Need ammunition for TCH - please!

[ExpectAMiracle]

I saw my onc for the 1st time on Monday to discuss treatment plans. She originally wanted to use AC followed by Herceptin but after we discussed things, she said the TCH sounded good because it was less heart toxic and I could start the Herceptin right away. We discussed four rounds of treatment with that combo to start 4/9. After reading this board, I realized that most everyone here on TCH is getting 6 rounds, not 4. So I left a message for my onc. to call me back to discuss this. She called me just now and boy have things changed. I'm not sure what's happened to change her way of thinking, but it's not good!

She said that she meant Taxotere and Cytoxan not Taxotere and Carboplatin. She said further that there was "not a shred" of evidence that Herceptin was helpful for node negative cancer and that it had only been used in clincal trials for metastatic disease! She said that my insurance company, on first pass, was not approving Herceptin for me because I was node negative, Stage 1. I am so upset, devestated and frustrated right now that I don't know what to do. She said she would try to get my insurance to approve the Herceptin if she could, but she just kept saying that there was no evidence that it was effective in node negative cancer. I know that's not right, but I need some hard info to show her. It was hard for me to "argue" with her on the phone because I was so upset about the Herceptin. She also said that she didn't know of anyone that was using Taxotere and Carboplatin together for node negative disease.

If anyone can provide links to any info that is contrary to what she is saying that may help my insurance case, please let me know. Did anyone else have insurance problems with Herceptin? I have been trying to stay so upbeat and positive and now I feel so depressed and sad. Help please!

Hugs to all!

[janet11]

I had NO problems with insurance. You might want to get a second opinion from an onc in a different practice. I believe Herceptin for hormone neg node neg people like us was only approved last year. Can anyone find the study urls?

Will look for more info, Susan.

[Jean]

I had that treatment from Dr. Slamon....

Also, this August herceptin was approved for non-metastatic patients.
I am confused with your onc. if you had node positive you would not
be considered early stage....node negative is early stagers once you
have node (even micro) you are a stage 2...

There are now many of us who have had chemo/hercpetin mine was piror
to August. My insurance had no problem with it. Have your onc. say
you are a high risk...etc. did you have an oncotype DX test done at all.
That can support your high risk dx. Demand the herceptin...have her
contact Dr. Slamon or his group. This is not a new treatment they are
now stating that "ALL" her2 should have herceptin. This is in print.
I will have to go back and find the articles.

Don't get upset - just get armed to battle with your onc. or just change
oncs. if you have to. I had taxatere and Carboplain.

Let us know how you are doing.
Good Luck,
Jean

Here's a start. If I can post the entire article, I’ll finish up in a second post.

Results of Second Planned Interim Analysis of Phase III Study: BCIRG 006
SAN ANTONIO, Dec. 14 /PRNewswire-FirstCall/ -- The Cancer International Research Group (CIRG) and sanofi-aventis today announced the results from the second interim efficacy and safety analysis from the BCIRG 006 Phase III breast cancer study, which confirms, at a 3-year median follow-up, that Herceptin(R) combined with Taxotere(R)-based regimens significantly improved disease-free survival for women with early HER2-positive breast cancer.<o></o>

The BCIRG 006 study randomized patients to receive the control arm AC-T [4 cycles of doxorubicin (A) and cyclophosphamide (C) followed by 4 cycles of Taxotere(R) (T)], or either of two experimental Herceptin(R)-(H) an<o></o>>

Taxotere(R)- based therapies: AC-TH (adds 1 year of Herceptin(R) treatment to the AC-T regimen with Herceptin(R) starting concurrently with Taxotere(R)), or TCH (6 cycles of Taxotere(R) and carboplatin (C) with 1 year of Herceptin(R) starting at the first cycle). Patients were
prospectively stratified according to their nodal status and hormone <o></o>receptor status.<o></o>

The primary endpoint was disease-free survival (DFS). Secondary<o> </o>endpoints included overall survival (OS), safety, including cardiotoxicity, and pathologic and molecular markers. The safety analysis was performed by an Independent Data Monitoring Committee.<o></o>

In terms of a reduction in the risk of death, 41% (p < 0.0041) and 34% (p < 0.017) of patients in the AC-TH and TCH arms, respectively when compared with the non-Herceptin-containing control arm. The relative
reduction in the risk of relapse was 39% (p < 0.001) and 33% (p = 0.0003) for AC-TH and TCH respectively vs. control. This interim analysis showed that 92% and 91% of patients were alive at 4 years in the herceptin/Taxotere-containing arms (AC- TH and TCH) respectively compared to 86% in the AC-T arm. Of note, TCH (combination of Taxotere(R)/carboplatin/Herceptin(R)), the regimen without anthracycline, demonstrated similarly significant improvement in disease free and overall survival as the AC-TH arm. However, the TCH arm yielded a five- fold decrease in significant cardiotoxicity when compared to the
anthracycline/Herceptin(R)-containing arm.<o></o>

These data were presented at the 29th annual San Antonio Breast Cancer Symposium (SABCS) in San Antonio, TX - USA.<o></o>

"This trial demonstrates an optimal therapeutic index for these patients with the use of TCH (which did not include doxorubicin), thus avoiding the significant cardiac damage related to the sequential use of
anthracyclines and Herceptin(R)," said Dennis Slamon, PhD, MD, Co-Chair of the BCIRG 006 study and Director of Clinical and Translational Research at UCLA's Jonsson Comprehensive Cancer Center. "In this interim analysis, 6 cycles of chemotherapy in the TCH regimen provided similar benefit as AC-TH (8 cycles of chemotherapy in total) without increasing cardiotoxicity. In addition, no secondary leukemias have been observed so far in the TCH arm compared to four leukemia events in the anthracycline-containing arms, although further long term hematologic adverse event follow up will continue. These data should help influence daily practice with TCH being considered an option for women with early stage HER2 positive breast cancer, irrespective of nodal status."<o></o>

The cardiac toxicity of the 2 experimental arms significantly favored the TCH regimen. No cardiac deaths were observed in either arm. There were 20 congestive heart failure events in AC-TH versus four in the TCH arm. Moreover, there were 50% fewer asymptomatic declines in cardiac function in the TCH arm as compared to AC-TH. Also, in terms of other toxicities, the TCH arm appeared to be superior to AC-TH with regards to the main toxicities in particular sensory neuropathy (36.1% vs 49.7%), nail changes (28.7% vs 43.6%), and myalgia (38.6% vs 55.5%). However, more grade 3 and 4 thrombocytopenia (5.4% vs 1.2%) and anemia (5.8% vs 3.1%), were observed in the TCH arm compared to the AC-TH arm.<o></o>

About the BCIRG 006 Study The BCIRG 006 study was designed to maximize efficacy while minimizing toxicity in adjuvant Herceptin(R)-based therapies. Between April 2001 and March 2004, the study enrolled 3, 222 women with early stage HER2-positive breast cancer, with positive axillary lymph nodes (LN) as well as those without LN involvement.<o></o>

In this second interim analysis, at a 3-year median follow-up, AC-TH and TCH significantly improved DFS and OS as compared to the control arm. The relative reduction in the risk of relapse was 39% (p < 0.001) and 33% (p = 0.0003) respectively, for AC-TH and TCH vs control. The relative reduction in the risk of death was 41% (p < 0.0041) and 34% (p < 0.017)respectively, for AC-TH and TCH vs control.<o></o>

In addition, the absolute DFS benefit at 4 years is similar for the two Herceptin(R)-containing arms (6% and 5% for AC-TH and TCH, respectively). Notably, the same level of DFS and OS benefit was also obtained for the 29% of node negative patients enrolled in the study.<o></o>

In terms of safety, there was a significant difference in the major toxicity that has been consistently seen with Herceptin(R)-based therapies i.e. cardiac toxicity. Common to all of the Herceptin(R) adjuvant trials was the evaluation of congestive heart failure and cardiac-related deaths. As mentioned above, the cardiac toxicity of the 2 experimental arms significantly favored the TCH regimen. Further, in terms of other toxicities, the TCH regimen appeared to also be superior to the AC-TH arm.<o></o>

[Jean]

Article about herceptin...discusses how Her2 is aggressive and the use
of herceptin. Will continue to look for addtional press articles when
it was approved in August.


http://www.cancer.gov/newscenter/pre...ombination2005

Jean

[Jean]

Here is another....

http://www.cancerbackup.org.uk/Treat...astuzumab#3164

Jean

[Jean]

THIS IS THE ONE I WAS SEARCHING FOR --- YOU WILL NOT BE SHUT DOWN

AFTER YOUR DR. READS THIS...HAVE HER CONSULT WITH DR. PEREZ...

YOUR DR. DOES NOT SOUND LIKE SHE/OR/HE IS UPDATED.....

THIS ARTICLE WILL UPDATE YOUR ONC.
http://www.mayoclinic.com/health/Herceptin/BR00012

Very Best of Luck...and Please us know how you are doing.

Jean

[ExpectAMiracle]

Thanks to everyone for all of this information. I have printed all of the articles for review with my onc. I went to the Genentech website to look for the FDA approval info on Herceptin and it says that the approval was for node positive cancer
:
<TABLE cellSpacing=0 cellPadding=3 width=514 border=0><TBODY><TR vAlign=top bgColor=#eeeeee><TD>November 2006 </TD><TD><TABLE cellSpacing=0 cellPadding=2 width=386 border=0><TBODY><TR vAlign=top><TD width=8></TD><TD width=378>The Food and Drug Administration (FDA) approves Herceptin as part of a treatment regimen containing doxorubicin, cyclophosphamide and paclitaxel, for the adjuvant treatment of patients with HER2-positive, node-positive breast cancer.</TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE>
This is all so confusing. I also found the following at the Genetech site:

The company also submitted in the fourth quarter of 2006 a supplemental Biologics License Application (sBLA) for the use of Herceptin® (Trastuzumab) in node-negative patients with administration once every three weeks, based on the one-year adjuvant HERA (HERceptin Adjuvant) trial conducted internationally by Roche and the Breast International Group (BIG).

Does anyone know if this has been approved yet? I guess not if Genentech doesn't say it at their site? If the FDA approved the use, I think my insurance would have to go along.

So many of the articles say "early stage" breast cancer, but they don't say "node negative". Isn't stage II still considered early stage?

I appreciate all of your help and will share it all with my onc! Keep it coming if there is any more info.

Hugs!

Susan

[Jean]

Susan,

Read the last link I sent to you, If you wish you can call Dr. Perez and
confirm.

The FDA approved the therapy for early stagers in August 2006 Until
recently herceptin was approved only for use in women with metastatic or advanced Her2 positive bc. Carefully designed clinical trials looked into the possiblility that herceptin might benefit women with early stage bc.
Her2-positive breast cancers. It does not say - node positive breast cancer.
It is now known that the cancer can spread via the blood system and
therefore the nodes are not the only outlet.

There has been a recent report released regarding Her2 status associated with recurrence in node - negative bc. presented at SSO
Absence of cancerous cells in sentinel lymph nodes is generally taken as predicting good prognosis, but according to research presented at the 60th annual meeting of the Society of Surgical Oncology (SSO) node-negative patients whose tumours express Her2 protein may be at a higher than expected risk for cancer recurrence.

Julie E. Lang MD surgical oncology fellow, University of Texas MD Anderson
Cancer Center reported on a retrospective analysis of women who underwent primary breast turmor resection and SLN dissection.
Results of Dr. Lang's analysis showed that Her2 positive patients were significantly more likely to have cancer recurrence...have your Dr. check
into Dr. Lang's research and Dr. Perez....your onc. need to update...

Show and tell your onc....and then sing...HI HO HI HO IT'S OFF TO HERCEPTIN I GO....

Hugs,
Jean

Susan,

Immediately below is the second to last paragraph of the article I posted:

In addition, the absolute DFS benefit at 4 years is similar for the two Herceptin(R)-containing arms (6% and 5% for AC-TH and TCH, respectively). Notably, the same level of DFS and OS benefit was also obtained for the 29% of node negative patients enrolled in the study.

I don't believe there were any trials on strictly node negative patients, but the trial referenced here included both. If you check the San Antonia webside, you shoud find even more information there on these studies. <o></o>

Also, here is the website, posted by someone on the board (don't remember the name), which provides a booklet on insurance coverage. This may help.

http://www.pabreastcancer.org/insurance_book.html

Also, I got herceptin because I live in New York, which has aggressive laws concerning what insurance companies cannot deny. You might call the Virgina Insurance Department to see what its laws are.

Also, and very important. You need an oncologist who feels strongly about the use of chemotherapy plus herceptin for HER2 positive patients. You might have to change oncologists if push comes to shove, but I think if you're persistent and provide her with lots of evidence to contradict her stand you'll push through. Good luck.

[janet11]

From what Susan says, it sounds like it's her insurance company that's not approving the Herceptin. Has anyone else had a problem with insurance companies disallowing payment for Herceptin for node neg (and hormone neg) patients?

Ahh.. maybe I do have something to contribute:
Herceptin® Improves Survival in HER2-positive Early Breast Cancer (1/8/2007)
According to updated results from the Herceptin Adjuvant (HERA) study, one year of Herceptin® (trastuzumab) following chemotherapy results in better overall survival than chemotherapy alone in women with HER2-positive early breast cancer. These results were published in the Lancet.

http://www.ufscc.ufl.edu/Patient/can...cernews&cid=18

[sassy]

Susan,

I'm in VA too--what insurance do you have and are you going to a private practice onc in Roanoke?

You may want to seek a second opinion from an onc associated with a teaching or research facility, perhaps UVA. They tend to be more progressive with treatment.
________
Live Sex

[Melinda]

Girls, I have to say this. I just read Susans post ( expectamiracle) about her ONC and the herceptin issue. I am usually not at a loss for words, but the positive outpouring and support that you all offered.......not only in emotional support but in your efforts of due diligence substantiated by links, collaboration with others DRs is INCREDIBLE! I want to thank Grace, Jean, Janet11, and Sassy. United we stand.... I am proud to be a member of tis group of sisters.
Melinda

[Bev]

Hi, I'm 2B node neg in No Va. Insurance company squawked a little before FDA approval of Herceptin. After contacting state insurance board, ole blue consented to treatment before FDA approval. Onc had to write note about medical necessity. We had to write numerous notes and email stating our position.

We don't know your whole story-path. If your cancer is grade 3 or highly IHC+ or Fish + or ER/Pr- , or size wise pushing stage 2, I would want to do Herceptin. Oncotype test could be done at some expense to prove your point.

I do see some sort of a regional thing with who uses TCH, and AC + TH. Stage 1, I might gravitate to TCH. C being carboplatin not cytoxin. I did AC + TH.

Plain wrong about Herceptin only for mets.

Do get a second opinion. I do have a nuclear bomb approach to cancer which many people may not choose to follow. You're at the hardest phase right now. Sort it out and fight for what you want.

By being on board here, I can tell you are going to find the info and get done what needs be.

Good luck, Bev

[Hopeful]

ExpectAMiracle,

Here are links to the Oct. 20, 2005 issue of the New England Journal of Medicine reporting on the results of the HERA (European) trial and the North American Trials. Have your doctor read the eligibility criteria for enrollment in these trials; based on the pathology you posted, you could have been eligibile for any of them:

http://content.nejm.org/cgi/content/full/353/16/1673

http://content.nejm.org/cgi/content/full/353/16/1659

Finally, here is a link to a medscape article that discusses the benefit of Herceptin in node negative patients: http://www.medscape.com/viewarticle/545591_2

My heart breaks for you. Hang in there, and get opinions from more than one doctor. There is no reason for you to be denied this drug that I can see based on current clinical practice. You may have to go through appeals with your insurance company, but don't stop fighting. Best of luck to you.

Hopeful

[ExpectAMiracle]

Thanks again to everyone for all of your wonderful support. I am so lucky to have found this site. I feel like a got a big "group hug" from everyone!

I printed out all of the articles that everyone gave me links to and delivered them this a.m. to my onc. office with a nice note. Fortunately, I had an appointment with my surgeon today because I had a "seroma" in my "lumpy" site and had to have it drained. She is an absolute angel. She asked how things went with the onc. and I told her the whole story. She called my onc. while I was there and told her that she definitely believes that I need Herceptin because while I am stage 1, node negative, I had a grade 3, poorly differentiated tumor and I am < 50 years old. The onc. told the surgeon that she agreed (!) and that she would do everything in her power to get it approved for me. She said she would file an appeal and see how they had gotten it approved for other women in my situation. That made me feel MUCH better. I can go ahead and start the TC (Taxotere and Cytoxan) and then add in Herceptin at whatever point it gets approved. I read some articles on this combo and it sounds fine. No heart toxicity like AC, but with better results.

To answer some questions from posts: I have Empire Blue Cross/Blue Shield (of New York). Does anyone else have that? I am being treated at the Carilion Cancer Center which is THE gold standard in Roanoke and my onc. is in that facility. I believe you would consider them a private practice though. My surgeon assures me that she will help in any way she can and that in the end, my onc. is great and will make things happen.

I am going to take a few deep breaths and relax and see what happens over the next week or two. If they don't get the Herceptin approved, then I will have to start making some other contacts.

Again, you are all so wonderful and I thank you wholeheartedly for the warm outpouring of support during my "meltdown".

Hugs to all!

Susan,

That's really good news. With your oncologist insisting you need the treatment, it will be difficult for your insurance company to refuse, particularly when so many insurance companies are covering women with the same diagnosis. And if they do refuse, just start writing letters with hundreds of attachments proving your point, to both the insurance company and to the Virginia Department of Insurance. I had your insurance, but years ago, so I can't comment. But for sure someone on this board has the same insurance. Good luck!

[Erin]

Here is the link to a very clear, informative study out of the Jonsson Cancer Center at UCLA

http://www.cancer.mednet.ucla.edu/ne...item_id=224168

The first part reads:

Survival Increased in Early Stage Breast Cancer After Herceptin-Chemotherapy

Combining the molecularly targeted therapy Herceptin with chemotherapy in women with early stage breast cancer significantly improves disease-free survival for patients with a specific genetic mutation that results in very aggressive disease, a top UCLA researcher reported Thursday.

Dr. Dennis Slamon, whose laboratory and clinical research lead to the development of Herceptin, reported results of the Phase III study of more than 3,200 women Thursday at the 29th annual San Antonio Breast Cancer Symposium.

I believe this is the study that was reported on at the San Antonia conference.

Best of luck!

[Jean]

Susan,

Glad to hear your update! That is very good news. Continue to fight.

Best of Luck,
Jean