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

[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

[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