand. Thanks so much for taking your time to go to San Antonio on our behalf.

[doh2pa]

Hi Becky,


Thanks so much for this quick review. I anxiously await the news out of this conference so it was great to have your "sneak peak".

Donna

[RobinP]

I've read everyone of your informative comments from the SABC. Thanks so much for going for us and making us all more informed. Nice job! Glad you're home now and can relax to enjoy the best birthday and Christmas ever. SMILE.
Yours, RobinP

[StephN]

Thanks for the info on those presentations, Becky.

We FINALLY have our power AND Comcast back after that horrendous storm we had out here in the Misty Woods.

<<17AAG is a targeted therapy for metastatic Her2+ bc. 17AAG is a heat shock protein 90 inhibitor. It inhibits Her2 to be able to unfold and go through the chemical reactions it needs to in order to be active (basically shutting down Her2 activity). This molecule, tested in only a few women who were Herceptin resistant, had great activity and is a promising new molecule that works in a different way, in a different pathway, that either Herceptin or Tykerb (thus - more combinations of Targeted therapies that could have syngergies with each other)>>

I know a woman from Montana on this trial who comes to Seattle to get this drug. She is one of only NINE patients here on it, and has had some positive results as of a couple of weeks ago. The stuff is purple and is a long infusion; it is mixed with something that makes her feel a little tipsy. One can't drive when you get it.

Abraxane/Avastin combo. I have another friend here (a women in her mid-70's) who just got off this for stubborn nodes and a spot on her ribs. It was not easy on her, but for the first time in YEARS her tumor markers are well into the normal range and her PET scan was clean. She is now bouncing back energywise. The only really bad thing is that somehow these drugs shot her blood pressure up and she still needs about 10-12 pills a day to control that. BP was never a problem for her prior to getting these drugs.

Keep the good news coming. Both my friends did not know how things would turn out, but they both are contributing to the GOOD side of the stats with their results.

[Shell]

Becky-

Thanks so much for the updates, and I echo especially our gratefulness in receiving them in "lay terms". I had failed on taxotere/herceptin, and thus we didn't use taxol with the avastin when I recently went off xeloda/tykerb trial. We tried doxil/avastin, which was unsuccessful. I am now on navelbine/herceptin/avastin, and i am hopeful about the herceptin/avastin synergy, and was grateful my onc let me try a second chemo with the avatin...

Thanks again for your notes.

Kind regards,
Shell

[Adriana Mangus]

Becky: Thank you very much for participating at the conference and for providing us with such important information. What does first line means? I will be on Xeloda next month, this will be my secont time (first time was navelbine+herceptin), on chemo since recurrence in 2003. Does this mean that it will be my second line? I will appreciate your response. Also in your opinion how many times does one is supposed to be on chemo before your onc prescribes the latest drug (s) such as Tykerb. I remember my onc. mentioning that I was at the beginning of the rope and he did not believe I should be on any of the new drugs since my cancer even though is a recurrence is stable for now... With deepest gratitude for attending the conference in San Antonio.

[Becky]

If you are on your second chemotherapy it is second line. Your onc is right to try what is available before pulling out all the stops and new drugs. I am sure there is the right combo out there for you.


Happy Holidays

[mamacze]

Dear Becky,
You have found your gift and that is the ability to take complex scientific information and translate it into plain English for the rest of us; THANK YOU for sharing this talent; it is incredibly helpful.
The news on the 17 AAG is incredibly positive, the next thing on my to do list is to google this and see if I can find out about a phase 3 trial.
I think of you often and I was so pleased to see you were in the posse that went to San Antonio.
Stay healthy, and don't work too hard.
Love Kim from CT

[Nguyen]

>TanDem Trial

>....Therefore, could Arimidex be started and when
>the women progress, add Herceptin, and get an even longer time to >progression (for quality of life purposes) before chemotherapy is started.

After disease progression while on Femara (similar to Arimidex), Herceptin was added to give my wife an additional 6-8 months of stable disease.

- Nguyen

01/2005 - current: Herceptin and Femara
07/2004: It returns via several small nodules in the lung
10/2002: NED (via CT and CA27.29)!
10/2001 - 01/2005: Femara, (Fosamax)
12/2000 - 10/2001: Herceptin and Navelbine
12/2000: lung metastatic was diagnosed (a few small nodules)
02/1998 - 12/2000: Daily Tamoxifen
05/1997 - 04/1998: Modified Radical Mastectomy, many many cycles of chemo regiments (CAF,Taxol, Carpoplatin, Thiotepa, Navelbine, Taxotere), including HDC, and radiation
05/1997: First diagnosed with BC stage 3A, ER+, PR+, HER2 +, poorly differetiated, nuclear grade 3.